Codman Neuro Announces Acquisition Of Neuravi Limited To Accelerate Innovation In Acute Ischemic Stroke Therapy

Second Acquisition in Months Demonstrates Commitment to Addressing Unmet Needs in Stroke

 

IRVINE, Calif. -- Codman Neuro today announced the acquisition of Neuravi Limited, a privately held Irish company dedicated to advancing neurovascular therapies and improving clinical outcomes for acute ischemic stroke patients. This acquisition, and the recent acquisition of Pulsar Vascular Inc., demonstrates the company's strong commitment to delivering innovative products for stroke therapy and complements its comprehensive portfolio of products for hemorrhagic and ischemic stroke. DePuy Ireland Unlimited Company, an affiliate of Codman Neuro, is the acquiring entity. Financial terms of the transaction were not disclosed.

Founded in 2009, Neuravi has invested extensively in scientific research on the varieties of clots that cause acute ischemic stroke, and has translated learnings into its EmboTrap® Revascularization Platform. The EmboTrap® device is engineered to restore blood flow to the brain by retrieving a clot with its proprietary dual-layer stent-like structure, and it has already been used to treat over 3,000 patients in Europe.

Globally, stroke is the second leading cause of death after the age of 601, and ischemic strokes, caused by blockages in vessels supplying blood to the brain, account for 87% of all strokes.2 According to the European Journal of Neurology, the number of stroke events in Europe is projected to rise from 1.1 million in 2000 to 1.5 million per year by 20253, while the American Heart Foundation estimates someone dies of a stroke every 4 minutes.4 In the U.S. alone, the economic burden of stroke is estimated at $33 billion annually, including the cost of health care services, medications, and lost productivity.5

"Rapid restoration of flow is of utmost importance when treating stroke patients," said Shlomi Nachman, Company Group Chairman of Johnson & Johnson Medical Devices Cardiovascular & Specialty Solutions. "The EmboTrap® platform was designed to address this critical need and we are excited to combine Neuravi's expertise in clot research with Codman Neuro's global resources to accelerate innovation in acute ischemic stroke treatment."

The EmboTrap and EmboTrap II Revascularization Devices are commercially available in Europe and has been available in the U.S. for investigational use only under the ARISE II clinical trial, which will support a U.S. Food and Drug Administration (FDA) submission planned for later this year.

 

About Codman Neuro
 

Codman Neuro is a global neurosurgery and neurovascular business that offers a broad portfolio of devices for hydrocephalus management, neuro intensive care and cranial surgery, as well as aneurysm coils, vascular reconstruction devices and other technologies used in the endovascular treatment of cerebral aneurysms and stroke. Visit www.codman.com for more information.

 

Cautions Concerning Forward-Looking Statements

This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding the acquisition of Neuravi Limited and anticipated market expansion of Neuravi Limited's technology and products. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of DePuy Ireland Unlimited Company and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges related to integrating the products and employees of Neuravi Limited, as well as the ability to ensure continued performance or market growth of its products; the potential that the expected benefits and opportunities related to the transaction may not be realized or may take longer to realize than expected; challenges and uncertainties inherent in product research and development, including the uncertainty of obtaining regulatory approvals; challenges to patents; competition, including technological advances, new products and patents attained by competitors; changes to applicable laws and regulations, including global health care reforms; changes in behavior and spending patterns or financial distress of purchasers of health care products and services; product efficacy or safety concerns resulting in product recalls or regulatory action; manufacturing difficulties and delays; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 1, 2017, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither DePuy Ireland Unlimited Company nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

1 World Heart Federation http://www.world-heart-federation.org/cardiovascular-health/stroke/
2 Stroke Facts, Centers For Disease Control and Infection https://www.cdc.gov/stroke/facts.htm
3 Truelsen T, Piechowski-Jozwiak B, Bonita R et al. Stroke incidence and prevalence in Europe: a review of available data. European Journal of Neurology, 2006, 13: 581–598
4 Heart Disease and Stroke Statistics—2017 Update: A Report From the American Heart Association http://circ.ahajournals.org/content/135/10/e146#sec-2
5 Centers for Disease Control https://www.cdc.gov/dhdsp/data_statistics/fact_sheets/docs/fs_stroke.pdf

Gurnet Point L.P. enters into agreement to acquire Innocoll Holdings plc

Transaction Unanimously Supported by Innocoll Board and Key Shareholders

 

CAMBRIDGE, Mass. & ATHLONE, Ireland--(BUSINESS WIRE)--Gurnet Point L.P., a healthcare investment fund, and Innocoll Holdings plc (NASDAQ:INNL), a global pharmaceutical and medical device company, today announced that they have reached an agreement on the terms of a recommended offer. Under the recommended offer, Gurnet Point will acquire Innocoll for $1.75 per share in cash, and up to $4.90 in cash from a contingent value right (CVR), for a total potential per share value of up to $6.65 or up to approximately $209 million in aggregate. The initial cash consideration of $1.75 represents a premium of approximately 120 percent to the closing price per Innocoll Share on March 10, 2017, the last dealing day prior to the date on which the anomalous movement in Innocoll’s shares commenced (and a premium of approximately 28 percent to the closing price per Innocoll Share on March 15, 2017, the day prior to Innocoll initiating the commencement of the offer period).

During the offer period, Gurnet Point plans to provide a term loan of $10 million to give Innocoll additional resources needed for the continued development of XARACOLL within the post-operative pain market. Innocoll believes that the loan will provide it with the additional capital needed to prepare for the re-submission of the XARACOLL new drug application (“NDA”) to the U.S. Federal Drug Administration (“FDA”) in order to achieve the milestones related to the CVR.

This transaction builds on Gurnet Point’s strategy of investing in life science, medical technology and healthcare service companies. Since its initial NASDAQ public offering in 2014, Innocoll has leveraged its proprietary collagen-based technology to successfully complete two Phase 3 studies for XARACOLL, Innocoll’s late-stage surgically implantable and bioresorbable collagen matrix. XARACOLL was developed to provide sustained post-operative pain relief through controlled delivery of bupivacaine at the surgical site.

Innocoll noted that its Board had explored a sale of the company, to achieve its goal of bringing XARACOLL to market, as well as keeping the company independent and funding the over $100 million required to fund operations through 2019 from raising equity or debt. The “go-it-alone” option was dismissed due to the potential for significant shareholder dilution and execution risk. A potential license for XARACOLL in the United States was also investigated, but no suitable partner has been found.

“Having studied a number of strategic options over the past several months, our Board and management team believe this strategic transaction will give Innocoll access to the financial resources it needs to pursue its goals of bringing XARACOLL through its development to commercialization, and address important unmet medical needs in the post-operative pain market. We believe that the combined leadership of the two companies, supported by Gurnet Point’s financial strength, will better position Innocoll to pursue a successful filing and subsequent commercialization of XARACOLL,” said Jonathan Symonds, Chairperson of Innocoll. “The Innocoll directors unanimously support the offer, which represents a significant premium to the recent share price. In addition, the CVR allows shareholders to participate in the continued development of XARACOLL without further investment."

The directors of Innocoll and major shareholders, including holdings managed by Fortress, Morgan Stanley, Sofinnova and Unique Technologies, have provided irrevocable undertakings to vote in favor of the scheme. In total, management, directors and shareholders have provided irrevocable undertakings representing 46% of the issued ordinary share capital of Innocoll. Details of these irrevocable undertakings, including the circumstances in which they cease to be binding, are set out in the announcement pursuant to Rule 2.5 of the Irish Takeover Rules made by Gurnet Point, Gurnet Bidco and Innocoll today.

“Gurnet Point intends to work with Innocoll’s team to help bring XARACOLL to market by infusing substantial additional capital for its continued development and regulatory approval. We have great respect for Tony Zook and his team at Innocoll and look forward to investing in the business and assisting with the approval of XARACOLL and its commercialization,” said Christopher Viehbacher, Managing Partner at Gurnet Point Capital.

Innocoll had expected to receive FDA approval of XARACOLL this year. On December 29, 2016, Innocoll announced that it had received a Refusal to File Letter from the FDA for XARACOLL. Among other points, the FDA indicated that XARACOLL should be characterized as a drug-device combination product and that additional clinical and nonclinical information on XARACOLL may be required. To provide this information, Innocoll proposes to conduct an additional short-term pharmacokinetic study and several short-term non-clinical toxicology and biocompatibility studies.

The Innocoll directors believe that, if adequately financed and successful, such studies may be completed in time for an end of year re-submission of the XARACOLL NDA. Data from these studies, along with additional manufacturing information required to address the new combination product designation by the FDA and other chemistry, manufacturing and control activities, are also expected to be included in the re-submission.

If the re-submitted NDA is accepted by the FDA, thereby allowing XARACOLL to ultimately be approved, the Innocoll directors believe that Innocoll could be in a position to commercialize XARACOLL by the end of 2018.

 

Terms of the Transaction

The transaction, which is valued at up to approximately $209 million (including the maximum amount payable upon achievement of the CVR milestones listed below), is expected to be implemented by means of a court-sanctioned scheme of arrangement under Irish law or, with the consent of the Irish Takeover Panel, a takeover offer if Gurnet Bidco so chooses. Innocoll's Board of Directors intends to recommend unanimously that Innocoll shareholders vote or procure votes in favor of the Transaction.

Under the terms of the acquisition, each CVR represents the right to receive a specified amount of cash payments, with each payment conditioned upon the achievement of certain events, called CVR Payment Events.

These CVR Payment Events are:

  • First CVR Payment Event: Gurnet Bidco will pay $0.70 in cash per CVR if on or before December 31, 2018, XARACOLL is approved by the FDA with a label covering indications for the treatment of postsurgical pain immediately following open abdominal Hernia repair.
  • Second CVR Payment Event: Gurnet Bidco will pay an additional $1.33 in cash per CVR if, on or before December 31, 2018, XARACOLL is approved by the FDA with a label covering indications for the treatment of postsurgical pain immediately following Soft Tissue repair (and not limited to hernia repair).
  • Third CVR Payment Event: If the milestone is met, Gurnet Bidco will either pay: $1.00 in cash per CVR if, on or before December 31, 2019, XARACOLL is approved by the FDA with a label covering indications for the treatment of postsurgical pain immediately following Hard Tissue repair; or, if not $0.60 in cash per CVR if, after December 31, 2019 but on or before June 30, 2020, XARACOLL is approved by the FDA with a label covering indications for the treatment of postsurgical pain immediately following Hard Tissue repair.
  • Fourth CVR Payment Event: If the milestone is met, Gurnet Bidco will either pay: $1.87 in cash per CVR if global net sales of XARACOLL exceed $60 million in any four consecutive Calendar Quarters ending on or prior to December 31, 2019; or, if not, $1.00 in cash per CVR if global net sales of XARACOLL exceed $60 million in any four consecutive Calendar Quarters ending on or prior to March 31, 2020.
  • In the event that none of the CVR Payment Events occur by the relevant dates, then the CVR will have no value. The minimum payment of the CVR is zero and the maximum payment is $4.90 in cash per Innocoll Share.


About Gurnet

Gurnet Point is a healthcare investment fund led by Christopher Viehbacher, managing partner, Gurnet Point Capital. Gurnet Point is based in Cambridge, Massachusetts, USA, and invests in life sciences and medical technologies as well as healthcare services across all stages of development through to commercialization.


About Innocoll

Innocoll is a global, commercial stage specialty pharmaceutical and medical device company with late stage development programs targeting areas of significant unmet medical need. Innocoll’s shares are listed for trading on the NASDAQ under the symbol “INNL.” Innocoll utilizes its proprietary collagen-based technology platform to develop biodegradable and fully bioresorbable products and product candidates which can be broken down by the body without the need for surgical removal or topical application. Using its proprietary processes at its manufacturing facility, Innocoll derives and purifies bovine and equine collagen and then utilizes its technology platform to incorporate the purified collagen into its topical and implantable products. Innocoll’s proprietary processes and technologies also enable it to control the texture, consistency, drug elution dynamics, resorption time and other physical characteristics of the finished product. All of Innocoll’s native collagen products – from extraction/purification of type-1 collagen through final delivery form – are manufactured at its certified, integrated plant in Saal, Germany.

 

General

This summary should be read in conjunction with the full text of the Rule 2.5 announcement, being the formal transaction announcement made by Gurnet Point, Gurnet Bidco and Innocoll earlier today. The Rule 2.5 announcement and this announcement will be made available on a Gurnet Point website for the purposes of the Acquisition (www.GurnetPointLPOffer.com) and on Innocoll’s website (www.Innocoll.com). Certain capitalized words used in this announcement and not defined have the meaning given to such words in the Rule 2.5 announcement. The bases and sources set out in the Rule 2.5 announcement have been used in this announcement, unless otherwise stated or the context otherwise requires. Certain figures included in this announcement have been subjected to rounding adjustments.

NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN WHOLE OR IN PART IN, INTO OR FROM ANY JURISDICTION WHERE TO DO SO WOULD CONSTITUTE A VIOLATION OF THE RELEVANT LAWS OR REGULATIONS OF THAT JURISDICTION.

Important Additional Information for U.S. Investors and Where to Find It

Innocoll intends to file the Scheme Document, which will also constitute the proxy statement of Innocoll (the “Proxy Statement”), with the SEC and mail a copy to Innocoll Shareholders in advance of the Scheme Meeting and the EGM and in connection with the Acquisition and the Scheme. INNOCOLL SHAREHOLDERS ARE URGED TO READ THE SCHEME DOCUMENT/PROXY STATEMENT AND OTHER RELEVANT DOCUMENTS FILED OR TO BE FILED WITH THE SEC CAREFULLY WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT INNOCOLL, THE ACQUISITION, THE SCHEME AND RELATED MATTERS. Innocoll Shareholders will be able to obtain free copies of the Scheme Document/Proxy Statement and other documents filed with or furnished to the SEC by Innocoll through the website maintained by the SEC at www.sec.gov. In addition, Innocoll Shareholders will be able to obtain free copies of the Scheme Document/Proxy Statement on www.Innocoll/com/investors.

 

Participants in the Solicitation

Innocoll, Gurnet Point and Gurnet Bidco and certain of its respective directors and executive officers and employees may be considered participants in the solicitation of proxies from the shareholders of Innocoll in respect of the transactions contemplated by the Scheme Document/Proxy Statement. Information regarding the persons who may, under the rules of the SEC, be deemed participants in the solicitation of the shareholders of Innocoll in connection with the proposed transactions, including a description of their direct or indirect interests, by security holdings or otherwise, will be set forth in the Proxy Statement when it is filed with the SEC. Information regarding Innocoll’s directors and executive officers is contained in Innocoll’s Annual Report on Form 10-K for the fiscal year ended December 31, 2016 which is filed with the SEC. Information concerning the interests of Innocoll’s participants in the solicitation, which may, in some cases, be different than those of Innocoll’s shareholders generally will be set forth in the Proxy Statement relating to the transaction when it becomes available.

 

No Offer or Solicitation

This announcement is for information purposes only and is not intended to and does not constitute an offer to purchase, sell, subscribe for or exchange, or the solicitation of an offer to purchase, sell, subscribe for or exchange or an invitation to purchase, sell, subscribe for or exchange any securities or the solicitation of any vote or approval in any jurisdiction pursuant to the Acquisition or otherwise, nor shall there be any sale, issuance or transfer of securities in any jurisdiction in contravention of applicable law. The Acquisition will be made solely by means of the Scheme Document (or, if applicable, the Takeover Offer Document), which will contain the full terms and conditions of the Acquisition, including details of how to vote in respect of the Acquisition. Any decision in respect of, or other response to, the Acquisition, should be made only on the basis of the information contained in the Scheme Document (of, if applicable, the Takeover Offer Document). No offer of securities shall be made except by means of a prospectus meeting the requirements of section 10 of the Securities Act.

 

Cautionary Statement Regarding Forward-Looking Statements

Certain statements included in this announcement are forward-looking and involve risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such forward-looking statements. Forward-looking statements can typically be identified by the use of forward-looking terminology, such as “expects”, “believes”, “may”, “will”, “could”, “should”, “intends”, “plans”, “predicts”, “envisages”, “estimates”, “forecast”, “outlook”, “guidance”, “possible”, “projects”, “potential” or “anticipates” or other similar words and expressions and include, without limitation, any projections relating to results of operations and financial conditions of either Gurnet Point, Gurnet Bidco or Innocoll and their respective subsidiary undertakings from time to time, as well as plans and objectives for future operations, expected future revenues, financing plans, expected expenditures, expected synergies and divestments relating to Gurnet Point, Gurnet Bidco or Innocoll and discussions of Gurnet Point’s, Gurnet Bidco’s or Innocoll’s business plan. All forward-looking statements in this announcement made by Gurnet Point and / or Gurnet Bidco are based upon information known to Gurnet Point and / or Gurnet Bidco on the date of this announcement and all forward-looking statements in this announcement made by Innocoll are based upon information known to Innocoll on the date of this announcement. Except as expressly required by law, Gurnet Point, Gurnet Bidco and Innocoll disclaim any intent or obligation to update or revise these forward-looking statements. None of Gurnet Point, Gurnet Bidco or Innocoll undertake any obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, save as may be required by law.

 

Statements under the Irish Takeover Rules

The directors of Gurnet Bidco and the managers of Waypoint International GP LLC (in its capacity as general partner of Gurnet Point) accept responsibility for the information contained in this announcement, other than the information relating to Innocoll, the Innocoll Group and the Innocoll directors and members of their immediate families, related trusts and persons connected with them, for which the Innocoll directors accept responsibility. To the best of the knowledge and belief of the directors of Gurnet Bidco and the managers of Waypoint International GP LLC (in its capacity as general partner of Gurnet Point) (who have taken all reasonable care to ensure that such is the case), the information contained in this announcement for which they accept responsibility is in accordance with the facts and does not omit anything likely to affect the import of such information.

The Innocoll directors accept responsibility for the information contained in this announcement relating to Innocoll, the Innocoll Group and the Innocoll directors and members of their immediate families, related trusts and persons connected with them, except for statements made by Gurnet Point and Gurnet Bidco in respect of Innocoll. To the best of the knowledge and belief of the Innocoll directors (who have taken all reasonable care to ensure that such is the case), the information contained in this announcement for which they accept responsibility is in accordance with the facts and does not omit anything likely to affect the import of such information.

Evercore Partners International LLP (“Evercore”), which is authorized and regulated in the United Kingdom by the Financial Conduct Authority, is acting as Financial Adviser exclusively for Gurnet Point and Gurnet Bidco and no one else in connection with the Acquisition and the other matters referred to in this announcement, and will not regard any other person as its client in relation to the Acquisition and the other matters referred to in this announcement and will not be responsible to anyone other than Gurnet Point and / or Gurnet Bidco for providing the protections afforded to clients of Evercore, nor for providing advice in relation to the Acquisition or the other matters referred to in this announcement. Neither Evercore nor any of its subsidiaries, branches or affiliates owes or accepts any duty, liability or responsibility whatsoever (whether direct or indirect, whether in contract, in tort, under statute or otherwise) to any person who is not a client of Evercore in connection with this announcement, any statement contained herein or otherwise.

Piper Jaffray & Co. (“Piper Jaffray”), which is a securities broker-dealer registered with the U.S. Securities and Exchange Commission (“SEC”) and subject to regulation by the SEC and the Financial Industry Regulatory Authority (“FINRA”), is acting as financial adviser exclusively for Innocoll and for no one else in connection with the Acquisition and the other matters referred to in this announcement, and will not be responsible to anyone other than Innocoll for providing the protections afforded to clients of Piper Jaffray or for providing advice in relation to the Acquisition or any other matters referred to in this announcement.

 

Disclosure Requirements under the Irish Takeover Rules

Persons interested in 1% or more of any relevant securities in Innocoll may have disclosure obligations under Rule 8.3 of the Irish Takeover Panel Act, 1997, Takeover Rules 2013. See the Rule 2.5 announcement of earlier today for further details.

 

No Profit Forecast / Asset Valuation

No statement in this announcement is intended to constitute a profit forecast for any period, nor should any statements be interpreted to mean that earnings, earnings per share, losses or losses per share will necessarily be greater or lesser than those for the relevant preceding financial periods for any of Innocoll, Gurnet Point or Gurnet Bidco as appropriate. No statement in this announcement constitutes an asset valuation.

 

Contacts
 

Enquiries:
Gurnet Point and Gurnet Bidco
Evercore (Financial Adviser to Gurnet Point and Gurnet Bidco)
Francois Maisonrouge
John Honts Tel: +1 212 857 3100
Edward Banks Tel: +44 (0) 20 7653 6000
or
Abernathy MacGregor (Press Inquiries)
Tom Johnson Tel: +1 212 371 5999
tbj@abmac.com
or
Innocoll
Tel: Jose (Pepe) Carmona, Chief Financial Officer
pcarmona@innocoll.com
Piper Jaffray (Financial Adviser to Innocoll)
Peter Day Tel: + 1 617 654 0772
Peter Lombard Tel: + 1 617 654 0751
Michael Burton-Williams Tel: + 1 212 284 6126

Innocoll announces regulatory path forward after receiving formal FDA Type A meeting minutes regarding its XARACOLL® (bupivacaine HCl collagen-matrix implant) New Drug Application

ATHLONE, Ireland -- Innocoll Holdings plc (NASDAQ:INNL) ("Innocoll" or the "Company"), a global, commercial-stage, specialty pharmaceutical and medical device company, today announced receipt of formal Type A Meeting minutes from the United States Food and Drug Administration (FDA) relating to its New Drug Application (NDA) for XARACOLL (bupivacaine HCl collagen-matrix implant).  XARACOLL is the company’s product in development for the treatment of postsurgical pain.

Innocoll received a Refusal to File (RTF) Letter from the FDA in December 2016 pertaining to the XARACOLL NDA initially submitted on October 31, 2016.  In the RTF letter, the FDA indicated among other things, that XARACOLL should be characterized as a drug/device combination, which would require that the Company submit additional information.  During the Type A meeting, representatives of the FDA, after reviewing information provided by Innocoll to address matters raised in the RTF letter, provided guidance which was confirmed in the formal FDA meeting minutes.  The minutes serve as the official record of the FDA response to our proposal to address certain issues raised in the RTF by conducting an additional short-term pharmacokinetic study and several short-term non-clinical toxicology and biocompatibility studies. Innocoll believes, if adequately financed and successful, such studies may be completed in time for a resubmission of the NDA at the end of 2017.  Data from these studies, along with additional manufacturing information required to address the new combination product designation and other chemistry, manufacturing and control (CMC) issues, are expected to be included in the resubmission.  The acceptability of this data and other data that we reviewed with FDA during the meeting will be evaluated by the FDA during its review of the resubmission.

“I am pleased that we have clarified the data needed to address the questions raised in the RTF letter. With the official minutes from the FDA now in hand, we believe that we have a path forward for a possible resubmission of the XARACOLL NDA by the end of 2017, assuming adequate financing to commence the proposed studies, and further assuming positive results,” said Tony Zook, CEO of Innocoll.


About XARACOLL®

XARACOLL is Innocoll’s late-stage surgically implantable and bioresorbable collagen matrix developed to provide sustained postsurgical pain relief through controlled delivery of bupivacaine at the surgical site.


About Innocoll Holdings plc

Innocoll is a global, commercial stage specialty pharmaceutical and medical device company with late stage development programs targeting areas of significant unmet medical need. Innocoll utilizes its proprietary collagen-based technology platform to develop biodegradable and fully bioresorbable products and product candidates which can be broken down by the body without the need for surgical removal or topical application.

Mainstay Medical Publishes 2016 Full Year Results and Business Update

Mainstay Medical International plc (“Mainstay” or the “Company”, Euronext Paris: MSTY.PA and ESM of the Irish Stock Exchange: MSTY.IE), a medical device company focused on bringing to market ReActiv8®, an implantable restorative neurostimulation system to treat people with disabling Chronic Low Back Pain (“CLBP”), announces today the publication of its 2016 Annual Report.
 

  • ReActiv8-B Clinical Trial - on track to complete enrolment around the end of 2017, with data availability in 2018
  • First sale and implant of ReActiv8 in Germany announced in February 2017
  • CE Marking based on positive results from ReActiv8-A Clinical Trial, one year data showed performance maintained
  • Completion of €30m private placement in June 2016
  • Cash at hand on 31 December 2016 - $36.7m


Peter Crosby, CEO of Mainstay, said: “We are pleased to have moved forward to the commercial phase of Mainstay’s development. Our ReActiv8-B Clinical Trial is on track and is a key step towards commercialization in the US, our most significant target market. Early in 2017, we began commercialization in Europe, with the first sale and implantation of ReActiv8 in Germany, and look forward to gaining experience from our focused activities in this first market ahead of potential expansion to other territories.”


Business Update

  • Enrollment in the ReActiv8-B Clinical Trial commenced in September 2016 and the first subject was implanted on 6 October 2016. The ReActiv8-B Clinical Trial is an international, multi-center, prospective randomized sham-controlled triple blinded trial with one-way crossover, conducted under an Investigational Device Exemption (IDE) from the US Food and Drug Administration (FDA). The purpose of the ReActiv8-B Clinical Trial is to gather data in support of an application for pre-market approval (PMA) to the FDA, a key step towards the commercialization of ReActiv8 in the US. Summary details of the ReActiv8-B Trial, including enrollment criteria and a list of sites, can be found at https://clinicaltrials.gov/ct2/show/study/NCT02577354.
  • We are pleased with the progress of the ReActiv8-B Clinical Trial. We have selected 27 Clinical Trial sites of which 18 are enrolling subjects and the remainder are working with us to begin enrolling as soon as possible. 75 subjects have been enrolled of whom 22 have been implanted with ReActiv8 and 9 subjects are either awaiting implant or are still being assessed. Based on our experience to date, we estimate completion of enrollment in the ReActiv8-B Trial around the end of 2017, with data availability in 2018, which is in line with our target.
  • The first sale and implant of ReActiv8 in Germany was announced on 1 February 2017. The implant was performed by Dr. med. Francis Kilian, Orthopedic and Neurosurgeon at the Catholic Hospital Koblenz-Montabaur in Koblenz Germany. We are progressing discussions with a number of customers across Germany. Our European commercial activities for ReActiv8 are initially focused on Germany where we aim to drive adoption of ReActiv8 in a select number of high volume multi‑disciplinary spine care centers which will become reference sites.
  • During 2016, we received CE Marking approval for ReActiv8 based on positive results from the ReActiv8-A Clinical Trial. This Clinical Trial demonstrated a clinically important, statistically significant and lasting improvement in pain, disability and quality of life in people with disabling Chronic Low Back Pain and few other treatment options. One year results announced in 2016 showed sustained performance.
  • In January 2017, we applied for regulatory approval to commercialize ReActiv8 in Australia.
  • During 2016, two new US Patents were issued, bringing the total current number of issued US Patents in the Mainstay portfolio to eight.


Financial Update

On 17 June 2016, we announced the completion of a private placement of €30 million (approximately $33.7 million) through a placement of 2,307,694 new ordinary shares with new and existing shareholders (the “Placement”). On 11 August 2016, we announced the publication of a prospectus (the “Prospectus”) in connection with the Placement. Cash on hand at 31 December 2016 was $36.7 million.

As at 31 December 2016, the Group had fully drawn down the debt facility of $15 million with IPF Partners. This facility was announced during 2015, and the last tranche of $4.5 million was received in July 2016 following CE Marking approval of ReActiv8.

Operating expenses were $16.8 million for the year and have increased by $3.9 million compared to 2015 primarily due to costs associated with the commencement and ramp up of the ReActiv-8 B Clinical Trial, and with commercialization activities. Operating cash outflows for 2016 were $16.7 million.

Outlook

We are pleased with the progress of the ReActiv8-B Clinical Trial. Enrollment is well under way and we estimate that enrollment will complete around the end of 2017 with data availability in 2018, which is in line with our target. If successful, the ReActiv8-B Clinical Trial will yield level 1 evidence of efficacy, which we will use to support an application for PMA approval to allow for commercialization in the US. We also anticipate the data from this Clinical Trial will help with expansion of commercialization of ReActiv8 outside the US.

The initial focus for our European commercial activities for ReActiv8 is on Germany where we aim to drive adoption of ReActiv8 in a select number of high volume multi-disciplinary spine care centers. We have recruited a direct sales force, which is supported by our team of experienced field clinical specialists, and we are working with customers to integrate ReActiv8 into their routine clinical practice and provide a new treatment option for the many people suffering from Chronic Low Back Pain. As we gain experience and momentum, and as we identify other early opportunities to build our business, we will consider expansion to other sites and countries.


About Mainstay

Mainstay is a medical device company focused on bringing to market an innovative implantable restorative neurostimulation system, ReActiv8®, for people with disabling Chronic Low Back Pain (CLBP). The Company is headquartered in Dublin, Ireland. It has subsidiaries operating in Ireland, the United States, Australia and Germany, and its ordinary shares are admitted to trading on Euronext Paris (MSTY.PA) and the ESM of the Irish Stock Exchange (MSTY.IE).

About Chronic Low Back Pain

One of the recognised root causes of CLBP is impaired control by the nervous system of the muscles that dynamically stabilise the spine in the low back, and an unstable spine can lead to back pain. ReActiv8 is designed to electrically stimulate the nerves responsible for contracting these muscles and thereby help to restore muscle control and improve dynamic spine stability, allowing the body to recover from CLBP.

People with CLBP usually have a greatly reduced quality of life and score significantly higher on scales for pain, disability, depression, anxiety and sleep disorders. Their pain and disability can persist despite the best available medical treatments, and only a small percentage of cases result from an identified pathological condition or anatomical defect that may be correctable with spine surgery. Their ability to work or be productive is seriously affected by the condition and the resulting days lost from work, disability benefits and health resource utilisation put a significant burden on individuals, families, communities, industry and governments.

Further information can be found at www.mainstay-medical.com

CAUTION – in the United States, ReActiv8 is limited by federal law to investigational use only.

Innocoll Holdings plc Announces Fourth Quarter and Full-Year 2016 Financial and Operating Results and Provides Corporate Update

ATHLONE, Ireland -- Innocoll Holdings plc (Nasdaq:INNL), a global, commercial stage, specialty pharmaceutical company with late stage development programs targeting areas of significant unmet medical need announced financial and operating results for the three months and full year ended December 31, 2016. Innocoll manufactures and supplies a range of pharmaceutical products and medical devices using its proprietary collagen-based biodegradable and fully bioresorbable technology platform.

“In 2016, Innocoll successfully achieved milestones, but also faced challenges.  On the one hand, XARACOLL achieved positive pivotal results in Phase 3 trials and we were able to substantially finalize the expansion of our manufacturing facility in Saal, Germany. On the other hand, COGENZIA did not achieve statistical significance in improving clinical cure in diabetic foot infections (DFI) and XARACOLL received the Refusal-to-File letter from the U.S. Food and Drug Administration (FDA)," said Tony Zook, Chief Executive Officer of Innocoll. “In February 2017, we attended a Type-A meeting with representatives of the FDA to review pathways forward following our receipt of the Refusal-To-File letter.  During the meeting, we proposed a plan to conduct an additional short-term Pharmacokinetic study and several short-term non-clinical studies, which we believe will allow us to submit a revised NDA to the FDA by the end of 2017.  If the formal minutes from the Type-A meeting, which we expect to receive at the end of this month, confirm that the FDA agrees with our plan, we would submit a revised NDA to the FDA soon after the completion of the additional studies, assuming adequate financing to commence the proposed studies, and further assuming positive results."

Innocoll plans to update investors with additional information about the outcome of its Type A meeting shortly after receiving formal written FDA minutes. In the interim, Innocoll intends to continue to explore strategic options to maximize value to its shareholders.

 

Fourth Quarter 2016 and Recent Updates

  • Substantially finalized expansion of its Saal, Germany manufacturing facility.
  • Following receipt of the XARACOLL Refusal to File Letter in December, 2016, in January 2017, Innocoll requested a Type A meeting with the FDA, which was held in late February 2017. At the meeting, management presented a plan for a path forward, including an additional short-term Pharmacokinetic study and several short-term non-clinical studies, which assuming FDA concurrence, adequate financing and further positive trial results, could enable Innocoll to submit a revised NDA for XARACOLL in the latter part of 2017.

 

Fourth Quarter 2016 Financial Results

Net Loss Attributable to Ordinary Shareholders: Innocoll reported a net loss attributable to ordinary shares of $3.8 million, or $0.13 per share, for the fourth quarter of 2016, compared to a loss of $7.7 million, or $0.33 per share for the fourth quarter of 2015.

Non-GAAP diluted loss excluding nonrecurring items was $7.6 million or $0.26 per share, for the fourth quarter of 2016, compared to a loss of $16.9 million or $0.72 per share, for the fourth quarter of 2015.

The weighted average number of ordinary shares outstanding increased from 23.5 million in the fourth quarter of 2015 to 29.7 million in the fourth quarter of 2016, primarily as a result of the follow-on public offering in the second quarter of 2016.

Revenues: Revenues were $0.6 million for the fourth quarter of 2016 as compared to $0.9 million for the fourth quarter of 2015. This decrease was primarily due to lower sales to EUSA Pharma of CollatampG®.

Research and Development (R&D) Expenses: R&D expenses were $4.7 million for the fourth quarter of 2016 as compared to $11.7 million for the fourth quarter of 2015. R&D expenses in the fourth quarter of 2016 included $3.7 million in external clinical research expenses, which was primarily driven by the finalization of our Phase 3 Cogenzia efficacy trials.

General and Administrative (G&A) Expenses: G&A expenses were $4.9 million for the fourth quarter of 2016 as compared to $6.1 million for the fourth quarter of 2015. Excluding stock-based compensation charges, G&A expenses for the fourth quarter of 2016 were $2.6 million as compared to $5.7 million for the fourth quarter of 2015. The decrease in G&A excluding stock-based compensation was primarily due to reduction in discretionary expenses and prior year expenses relating to the company’s re-domiciliation to Ireland.

Other Operating Income: Other operating income was $7.1 million for the fourth quarter of 2016 as compared to $10.9 million for the fourth quarter of 2015. Other income in the fourth quarter of 2016 consisted primarily of fair value income of warrants outstanding and foreign exchange gains, partially offset by accrued interest on the company’s existing loan with the European Investment Bank (EIB). Other income in the fourth quarter of 2015 consisted primarily of $9.7 million fair value income of warrants outstanding.

 

Full Year 2016 Financial Results

Net Loss Attributable to Ordinary Shareholders: Innocoll reported a net loss attributable to ordinary shareholders of $57.0 million, or $2.12 per share, for the year ended December 31, 2016, compared to a loss of $50.9 million, or $2.28 per share for the year ended December 31, 2015. 

Non-GAAP diluted loss excluding nonrecurring items was $59.1 million or $2.20 per share, for the year ended December 31, 2016, compared to a loss of $42.8 million, or $1.92 per share, for the year ended December 31, 2015. 

The weighted average number of ordinary shares outstanding increased from 22.3 million during the year ended December 31, 2015, to 26.9 million during the year ended December 31, 2016, primarily as a result of the follow-on public offering in the second quarter of 2016.

Revenues:  Revenues were $4.4 million for the year ended December 31, 2016 as compared to $2.9 million for year ended December 31, 2015.  This increase was primarily due to an increase in sales to EUSA Pharma of Collatamp G, our gentamicin implant for the treatment and prevention of post-surgical infection.

Research and Development (R&D) Expenses:  R&D expenses were $38.7 million for the year ended December, 31 2016 as compared to $29.8 million for the year ended December 31, 2015. R&D expenses in the year ended December 31, 2016 included $34.8 million in external clinical research expenses, which was primarily due to the completion of our pivotal Phase 3 studies of XARACOLL and Cogenzia. R&D expenses are expected to significantly decrease going forward.

General and Administrative (G&A) Expenses:  G&A expenses were $25.4 million for the year ended December 31, 2016 as compared to $19.7 million for the year ended December 31, 2015.   Excluding stock-based compensation charges, G&A expenses for the year ended December 31 2016 were $16.9 million as compared to $15.7 million for the year ended December 31, 2015. The increase in G&A, excluding stock-based compensation, was primarily due to our continued infrastructure build out to support clinical programs and expenses related to the company’s re-domiciliation to Ireland.

Other Operating Income: Other operating income was $10.0 million for the year ended December 31, 2016 as compared to $1.6 million for the year ended December 31, 2015. Other income for the year ended December 31, 2016 consisted primarily of non-cash items due to the fair value income of warrants outstanding and foreign exchange gains, partially offset by accrued interest on the company’s existing loan with the EIB. Other expense for the year ended December 31, 2015 consisted primarily of foreign exchange gains of $5.6 million, partially offset by fair value expense of warrants outstanding of $4.0 million.

 

Cash Position

As of December 31, 2016, cash and cash equivalents totalled $15.8 million compared to $30.4 million as of September 30, 2016. For further financial information for the period ending December 31, 2016, please refer to the financial statements appearing at the end of this release.

In management's opinion, Innocoll's anticipated expenditures during the next 12 months to advance its current operations, including plans to conduct further studies to enable it to submit a revised NDA for XARACOLL and to develop CollaGUARD will be greater than the amount of its current cash and cash equivalents.  The Company may not be able to generate revenues from the sale of XARACOLL until the end of 2018, if at all.

Innocoll's need for additional capital will vary depending on a variety of circumstances, including, for example, if it is required to conduct additional tests not currently contemplated, the level and timing of regulatory approval, as well as the extent to which it chooses to establish collaboration, co-promotion, distribution or other similar agreements for its products and product candidates. Moreover, changing circumstances may cause it to spend cash significantly faster than it currently anticipates, and it may need to spend more cash than currently expected because of circumstances beyond its control.

To the extent that Innocoll's capital resources are insufficient to meet its future operating and capital requirements, it will need to finance its cash needs through public or private equity offerings, debt financings, corporate collaboration and licensing arrangements, or strategic alternatives.

 

About Innocoll Holdings plc

Innocoll is a global, specialty pharmaceutical company with late stage development programs that is dedicated to engineering better medicines to help patients get better. Its proprietary, biocompatible, and biodegradable collagen products are precision-engineered for targeted use. Applied locally to surgery sites, they are designed to provide a range of benefits. Its late stage product pipeline is focused on addressing a number of large unmet medical needs, including: XARACOLL for the treatment of postoperative pain and CollaGUARD (INL-003), a barrier for the prevention of post-surgical adhesions.

Innocoll's currently approved products include: CollaGUARD® (ex-US), COLLATAMP® G, SEPTOCOLL® E, REGENEPRO®, COLLACARE®, COLLEXA®, and ZORPREVA®, some of which are sold globally through strategic partnerships, including those with Takeda, EUSA Pharma, Biomet 3i and Biomet.  All of its native collagen products — from extraction/purification of type-1 collagen through final delivery form — are manufactured at its certified, integrated plant in Saal, Germany.

 

For more information, please visit www.innocoll.com. 

CollaRx®, Collatamp®, CollaGUARD®, Collieva®, CollaCare®, Collexa®, COGENZIA® LidoColl®, LiquiColl®, and XARACOLL® are registered trademarks, and CollaPress™, DermaSil™, Durieva™, and Zorpreva™ are trademarks of the company.

 

 

Innocoll Holdings Announces Statement re: Possible Offer

ATHLONE, Ireland -- The Board of Innocoll Holdings plc (“Innocoll” or the “Company”) (NASDAQ:INNL) notes anomalous movements in Innocoll’s share price this week and confirms that it is in discussions which may or may not lead to an offer for the entire issued share capital of the Company.

Management has been investigating and continues to investigate strategic options for the Company to maximise shareholder value. There can be no certainty that this will lead to an offer for Innocoll or any of its share capital nor as to the terms on which an offer, if any, might be made. The Company has participated in a Type A meeting with the United States Food and Drug Administration ("FDA") regarding the re-submission to the FDA for approval of XARACOLL. It expects to receive the minutes of the Type A meeting before the end of March and will make a further announcement at that time. 

A further announcement will be made when appropriate.

ENQUIRIES

Innocoll Holdings plc

Jose (Pepe) Carmona, Chief Financial Officer
pcarmona@innocoll.com

Piper Jaffray & Co

Peter Day, Managing Director
Peter.c.day@pjc.com

Peter Lombard, Managing Director
peter.a.lombard@pjc.com

Michael Burton-Williams, Principal
michael.g.burton-williams@pjc.com

Neuravi Announces Completion of Patient Enrollment in Clinical Trial of a Novel Stent Retriever for Acute Ischemic Stroke

ARISE II Data Will Be Submitted to the FDA in Support of Market Clearance for EmboTrap in the U.S.

 

Galway, Ireland - Neuravi, a company dedicated to improving clinical outcomes for stroke patients, today announced completion of enrollment in the company’s international clinical trial assessing the safety and effectiveness of the EmboTrap®II Revascularization Device, an advanced stent retriever platform for the treatment of acute ischemic stroke.   

Data from the pivotal study, called ARISE II (Analysis of Revascularization in Ischemic Stroke with EmboTrap), will be submitted as part of an application to U.S. Food and Drug Administration (FDA) for market clearance of the device in the United States.

The ARISE II study enrolled 228 patients in 19 enrolling sites across the United States and Europe.  Sam Zaidat, M.D., Stroke and Neuroscience Medical Director of St. Vincent Mercy Hospital in Toledo, Ohio, is the study’s principal investigator.  Professor Tommy Andersson, M.D., Ph.D., of the Karolinska Institute in Stockholm, Sweden, is the European principal investigator of the study.

“The value of stent retrievers has been demonstrated by multiple positive trials. Now our focus has moved on to further refinements of mechanical thrombectomy that will yield better patient outcomes,” said Dr. Zaidat. “International cooperation has been excellent. I’m excited to be a part of the process to provide physicians and patients in the United States with access to the latest technology.” 

The study enrolled ahead of schedule, with enrollment led by Dr. Hormozd Bozorgchami’s team at Oregon Health Sciences University in Portland and Dr. Marc Ribo’s team at Vall d’Hebron in Barcelona. 

 “Evaluating new technology is an important part of advancing stroke treatment and we are enthusiastic about our experience in the ARISE II trial,” said Raul Nogueira, M.D., director of Neuroendovascular Service at Grady Memorial Hospital at Emory University in Atlanta, where the final U.S. patient was enrolled. “As we continue to learn more about the clots that cause stroke, it is important that we have the best tools available to treat those occlusions.”     

The EmboTrap platform is designed to restore blood flow to the brain by retrieving and retaining clot with a proprietary dual-layer stent-like structure. 

“We’d like to thank the stroke center teams in the United States and Europe for their dedication and commitment to the ARISE II trial. In fully enrolling the ARISE II clinical trial, we are building a strong data set in support of our EmboTrap device as well as adding to the broader pool of stent retriever thrombectomy data for stroke treatment,” said Eamon Brady, Neuravi CEO. “Our vision is to be the therapy leader in acute ischemic stroke intervention and we will continue to develop innovative therapy solutions to advance patient care.”

Ischemic strokes, caused by blockages in vessels supplying blood to the brain, account for 87% of all strokes and are a leading cause of death and disability. Approximately one million Europeans and 700,000 Americans suffer ischemic strokes each year. 

 

About Neuravi
Based in Galway, Ireland, Neuravi is dedicated to improving clinical outcomes for stroke patients. The company’s stroke therapy platform, the EmboTrap®II Revascularization Device, is CE marked and commercially available in Europe.   The device has been available for investigational use only in the United States.   Through its investment in the Neuravi Thromboembolic Initiative (NTI), Neuravi supports collaboration between engineers, clinicians and researchers to deepen the understanding of clot and occlusion dynamics, in order to improve patient outcomes in stroke. Neuravi is led by a team experienced in endovascular device development and global commercialization. More information can be found at www.neuravi.com.

 

 
Media Contact:

Nicole Osmer, +1 (650) 454-0504
nicole@nicoleosmer.com
 
 

Mainstay Medical Starts Commercialization of ReActiv8® for the Treatment of Chronic Low Back Pain

First sale and implant in Germany following CE Marking
 

Mainstay Medical International plc ("Mainstay" or the "Company", Euronext Paris: MSTY.PA and ESM of the Irish Stock Exchange: MSTY.IE), a medical device company focused on bringing to market ReActiv8®, an implantable neurostimulation system to treat disabling Chronic Low Back Pain ("CLBP"), today announces the first sale and implant of ReActiv8 in Germany.

The ReActiv8 implant was performed by Dr. med. Francis Kilian, Orthopedic and Neurosurgeon at the Catholic Hospital Koblenz-Montabaur in Koblenz Germany.

Dr. Kilian commented: "As spine surgeons we are always looking to address the underlying cause of a patient's condition but until now we had no effective option to offer to patients with Chronic Low Back Pain due to impaired control of their back muscles. ReActiv8 represents a significant breakthrough for this large group of patients who are not candidates for spine surgery and fills an important void in our restorative treatment portfolio."

ReActiv8 works by electrically stimulating the nerves responsible for contracting the key stabilizing muscles of the lumbar spine. Activation of these muscles to restore functional spine stability has been shown to facilitate recovery from CLBP.

Peter Crosby, CEO of Mainstay, commented: "The first sale and implant of ReActiv8 in Germany is an important milestone for Mainstay. We are fully committed to working with our customers to integrate ReActiv8 into their routine clinical practice and provide a new option for many people suffering from chronic low back pain."

Mainstay's European commercial activities for ReActiv8 are initially focused on Germany where the Company aims to drive adoption of ReActiv8 in a select number of high volume multi-disciplinary spine care centers. As the Company gains experience and momentum, it will expand to other sites and countries.

Mainstay received CE Marking for ReActiv8 supported by positive results from the ReActiv8-A Clinical Trial that demonstrated a clinically important, statistically significant and lasting improvement in pain, disability and quality of life in people with disabling CLBP and few other treatment options.

About Mainstay
Mainstay is a medical device company focused on bringing to market an innovative implantable neurostimulation system, ReActiv8®, for people with disabling Chronic Low Back Pain (CLBP). The Company is headquartered in Dublin, Ireland. It has subsidiaries operating in Ireland, the United States, Australia and Germany, and its ordinary shares are admitted to trading on Euronext Paris (MSTY.PA) and the ESM of the Irish Stock Exchange (MSTY.IE).

About Chronic Low Back Pain
One of the recognised root causes of CLBP is impaired control by the nervous system of the muscles that dynamically stabilise the spine in the low back, and an unstable spine can lead to back pain. ReActiv8 is designed to electrically stimulate the nerves responsible for contracting these muscles and thereby help to restore muscle control and improve dynamic spine stability, allowing the body to recover from CLBP.

People with CLBP usually have a greatly reduced quality of life and score significantly higher on scales for pain, disability, depression, anxiety and sleep disorders. Their pain and disability can persist despite the best available medical treatments, and only a small percentage of cases result from an identified pathological condition or anatomical defect that may be correctable with spine surgery. Their ability to work or be productive is seriously affected by the condition and the resulting days lost from work, disability benefits and health resource utilisation put a significant burden on individuals, families, communities, industry and governments.

Further information can be found at www.mainstay-medical.com

CAUTION – in the United States, ReActiv8 is limited by federal law to investigational use only.

PR and IR Enquiries:
Consilium Strategic Communications (international strategic communications – business and trade media)
Chris Gardner, Mary-Jane Elliott, Jessica Hodgson, Hendrik Thys
Tel: +44 203 709 5700 / +44 7921 697 654
Email: mainstaymedical@consilium-comms.com

FTI Consulting (for Ireland)
Jonathan Neilan Tel: +353 1 663 3686
Email: jonathan.neilan@fticonsulting.com

NewCap (for France)
Julie Coulot
Tel: +33 1 44 71 20 40
Email: jcoulot@newcap.fr

AndreasBohne.Com/Kötting Consulting (for Germany)
Andreas Bohne
Tel : +49 2102 1485368
Email : abo@andreasbohne.com

Wilhelm Kötting
Tel: +49 69 75913293
Email: wkotting@gmail.com

Investor Relations:
LifeSci Advisors, LLC
Brian Ritchie
Tel: + 1 (212) 915-2578
Email: britchie@lifesciadvisors.com

ESM Advisers:
Davy
Fergal Meegan or Barry Murphy
Tel: +353 1 679 6363
Email: fergal.meegan@davy.ie or barry.murphy2@davy.ie

Mainstay Medical Applies for Approval to Market ReActiv8® in Australia

Application for inclusion in Australian Register of Therapeutic Goods a key step towards commercialization of innovative treatment of Chronic Low Back Pain in Australian market

 

Dublin, Ireland -  Mainstay Medical International plc (“Mainstay” or the “Company”, Euronext Paris: MSTY.PA and ESM of the Irish Stock Exchange: MSTY.IE), a medical device company focused on bringing to market ReActiv8, an implantable neurostimulation system to treat disabling Chronic Low Back Pain (“CLBP”), announces that it has applied for ReActiv8 to be admitted to the Australian Register of Therapeutic Goods (ARTG) which would allow for commercialization in Australia.


Mainstay’s ARTG application includes the results of the ReActiv8-A Clinical Trial, which showed clinically important, statistically significant, and lasting improvement in pain, disability, and quality of life for people with Chronic Low Back Pain and limited treatment options.
 

Peter Crosby, CEO of Mainstay, said: “This application for approval to sell ReActiv8 in Australia is another step on our path to commercializing ReActiv8 in major world markets, adding to our initial commercialization activities in Germany and plans for other European markets. We are also making good progress with the ReActiv8-B Trial to gather data for an application for US marketing approval.”
 

The Therapeutic Goods Agency will review the application and may request additional data during the review process. Subject to successful ATRG registration and reimbursement, Mainstay plans to establish its own direct sales force to market ReActiv8 in Australia.
 

About Mainstay
Mainstay is a medical device company focused on bringing to market an innovative implantable neurostimulation system, ReActiv8®, for people with disabling Chronic Low Back Pain (CLBP). The Company is headquartered in Dublin, Ireland. It has subsidiaries operating in Ireland, the United States, Australia and Germany, and its ordinary shares are admitted to trading on Euronext Paris (MSTY.PA) and the ESM of the Irish Stock Exchange (MSTY.IE).
 

About Chronic Low Back Pain
One of the recognised root causes of CLBP is impaired control by the nervous system of the muscles that dynamically stabilise the spine in the low back, and an unstable spine can lead to back pain. ReActiv8 is designed to electrically stimulate the nerves responsible for contracting these muscles and thereby help to restore muscle control and improve dynamic spine stability, allowing the body to recover from CLBP.
 

People with CLBP usually have a greatly reduced quality of life and score significantly higher on scales for pain, disability, depression, anxiety and sleep disorders. Their pain and disability can persist despite the best available medical treatments, and only a small percentage of cases result from an identified pathological condition or anatomical defect that may be correctable with spine surgery. Their ability to work or be productive is seriously affected by the condition and the resulting days lost from work, disability benefits and health resource utilisation put a significant burden on individuals, families, communities, industry and governments.
 

Further information can be found at www.mainstay-medical.com
 

CAUTION – in the United States, ReActiv8 is limited by federal law to investigational use only.
 

PR and IR Enquiries:
Consilium Strategic Communications (international strategic communications – business and trade media)
Chris Gardner, Mary-Jane Elliott, Jessica Hodgson, Hendrik Thys
Tel: +44 203 709 5700 / +44 7921 697 654
Email: mainstaymedical@consilium-comms.com
 

FTI Consulting (for Ireland)
Jonathan Neilan Tel: +353 1 663 3686
Email: jonathan.neilan@fticonsulting.com
 

NewCap (for France)
Julie Coulot
Tel: +33 1 44 71 20 40
Email: jcoulot@newcap.fr
 

AndreasBohne.Com/Kötting Consulting (for Germany)
Andreas Bohne
Tel : +49 2102 1485368
Email: abo@andreasbohne.com
 

Investor Relations:
LifeSci Advisors, LLC
Brian Ritchie
Tel: + 1 (212) 915-2578
Email: britchie@lifesciadvisors.com
 

ESM Advisers:
Davy
Fergal Meegan or Barry Murphy
Tel: +353 1 679 6363
Email: fergal.meegan@davy.ie or barry.murphy2@davy.ie
 

 

NeRRe Therapeutics raises £23million in oversubscribed Series B financing round

New funds to advance unique neurokinin receptor antagonist pipeline towards late-stage clinical development in common, chronic and debilitating respiratory and women’s health conditions.

New investors Fountain Healthcare Partners, Forbion Capital Partners and Orbimed join existing investors Advent Life Sciences, Novo A/S and GlaxoSmithKline

Stevenage, UK – NeRRe Therapeutics (‘NeRRe’), a clinical-stage company developing a unique portfolio of neurokinin (NK) receptor antagonists for the treatment of common, chronic and debilitating conditions caused by neuronal hypersensitivity, announced it has raised £23 million in an oversubscribed Series B financing round.

The funds will be used by NeRRe to generate Phase 2 data on orvepitant, its lead oral NK-1 antagonist candidate as a potential new treatment for a common, chronic respiratory condition; and to advance NT-814, a dual NK-1,3 antagonist, into Phase 2 trials as a potential non-hormonal treatment of distressing post-menopausal vasomotor symptoms. 

The financing round involved a syndicate of leading transatlantic life sciences investors led by new investor Fountain Healthcare Partners, and co-led by Forbion Capital Partners and OrbiMed. Existing investors, Advent Life Sciences and Novo A/S also participated, and the round was supported by GlaxoSmithKline plc (GSK).

Dr Ena Prosser, Partner at Fountain Healthcare Partners; Geert-Jan Mulder MD, General Partner at Forbion Capital Partners; and Dr Iain Dukes, Venture Partner at OrbiMed will join Dr Kaasim Mahmood, General Partner at Advent Life Sciences (Chairman), Dr Mary Kerr, NeRRe’s CEO and Jo Craig, Vice-President GSK (Board Observer) on the NeRRe Board of Directors.

OrbiMed’s Iain Dukes, formally Senior Vice President, Business Development & Licensing at Merck & Co., said: “We have been impressed by NeRRe's clear strategy, and are pleased to be involved in funding the company to deliver important Phase 2 clinical data on both of these exciting candidates. We look forward to supporting the company in achieving these aims.”

Mary Kerr, NeRRe’s CEO, said: “NeRRe is delighted to have attracted such a substantial investment from these high profile life sciences investors. Now that we are fully funded to execute the next phase of development, everyone at the company is focused on moving orvepitant and NT-814 closer to the market for the alleviation of these common, chronic and debilitating conditions.”

*Biographies of the Board of Directors can be found at www.nerretherapeutics.com

 

Notes to Editors About NeRRe Therapeutics (www.nerretherapeutics.com)

NeRRe Therapeutics is a private, UK-based clinical-stage company focused on the development of its unique portfolio of NK receptor antagonists for the treatment of common, chronic and debilitating conditions caused by neuronal hypersensitivity. 

NeRRe Therapeutics was founded in 2012 as a spin out from GSK, which transferred its NK antagonist portfolio, including clinical data, toxicity, safety and formulation packages, and all associated IP to NeRRe. NeRRe is led by an experienced management team including Dr Mary Kerr (CEO), formerly SVP and Global Franchise lead at GSK and Dr Mike Trower (Co-founder, CSO/COO), formerly VP & Head of the External Drug Discovery Group in the Neurosciences CEDD at GSK.

NeRRe Therapeutics is backed by leading international life sciences investors: Advent Life Sciences, Fountain Healthcare Partners, Forbion Capital Partners, Orbimed, Novo A/S, and by GSK. 

NeRRe is based at the state-of-the-art Stevenage Bioscience Catalyst (www.stevenagecatalyst.com), the UK’s first open innovation bioscience campus.

 

About Fountain Healthcare Partners

Fountain Healthcare Partners is a life science focused venture capital fund with €176 million ($200 million) under management. Within the life science sector, specific areas of interest to Fountain include specialty pharma, medical devices, biotechnology and diagnostics. The firm deploys the majority of its capital in Europe, with the balance in the United States. Fountain’s main office is in Dublin, Ireland, with a second office in New York. www.fh-partners.com

 

About Forbion Capital Partners

Forbion Capital Partners is a dedicated life sciences venture capital firm with offices in The Netherlands and Germany. Forbion invests in life sciences companies in the pharmaceutical, as well as the medical device space. Forbion’s investment team has built an impressive performance track record since the late nineties with successful investments in multiple companies. With the new FCFIII fund, Forbion manages well over EUR 700M across six funds, including the new fund FCF III. Its investors include the EIF through its European Recovery Programme (ERP), LfA and Dutch Venture Initiative (DVI) facilities and the KFW through the ERP - Venture Capital Fondsfinanzierung facility. Forbion also operates a joint venture with BioGeneration Ventures, who manages two separate seed and early stage funds focused on Benelux. For further information please visit www.forbion.com.

 

About OrbiMed

OrbiMed is a leading investment firm dedicated exclusively to the healthcare sector, with over $16 billion in assets under management. OrbiMed invests globally across the spectrum of healthcare companies, from venture capital start-ups to large multinational companies utilizing a range of private equity funds, public equity funds, royalty/debt funds and other investment vehicles. OrbiMed maintains its headquarters in New York City, with additional offices in San Francisco, Shanghai, Mumbai and Herzliya.

As the largest investment firm dedicated to the healthcare sector globally, OrbiMed seeks to be a capital provider of choice. OrbiMed has the flexibility to provide equity and debt capital along with the global team resources required to be an exceptional long-term partner for building world-class healthcare companies. www.OrbiMed.com

 

About Advent Life Sciences

Advent Life Sciences founds and invests in early- and mid-stage life sciences companies that have a first- or best-in-class approach to unmet medical needs. The investing team consists of 16 professionals, each with extensive scientific, medical and operational experience, a long-standing record of entrepreneurial and investment success in the US and Europe, and is particularly focused on supporting entrepreneurs and founders to take innovative new medical entities from concept to approval. The Firm invests in a range of sectors within life sciences, principally drug discovery, enabling technologies and med tech, always with an emphasis on innovative, paradigm-changing approaches. Advent Life Sciences has a presence in the UK, US and France. For more information, please visit www.AdventLS.com 

  

For more information, please contact:

Mary Kerr, CEO of NeRRe Therapeutics
Tel:  +44 1438 906960
Email: info@nerretherapeutics.com 

Katja Stout/Mark Swallow, Citigate Dewe Rogerson
Tel: +44 20 7282 1066/2948
Email: NeRRe@citigatedr.co.uk

Innocoll Receives Refusal to File Letter from U.S. FDA for XARACOLL® (bupivacaine HCl collagen-matrix implants) New Drug Application

ATHLONE, Ireland - Innocoll (NASDAQ:INNL), a global, commercial-stage, specialty pharmaceutical company, today announced that it has received a Refusal to File letter from the United States Food and Drug Administration (FDA) for XARACOLL, the company’s product candidate for the treatment of postsurgical pain.

Upon preliminary review, the FDA determined that the application, which was submitted in October 2016, was not sufficiently complete to permit a substantive review.  In the Refusal to File letter, the FDA indicated among other things, that XARACOLL should be characterized as a drug/device combination, which would require that the Company submit additional information.  The company will request a Type A meeting with the FDA to respond to several issues believed to be addressable and seek clarification of what additional information, if any, will be required.  Additional details will be disclosed in the future after discussions with the FDA.

“We expect to work with the FDA over the coming weeks in an effort to address the open issues and to define a path forward for a successful re-filing of our application at the earliest point in time,” said Tony Zook, CEO of Innocoll.

 

About XARACOLL® 
XARACOLL® is a surgically implantable and bioresorbable bupivacaine-collagen matrix that utilizes our CollaRx® proprietary collagen-based delivery technology and is being developed to provide sustained postsurgical pain relief directly into the surgical site. XARACOLL is also designed to reduce the need for systemic opioids and their associated risks.

 

About Innocoll Holdings plc
Innocoll is a global, specialty pharmaceutical company with late stage development programs that is dedicated to engineering better medicines to help patients get better. Our proprietary, biocompatible, and biodegradable collagen products are precision-engineered for targeted use. Applied locally to surgery sites, they are designed to provide a range of benefits. The company's late stage product pipeline is focused on addressing large unmet medical needs, including: XARACOLL for the treatment of postsurgical pain and COLLAGUARD (INL-003), a barrier for the prevention of postsurgical adhesions.

Our currently approved products include: COLLAGUARD® (ex-US), COLLATAMP® G, SEPTOCOLL® E, REGENEPRO®, COLLACARE®, COLLEXA®, and ZORPREVA®.

Opsona Therapeutics Ltd. announces preliminary results from ongoing study in second line lower risk MDS recently presented at the 58th Annual ASH Meeting

Dublin, Ireland – Opsona Therapeutics Ltd (‘Opsona’), the innate immune drug development company focused on novel therapeutic approaches to treat oncology, autoimmune and other inflammatory diseases, today announces the preliminary results from its ongoing prospective, open label Phase I/II study being conducted with OPN-305 in second-line lower (Low and intermediate-1) risk myelodysplastic syndrome (MDS) which created interest when presented recently at the 58th Annual Meeting of the American Society of Hematology (ASH) in San Diego by Prof Garcia-Manero from the MD Anderson Cancer Center.


OPN-305 is a novel proprietary humanized IgG4 monoclonal antibody (MAb) against Toll-Like Receptor 2 (TLR2), a key target within the innate immune system. Opsona has recently received orphan drug designation from the United States Food and Drug Administration for MDS.
The study in patients with lower risk, red cell transfusion dependent, MDS who have failed hypomethylating agents (HMA) ± an erythropoiesis stimulating agent is ongoing in collaboration with MD Anderson Cancer Center in Houston USA with additional sites now being added in the USA.


As of December 2016, 24 eligible patients have been enrolled, 11 at 5 mg dose and 13 at 10 mg/kg. A total of 15 (75%) patients are evaluable for response. Hematological improvement has been seen in 53% (8/15) with 3 (20%) patients achieving transfusion independence and of these 2/5 (40%) were receiving 10 mg/kg while on OPN-305 monotherapy. 12 patients remain on study.
Median age was 72 years (range 42-87). Nine (43 %) patients were classified as Low risk and 15 (63%) as Intermediate-1 risk by IPSS. Thirteen patients (61%) had diploid cytogenetics, 8 (38%) RAEB,5 (23%) RCMD, 3 (14%) RA, 2 (10%) RARS, and 1 (4%) 5q-, RCMD-RS, CMML.


The median number of prior HMA therapies was 2 (range 1-4) with a median duration of prior therapies from time of diagnosis to enrollment of 22.7 months (range 6.3-56.1). The median number of OPN-305 cycles administered is 5 (2-22) with 5 of 9 (55.5%) patients having received azacitidine add-back after 16 weeks of OPN-305 monotherapy. A total of 5 (29%) patients developed AEs related to OPN-305 all grade 1 with gastrointestinal disorders being the most
frequent (23.5%). At this point, no significant drug related toxicity or unexpected infectious complications have been seen and combination with azacitidine has been well tolerated.


To date three (20%) patients were taken off study due to progression to AML and 4 (27%) due to no response all at the 5 mg/kg dose. There is no evidence of treatment related anti-drug antibodies or statistically significant dynamic changes in cytokines in any of the patients.


Myelodysplastic syndromes are a complex and heterogeneous group of bone marrow failure disorders characterized by ineffective hematopoiesis and poor prognosis. There is an urgent need for the development of well tolerated, novel therapies in the treatment of MDS which can delay progression, improve patient survival and quality of life and reduce the social and economic burden of transfusion dependence.


Commenting on today’s announcement Mary Reilly VP Pharmaceutical Development & Operations said “OPN-305 data emerging in this heavily pre-treated group of patients is very encouraging, the unmet need for a safe and tolerable product for this patient population is significant and we are happy to be in collaboration with the MD Anderson Cancer Center one of the leading clinical center’s in this hematological area”


For further information, please contact:
Mary Reilly (VP Pharmaceutical Development and Operations) or Martin Welschof (CEO), telephone: + 353 16770223, e-mail: mreilly@opsona.com, mwelschof@opsona.com

About Opsona Therapeutics
Opsona is a leading immunology drug development company, focused on novel therapeutic approaches to key targets of the innate immune system associated with a wide range of major human diseases, including cancer, autoimmune and other inflammatory diseases. The company was founded in 2004 by three world-renowned immunologists at Trinity College, Dublin. Opsona has a strong international investor consortium including: Amgen Ventures, BB Biotech Ventures, EMBL Ventures, Enterprise Ireland, Fountain Healthcare Partners, Inventages Venture Capital, Novartis Venture Fund, Omnes Capital, Roche Venture Fund, Seroba Life Sciences, Shire and Sunstone Capital

Innocoll Holdings plc Announces Third Quarter 2016 Financial and Operating Results and Provides Corporate Update

ATHLONE, Ireland -- Innocoll Holdings plc (INNL), a global, specialty pharmaceutical company with late stage development programs targeting areas of significant unmet medical needs, today announced financial and operating results for the three months ended September 30, 2016. Using our proprietary collagen-based technology platform, we manufacture and supply a range of biodegradable and fully bioresorbable pharmaceutical products and medical devices that are precision-engineered for targeted use.

“As we recently announced, Innocoll achieved an exciting, new milestone with the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA), for XARACOLL for the treatment of post-surgical pain,” said Tony Zook, Chief Executive Officer of Innocoll. “We anticipate an FDA acceptance of the NDA, for review, by the end of this year, and with a target Prescription Drug User Fee Act (PDUFA) action date in late August 2017, this achievement will take us another step closer to the approval and launch of XARACOLL in potentially less than one year. In preparation, our Saal Germany based manufacturing facility has completed its construction phase, and we are on schedule to undergo pre-approval inspections soon. In addition to progressing XARACOLL, we were also pleased to announce the advancement of COLLAGUARD upon successful demonstration of medical safety in its pre-clinical studies, which cleared the way for our submission of an Investigational Device Exemption (IDE) this month for the prevention of post-surgical adhesions. The COLLAGUARD program is an ideal complement to XARACOLL, which we believe will position Innocoll competitively in the hospital segment. We reported earlier this month that while COGENZIA showed trends of clinical improvement as adjunct treatment of Diabetic Foot Infections (DFIs), the top-line results did not reach statistical significance for the primary endpoint. We will continue to assess all strategic options to bring these much needed new products to the market and the medical community. We plan to manage our cash runway until after the anticipated XARACOLL NDA approval, expected in the third quarter of 2017, and we feel confident about our ability to finance the commercialization of XARACOLL as well as our pipeline”.

 

Third Quarter 2016 and Recent Highlights

  • Submitted an NDA for XARACOLL to the FDA for the treatment of postsurgical pain
  • FDA acceptance anticipated by the end of 2016, with a target PDUFA action date in late August 2017.
  • Presented supportive pharmacokinetic data at American Society of Anesthesiologists (ASA) Annual Meeting in Chicago, in October.
  • Medical publication and presentation of full Phase 3 data are targeted for 2Q 2017. Also under preparation to be published next year are the results of our Health Economics (HECON) study, demonstrating the health economic benefits of using XARACOLL.
  • Assessment of strategic options around product development continues, as well the planning and preparation for commercialization has ramped up.
  • Advanced COLLAGUARD (INL-003), a collagen film being developed as a medical device implanted at the time of surgery for the prevention of postsurgical adhesions
  • Completed pre-clinical studies that demonstrated safety as a surgical adhesion barrier in preclinical studies.
  • The positive data support filing of an IDE this quarter, 4Q 2016. Thereafter, a Pilot (Feasibility) Study, for the prevention of post-surgical adhesions in patients undergoing open myomectomy, could be initiated next year, assuming the availability of resources to fund the study.
  • Announced that Phase 3 clinical trials for COGENZIA showed trends toward clinical response, but top-line data did not achieve statistical significance in improving clinical cure in DFIs.
  • The two COACT Phase 3 clinical trials in patients with moderate to severe DFIs studied COGENZIA administered in conjunction with the standard of care (SOC): systemic antibiotics and wound therapy. Based on top-line data, the COGENZIA plus SOC arm did not meet its primary endpoint of clinical cure of infection after 28 days versus placebo plus SOC or versus SOC alone.
  • While Innocoll continues to analyze the results, and there were trends toward clinical response in the COGENZIA and placebo collagen-matrix arms, the top-line data suggests that neither COACT-1 nor COACT-2 achieved statistical significance.
  • COGENZIA and the placebo collagen-matrix were well tolerated, and the incidence of overall adverse events was similar across all three treatment arms.
  • Continued expansion of Saal manufacturing facilities on schedule with successful completion of key stages
  • New Quality Control Laboratories approved and operational.
  • On-time completion of the CMC Sections and submission of the XARACOLL NDA to the FDA.
  • Construction phase of the commercial manufacturing area completed.  Site qualification/validation activities on target for completion prior to year-end.
  • Successful completion of a EU “Notified Body” medical device inspection.
  • Continuing efforts in preparation for Pre-approval Inspection by FDA.  Initial 3rd Party, ex-FDA compliance audit completed.

 

Third Quarter 2016 Financial Results

Net Loss Attributable to Ordinary Shareholders: Innocoll Holdings plc reported a net loss attributable to its ordinary shares of $17.2 million, or $0.58 per share, for the third quarter of 2016, compared to a loss of $9.1 million, or $0.39 per share, for the third quarter of 2015.

Non-GAAP basic and diluted net loss excluding non-cash expense with respect to share-based compensation and fair value gains and losses on warrants was $15.2 million or $0.51 per share, for the third quarter of 2016, compared to a loss of $12.5 million or $0.53 per share, for the third quarter of 2015.

The weighted average number of ordinary shares outstanding increased from 23.4 million in the third quarter of 2015 to 29.7 million in the third quarter of 2016, primarily as a result of Innocoll's follow-on public offering in the second quarter of 2016. The total number of shares outstanding as at September 30, 2016 was 29.7 million.

Revenues: Revenues were $0.9 million for the third quarter of 2016 compared to $0.7 million in the third quarter of 2015. This increase was primarily due to an increase in sales to EUSA Pharma of CollatampG, our gentamicin implant for the treatment and prevention of post-surgical infection, following the stabilization of the EUSA Pharma business following the transfer from Jazz Pharmaceuticals.

Research and Development (R&D) Expenses: R&D expenses were $8.4 million for the third quarter of 2016 compared to $7.7 million for the third quarter of 2015. R&D expenses in the third quarter of 2016 included $7.5 million in external clinical research expenses, which was primarily driven by our Phase 3 COGENZIA efficacy trials. R&D expenses are expected to decrease significantly in the future as the company concludes the COGENZIA clinical studies and files its NDA for XARACOLL.         

General and Administrative (G&A) Expenses: G&A expenses were $7.1 million for the third quarter of 2016 compared to $6.0 million for the third quarter of 2015. Excluding share-based compensation charges, G&A expenses for the third quarter of 2016 were $4.9 million, as compared to $4.2 million for the third quarter of 2015. The increase in G&A, excluding stock-based compensation, was primarily due to our continued infrastructure to support clinical programs and some pre-commercialization investment.

Other Operating (Expense)/Income: Other expense was $0.6 million for the third quarter of 2016 compared to other income of $5.2 million for the third quarter of 2015. Other expense in the third quarter of 2016 consisted primarily of accrued interest on the company’s existing loan with the European Investment Bank (EIB) and foreign exchange losses, partially offset by the fair value income of warrants outstanding. Other income in the third quarter of 2015 consisted primarily of $5.2 million fair value income of investor options outstanding.

 

Nine Month 2016 Financial Results

Net Loss Attributable to Ordinary Shareholders: Innocoll Holdings plc reported a net loss attributable to its ordinary shareholders of $53.1 million, or $2.05 per share, for the nine months ended September 30, 2016, compared to a loss of $43.1 million, or $1.96 per share, for the nine months ended September 30, 2015. 

Non-GAAP basic and diluted loss excluding non-cash expense with respect to share-based compensation and fair value gains and losses on warrants was $51.5 million or $1.99 per share, for the nine months ended September 30, 2016, compared to a loss of $25.6 million, or $1.17 per share, for the nine months September 30, 2015. 

The weighted average number of Innocoll ordinary shares outstanding increased from 21.9 million during the nine months ended September 30, 2015, to 25.9 million during the nine months ended September 30, 2016, primarily as a result of Innocoll’s follow-on public offering in the second quarter of 2016. The total number of shares outstanding at September 30, 2016 was 29.7 million.

Revenues: Revenues were $3.8 million for the nine months ended September 30, 2016 compared to $2.0 million for nine months ended September 30, 2015. This increase was primarily due to an increase in sales to EUSA Pharma of CollatampG, our gentamicin implant for the treatment and prevention of post-surgical infection, following the stabilization of the EUSA Pharma business following the transfer from Jazz Pharmaceuticals.

Research and Development (R&D) Expenses:  R&D expenses were $34.0 million for the nine months ended September 30, 2016 compared to $18.0 million for the nine months ended September 30, 2015. R&D expenses in the nine months ended September 30, 2016 included $31.1 million in external clinical research expenses, which was primarily due to ramp-up and completion of our Phase 3 XARACOLL efficacy trials and the ramp-up of our Phase 3 COGENZIA efficacy trials. R&D expenses are expected to decrease significantly in the future as the company concludes the COGENZIA clinical studies and files its NDA for XARACOLL.

General and Administrative (G&A) Expenses:  G&A expenses were $20.6 million for the nine months ended September 30, 2016 compared to $13.6 million for the nine months ended September 30, 2015.  Excluding share-based compensation charges, G&A expenses for the nine months ended September 30 2016 were $14.3 million compared to $10.0 million for the nine months ended September 30, 2015. The increase in G&A, excluding stock-based compensation, was primarily due to $2.2 million of one-off expenses related to the re-domiciliation of the company to Ireland, our continued infrastructure to support clinical programs, and some pre-commercialization investment.

Other Operating Income/(Expense): Other income was $2.9 million for the nine months ended September 30, 2016 compared to an expense of $9.3 million for the nine months ended September 30, 2015. Other income in the nine months ended September 30, 2016 consisted primarily of non-cash items due to the fair value income of warrants outstanding, partially offset by accrued interest on the company’s existing loan with the EIB and foreign exchange losses. Other expense in the nine months ended September 30, 2015 consisted primarily of $13.9 million fair value expense of warrants outstanding, partially offset by foreign exchange gains of $4.6 million.


Cash Position

As of September 30, 2016, cash and cash equivalents totaled $30.4 million compared to $53.8 million as of June 30, 2016. 

We expect that our rate of expenses will decrease significantly as our clinical study for COGENZIA concluded and as we finalise completion of the expansion of our Saal, Germany manufacturing facility. We plan to manage our resources to extend the cash runway until after the anticipated XARACOLL NDA approval, expected in the third quarter of 2017.

For further financial information for the quarter ended September 30, 2016, please refer to the financial statements appearing at the end of this release.

 

About Innocoll Holdings plc

Innocoll is a global, specialty pharmaceutical company with late stage development programs that is dedicated to engineering better medicines to help patients get better. Our proprietary, biocompatible, and biodegradable collagen products are precision-engineered for targeted use. Applied locally to surgery sites, they are designed to provide a range of benefits. The company's late stage product pipeline is focused on addressing a number of large unmet medical needs, including: XARACOLL for the treatment of postoperative pain and COLLAGUARD (INL-003), a barrier for the prevention of post-surgical adhesions.

Our currently approved products include: COLLAGUARD® (ex-US), COLLATAMP® G, SEPTOCOLL® E, REGENEPRO®, COLLACARE®, COLLEXA®, and ZORPREVA®, some of which are sold globally through strategic partnerships, including those with Takeda, EUSA Pharma, Biomet 3i and Biomet.  All of our native collagen products — from extraction/purification of type-1 collagen through final delivery form — are manufactured at our certified, integrated plant in Saal, Germany.

For more information, please visit www.innocoll.com. 

CollaRx®, Collatamp®, COLLAGUARD®, Collieva®, CollaCare®, Collexa®, COGENZIA® LidoColl®, LiquiColl®, and XARACOLL® are registered trademarks, and CollaPress™, DermaSil™, Durieva™, and Zorpreva™ are trademarks of the company.

 

Contact:

Corporate:
Pepe Carmona
Chief Financial Officer
(215) 983-3362
pcarmona@innocoll.com

Jeannie Sorenson, M.D.
Vice President, Investor Relations
(314) 458-7355
jsorenson@innocoll.com

Opsona Therapeutics Ltd. to present preliminary results from ongoing study in second line lower risk myelodysplastic syndrome at the 58th Annual Meeting of the American Society of Hematology (ASH)

Dublin, Ireland – Opsona Therapeutics Ltd (‘Opsona’), the innate immune drug development company focused on novel therapeutic approaches to treat oncology, autoimmune and other inflammatory diseases, today announces that it will present preliminary results from its ongoing prospective, open label Phase I/II study being conducted with OPN-305 in second-line lower (Low and intermediate-1) risk myelodysplastic syndrome (MDS). The presentation will take place on Saturday, 3 December at the 58th Annual Meeting of the American Society of Hematology (ASH) in San Diego.

Myelodysplastic syndromes are a complex and heterogeneous group of bone marrow failure disorders characterized by ineffective hematopoiesis and poor prognosis. There is an urgent need for the development of novel therapies in the treatment of MDS which can delay progression, improve patient survival and quality of life, and which have fewer adverse effects. Opsona has recently received orphan drug designation (ODD) from the United States Food and Drug


Administration for MDS.

OPN-305 is a novel proprietary humanized IgG4 monoclonal antibody (MAb) against Toll-Like Receptor 2 (TLR2), a key target within the innate immune system.

The study in patients with lower risk MDS who have failed hypomethylating agents is ongoing in collaboration with MD Anderson Cancer Center in Houston USA with additional sites now being added in the USA. The lead principal investigator Professor Guillermo Garcia-Manero will present the preliminary data at ASH and commenting on today’s announcement said “Inhibition of TLR2 with OPN-305 is safe and is currently demonstrating strong clinical activity in patients with lower risk MDS after hypomethylating agent therapy”

Details of the presentation are as follows:

A Clinical Study of OPN-305, a Toll-like receptor 2 (TLR-2) antibody, in patients with Lower Risk Myelodysplastic Syndromes (MDS) that have received prior Hypomethylating Agent (HMA) Therapy

Abstract # 227
Session Name: 637. Myelodysplastic Syndromes—Clinical Studies: Lower Risk MDS Clinical Studies
Session Date: Saturday, December 3, 2016
Session Time: 4:00 PM - 5:30 PM
Presentation Time: 5:00 PM Room: Manchester Grand Hyatt San Diego, Grand Hall C

The ASH abstract is now online can be accessed here:
https://ash.confex.com/ash/2016/webprogram/Paper97931.html


For further information, please contact:

Mary Reilly (VP Pharmaceutical Development and Operations) or Martin Welschof (CEO), telephone: + 353 16770223, e-mail: mreilly@opsona.com, mwelschof@opsona.com


About Opsona Therapeutics

Opsona is a leading immunology drug development company, focused on novel therapeutic approaches to key targets of the innate immune system associated with a wide range of major human diseases, including cancer, autoimmune and other inflammatory diseases. The company was founded in 2004 by three world-renowned immunologists at Trinity College, Dublin. Opsona has a strong international investor consortium including: Amgen Ventures, BB Biotech Ventures, EMBL Ventures, Enterprise Ireland, Fountain Healthcare Partners, Inventages Venture Capital, Novartis Venture Fund, Omnes Capital, Roche Venture Fund, Seroba Life Sciences, Shire and Sunstone Capital

Innocoll Announces Top-Line Data From Phase 3 Trials With COGENZIA and NDA Submission for XARACOLL

  • COACT-1 and COACT-2 Phase 3 clinical trials for COGENZIA did not achieve statistical significance in improving clinical cure in diabetic foot infections (DFI)
  • New Drug Application (NDA) for XARACOLL submitted to the U.S. Food and Drug Administration (FDA) for the treatment of postsurgical pain
  • COLLAGUARD pre-clinical safety studies completed; IDE submission on track for later this month
  • Conference call on top-line results scheduled for Friday, November 4, 2016 at 8:30 a.m. Eastern Daylight Time

ATHLONE, Ireland -- Innocoll Holdings plc (NASDAQ:INNL) a global, commercial-stage, specialty pharmaceutical company, today announced that  based on top-line data from its COACT-1 and COACT-2 Phase 3 clinical trials of COGENZIA (gentamicin collagen topical matrix) in patients  with moderate to severe diabetic foot infections administered in conjunction with systemic antibiotics and wound therapy, the standard of care (SOC), did not meet their primary endpoint of clinical cure of infection after 28 days versus either placebo plus SOC or SOC alone. 

While there were trends toward clinical response (clinical cure plus improvement) in the COGENZIA arm and the placebo collagen-matrix arm, neither COACT-1 nor COACT-2 achieved statistical significance on their shared primary endpoint of clinical cure after 28 days.  While Innocoll continues to analyze the clinical results, the top-line data suggests that the addition of gentamicin delivered topically through COGENZIA, in conjunction with SOC, does not confer sufficient additional clinical benefit over the placebo, administered with SOC, or SOC alone.  

COGENZIA and the placebo collagen-matrix were well-tolerated in both studies.  Incidence of overall adverse events was similar across all three treatment arms in the COACT-1 and COACT-2 studies, respectively.

Innocoll also announced the submission of a New Drug Application (NDA) for XARACOLL (bupivacaine HCl collagen-matrix implants) to the U.S. Food and Drug Administration (FDA) for the treatment of postsurgical pain.  The submission was based upon the successful results of the MATRIX trials which showed statistically significant differences in the primary endpoint, the sum of pain intensity in both studies, as well as statistically significant reductions in opioid use and other secondary endpoints.

Finally, Innocoll announced the pre-clinical safety studies for COLLAGUARD (INL-003) have been completed.  COLLAGUARD is a collagen film being developed as a medical device for the prevention of postsurgical adhesions implanted at the time of surgery.  Innocoll is preparing to submit an Investigational Device Exemption (IDE) later this month.

“Having multiple late-stage product opportunities has always underpinned the value of Innocoll,” said Innocoll CEO Tony Zook.  “The submission of the XARACOLL NDA with potential commercialization in 2017 and the progress of the registration program for COLLAGUARD positions Innocoll competitively in the hospital segment.  We will also continue to assess all strategic options to bring these needed therapies to the market.”  

 

About COGENZIA

COGENZIA is a topical gentamicin collagen-matrix patch that utilizes our COLLARX® proprietary collagen-based delivery technology and was under development to provide topical anti-infective efficacy in combination with systemic antibiotic therapy and standard ulcer care in patients with diabetic foot infections (DFI). 

 

About COACT-1 and COACT-2

COACT-1 and COACT-2 Phase 3 studies are two identical, randomized, placebo-controlled, blinded studies that enrolled 1,136 patients at 160 separate centers in the United States, Europe and Australia.  The primary objective was to determine the effect of COGENZIA in combination with systemic antibiotic therapy compared to placebo matrix and no matrix, both in combination with systemic antibiotic therapy on diabetic patients’ clinical outcome in the treatment of infected foot ulcers.  Patients were randomized to receive 1 of 3 study treatments; systemic antibiotic therapy and standard ulcer care with either (1) daily application of a topical gentamicin collagen-matrix patch, (2) daily application of a topical placebo-matrix patch or (3) no-matrix, in the ratio 2:1:1.  Patients were treated up to 28 days and returned to the clinic weekly for safety and efficacy assessments. Final efficacy assessments used in the primary efficacy analyses were obtained at the first follow-up visit approximately 10 days after treatment was stopped. The remaining follow-up visits occurred at approximately 30, 60 and 90 days after treatment stopped.   The primary endpoint is the percent of patients achieving resolution of all clinical signs and symptoms of infection at the first follow-up visit per the judgment of each treating clinician using the 2012 IDSA Clinical Practice Guideline for the Diagnosis and Treatment of Diabetic Foot Infections.

The study design was in agreement with the FDA under a special protocol assessment (SPA) and COGENZIA was granted a Qualified Infectious Disease Product (QIDP) designation for a potential priority review of 6 months for approval in addition to expanding the marketing exclusivity to 8 years.

 

About Innocoll

Innocoll is a global, commercial-stage, specialty pharmaceutical company that is dedicated to engineering better medicines. Our proprietary, biocompatible, and biodegradable collagen-based products are engineered for targeted use. Applied locally to wound and/or surgery sites, they are designed to provide a range of treatment benefits. The company's late stage product pipeline is focused on addressing a number of large unmet medical needs, including: XARACOLL for the treatment of postsurgical pain; COGENZIA, a topical gentamicin collagen-matrix patch for the adjuvant treatment of diabetic foot infections; and INL-003, a barrier for the prevention of postsurgical adhesions.

Our currently approved products include: COLLAGUARD® (ex-US), COLLATAMP® G, SEPTOCOLL® E, REGENEPRO®, COLLACARE®, COLLEXA®, and ZORPREVA®, some of which are sold globally through strategic partnerships. All of our collagen products—from extraction/purification of Type-1 collagen through final delivery form—are manufactured at our certified, integrated plant in Saal, Germany.

For more information, please visit www.innocoll.com.

 

Ongoing Pipeline Studies

On May 25, 2016 Innocoll announced that two placebo-controlled Phase 3 pivotal studies evaluating XARACOLL® (bupivacaine HCl collagen-matrix implants) each achieved the primary endpoint as a postsurgical pain relief treatment immediately following open abdominal hernia repair. XARACOLL showed consistency across both studies in treatment effect for pain reduction and opioid reduction. Based on these results, Innocoll has submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA).

Additionally, a clinical program is under development for COLLAGUARD (INL-003), a collagen barrier for the prevention of postsurgical adhesions, to support approval in the U.S. The nonclinical program has been completed and Innocoll is preparing to submit an Investigational Device Exemption (IDE) later this year.

For more information, please visit www.innocoll.com.

Neuravi Secures €15 Million to Fund Expansion

Financing Will Support U.S. Commercialization and Broaden the Company’s Product Offering for Stroke Treatment

 

Galway, Ireland – Neuravi, a company dedicated to better clinical outcomes for stroke patients, today announced €15 million in venture debt financing from IPF Partners, a leading alternative financing provider focused on the healthcare sector.
 
This financing allows Neuravi to invest in U.S. commercialization and stroke treatment portfolio expansion, building upon successful commercialization of the company’s EmboTrap® Revascularization Device in Europe and rapid progress enrolling the ARISE II U.S. pivotal study.
 
Landmark acute stroke clinical trials published in 2014 and 2015 demonstrating the superiority of stent retriever technology in treating large vessel strokes have driven a surge in the number of stent retriever procedures. Based on extensive physician engagement and Neuravi’s groundbreaking work on the science of clot, Neuravi has built a strong pipeline of products focused exclusively on acute ischemic stroke and intends to commercialize this pipeline globally in the years ahead.
 
“With the recent European launch of the EmboTrap II device and the excellent progress in enrolling our pivotal clinical trial, we are making significant headway in delivering next-generation technology for stroke treatment to physicians. This financing allows us to build our commercial presence in the U.S. and further invest in R&D for our exciting product pipeline,” said Eamon Brady, Neuravi CEO. “We see significant innovation opportunity due to the under-developed stroke treatment ‘toolbox’ available to stroke clinicians today. Our vision is to design and build devices that truly address the needs of acute stroke patients and put them in the hands of stroke physicians all over the world. This funding is an important step on our roadmap.”
 

About EmboTrap
The EmboTrap Revascularization Device is engineered to restore blood flow to the brain by retrieving clot with a proprietary dual-layer stent-like structure. The device’s integrated distal protection zone is designed to reduce the risk of clot fragmentation during retrieval, which could cause additional harm to the patient.  The EmboTrap II Revascularization Device is available in Europe to treat patients with acute ischemic stroke. The EmboTrap is currently available for investigational use only in the U.S. under the ARISE II clinical trial, which will support a U.S. Food and Drug Administration (FDA) submission for approval to market the device in the United States. 
 

About Neuravi
Neuravi designs, develops and manufactures innovative medical devices for the treatment of acute ischemic stroke. Through the Neuravi Thromboembolic Initiative (NTI), Neuravi supports collaboration between engineers, clinicians and researchers to improve patient outcomes in stroke by deepening the understanding of the science of clot and occlusions.  Neuravi is exclusively focused on acute ischemic stroke.  More information can be found at www.neuravi.com.
 

IPF Partners
IPF Partners, based in Luxembourg, is a leading alternative financing provider focused on the healthcare sector. IPF invests directly in emerging pharma/biotech, medtech and diagnostics companies. Founded in 2011 by a seasoned multi-disciplinary team combining over fifty years of finance and investment and over thirty years of healthcare experience, IPF has developed a unique business model using the team’s specialist sector knowledge to provide bespoke, long-term financing. For more information visit www.ipfpartners.com.
 

# # #
 
Media Contact:
Nicole Osmer, +1 (650) 454-0504
nicole@nicoleosmer.com

Vivasure Medical Appoints Robert (Chip) Hance to Company’s Board of Directors

25-Year Medical Device Veteran Brings Deep Industry, Commercialization Experience

Galway, Ireland — Vivasure Medical™, a company developing a novel bioabsorbable technology for percutaneous vessel closure, today announced the appointment of Robert (Chip) Hance to the company’s board of directors. 

Hance is a 25-year veteran of the medical device industry. He is the former CEO of Creganna Medical, a private equity-backed Ireland-based supplier to the minimally invasive medical device industry, which was recently acquired by TE Connectivity. Previously, he served as an Entrepreneur in Residence at the U.S. Food and Drug Administration (FDA) and in multiple executive roles at Abbott including president of Abbott Vascular, president of Abbott Diabetes Care, president of Vascular Devices and divisional vice president of Abbott Diagnostics in Europe.

“I can think of no one better suited than Chip to help lead Vivasure to the next stage in its evolution,” said Gerard Brett, co-founder and CEO of Vivasure Medical. “Chip is a highly respected leader who has done much to advance innovation in our industry and to improve healthcare outcomes for patients around the world. We look forward to working closely with him as we further our mission of developing novel bioabsorbable technologies for percutaneous vessel closure.”

Hance’s appointment follows the recent completion of Vivasure’s Series C financing of €16.2M ($18.3M) to support European commercialization of the company’s PerQseal™ technology and to advance execution of a FDA regulatory study.

“I look forward to joining the Board as Vivasure advances its progress toward European market expansion and securing U.S. approval and commercialization of the company’s first product,” said Hance. “Vivasure’s closure device meets an important and growing clinical need and I am excited about the potential of this innovative technology to improve arteriotomy closure outcomes for patients.”

“On behalf of the entire Board and Vivasure’s investors, we are pleased to welcome Chip to the company’s Board of Directors,” said Bernard Collins, chairman of Vivasure’s Board of Directors. “His guidance will be invaluable as Vivasure moves toward this next stage of accelerated growth and opportunity.”

The Vivasure Closure Device is the first product from the company’s PerQseal™ technology platform, and is the only approved fully bioabsorbable, sutureless and entirely synthetic option to close large-bore arteriotomies that result from percutaneous transcatheter procedures, including transcatheter aortic valve replacement (TAVR) and endovascular abdominal aortic aneurysm repair (EVAR). The device has been successfully evaluated in clinical studies, with patients treated in four European countries, achieving 97 percent device technical success with no major device-related complications. Long-term follow-up data has been collected to 12 months post-procedure, and CE Mark was received in January 2016. The global market for large arteriotomy closure devices is growing rapidly and is expected to be more than $500 million by 2021.

Hance holds a bachelor’s degree in chemical engineering from Massachusetts Institute of Technology and an MBA from Harvard Business School.

 

About Vivasure Medical    

Based in Galway, Ireland, Vivasure Medical has developed a patented bioabsorbable implant platform technology for applications in vessel closure. Its first product from this PerQseal platform features a bioabsorbable implant and percutaneous delivery system, designed to close large arteriotomies. For more information visit www.vivasuremedical.com

 

Mainstay Medical Announces Additional U.S. Patent Issued

Mainstay Medical International plc ("Mainstay" or the "Company", Euronext Paris: MSTY.PA and ESM of the Irish Stock Exchange: MSTY.IE), a medical device company focused on bringing to market ReActiv8®, an implantable neurostimulation system to treat disabling Chronic Low Back Pain ("CLBP"), today announced the issuance of a new U.S. Patent, which strengthens its intellectual property portfolio.

  • U.S. Patent No. 9,474,906 "Systems and Methods for Restoring Muscle Function to the Lumbar Spine"

Corresponding applications have been made in other countries. Mainstay continues to add to its portfolio of issued patents and pending applications.
 
Peter Crosby, CEO of Mainstay, commented: "This new U.S. patent bolsters our growing intellectual property portfolio, which now includes eight issued U.S. patents. We are proud of the continued development of the intellectual property underpinning ReActiv8, a medical device which offers a new approach to the treatment of CLBP, addressing cause and not simply symptoms."

ReActiv8 is designed to electrically stimulate the nerves responsible for contracting muscles which stabilize the lumbar spine. Activation of these muscles to restore functional stability has been shown to facilitate recovery from CLBP. Mainstay received CE Marking for ReActiv8 in May 2016 based on positive results from the ReActiv8-A Clinical Trial that demonstrated a clinically important, statistically significant and lasting improvement in pain, disability and quality of life in people with disabling CLBP and few other treatment options.

The ReActiv8-B Clinical Trial is intended to gather data in support of an application for pre-market approval (PMA) from the U.S. Food and Drug Administration (FDA), and the first subject in the Clinical Trial was implanted with ReActiv8 in October 2016.

 

About Mainstay
Mainstay is a medical device company focused on bringing to market an innovative implantable neurostimulation system, ReActiv8®, for people with disabling Chronic Low Back Pain (CLBP). The Company is headquartered in Dublin, Ireland. It has subsidiaries operating in Ireland, the United States, Australia and Germany, and its ordinary shares are admitted to trading on Euronext Paris (MSTY.PA) and the ESM of the Irish Stock Exchange (MSTY.IE).

 

About Chronic Low Back Pain
One of the recognised root causes of CLBP is impaired control by the nervous system of the muscles that dynamically stabilise the spine in the low back, and an unstable spine can lead to back pain. ReActiv8 is designed to electrically stimulate the nerves responsible for contracting these muscles and thereby help to restore muscle control and improve dynamic spine stability, allowing the body to recover from CLBP.

People with CLBP usually have a greatly reduced quality of life and score significantly higher on scales for pain, disability, depression, anxiety and sleep disorders. Their pain and disability can persist despite the best available medical treatments, and only a small percentage of cases result from an identified pathological condition or anatomical defect that may be correctable with spine surgery. Their ability to work or be productive is seriously affected by the condition and the resulting days lost from work, disability benefits and health resource utilisation put a significant burden on individuals, families, communities, industry and governments.

Further information can be found at www.mainstay-medical.com

 

PR and IR Enquiries:
Consilium Strategic Communications (international strategic communications – business and trade media)
Chris Gardner, Mary-Jane Elliott, Jessica Hodgson, Hendrik Thys
Tel: +44 203 709 5700 / +44 7921 697 654
Email: mainstaymedical@consilium-comms.com

FTI Consulting (for Ireland)
Jonathan Neilan Tel: +353 1 663 3686
Email: jonathan.neilan@fticonsulting.com

NewCap (for France)
Julie Coulot
Tel: +33 1 44 71 20 40
Email: jcoulot@newcap.fr

 

Investor Relations:
LifeSci Advisors, LLC
Brian Ritchie
Tel: + 1 (212) 915-2578
Email: britchie@lifesciadvisors.com

 

ESM Advisers:
Davy

Fergal Meegan or Barry Murphy
Tel: +353 1 679 6363
Email: fergal.meegan@davy.ie or barry.murphy2@davy.ie

Opsona Therapeutics Ltd. receives orphan designation for myelodysplastic syndrome (MDS) with OPN-305, a first-in-class monoclonal antibody that blocks Toll-Like Receptor 2

Dublin, Ireland – Opsona Therapeutics Ltd (‘Opsona’), the innate immune drug and development company focused on novel therapeutic approaches to treat oncology, autoimmune and other inflammatory diseases, today announced that it has received orphan drug designation (ODD) from United States Food and Drug Administration for myelodysplastic syndromes (MDS).

Myelodysplastic syndromes are a complex and heterogeneous group of bone marrow failure disorders characterized by ineffective hematopoiesis, and poor prognosis. There is an urgent need for the development of novel therapies in the treatment of MDS which can delay progression, improve patient survival and quality of life, and which have fewer adverse effects.

OPN-305 is a novel proprietary humanized IgG4 monoclonal antibody (MAb) against Toll-Like Receptor 2 (TLR2), a key target within the innate immune system.

Evaluation of OPN-305 in MDS is the first of a range of oncology indications that the company is exploring with its leading drug in development, OPN-305. A study in patients with lower risk MDS who have failed hypomethylating agents is ongoing in collaboration with MD Anderson Cancer Center in Houston USA. Opsona believes that OPN-305 has the potential to be first and best-in-class while also providing a novel treatment option for a wide variety of oncology, autoimmune and other inflammatory diseases.

Commenting on today’s announcement, Mary Reilly, VP Pharmaceutical Development and Operations at Opsona Therapeutics, said: “We are pleased to receive FDA Orphan Drug Designation for OPN-305 in MDS. This is an important regulatory milestone for the company and a significant step forward in our clinical development of OPN-305 targeting this rare disease associated with an unmet medical need for safe and effective therapeutics."

 

For further information, please contact:

Mary Reilly (VP Pharmaceutical Development and Operations) or Martin Welschof (CEO), telephone: + 353 16770223, e-mail: MReilly@opsona.com, mwelschof@opsona.com
Or
Jim Devlin, FTI Consulting, e. jim.devlin@fticonsulting.com ; d. +353 (0)1 6633600; m. +353 (0)87 2631057
 


About Opsona Therapeutics

Opsona is a leading immunology drug development company, focused on novel therapeutic approaches to key targets of the innate immune system associated with a wide range of major human diseases, including cancer, autoimmune and other inflammatory diseases. The company was founded in 2004 by three world-renowned immunologists at Trinity College, Dublin. Opsona has a strong international investor consortium including: Amgen Ventures, BB Biotech Ventures, EMBL Ventures, Enterprise Ireland, Fountain Healthcare Partners, Inventages Venture Capital, Novartis Venture Fund, Omnes Capital, Roche Venture Fund, Seroba Life Sciences, Shire and Sunstone Capital

First Subject Implanted in Mainstay Medical's ReActiv8-B Clinical Trial for Treatment of Chronic Low Back Pain

Trial to gather data in support of an application for US pre-market approval (PMA)

 

Dublin - Ireland - Mainstay Medical International plc ("Mainstay" or the "Company", Euronext Paris: MSTY.PA and ESM of the Irish Stock Exchange: MSTY.IE), a medical device company focused on bringing to market ReActiv8®, an implantable neurostimulation system to treat disabling Chronic Low Back Pain ("CLBP"), announces that the first subject in the ReActiv8-B Clinical Trial (the "Clinical Trial") has been implanted with ReActiv8.

The first subject was implanted at the Monash House Private Hospital in Melbourne, Australia by Dr. Bruce Mitchell, a sports and interventional pain physician.

Dr. Mitchell commented: "Following our positive experience in the ReActiv8-A trial, we are very excited to be part of this pivotal trial to support a PMA in the US. Many of our patients have been suffering from chronic low back pain for years and have exhausted all available treatment options. ReActiv8 allows us to offer them a new, unique approach which addresses the cause of pain rather than just the symptoms."

The ReActiv8-B Clinical Trial is intended to gather data in support of an application for pre-market approval (PMA) from the US Food and Drug Administration (FDA), a key step towards commercialization of ReActiv8 in the US.

As the Clinical Trial progresses, the information at https://clinicaltrials.gov/show/NCT02577354 will be updated.

ReActiv8 is designed to electrically stimulate the nerves responsible for contracting muscles which stabilize the lumbar spine. Activation of these muscles to restore functional stability has been shown to facilitate recovery from CLBP. Mainstay received CE Marking for ReActiv8 in May 2016 based on positive results from the ReActiv8-A Clinical Trial that demonstrated a clinically important, statistically significant and lasting improvement in pain, disability and quality of life in people with disabling CLBP and few other options.[1]

Peter Crosby, CEO of Mainstay, commented: "The implant of the first subject in the ReActiv8-B Clinical Trial represents further significant progress for Mainstay. During a year in which we have obtained CE Mark for ReActiv8, triggering the start of European commercialization activities, and raised €30m of new capital in June, the ReActiv8-B Clinical Trial provides further traction for our route to market in the US."


ReActiv8-B Clinical Trial

The ReActiv8-B Clinical Trial is an international, multi-center, prospective randomized sham controlled blinded trial with one-way crossover, conducted under an Investigational Device Exemption (IDE). The statistical design of the Clinical Trial requires data from the pivotal cohort of 128 randomized subjects at the 120-day primary outcome assessment visit.

The primary efficacy endpoint of the ReActiv8-B Clinical Trial is a comparison of responder rates between the treatment and control arms. The Clinical Trial will be considered a success if there is a statistically significant difference in responder rates between the treatment and control arms. The Clinical Trial, if successful, will provide Level 1 Evidence of efficacy of ReActiv8, which may be used to support applications for favourable reimbursement in the US. Evidence from the ReActiv8-B Trial will also be used to support market development activities worldwide.

Based on experience with enrolment in the ReActiv8-A Clinical Trial, it is estimated that full enrolment in the ReActiv8-B Clinical Trial will take 12 to 18 months from first enrolment, with results anticipated to be available approximately six months following full enrolment.

CAUTION - in the United States, ReActiv8 is limited by federal law to investigational use only.

________________________________

[1]    Please refer to the Company's web site for the Press Release of 20 September 2016 with details of results of the ReActiv8-A Clinical Trial and follow-up data after a one-year period.


 

About Mainstay
Mainstay is a medical device company focused on bringing to market an innovative implantable neurostimulation system, ReActiv8®, for people with disabling Chronic Low Back Pain (CLBP). The Company is headquartered in Dublin, Ireland. It has subsidiaries operating in Ireland, the United States, Australia and Germany, and its ordinary shares are admitted to trading on Euronext Paris (MSTY.PA) and the ESM of the Irish Stock Exchange (MSTY.IE).

 

About the ReActiv8-B Clinical Trial
The ReActiv8-B Clinical Trial is an international, multi-center, prospective randomized sham controlled blinded trial with one-way crossover conducted under an Investigational Device Exemption (IDE). The ReActiv8-B Clinical Trial is designed to generate data to form part of the Pre-Market Approval Application (PMAA) of ReActiv8 to the FDA. Further details can be found at https://clinicaltrials.gov/show/NCT02577354

 

About Chronic Low Back Pain
One of the recognised root causes of CLBP is impaired control by the nervous system of the muscles that dynamically stabilise the spine in the low back, and an unstable spine can lead to back pain. ReActiv8 is designed to electrically stimulate the nerves responsible for contracting these muscles and thereby help to restore muscle control and improve dynamic spine stability, allowing the body to recover from CLBP.

People with CLBP usually have a greatly reduced quality of life and score significantly higher on scales for pain, disability, depression, anxiety and sleep disorders. Their pain and disability can persist despite the best available medical treatments, and only a small percentage of cases result from an identified pathological condition or anatomical defect that may be correctable with spine surgery. Their ability to work or be productive is seriously affected by the condition and the resulting days lost from work, disability benefits and health resource utilisation put a significant burden on individuals, families, communities, industry and governments.

Further information can be found at www.mainstay-medical.com

 

PR and IR Enquiries:
 

Consilium Strategic Communications (international strategic communications – business and trade media)
Chris Gardner, Mary-Jane Elliott, Jessica Hodgson, Hendrik Thys
Tel: +44 203 709 5700 / +44 7921 697 654
Email: mainstaymedical@consilium-comms.com

FTI Consulting (for Ireland)
Jonathan Neilan Tel: +353 1 663 3686
Email: jonathan.neilan@fticonsulting.com

NewCap (for France)
Julie Coulot
Tel: +33 1 44 71 20 40
Email: jcoulot@newcap.fr

Investor Relations:
LifeSci Advisors, LLC
Brian Ritchie
Tel: +1 (212) 915-2578
Email: britchie@lifesciadvisors.com

ESM Advisers:
Davy
Fergal Meegan or Barry Murphy
Tel: +353 1 679 6363
Email: fergal.meegan@davy.ie or barry.murphy2@davy.ie