Innocoll AG Announces First Patient Dosed in the Cogenzia COACT-1 Phase 3 Study for the Treatment of Diabetic Foot Infection

ATHLONE, Ireland, - Innocoll AG (Nasdaq:INNL), a global, commercial-stage, specialty pharmaceutical company that develops, manufactures and supplies a range of pharmaceutical products and medical devices using its proprietary collagen-based technologies, today announced that the first patient was dosed in the COACT-1 (COgenzia Adjuvant for Complete Therapy) Phase 3 study for the treatment of diabetic foot infections (DFIs) using Cogenzia, Innocoll's topically applied, bioresorbable collagen sponge.

Diabetic foot ulcers are a serious health concern and affect approximately 7% of diabetic patients each year. Up to approximately 58% of these ulcers may become infected. Published data demonstrates that the current standard of care for DFIs with systemic antibiotics has a 30-50% failure rate. Failure of treatment can lead to significantly increased risk of hospitalization and often to the need for amputation resulting in increased costs to the healthcare system and a much higher risk of mortality for patients. We believe Cogenzia has the potential to be the first topical antibiotic approved as adjuvant therapy for the treatment of DFIs and could significantly improve upon the current cure success rate.

Cogenzia acts in conjunction with systemic antibiotics and standard wound care to provide high concentrations of gentamicin directly to the site of DFIs. These concentrations are not normally possible with systemic gentamicin treatment due to the risk of side effects. In the Cogenzia Phase 2 program, data demonstrated a statistically significant improvement in the clinical cure rate when compared to systemic antibiotics and wound care alone. In the Phase 2 study, 100% of Cogenzia-treated subjects experienced a clinical cure compared to 70% for the control group.

"DFIs are a serious concern for diabetics which can result in significant morbidity such as inpatient hospitalization, delayed healing and even amputation," said Dr. James Tursi, chief medical officer at Innocoll. "With no FDA approved topical therapy options for DFIs, this first patient dosed in COACT-1 signifies an important step forward in addressing this serious health concern. We believe that Cogenzia, if successful in clinical trials, could lead to the first FDA-approved, topical adjuvant treatment option for DFIs."

The COACT-1 Phase 3 study is one of two identical randomized, placebo-controlled, blinded studies to investigate the safety and efficacy of a topical gentamicin-collagen sponge in combination with systemic antibiotic therapy in diabetic patients with an infected foot ulcer. The second Phase 3 study, COACT-2, is expected to start later this year. Each study is expected to enroll approximately 500 patients between the ages of 18 and 85 in the United States (COACT-1 and 2) and EU (COACT-2). Patients diagnosed with moderate to severe DFIs will be treated in one of three arms per study: a Cogenzia sponge, a placebo sponge or no sponge with all patients in the study receiving systemic antibiotics and standard would care.

The primary endpoint is treatment effectiveness, test of clinical cure, which will be evaluated by the investigator at the post-treatment visit scheduled approximately 10 days post completion of treatment. Safety will be evaluated through the collection of adverse events through 90 days post-test of clinical cure. Additional key secondary endpoints include the percentage of patients with complete eradication of the pathogen, time to clinical cure, percentage of patients with an amputation and percentage with ulcer closure.

To qualify for the study, patients must have diabetes mellitus, according to the American Diabetes Association (ADA) criteria and have at least one skin ulcer located on or below the ankle that presents as a moderate or severe infection based on the Infectious Disease Society of America guidelines for the "Diagnosis and Treatment of Diabetic Foot Infections" (CID 2012; 54:132-173). Following screening and determination of eligibility, study participants will be assigned to one of three groups. Patients will be treated with daily sponge / dressing changes and systemic antibiotics for up to 28 days and the evaluation of clinical cure will occur 10 days thereafter. Topline results from the study are expected in the middle of 2016.

More information on the study will be posted at www.clinicaltrials.gov.

About Innocoll AG

Innocoll is a global, commercial-stage, specialty pharmaceutical company. The company develops and manufactures a range of pharmaceutical products and medical devices using its proprietary collagen-based technologies. The company's late stage product pipeline is focused on addressing a number of large unmet medical needs, including: XaraColl® for the treatment of post-operative pain; Cogenzia® for the adjuvant treatment of diabetic foot infections; and CollaGUARD®, a barrier for the prevention of post-surgical adhesions. The Company's approved products include: CollaGUARD(Ex-US), Collatamp® G, Septocoll®, RegenePro®, Collieva®, CollaCare®, Collexa®, and Zorpreva™, which are sold through strategic partnerships with various partners including Takeda, Biomet, and EUSA Pharma. All of the company's products and product candidates are made using Type 1 collagen and are manufactured in-house at its facility in Saal, Germany. CollaRx®, Collatamp®, CollaGUARD®, Collieva®, CollaCare®, Collexa®, Cogenzia® LidoColl®, LiquiColl®, Septocoll®, and XaraColl® are registered trademarks, and CollaPress™, DermaSil™, Durieva™, and Zorpreva™ are trademarks of the company.

Mainstay Medical – Interim Management Statement

Dublin, Ireland: Mainstay Medical International plc (“Mainstay” or the “Company” listed on Euronext Paris: MSTY.PA and ESM of the Irish Stock Exchange: MSTY.IE) is issuing this Interim Management Statement covering the period from 1 January 2015 to today’s date.

Mainstay is an Irish medical device company with operations in Ireland, the United States and Australia. The Company is focused on the development and commercialisation of ReActiv8®, an innovative implantable neurostimulation system designed to treat people with Chronic Low Back Pain (“CLBP”) by helping to restore control to the muscles that dynamically stabilise the lumbar spine.

Business Update

The ReActiv8-A clinical trial is at an advanced stage in Australia and Europe. Over 40 subjects have been implanted in the trial and the Company is pleased with this progress. Mainstay believes that data from these subjects may be sufficient to apply for a CE Mark. The Company plans to announce data from the ReActiv8-A clinical trial after the outcome data from all implanted subjects are available, audited and adjudicated.

In January 2015, the Company submitted an application to the US Food and Drug Administration (“FDA”) for approval to start a clinical trial of ReActiv8 under an Investigational Device Exemption (an “IDE”). The Company is interacting with the FDA to develop a clinical trial that meets the needs of the Company, the FDA and the people who could potentially benefit from ReActiv8.

Financial Update

There have been no significant changes in the financial position of the Company since publication of the Annual Report for the year ended 31 December 2014. The Company had $15.0 million cash on hand as at 31 March 2015.

Outlook

Mainstay looks forward to continuing progress with the ReActiv8-A clinical trial as it works towards obtaining CE Mark, commencing commercialisation of ReActiv8 in Europe and advancing its interactions with the FDA on its IDE application.

Mainstay will host its first Annual General Meeting on 18 June, 2015 in Dublin.

About Mainstay

Mainstay is a medical device company which is developing an innovative implantable neurostimulation system, ReActiv8®, for people with disabling Chronic Low Back Plan (CLBP). Low Back Pain is a leading cause of activity limitation and work absence throughout much of the developed world, imposing a high economic burden on individuals, families, communities, industry, and governments.

The Company is headquartered in Dublin, Ireland. It has subsidiaries operating in Ireland, the United States and Australia, and is listed on Euronext Paris (MSTY.PA) and the ESM of the Irish Stock Exchange (MSTY.IE).

About the ReActiv8-A Trial

The ReActiv8-A clinical trial, is a prospective single arm clinical trial with up to 96 subjects at sites in Australia and Europe. Outcome measures for the ReActiv8-A clinical trial are assessed at a three month endpoint after activation of stimulation and compared to baseline prior to implant. Further details can be obtained at https://clinicaltrials.gov/show/NCT01985230.

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 lower 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 economies.

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

European queries:
Jonathan Neilan, FTI Consulting Tel: +353 1 663 3686
Email: jonathan.neilan@fticonsulting.com

Astrid Villette, FTI Consulting (French language enquiries)
Tel: +33 1 47 03 69 51
Email: Astrid.Villette@fticonsulting.com

US queries:
Jillian Connell, The Trout Group LLC Tel: +1 646 378 2956 / +1 617 309 8349
Email: jconnell@troutgroup.com

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

Innocoll AG Announces Pricing of Follow-On Offering

ATHLONE, Ireland -- Innocoll AG (INNL), a specialty pharmaceutical company, today announced the pricing of its follow-on public offering of 3,321,669 American Depositary Shares ("ADSs") at a public offering price of $9.00 per ADS. Of the ADSs in the offering, 1,999,690 ADSs are being offered by the Company and 1,321,979 ADSs are being offered by selling shareholders. The Company will not receive any proceeds from the sale of ADSs by the selling shareholders. The offering is expected to close on April 30, 2015, subject to the satisfaction of customary closing conditions.

The Company expects to receive total estimated net proceeds from this offering of approximately $16.1 million after deducting underwriting discounts and commissions and estimated offering expenses payable by the Company. The Company intends to use the net proceeds from the offering for general corporate purposes and the development of its products.

Piper Jaffray & Co. is acting as sole manager for the offering. The offering of these securities is being made only by means of a prospectus, copies of which can be obtained from: Piper Jaffray & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, or by telephone at (800) 747-3924, or by email at prospectus@pjc.com.

A registration statement relating to these securities was declared effective by the U.S. Securities and Exchange Commission on April 23, 2015. This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the offered securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About Innocoll AG

Innocoll is a global, commercial-stage, specialty pharmaceutical company. The Company develops and manufactures a range of pharmaceutical products and medical devices using its proprietary collagen-based technologies. The Company's late stage product pipeline is focused on addressing a number of large unmet medical needs, including: XaraColl(R) for the treatment of post-operative pain; Cogenzia(R) for the adjuvant treatment of diabetic foot infections; and CollaGUARD(R), a barrier for the prevention of post-surgical adhesions. The Company's approved products include: CollaGUARD(Ex-US), Collatamp(R) G, Septocoll(R), RegenePro(R), Collieva(R), CollaCare(R), Collexa(R), and Zorpreva(TM), which are sold through strategic partnerships with various partners including Takeda, Biomet, and EUSA Pharma.

CollaRx(R), Collatamp(R), CollaGUARD(R), Collieva(R), CollaCare(R), Collexa(R), Cogenzia(R) LidoColl(R), LiquiColl(R), Septocoll(R), and XaraColl(R) are registered trademarks, and CollaPress(TM), DermaSil(TM), Durieva(TM), and Zorpreva(TM) are trademarks of the Company.

Pivotal Pharmacokinetic Study of Innocoll's XaraColl® Supports Use of 300 mg Dose for Phase 3 Clinical Studies in Post-Operative Pain

ATHLONE, Ireland -- Innocoll AG (Nasdaq:INNL), a global, commercial-stage, specialty pharmaceutical company that develops and manufactures a range of pharmaceutical products and medical devices using its proprietary collagen-based technologies, today announced that the results of a pharmacokinetic (PK) study to support using a dose of 300 mg of XaraColl, Innocoll's collagen/bupivacaine bioresorbable implant, in its planned Phase 3 studies to evaluate the efficacy of XaraColl in the treatment of post-operative pain.

The 62-patient PK study had 3 main objectives:

• To evaluate the PK profile of 200 mg and 300 mg doses of XaraColl compared to a 150 mg bupivacaine HCl injection in patients undergoing open laparotomy hernioplasty;
• To document maximal systemic levels (Cmax) of bupivacaine; and
• To evaluate the preliminary safety and tolerability of XaraColl treatment.

The study confirmed proportional systemic levels of bupivacaine for both the 200 mg and 300 mg dose XaraColl implants. The maximal mean serum concentrations (Cmax) were below levels that would be expected to result in systemic toxic effects. A preliminary review of safety observations in connection with the PK study suggested both doses were well tolerated.

"We were pleased to find that the PK results are consistent with the expected values across each treatment group and no subjects were reported to have a Cmax that might suggest the risk of systemic toxicity," stated James P. Tursi, M.D., Chief Medical Officer of Innocoll. "Additionally, a preliminary safety evaluation suggests that both the 200 mg and 300 mg doses were well tolerated. This top-line data supports a dose selection of 300 mg to move into our Phase 3 program for XaraColl. We look forward to discussing our plans with the FDA."

Tony Zook, Chief Executive Officer of Innocoll added, "Initiating the XaraColl Phase 3 development program is one of our key objectives for 2015 as we continue to execute on our plans. I'm pleased to also announce that we delivered a positive result for this study within our target timelines. We have previously stated that throughout 2015 we will focus on the execution of our key deliverables. With the previously announced debt financing that we have secured and the generation of this positive data, we are off to a solid start towards achieving those targets."

About XaraColl:

XaraColl is a biodegradable and fully bioresorbable collagen/bupivacaine matrix formulated and manufactured using Innocoll's proprietary collagen-based drug delivery technology, CollaRx®. This technology achieves a high concentration of drug at the target tissue, while maintaining relatively low systemic levels. XaraColl is intended to provide pain control directly at the surgical site and thus reduce the level of additional analgesia required following surgery. The product is expected to be available in several different strengths, and is designed such that multiple units can be used per patient, for optimum dosing flexibility and efficacy. XaraColl is easy to use and can be cut or rolled depending on the surgical setting and can be used laparoscopically.

About Innocoll AG

Innocoll is a global, commercial-stage, specialty pharmaceutical company. The company develops and manufactures a range of pharmaceutical products and medical devices using its proprietary collagen-based technologies. The company's late stage product pipeline is focused on addressing a number of large unmet medical needs, including: XaraColl® for the treatment of post-operative pain; Cogenzia® for the adjuvant treatment of diabetic foot infections; and CollaGUARD®, a barrier for the prevention of post-surgical adhesions. The Company's approved products include: CollaGUARD(Ex-US), Collatamp® G, Septocoll®, RegenePro®, Collieva®, CollaCare®, Collexa®, and Zorpreva™, which are sold through strategic partnerships with various partners including Takeda, Biomet, and EUSA Pharma. All of the company's products and product candidates are made using Type 1 collagen and are manufactured in-house at its facility in Saal, Germany. CollaRx®, Collatamp®, CollaGUARD®, Collieva®, CollaCare®, Collexa®, Cogenzia® LidoColl®, LiquiColl®, Septocoll®, and XaraColl® are registered trademarks, and CollaPress™, DermaSil™, Durieva™, and Zorpreva™ are trademarks of the company.

Innocoll AG Secures EUR 25 Million Loan Commitment From European Investment Bank (EIB)

EIB's InnovFin Financing Supports Innovative Companies under Horizon 2020

Financing to Support Manufacturing Facility Expansion and Development of Lead Product Candidates

ATHLONE, Ireland -- Innocoll AG (Nasdaq:INNL) today announced the securing of a credit facility for up to €25 million ($27.5 million) of debt financing to support the expansion of the Company's manufacturing and research and development facility in Saal Germany and clinical development of the Company's lead product candidates, XaraColl®, Cogenzia® and CollaGUARD®. The debt financing, which Innocoll AG entered into together with its subsidiary, Innocoll Pharmaceuticals Limited, is provided by the European Investment Bank (EIB), the long-term lending institution of the European Union owned by its Member States, pursuant to the "InnovFin – EU Finance for Innovators" Midcap Growth Finance program under the European Union's Horizon 2020 research and innovation program.

"The next 12-18 months is a critical period of execution for Innocoll," said Tony Zook, chief executive officer of Innocoll. "This funding will enable us to remain aggressive in our efforts to deliver on our key near term milestones, including the expansion of our manufacturing facility in Saal, Germany as well as the advancement of our late stage clinical development programs. We are pleased to be working with EIB and delighted to be able to participate in the InnovFin program, which provides Innocoll with very favorable financing terms."

The EIB loan commitment of €25 million is comprised of a €15 million tranche which can be drawn in whole or in part at any time up to June, 2016, and a €10 million tranche which can be drawn subject to either of the company's Phase 3 trials for XaraColl or Cogenzia meeting the required primary end points, at any time up to September 2016. The loan has a five year maturity, and an interest rate of 12% per annum, compounded annually. Interest accrues during the term of the loan and is payable only at maturity, and principal is repaid in a single bullet payment at maturity, resulting in no cash payments required during the five year term of the loan. The loan may be repaid by Innocoll early at any time or could be required to be prepaid early by EIB in certain circumstances, in each case subject to a 1% or lower repayment indemnity. There are no commitment fees and no warrants. The loan, which is guaranteed by Innocoll AG, is subject to the EIB's standard loan terms and conditions and, once a tranche is drawn, will include a pledge over the shares of Innocoll Pharmaceuticals Limited and a floating charge over the assets of Innocoll Pharmaceuticals Limited.

The EIB is the long-term lending institution of the European Union owned by its member states. It makes long-term finance available for sound investment in order to contribute towards EU policy goals. "InnovFin – EU Finance for Innovators" MidCap Growth Finance, is backed by the European Union under Horizon 2020 Financial Instruments. InnovFin is a new range of EIB Group products designed to facilitate access to finance for innovative businesses. InnovFin MidCap Growth Finance offers long-term senior, subordinated or mezzanine loans from €7.5 to 25 million for innovative larger midcaps (up to 3000 employees), but also to small-to-medium enterprises and small midcaps.

About Innocoll AG

Innocoll is a global, commercial-stage, specialty pharmaceutical company. The company develops and manufactures a range of pharmaceutical products and medical devices using its proprietary collagen-based technologies. The company's late-stage product pipeline is focused on addressing a number of large unmet medical needs, including: XaraColl® for the treatment of post-operative pain; Cogenzia® for the adjuvant treatment of diabetic foot infections; and CollaGUARD®, a barrier for the prevention of post-surgical adhesions. The Company's approved products include: CollaGUARD, Collatamp® G, Septocoll®, RegenePro®, Collieva®, CollaCare®, Collexa®, and Zorpreva™, which are sold through strategic partnerships with various partners including Takeda, Biomet, and EUSA Pharma.

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 AG Announces Fourth Quarter and Full Year 2014 Financial and Operating Results

ATHLONE, Ireland -- Innocoll AG (Nasdaq:INNL), a global, commercial-stage, specialty pharmaceutical company that develops and manufactures a range of pharmaceutical products and medical devices using its proprietary collagen-based technologies, today announced financial and operating results for the three months and full year ended December 31, 2014.

"2014 was a transformative year for Innocoll as we became a publicly-traded company and laid the foundations to advance our late-stage portfolio to Phase 3 trials in 2015. I'm honored to join Innocoll as we drive the transition toward a commercial stage pharmaceutical company," said Tony Zook, Chief Executive Officer of Innocoll. "Our late stage portfolio is very exciting and one where each of our products holds the promise of providing physicians with clinically meaningful improvements for the patients they serve."

2014 and Recent Highlights

• Completed an IPO of the company on the NASDAQ Global Market, raising proceeds of approximately $52.7 million, net of underwriting discounts and commissions and offering expenses, from the issuance and sale of approximately 6.7 million American Depository Shares (ADSs) in its initial public offering, including shares issued upon the partial exercise of the underwriters' over-allotment option
• Appointed Tony Zook as Chief Executive Officer to better position the company as our pipeline advances to late-stage clinical development and Innocoll prepares to become a fully-integrated specialty pharmaceutical company. Michael Myers becomes Head of Portfolio Operations.
• Appointed James Tursi, M.D., as Chief Medical Officer, a seasoned pharmaceutical executive with extensive experience developing drugs across a number of therapeutic areas. He will be responsible for managing all clinical development programs and medical affairs for the company.
• Assembled a highly experienced Supervisory Board comprised of individuals with broad corporate and industry knowledge, rich in drug development and commercialization experience.
• In definitive documentation stage in relation to a debt facility which, if and when closed, is expected to fully fund expansion of our manufacturing facility in Saal, Germany.
• Completed enrolment in our Phase 3 pivotal XaraColl® pharmacokinetic study.
• Reaffirmed the contents of our SPA for Cogenzia® with the FDA and initiated the Phase 3 efficacy studies.
• Initiated two pilot clinical studies for CollaGUARD® in hysteroscopy and in gynaecological laparoscopic adhesioloysis.
• Our partner, Takeda, received approval for CollaGUARD in Ukraine, Belarus and Kazahkstan supplementing the product's existing approval in Russia.
• Cogenzia approved in Argentina, Australia, Canada, Mexico, and Russia
• Our partner, Biomet 3i, launched RegenePro®, our product to treat dental wounds, in the US.

Clinical Program Update

XaraColl

In July, we initiated a pivotal study comparing the pharmacokinetics and safety of XaraColl our implantable bioresorbable collagen sponge at doses of 200mg and 300mg to a standard bupivacaine solution. Enrollment in the study has now been fully completed and we anticipate that data will be available by the end of Q1. As previously discussed, and assuming there are no safety signals from the study, we intend to test only the 300mg dose in our Phase 3 efficacy program and run both studies in parallel. We will discuss this approach with the FDA prior to initiating the studies, which we anticipate will start in Q2. Top-line data from these studies is expected to be available in Q1 2016.

Cogenzia

On October 27th, we submitted a document to the FDA for Cogenzia requesting confirmation of all of the key understandings that were agreed upon with the FDA in the Special Protocol Assessment (SPA). We subsequently received written feedback from the FDA confirming the full contents of the SPA and Phase 3 clinical trial activity has been initiated both in the US and Europe. We anticipate that data from our two Phase 3 studies will be available in the first half of 2016.

CollaGUARD

The company has commenced recruitment for a pilot clinical study in patients undergoing intrauterine adhesiolysis via operative hysteroscopy. In addition, we have initiated a second pilot clinical study in patients undergoing gynaecological laparoscopic adhesiolysis. The goal of both of these studies, is to generate data that will be used to finalize our pivotal clinical protocol to obtain PMA approval in the U.S. The data will also be used to support commercialization of CollaGUARD in countries where the product is already approved. Innocoll is planning on holding a Pre-IDE meeting with FDA later this year to discuss the planned US clinical program.

Manufacturing Update

Innocoll has developed multiple collagen delivery technologies that provide a variety of approaches to deliver therapeutics for specific patient conditions. These include our primary technologies CollaRx®, which is used in Cogenzia and XaraColl and, CollaFilm®, which is used in CollaGUARD. All of our products, both on the market and in clinical development, are manufactured at our manufacturing facility in Saal,Germany. We are in the definitive documentation stage on a debt facility which we expect will fully fund our planned expansion of the Saal facility. The Saal facility expansion, which we expect to complete by the second half of 2016, will increase capacity seven-fold and position Innocoll for the anticipated launches of both XaraColl and Cogenzia.

Fourth Quarter 2014 Financial Results

• Net Profit/(Loss) Available to Ordinary Shareholders: Innocoll reported a net loss attributable to ordinary shareholders of €4.2 million, or €(2.91) per ordinary share, equal to $(0.27) per ADS, for the three months ended December 31, 2014, compared to a loss of €4.6 million, or €(118.22) per ordinary share for the three months ended December 31, 2013.
• Non-GAAP loss, excluding stock-based compensation and certain non-cash finance or other income was, €2.0 million or €(1.38) per ordinary share, or $(0.13) per ADS, for the three months ended December 31, 2014, compared to a loss of €4.6 million, or €(118.22) per ordinary share, for the three months ended December 31, 2013.
• Weighted average shares outstanding increased from 0.04 million during the three months ended December 31, 2013 to 1.46 million during the three months ended December 31, 2014, respectively, primarily as a result of the conversion of preference shares into ordinary shares and pre-IPO and IPO equity issuances in 2014.
• Revenues: Revenues were €755 thousand for the three months ended December 31, 2014 as compared to €834 thousand for the three months ended December 31, 2013 a decrease of 9%. This decrease was primarily due to a decrease in sales to Jazz Pharmaceuticals of CollatampG, our gentamicin implant for the treatment and prevention of post-surgical infection.
• Cost of Sales: Cost of sales were €1.4 million for the three months ended December 31, 2014 as compared to €1.5 million for the three months ended December 31, 2013. Gross margins in each quarter were negative primarily due to the effect of absorbing indirect overhead costs associated with operating our manufacturing facility, as explained more fully below in the Full Year 2014 Financial Results.
• Research and Development (R&D) Expenses: R&D expenses were €1.3 million for the three months ended December 31, 2014 as compared to €0.5 million for the three months ended December 31, 2013, an increase of 277%. The increase was primarily due to increased external clinical research costs due to the continuation of our pharmacokinetics and safety study of XaraColl, and our CollaGUARD pilot study in the Netherlands. Going forward, we expect R&D expenses to increase significantly as we advance our clinical trial programs.
• General and Administrative (G&A) Expenses: G&A expenses were €4.3 million for the three months ended December 31, 2014 as compared to €1.3 million for the three months ended December 31, 2013. G&A expenses in the three months ended December 31, 2014 included €2.3 million in non-cash charges for stock-based compensation compared to €0.0 of such charges in the three months ended December 31, 2013. Stock-based compensation expense in the quarter and year ended December, 31, 2014 was exceptionally high due to the timing of share grants and vesting linked to the completion of our initial public offering in the third quarter of 2014. Excluding such charges for stock-based compensation, G&A expenses for the three months ended December 31, 2014 were €2.0 million as compared to €1.3 million for the three months ended December 31, 2013. The increase in G&A was primarily due to accounting, legal and consulting professional fees, insurance costs and investor relations costs related to becoming a public company in the third quarter of 2014. Excluding stock-based compensation, we expect further increases in G&A going forward as we build out our infrastructure to support our clinical programs and commercialization.
• Finance Expense (Income): Finance income was €2.1 million for the three months ended December 31, 2014 primarily due to the foreign exchange gains, as compared to a finance expense of €2.2 million for the three months ended December 31, 2013, which primarily consisted of non-cash interest accrued on our outstanding preferred shares, which have since been converted into ordinary shares.

Full Year 2014 Financial Results

• Net Profit/(Loss) Available to Ordinary Shareholders: For the year ended December 31, 2014 net loss attributable to ordinary shareholders was €20.7 million or €(28.10) per ordinary share (basic and diluted),$(2.57) per ADS, compared to a profit of €2.1 million, or €47.02 per ordinary share (basic) and a loss of (€9.50) per ordinary share (diluted) for the year ended December 31, 2013.
• Non-GAAP loss excluding stock-based compensation and certain non-cash finance and other income was €9.3 million or €(12.58) per ordinary share (basic and diluted) , ($1.15) per ADS, for the year endedDecember 31, 2014, compared to a loss of €6.9 million, or €51.6 and €(9.23) per ordinary share (basic and diluted, respectively) for the year ended December 31, 2013.
• Weighted average shares outstanding increased from 0.04 million during the year ended December 31, 2013, to 0.74 million during the 12 months ended December 31, 2014, primarily as a result of the conversion of preferred shares into ordinary shares and pre-IPO and IPO equity issuance in 2014.
• Revenues: Revenues for the year ended December 31, 2014 were 27% higher at €4.5 million, compared to €3.5 million for year ended December 31, 2013. This increase was primarily due to an increase in sales to Jazz Pharmaceuticals of CollatampG of €0.7 million, or 26%, and an increase in CollaGUARD sales of €0.2 million, or 131%, primarily due to the first shipment of our adhesion barrier CollaGUARD to our partner Takeda in connection with the product's launch in Russia in the third quarter of 2014. In addition, during the third quarter of 2014 Biomet 3i launched RegenePro, our product to treat dental wounds in the United States.
• Cost of Sales. Cost of sales of €5.6 million in the year ended December 31, 2014 increased by €1.0 million, or 23%, compared to €4.6 million in the year ended December 31, 2013. All overhead costs associated with operating our manufacturing facility are included in the standard cost of our products as indirect costs and charged to cost of sales based on sales volume. Excluding these indirect costs, gross margins were 36% and 34% for the years ended December 31, 2014 and 2013, respectively. Including indirect costs gross margins were (24)% and (28)% for the year ended December 31, 2014 and 2013, respectively.
• Research and Development (R&D) Expenses: R&D expenses were €3.3 million for the year ended December, 31 2014 as compared to €1.7 million for the year ended December 31, 2013. The increase was primarily due to the commencement of our pharmacokinetics and safety study of XaraColl, and our CollaGUARD pilot study in the Netherlands.
• General and Administrative (G&A) Expenses: G&A expenses were €11.7 million for the year ended December 31, 2014 as compared to €4.1 million for the year ended December 31, 2013. G&A expenses in the year ended December 31, 2014 included €5.1 million in non-cash charges for stock-based compensation, compared to €0.0 of such charges in the corresponding period in 2013. As stated above, stock-based compensation expense in the year ended December 31, 2014 was exceptionally high due to the timing of share grants and vesting linked to the completion of our initial public offering in the third quarter 2014. Excluding such charges for stock-based compensation, G&A expenses were €6.6 million for the year ended December 31, 2014 as compared to €4.1 million for the year ended December 31, 2013. The increase in G&A was primarily due to accounting, legal and consulting professional fees, insurance costs and investor relations costs related to becoming a public company.
• Finance Expense: Finance expense was €4.5 million for the year ended December 31, 2014 as compared to €6.9 million in the year ended December 31, 2013. Finance expense in the year ended December 31, 2014 consisted primarily of €6.3 million fair value expense of investor options outstanding and €3.1 million interest on preferred shares, partially offset by €4.7 million in foreign exchange gains. Finance expense in the year ended December 2013 consisted primarily of interest on preferred shares and convertible promissory notes of €6.6 million. All preferred shares were converted into ordinary shares in the second quarter of 2014.
• Although Innocoll options issued to investors are settled in stock and are included in our authorized capital, under IFRS accounting rules, they will continue to be valued on a quarterly basis, which is likely to result in significant non-cash finance expense or income going forward.
• Other Income: Other income was €0.1 million in the year ended December 31, 2014 compared to €16.1 million in the year ended December 31, 2013. Other income in the year ended December 31, 2013 consisted of exceptionally high non-cash fair value gains on exchange of warrants, and settlement of preferred shares in connection with the re-domicile of the parent company.
• For further financial information for the period ending December 31, 2014, please refer to the financial statements appearing at the end of this release. As the financial statements are in euros, all amounts shown in U.S. dollars are for the convenience of the reader only, exchanged at a rate of $1.2141 per euro, the exchange rate as of December 31, 2014.

Cash Position

As of December 31, 2014, cash, cash equivalents, and short-term investments totalled €45.6 million ($55.4 million) compared to €2.7 million as of December 31, 2013. The increase in cash, cash equivalents, and short-term investments was due to proceeds from the issuance of shares of €52.1 million, consisting of €12.4 million net proceeds of pre-IPO equity issuance and €39.7 million net proceeds from the IPO. Existing cash, combined with debt facilities which we expect will be available to us should be sufficient to fund the company's clinical programs and operational expenses through the first half of 2016 and to fully fund anticipated capital expenditure in connection with the expansion of our manufacturing facility.

Conference Call

Innocoll management will host a conference call today at 8:30 a.m. EDT to discuss fourth quarter and full year 2014 financial results and provide a business update.

To participate in the conference call, please dial 877-407-4018 (domestic) or 201-689-8471 (international) and ask for the "Innocoll fourth quarter financial results conference call." A live webcast of the call can be accessed under "Events and Presentations" in the News & Investors section of the Company's website at www.innocollinc.com

An archived webcast recording and telephone replay will be available on the Innocoll website beginning approximately two hours after the call. To access the telephone replay, please dial 877-870-5176 for domestic callers or 858-384-5517 for international callers and entering the conference code: 13601691. The telephone replay will be available until midnight EDT on March 22, 2015.

About Innocoll AG

Innocoll is a global, commercial-stage, specialty pharmaceutical company. We develop and manufacture a range of pharmaceutical products and medical devices using its proprietary collagen-based technologies. Our late stage product pipeline is focused on addressing a number of large unmet medical needs, including: XaraColl® in Phase 3 development for the treatment of post-operative pain; Cogenzia® in Phase 3 for the adjuvant treatment of diabetic foot infections; and CollaGUARD®, a barrier for the prevention of post-surgical adhesions. Our approved products include: CollaGUARD (Ex-US), Collatamp® G, Septocoll®, RegenePro®, Collieva®, CollaCare®, Collexa®, and Zorpreva™, which are sold through strategic partnerships with various partners including Takeda, Biomet, and Jazz Pharmaceuticals. All of our products are made using Type 1 collagen and are manufactured in-house at our facility in Saal, Germany.

For more information, please visit www.innocollinc.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.

Use of Non-IFRS/non-GAAP Financial Measures

To supplement our unaudited consolidated financial statements prepared in accordance with IFRS, we disclose certain non-IFRS, or non-GAAP, financial measures. We define adjusted non-GAAP earnings per share as basic and diluted earnings per share excluding share based payments and fair value expense on warrants outstanding. We believe adjusted non-GAAP earnings per share is meaningful to our investors to enhance their understanding of our financial condition and results. The items excluded from non-GAAP earnings per share represent significant non-cash expense which may be settled through issuance of shares included in our authorised or contingent capital. We believe that non-GAAP earnings per share excluding these non-cash items may provide securities analysts, investors and other interested parties with a useful measure of our operating performance and cash requirements. Disclosure in this press release of non-GAAP earnings per share, which is a non-IFRS financial measure, is intended as a supplemental measure of our performance that is not required by, or presented in accordance with, IFRS. Non-GAAP earnings per share should not be considered as an alternative to earnings per share, profit (loss) or any other performance measure derived in accordance with IFRS. Our presentation of adjusted earnings per share should not be construed to imply that our future results will be unaffected by unusual non-cash or non-recurring items.

Mainstay Medical Announces 2014 Financial Results

DUBLIN -- Mainstay Medical International plc (“Mainstay” or the “Company” listed on Euronext Paris: MSTY.PA and ESM of the Irish Stock Exchange: MSTY.IE) announces its results for the year ended 31 December 2014. Mainstay is an Irish medical device company with operations in Ireland, the United States and Australia. The Company is focused on developing an innovative implantable neurostimulation medical device, ReActiv8, for people with Chronic Low Back Pain (“CLBP”). ReActiv8® is designed to address the root cause of CLBP by helping to restore control to the muscles that dynamically stabilise the lumbar spine.

Highlights

• The clinical trial of ReActiv8, the ReActiv8-A clinical trial, commenced in March 2014. The ReActiv8-A trial is a prospective single arm clinical trial with up to 96 subjects at sites in Australia and Europe. Outcome measures for the ReActiv8-A clinical trial are assessed at a three month endpoint after activation of stimulation and compared to baseline prior to implant. Further details can be obtained at https://clinicaltrials.gov/show/NCT01985230.
• The Company is pleased with the progress of the ReActiv8-A clinical trial. Over 40 subjects have been implanted in the ReActiv8-A clinical trial and the Company believes that data from these subjects may be sufficient to apply for a CE Mark. The Company plans to announce data from the ReActiv8-A clinical trial after the outcome data from all implanted subjects are available, audited and adjudicated.
• We are pleased to announce that more complete data of the Mainstay Sponsored Feasibility study have now been published in the peer reviewed journal, Neuromodulation. This study, which commenced in 2011, evaluated the therapy which is now delivered by ReActiv8 and summary data were reported previously. The paper is available to subscribers or for purchase from the journal.
• In January 2015, the Company submitted an application to the US Food and Drug Administration (“FDA”) for approval to start a clinical trial of ReActiv8 under an Investigational Device Exemption (an “IDE”). The Company anticipates that there will be multiple interactions with the FDA to develop a clinical trial that meets the needs of the Company, the FDA and the people who could potentially benefit from ReActiv8.
• In December 2014, the Company announced that it had achieved certification of its Quality Management System in compliance with the international quality standards ISO 13485:2003 and EN ISO 13485:2012. This certification is a necessary requirement prior to obtaining CE Mark approval of ReActiv8.
• The Company continues to expand its intellectual property portfolio, and additional patents were filed during 2014.
• On 2 May 2014, the Company completed an initial public offering (“IPO”), listing its ordinary shares on the ESM of the Irish Stock Exchange and Euronext Paris. Proceeds of $20.9 million (net of costs) were raised by way of the IPO.
• Operating expenses were $11.1 million during 2014 and have increased by $2.7 million compared to 2013 due to increased costs associated with the ReActiv8-A clinical trial, and the expansion of our team.
• Cash on hand at 31 December 2014 was $18.3 million and operating cash out flows for 2014 were $11.4 million.

Mr. Peter Crosby, Mainstay’s Chief Executive Officer, commented, “2014 has been a significant year for Mainstay, with the milestones achieved being a testament to the diligence and focus of the team. The successful IPO has allowed us to progress our ReActiv8-A clinical trial as planned in Australia and Europe. Study investigators continue to express enthusiasm for ReActiv8 and its potential to help the large population suffering from chronic low back pain. The submission of the IDE application to start a US clinical trial of ReActiv8 is a key milestone towards commercialisation of ReActiv8 in the US market.”

About Mainstay

Mainstay is a medical device company which is developing an innovative implantable neurostimulation medical device, ReActiv8, for people with CLBP. Low Back Pain is a leading cause of activity limitation and work absence throughout much of the developed world, imposing a high economic burden on individuals, families, communities, industry, and governments.  The Company is headquartered in Dublin, Ireland. It has subsidiaries operating in Ireland, the United States and Australia, and is listed 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 lower 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 economies.

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

European queries:

FTI Consulting
Jonathan Neilan, +353 1 663 3686, jonathan.neilan@fticonsulting.com

or

FTI Consulting (French language enquiries)
Astrid Villette, +33 1 47 03 69 51, Astrid.Villette@fticonsulting.com

or

US queries:

The Trout Group LLC
Jillian Connell, +1-646-378-2956 / +1-617-309-8349, jconnell@troutgroup.com

or

ESM Advisers:

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Innocoll AG Appoints James Tursi, M.D., as Chief Medical Officer

ATHLONE, Ireland -- Innocoll AG (Nasdaq:INNL) today announced that James Tursi, M.D., has been appointed chief medical officer. Dr. Tursi will be responsible for managing all clinical development programs and medical affairs for the company.

"James is a great addition to the Innocoll team and is joining the company at a very exciting time as we advance our lead products through late stage clinical testing," said Tony Zook, chief executive officer of Innocoll. "His experience and background add significant depth and expertise to our clinical development function. James' joining Innocoll is further evidence of our progress at the company since our IPO last summer."

Dr. Tursi has extensive experience developing pharmaceuticals across a number of therapeutic areas. Most recently, as vice president of Research & Development and chief medical officer at Auxilium, he oversaw the development and regulatory approval of Xiaflex® in the U.S. and in global markets for two indications as well as moving four additional indications into advanced clinical development. Prior to his tenure at Auxilium, Dr. Tursi was responsible for medical affairs for cervical cancer vaccines in North America for GlaxoSmithKline. Dr. Tursi was also previously medical director for Proctor & Gamble Pharmaceuticals where he managed development of products in female sexual dysfunction, overactive bladder, and osteoporosis.

"Innocoll is at a transformative time in its history with three late-stage candidates and with a drug development engine based on its proprietary collagen drug formulation platform," said Dr. Tursi. "I am looking forward to working with the team to move our current assets toward the market and to developing new drug candidates that have the promise of improving patient care."

About Innocoll AG

Innocoll is a global, commercial-stage, specialty pharmaceutical company. The company develops and manufactures a range of pharmaceutical products and medical devices using its proprietary collagen-based technologies. The company's late-stage product pipeline is focused on addressing a number of large unmet medical needs, including: XaraColl® for the treatment of post-operative pain; Cogenzia® for the adjuvant treatment of diabetic foot infections; and CollaGUARD®, a barrier for the prevention of post-surgical adhesions. The Company's approved products include: CollaGUARD, Collatamp® G, Septocoll®, RegenePro®, Collieva®, CollaCare®, Collexa®, and Zorpreva™, which are sold through strategic partnerships with various partners including Takeda, Biomet, and Jazz Pharmaceuticals.

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.

Chrono Therapeutics Receives Investment from Rock Health to Advance SmartStopTM Smoking Cessation Technology

HAYWARD, California -- Chrono Therapeutics, a pioneer in digital drug products, today announced an investment by Rock Health, the leading seed fund in digital health, to support the advancement of Chrono's SmartStop™ programmable transdermal drug delivery system and real-time behavioral support program for smoking cessation.

Smoking kills more than 500,000 Americans each year, and is responsible for approximately one in five deaths in the United States. Of the 45 million smokers in the US, 70 percent report that they want to quit, according to the Centers for Disease Control, while 23 million try to quit each year. The average smoker will attempt to quit eight to ten times. Nicotine replacement therapy (NRT) is one method used to help smokers quit, but conventional NRT does not match craving cycles, leading to six-month efficacy of less than 20 percent.

SmartStop is a wearable device that offers programmable, transdermal nicotine replacement therapy (NRT) in combination with real-time behavioral support. Research shows that smokers have clear, consistent and predictable daily peak nicotine craving patterns. SmartStop is designed to automatically vary nicotine levels throughout the day to match those patterns. The device uses Bluetooth technology to wirelessly communicate with the SmartStop behavioral support mobile app, providing real-time guidance to help smokers cope with cravings as well as a means for promoting compliance to the NRT and overall quit process.

"Chrono Therapeutics is a leading digital health company developing a truly innovative approach to solve one of the world's most significant public health challenges–the global epidemic of smoking," said Malay Gandhi, Managing Director of Rock Health. "Chrono's SmartStop drug delivery system represents the type of next-generation product technology that Rock Health is seeking to identify and advance in order to significantly impact the future of healthcare. By adopting digital technology to deliver and target treatment along with guided coaching, SmartStop is designed to help smokers quit their addictive, life-threatening habit with a reliable, convenient and effective wearable device."

Rock Health will join Chrono's current investor syndicate, which includes Canaan Partners, 5AM Ventures, Fountain Healthcare Partners, Mayo Clinic and GE Ventures, all of whom participated in the Company's $32 million Series A financing announced in June of 2014.

"Chrono Therapeutics is developing a unique delivery method for nicotine replacement therapy with an automated wearable device integrated with real-time coaching support to help smokers effectively quit," said Alan Levy, Ph.D., CEO of Chrono. "Rock Health's mission is directly aligned with our vision of transforming disease and addiction management through digital health technology, and we're thrilled to have them onboard as an investor."

About Rock Health

Rock Health funds and supports startups building the next generation of technologies transforming healthcare. Find out more at www.rockhealth.com.

About Chrono Therapeutics

Chrono Therapeutics is a pharmaceutical company with a vision of transforming disease and addiction management to become the market leader in programmable passive transdermal drug delivery that offers real-time behavioral support. Chrono's executive leadership combines years of professional experience and personal passions for developing life-saving medical products. For more information, visit www.chronothera.com.

Opsona Therapeutics Ltd. commences Part B of phase II study of Blocking Toll-Like Receptor 2 in Extended Criteria Donor renal transplant recipients at high risk of Early Graft Dysfunction

Dublin, Ireland – Opsona Therapeutics Ltd (‘Opsona’), the innate immune drug development company focused on novel therapeutic approaches to treat autoimmune inflammatory diseases and oncology, today announced the continuation of its double-blind renal transplant study by the initiation of Part B of its adaptive phase II clinical trial in Extended Criteria Donors (ECD) renal transplant recipients at high risk of early graft dysfunction with its lead drug candidate OPN-305.

Based on the completion of Part A of this double blind study, OPN-305 was well tolerated and deemed to be safe by the data and safety monitoring board across all dose groups with no evidence of increased risk of infection in these highly immuno-suppressed patients.

The company is proceeding with Part B in a modified patient population evaluating ECD-only recipients. ECD kidneys make up the largest pool of the cadaveric donor population. Currently up to 45% of ECD kidneys are discarded resulting in a significant deficit in supply versus demand. OPN-305 has the opportunity to turn borderline non-transplantable organs into viable kidneys and functioning grafts resulting in fewer ECD discards, driving an overall increase in the number of deceased donor transplants.

Commenting on today’s announcement, Mary Reilly VP Pharmaceutical Development & Operations said: “We are excited about the initiation of Part B and hope that we can demonstrate an effect of TLR2 blockade on reducing early graft dysfunction in this patient population which is a significant unmet medical need.

Opsona remains committed to further development of OPN-305 and believe 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 autoimmune, inflammatory and oncology diseases.”

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 autoimmune and inflammatory diseases, solid organ transplantation, cancer, diabetes, Alzheimer's disease and others. The company was founded in 2004 by three world-renowned immunologists at Trinity College in Dublin. Opsona have a strong international investor consortium including:

• Amgen Ventures (www.amgen.com/partners/amgen_ventures)

• Baxter Ventures (www.baxter.com/about_baxter/scientific_excellence/baxter_ventures)

• BB Biotech Ventures (www.bbbiotechventures.com)

• EMBL Ventures (www.embl-ventures.com)

• Enterprise Ireland (www.enterprise-ireland.com)

• Fountain Healthcare Partners (www.fh-partners.com)

• GenenFund (www.gene.com)

• Inventages Venture Capital (www.inventages.com)

• Novartis Venture Fund (www.nvfund.com)

• Omnes Capital (www.omnescapital.com)

• Roche Venture Fund (www.venturefund.roche.com)

• Seroba Kernel Life Sciences (www.seroba-kernel.com)

• Sunstone Capital (www.sunstone.eu)

Opsona Therapeutics Ltd. Patent issued in USA covering an antibody directed against Toll-like Receptor-2 (TLR-2) and the use and development thereof

Dublin, Ireland – Opsona Therapeutics Ltd (‘Opsona’), the innate immune drug development company focused on novel therapeutic approaches to treat autoimmune, inflammatory diseases and oncology, today announced that the US Patent Office has issued US Patent 8,623,353, which covers an antibody directed against Toll-like Receptor-2 (TLR-2) and the use and development thereof.

TLR-2 plays an important role in the induction and progression of a number of non-pathogen associated inflammatory conditions including ischaemia reperfusion injury (delayed graft function in renal transplantation, myocardial infarct), certain cancer, autoimmune diseases, diabetes, Alzheimer's disease and atherosclerosis.

TLR-2 is one of the key structures of the innate immune system and is part of the first line defense against microbial organisms. Upon stimulation it induces and propagates inflammation. TLR-2 is activated through so called external danger signals (microbial cell wall components) as well as through so called internal danger signals resulting from tissue injury.

This patent describes a cross-reactive antibody which specifically blocks mammalian TLR-2 and further provides for a pharmaceutical composition for the treatment of various inflammatory conditions. The recently issued patent is assigned to the Technische Universitat Munchen (TUM) and Amgen Inc., and is exclusively licensed by Opsona Therapeutics.

Commenting on today's announcement, Mary Reilly VP Pharmaceutical Development and Operations of Opsona Therapeutics said, "The issuance of this patent is an important milestone in the development of Opsona's TLR2 intellectual property portfolio and will facilitate market exclusivity for the use of OPN-305 in the ever expanding area of TLR2 mediated diseases."

Using the TUM/Amgen license, Opsona has developed a clinical anti-TLR-2 antibody candidate, termed ‘OPN-305'. OPN-305 is a humanised IgG4 monoclonal antibody (mAb) antagonizing TLR-2 and is under development as a treatment for the prevention of Early Graft Dysfunction following renal transplantation and Myelodysplastic Syndromes (MDS), in addition to other therapeutic indications.

A three-part multi-center, double blinded and placebo controlled Phase II clinical study to evaluate the safety, tolerability and efficacy of OPN-305 in renal transplant patients at high risk of Early Graft Dysfunction as the first clinical target indication for the development of OPN-305 was initiated in April 2013 and is currently ongoing.

An open label Phase I/II study to assess the safety and efficacy of cycles of intravenously infused doses of OPN-305 in second-line lower (low and intermediate-1) risk MDS, a form of blood cancer, as the second clinical target indication for OPN-305 was initiated in January 2015.

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 autoimmune and inflammatory diseases, solid organ transplantation, cancer, diabetes, Alzheimer's disease and others. The company was founded in 2004 by three world-renowned immunologists at Trinity College in Dublin. Opsona have a strong international investor consortium including:

• Amgen Ventures (www.amgen.com/partners/amgen_ventures)

• Baxter Ventures (www.baxter.com/about_baxter/scientific_excellence/baxter_ventures)

• BB Biotech Ventures (www.bbbiotechventures.com)

• EMBL Ventures (www.embl-ventures.com)

• Enterprise Ireland (www.enterprise-ireland.com)

• Fountain Healthcare Partners (www.fh-partners.com)

Opsona Therapeutics Ltd. initiates Phase I/II study in a First-in Class Monoclonal Antibody that blocks Toll-Like Receptor 2

Opsona Therapeutics Ltd. initiates a prospective open label Phase I/II study in second-line lower (Low and intermediate-1) risk myelodysplastic syndrome (MDS) with OPN-305, a First-in Class Monoclonal Antibody that blocks Toll-Like Receptor 2

Dublin – Opsona Therapeutics Ltd (‘Opsona’), the innate immune drug development company focused on novel therapeutic approaches to treat autoimmune, inflammatory diseases and oncology, announces that it has initiated a phase I/II clinical trial in second-line lower (Low and intermediate-1) risk myelodysplastic syndrome (MDS) patients with its lead drug candidate, OPN-305.

The lead principal investigator Professor Guillermo Garcia-Manero, who was closely involved in the preliminary work on the potential benefit of TLR2 antagonism in MDS, will conduct the trial at MD Anderson Cancer Center, Houston, USA, one of the premier cancer centres in the world.

Myelodysplastic syndromes (MDS) are a complex 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 which have fewer adverse effects.

OPN-305 is a novel proprietary humanized IgG4 monoclonal antibody (MAb) against the Toll-Like Receptor 2 (TLR2), a target within the innate immune system. Evaluation of OPN-305 in MDS will be the first of a range of oncology indications that the company plans to explore and this will be the first multiple dosing trial with OPN-305 in patients.

OPN-305 is also under development in a large multi-center phase II clinical trial as a treatment in the prevention of delayed graft function (DGF) following renal transplantation. OPN-305 has orphan status in the EU and USA for solid organ transplantation.

Opsona believes that OPN-305 has the potential to provide novel treatment options for a wide variety of autoimmune, inflammatory and oncology diseases.

Professor Guillermo Garcia Manero commented: “Data from our laboratory has indicated that TLR2 is commonly overexpressed in MDS and that alterations in innate immune signalling are a potential therapeutic target in MDS. We are very excited about using OPN-305 in patients with MDS.”

Commenting on today’s announcement, Mary Reilly, VP Pharmaceutical Development and Operations of Opsona Therapeutics said: “We are privileged to be working with world class leaders from MD Anderson, one of the premier cancer center‘s in the world. We are continuing to develop and explore the potential of OPN-305 in bringing a much needed novel therapy option to MDS patients”

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

For media enquiries, please contact:

Jim Devlin or Aoife Kelly at FTI Consulting, t. 01 6633600; e. jim.devlin@fticonsulting.com or aoife.kelly@fticonsulting.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 autoimmune and inflammatory diseases, solid organ transplantation, cancer, diabetes, Alzheimer's disease and others. The company was founded in 2004 by three world-renowned immunologists at Trinity College in Dublin. Opsona have a strong international investor consortium including:

• Amgen Ventures (www.amgen.com/partners/amgen_ventures)

• Baxter Ventures (www.baxter.com/about_baxter/scientific_excellence/baxter_ventures)

• BB Biotech Ventures (www.bbbiotechventures.com)

• EMBL Ventures (www.embl-ventures.com)

• Enterprise Ireland (www.enterprise-ireland.com)

• Fountain Healthcare Partners (www.fh-partners.com)

• GenenFund (www.gene.com)

• Inventages Venture Capital (www.inventages.com)

• Novartis Venture Fund (www.venturefund.novartis.com)

• Omnes Capital (www.omnescapital.com)

• Roche Venture Fund (www.venturefund.roche.com)

• Seroba Kernel Life Sciences (www.seroba-kernel.com)

• Sunstone Capital (www.sunstone.eu)

Mainstay Medical Applies to Start US Clinical Trial of ReActiv8®

Dublin – Ireland – Mainstay Medical International plc (“Mainstay” or the “Company” listed on Euronext Paris: MSTY.PA and ESM of the Irish Stock Exchange: MSTY.IE) has submitted an application to the United States Food and Drug Administration (FDA) to begin a clinical trial of ReActiv8® under an Investigational Device Exemption (IDE). ReActiv8 is an innovative implantable neurostimulation device designed to treat people with disabling Chronic Low Back Pain (CLBP) for whom conventional therapy has not been successful and for whom surgery is not indicated. The goal of ReActiv8 is to reduce pain and disability by addressing the root cause of CLBP in many people by helping to restore control to the muscles that dynamically stabilise the lumbar spine.

The clinical trial protocol submitted to the FDA as part of the IDE submission is for an international, multi-centre, prospective randomized controlled trial designed to show safety and efficacy of ReActiv8. The IDE submission includes details of the extensive preclinical and clinical testing conducted on ReActiv8. Upon successful completion of the trial and if the results support it, the Company plans to submit an application for a Pre-Market Approval (PMA) which is the final step to allow start of commercialization in the United States.

"The submission of the IDE application to start a US clinical trial of ReActiv8 marks a significant milestone in our journey to bring ReActiv8 to the US market," said Peter Crosby, the CEO of Mainstay Medical. "As with all IDE applications, we anticipate that there may be one or more rounds of review by the FDA as we work together to develop a clinical trial that meets the needs of the Company, the FDA, and the millions of people who could potentially benefit from ReActiv8."

Currently, ReActiv8 is an investigational device and is not approved for commercialisation anywhere in the world. The ReActiv8-A Trial is ongoing in Europe and Australia to gather data to support an application for a CE Mark which, if granted, would allow start of commercialization in Europe.

About Mainstay

Mainstay is a medical device company which is developing an innovative implantable neurostimulation medical device, ReActiv8, for people with CLBP. Low Back Pain is a leading cause of activity limitation and work absence throughout much of the developed world, imposing a high economic burden on individuals, families, communities, industry, and governments.

The Company is headquartered in Dublin, Ireland. It has subsidiaries operating in Ireland, the United States and Australia, and is listed 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 lower back, and a dynamically 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 disabled by 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 economies.

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

Fountain Healthcare Partners Launches Second Fund

Initial Fund Close of €85 million

Dublin, Ireland and New York, USA – Fountain Healthcare Partners (“Fountain”) today announces the initial closing of its second fund, Fountain Healthcare Partners Fund II, L.P. with €85 million of committed capital.

The fund is a dedicated life science venture capital (“VC”) fund and brings Fountain’s total capital under management to €158 million. Within the life science sector, Fund II will primarily focus on specialty pharmaceuticals, biotechnology, medical devices and diagnostics.

Fountain will invest over 75% of its capital in Europe with the balance in the US market. Having exceeded its initial close target, Fountain is now seeking additional investors to close Fund II with a hard cap of €125 million.

Over 90% of the initial €85 million capital raised was sourced from major domestic and international institutional investors, predominantly fund of funds, sovereign funds, pension funds, and a strategic corporate investor.

Fund II is expected to make 10 to 15 investments and has already completed two deals:

• Chrono Therapeutics, developing a novel, digital transdermal drug delivery platform coupled with real-time behavioral support with initial focus on a next generation smoking cessation therapy; and,

• Innocoll, a Phase III clinical stage specialty pharma company developing products for the treatment of post-operative pain, diabetic foot infections and surgical adhesions.

Dr Manus Rogan, co-Founder and Managing Partner at Fountain, commented:

“Fountain’s investment strategy focuses on building a balanced portfolio of companies with complementary risk and return profiles within the life science sector. This strategy has resulted in both strong absolute and relative returns from our first fund. The performance of our first fund is reflected in both the level and quality of new and existing investor participation in Fund II. With €85 million raised we are also pleased to have exceeded our initial close target of €75 million against a widely accepted challenging fundraising backdrop in the venture capital sector.”

Aidan King, co-Founder and Managing Partner at Fountain, added:

“The life science sector has been one of the best performing sectors in the past two years with returns surpassing the major global indices and a record number of IPOs and public offerings. Strong demand for life science investments is a reflection of investor’s belief in the underlying growth dynamics of the sector and the investment return opportunities presented by innovative life science companies.”

About Fountain Healthcare Partners

Fountain Healthcare Partners is a life science venture capital fund with offices in Dublin, and New York. Founded in 2008, Fountain is Ireland’s largest dedicated life science venture capital fund with more than €155 million under management.

Fountain invests in entrepreneurs and companies with disruptive technologies or products that have a clear pharmacoeconomic benefit and a defined pathway to commercialisation, value enhancement and exit. Fountain typically leads or co-leads its investments and has sourced private and public deals from start-ups, corporate spin-outs and turnaround situations. The four principals at Fountain, Manus Rogan, Aidan King, Ena Prosser and Justin Lynch brings to investees over 70 years of collective experience in the pharmaceutical industry, corporate venture capital and VC across multiple investment and market cycles.

For more information please visit: www.fh-partners.com

Contact Information:

Manus Rogan | Managing Partner
Manus.Rogan@fh-partners.com
T: +353 1 5225111

Jonathan Neilan | FTI Consulting
jonathan.neilan@fticonsulting.com
T: +353 1 6633686, M: +353 (0) 86 231 4135

Jennifer Peters | FTI Consulting
jennifer.peters@fticonsulting.com
T: +353 1 6633684, M: +353 (0) 87 178 7021

Innocoll AG Appoints Tony Zook as Chief Executive Officer as Company Progresses Toward Becoming a Fully-Integrated Commercial Company

Michael Myers Appointed as Head of Portfolio Operations to Continue Guiding Late-Stage Clinical Programs

ATHLONE, Ireland - Innocoll AG (Nasdaq:INNL) today announced that Tony Zook, formerly executive vice president, Global Commercial Operations, at AstraZeneca, has been appointed chief executive officer effectively immediately. Michael Myers, will continue with the company as head of Portfolio Operations. The executive changes were made to better position the company as its pipeline advances to late-stage clinical development and Innocoll prepares to become a fully-integrated specialty pharmaceutical company.

"Having the right people in executive positions has been an important topic during board meetings, especially due to the rapid progress at the company," said Jonathan Symonds, chairman of the Board of Directors. "Michael and his team are to be commended for successfully advancing our pipeline. As we looked forward, the Board and the current management team planned to appoint an experienced senior pharmaceutical executive as CEO to manage the company's evolution to a commercial-stage company. I worked with Tony during his time at AstraZeneca and he is a highly experienced and accomplished pharmaceutical executive with proven ability to manage both commercial and development organizations and successfully develop and launch innovative new medicines. As we were rapidly approaching the point where we will have multiple late stage opportunities in our pipeline, we believed we needed to move quickly with this exciting appointment."

Michael Myers, Head of Portfolio Operations, and former chief executive officer said, "The opportunity to have Tony join Innocoll adds significant depth and experience to our executive team as we advance toward our goal of becoming a fully integrated pharmaceutical company. I look forward to working with Tony, on behalf of the entire company and its shareholders, to reach our business objectives."

Mr. Zook has extensive pharmaceutical executive management, commercialization and marketing experience. He held several executive positions at AstraZeneca including executive vice president of Global Commercial Operations from 2010 to 2013, president and chief executive officer of the North American division from 2007 to 2010 and president of Medimmune from 2008 to 2010. Prior to joining Innocoll, Mr. Zook was chief executive officer and member of the Board of Directors of Vivus, Inc. in 2013. He has served or continues to serve on several boards including the boards of AltheRx, Inhibikase, Rib-X Pharmaceuticals, the National Pharmaceutical Council, PhRMA, the Pennsylvania Division of the American Cancer Society and his alma mater, Frostburg State University. Mr. Zook earned a B.S. degree fromFrostburg State University and an A.A. degree in chemical engineering from Pennsylvania State University.

"I am excited to be joining the Innocoll team at this time in the company's development," said Mr. Zook. "Our late-clinical stage pipeline, which includes XaraColl, Cogenzia and CollaGUARD, is particularly promising as each candidate addresses patient needs in large global markets that are underserved today. I look forward to working with the Innocoll team to move our clinical candidates forward with the goal of bringing these important products to patients and their physicians in the near future."

About Innocoll AG

Innocoll is a global, commercial-stage, specialty pharmaceutical company. The Company develops and manufactures a range of pharmaceutical products and medical devices using its proprietary collagen-based technologies. The Company's late stage product pipeline is focused on addressing a number of large unmet medical needs, including: XaraColl® for the treatment of post-operative pain; Cogenzia® for the adjuvant treatment of diabetic foot infections; and CollaGUARD®, a barrier for the prevention of post-surgical adhesions. The Company's approved products include: CollaGUARD(Ex-US), Collatamp® G, Septocoll®, RegenePro®, Collieva®, CollaCare®, Collexa®, and Zorpreva™, which are sold through strategic partnerships with various partners including Takeda, Biomet, and Jazz Pharmaceuticals.

CollaRx®, Collatamp®, CollaGUARD®, Collieva®, CollaCare®, Collexa®, Cogenzia® LidoColl®, LiquiColl®, Septocoll®, and XaraColl® are registered trademarks, and CollaPress™, DermaSil™, Durieva™, and Zorpreva™ are trademarks of the Company.

Sagentia selected as lead development partner for Chrono Therapeutics’ wearable ‘smart’ smoking cessation device

Sagentia, a global science, product and technology development company, announced today that it is working with Chrono Therapeutics on the development of SmartStop™, the world’s first programmable and wearable nicotine delivery device to help people quit smoking.

Chrono Therapeutics is a California-based pharmaceutical company with a vision of transforming disease and addiction management to become the market leader in programmable passive transdermal drug delivery (TDD) that offers real-time behavioral support. This past summer, Chrono secured $34M in Series A financing to complete product development and clinical studies for its flagship product SmartStop™, a new and revolutionary wearable device, which offers programmable, transdermal nicotine replacement therapy (NRT) in combination with real-time digital behavioral support that promotes compliance.

To date, many products on the market which aim to help people stop smoking exhibit low rates of success. For example, standard nicotine patches deliver a steady stream of nicotine throughout the day, while nicotine gum delivers spikes of nicotine, but often the doses are too low or compliance is poor resulting in relatively low efficacy in helping smokers to quit.

SmartStop™ offers a novel solution. It is designed to be worn 24 hours a day and to automatically coincide the dose of nicotine that it delivers with the cigarette craving patterns that have been identified in smokers. The device then uses Bluetooth technology to wirelessly communicate with the SmartStop™ digital support program, providing real-time guidance to help smokers cope with cravings and quit for good.

Sagentia was selected as the lead development partner to help Chrono Therapeutics bring the technology to market. Sagentia’s involvement began with concept generation and early feasibility testing to ensure that the product is small enough to wear comfortably and can be manufactured at the right price point. The Sagentia team is now continuing through the full design, miniaturization and development of the electromechanical microfluidic system, including the durable control unit and the nicotine pump delivery system. Key requirements are that the device be low cost and have a small and light design that is attractive to consumers.

Alan Levy, Ph.D., CEO of Chrono Therapeutics, comments: “Smoking costs people their health and eventually their lives, but current technologies like nicotine gums and patches are not effective in enabling smokers to quit permanently because they do not address the cyclical nature of nicotine cravings and offer little to no behavioral support. We believe we have a very compelling technology that will solve many of the problems that make smoking cessation so difficult and working with Sagentia as a product development partner is allowing us to get this to market faster.”

Dr. Gregory Berman, Head of Drug Delivery at Sagentia, adds: “The SmartStop™ technology has the potential to revolutionize the smoking cessation market and make a big difference to peoples’ lives. The compliance aspect of this device is particularly exciting, providing patients with feedback, support and encouragement on their progress.”

About Sagentia

Sagentia is a global science, product and technology development company. Our scientists and engineers redefine what’s possible and help R&D groups achieve commercial return from their most complex technology projects. We have over 27 years’ experience and have successfully completed over 10,000 projects for start-up and global market leader clients alike, across the medical, industrial, oil & gas and consumer sectors.

Our services span the full product development lifecycle, from new concept generation and technology validation, through prototyping and full product development, to transfer to manufacture and sustainability. Sagentia employs over 150 scientists, engineers and market experts and is part of the Sagentia Group, with headquarters in Cambridge, UK and offices in London, Guildford, Boston, Houston and Dubai.

For further information visit us at: www.sagentia.com or email info@sagentia.com

About Chrono Therapeutics

Chrono Therapeutics (CHRONO) is a pharmaceutical company with a vision of transforming disease and addiction management to become the market leader in programmable passive transdermal drug delivery (TDD) that offers real-time behavioral support. Chrono’s executive leadership combines years of professional experience and personal passions for developing life-saving medical products. Steeped with years of experience in product development, science, R&D an understanding of the consumer smoking cessation market, FDA approval experience and bringing life-saving products to market, the team represents a wide-array of knowledge that combined can help address the serious epidemic of smoking.

Background information

Smoking is highly addictive and remains one of the world’s great killers. The World Health Organization estimates that the global death toll is 6 million per year and this is expected to rise to 7 million by 2020. For every death caused by smoking, approximately 20 smokers are suffering from a smoking related disease.

Mainstay Medical Achieves Quality System Certification

Certification is an important step towards the commercialisation of ReActiv8

Dublin, Ireland – Mainstay Medical International plc (“Mainstay” or the “Company”) announces that its Quality Management System has been evaluated and found to be in compliance with the international quality standards ISO 13485:2003 and EN ISO 13485:2012. These international standards provide an accepted international framework for meeting medical device quality standards and compliance certification is an important step towards CE Mark and the commercialisation of ReActiv8. This certification granted by the Company’s Notified Body, BSI Group-Medical Devices, covers the operational activities for developing and bringing to market implantable stimulation systems in the area of pain management.

Mainstay is focused on the development and commercialisation of ReActiv8, an innovative implantable neurostimulation device designed to treat people with Chronic Low Back Pain (CLBP) by helping to restore control to the muscles that stabilise the lumbar spine.

Mr. Peter Crosby, Mainstay’s Chief Executive Officer, noted “We are delighted that all the hard work of the Mainstay team was recognized with the ISO 13485 certification after passing the audits of our Quality Management System at all our facilities in Ireland, Australia and USA without any major observations. This is a testament to the quality and experience of the individuals in the team that made this happen, and an important step towards the commercialization of ReActiv8.”

The International Organization for Standardization (ISO) is the world's largest developer and publisher of international standards for the implementation of quality management systems and various other technical and operational procedures. In the “full quality assurance” conformity route the Company has chosen, the EU Active Implantable Medical Device Directive requires an evaluation of the Company’s Quality Management System as a prerequisite to obtaining CE Mark. By achieving ISO 13485 certification, Mainstay has met this requirement.

Clinical trials with ReActiv8 are ongoing in Europe and Australia, and several sites continue to enrol subjects. The purpose of the clinical trial is to investigate ReActiv8 as a treatment for adults with CLBP who have few other treatment options.

About Mainstay

Mainstay is a medical device company which is developing an innovative implantable neurostimulation medical device, ReActiv8, for people with CLBP. Low Back Pain is a leading cause of activity limitation and work absence throughout much of the developed world, imposing a high economic burden on individuals, families, communities, industry, and governments.  The Company is headquartered in Dublin, Ireland. It has subsidiaries operating in Ireland, the United States and Australia, and is listed 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 stabilize the spine in the lower 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 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 spinal 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 economies.

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

Innocoll AG Announces Third Quarter 2014 Financial and Operating Results

ATHLONE, Ireland -- Innocoll AG (Nasdaq:INNL), a global, commercial-stage, specialty pharmaceutical company that develops and manufactures a range of pharmaceutical products and medical devices using its proprietary collagen-based technologies, today announced financial and operating results for the three months and nine months ending September 30, 2014.

"This is our first quarterly report as a public company," said Michael Myers, Ph.D., Chairperson of the Management Board and Chief Executive Officer of Innocoll. "The successful completion of our IPO in July has provided us with funds that have enabled us to advance our clinical development programs for our key pipeline products, XaraColl® for the treatment of post-operative pain, Cogenzia® for the adjuvant treatment of diabetic foot infections, and CollaGUARD®, our collagen membrane barrier for the prevention of post-surgical adhesions. We have significant momentum now and look forward to keeping you updated on the progress of our clinical development programs over the coming quarters."

Summary of Year-to-Date 2014 Highlights

Financial Highlights

• Innocoll received net proceeds of approximately $52.7 million, net of underwriting discounts and commissions and offering expenses, from the issuance and sale of approximately 6.7 million American Depository Shares (ADSs) in its initial public offering, including shares issued upon the partial exercise of the underwriters' over-allotment option.
• On July 25, 2014, Innocoll's ADSs began trading on the NASDAQ Global Market under the symbol "INNL".
• Year to date product sales revenue of €3.7 million was up by 38% compared to the corresponding period last year.
• As of September 30, 2014 cash and cash equivalents were €47.3 million ($60.0 million).

Clinical Highlight

• In July, we initiated a pivotal study comparing the pharmacokinetics and safety of XaraColl our implantable bioresorbable collagen sponge at doses of 200mg and 300mg to a standard bupivacaine solution. Once the data from this study becomes available, which is currently anticipated to be in the first quarter of 2015, we plan to initiate our Phase 3 efficacy program in post-operative pain in the United States.
• On October 27th, we submitted a document to the FDA for Cogenzia for our planned clinical trials in patients with moderate to severe diabetic foot ulcer infections requesting approval for certain improvements to the Phase 3 clinical protocols and for reconfirmation of all of the key understandings that were agreed upon with the FDA in the Special Protocol Assessment (SPA). The agency has informed Innocoll that written feedback to this document will be sent within 30 days of its submission, following which the Phase 3 program for Cogenzia is expected to be initiated.
• We developed a clinical protocol and obtained approval to run a CollaGUARD pilot study in patients undergoing intrauterine adhesiolysis via operative hysteroscopy. This study, which will be conducted in the Netherlands and will commence recruiting patients this month, is being run to generate data that will be used to finalize our pivotal clinical protocol to obtain PMA approval in the U.S. The data will also be used to support commercialization of CollaGUARD in countries where the product is already approved. Innocoll will plan on holding a Pre-IDE meeting with FDA once the pilot study results are available.

Regulatory and Commercial Highlights

• During the quarter, Cogenzia received marketing approval in Canada, Russia, Argentina and Mexico. Cogenzia is now approved in six countries and has also been filed for approval in India and Australia.
• CollaGUARD was approved in Argentina bringing the total number of country approvals to 46 countries in Europe, Asia and emerging markets. The first shipment of product was made to our partner Takeda in preparation for their planned launch of CollaGUARD in Russia. Takeda also filed for approval for CollaGUARD in Ukraine, Belarus, and Kazakhstan this year.
• The RegenePro dental product line was launched in the U.S. by Biomet 3i LLC during the quarter.

Organizational Highlights

• Earlier this year, Innocoll strengthened its supervisory board with the appointment of Jonathan Symonds CBE as Chairman, former CFO of Novartis and AstraZeneca, David Brennan, former CEO of AstraZeneca, Shumeet Banerji, former senior executive at Booz Allen Hamilton and member of the board of directors of Hewlett-Packard, and the pending appointment, subject to shareholder approval, of Joseph Wiley, of Sofinnova Ventures.

Three Month 2014 Financial Results

Net Profit/(Loss) Available to Ordinary Shareholders: Innocoll reported a net profit attributable to ordinary shareholders of €2.0 million, or €1.57 per share ($0.15 per ADS), for the three months ended September 30, 2014, compared to a profit of €13.0 million, or €336.13 per share, for the three months ended September 30, 2013.

Non-GAAP diluted profit excluding stock-based compensation and certain non-cash finance or other income was €0.3 million or €0.20 per share ($0.02 per ADS), for the three months ended September 30, 2014, compared to a loss of €0.8 million, or €1.04 per share, for the three months ended September 30, 2013.

Weighted average shares outstanding increased from 0.04 million during the three months ended September 30, 2013 to 1.25 million during the three months ended September 30, 2014, respectively, primarily as a result of the conversion of preference shares into ordinary shares and pre-IPO and IPO equity issuances in 2014.

Revenues: Revenues were €1.1 million for the three months ended September 30, 2014 as compared to €0.6 million for the three months ended September 30, 2013 an increase of 82%. This increase was primarily due to an increase in sales by Jazz Pharmaceuticals of CollatampG, our gentamicin implant for the treatment and prevention of post-surgical infection, the first shipment of our adhesion barrier CollaGUARD to our partner Takeda in connection with the product's launch in Russia, and Biomet 3i's launch of RegenePro, our product to treat dental wounds in the US.

General and Administrative (G&A) Expenses: G&A expenses were €2.6 million for the three months ended September 30, 2014 as compared to €1.0 million for the three months ended September 30, 2013. G&A expenses in the three months ended September 30, 2014 included €1.2 million in non-cash charges for stock-based compensation compared to €0.0 of such charges in the three months ended September 30, 2013.

Excluding such charges for stock-based compensation, G&A expenses for the three months ended September 30, 2014 were €1.4 million as compared to €1.0 million for the three months ended September 30, 2013. We expect increases in G&A going forward as we build out our infrastructure to support our clinical programs and commercialization.

Research and Development (R&D) Expenses: R&D expenses were €0.9 million for the three months ended September 30, 2014 as compared to €0.2 million for the three months ended September 30, 2013. The increase was primarily due to the commencement of our pharmacokinetics and safety study of XaraColl. Going forward, we expect R&D expenses to increase significantly as we advance our clinical trial programs.

Operating Losses: Operating losses in the three months ended September 30, 2014 and 2013 were €3.6 million and €1.5 million, respectively. Excluding stock-based compensation, adjusted operating losses in the three months ended September 30, 2014 were €2.4 million. The difference between the €2.4 million adjusted operating losses and the €0.3 million non-GAAP diluted profit set out above was primarily due to foreign exchange gains of €2.7 million during the three months ended September 30, 2014.

Finance and Other Income: Finance and other income was €5.6 million for the three months ended September 30, 2014 as compared to €14.5 million for the three months ended September 30, 2013. Finance and other income or expense items were non-cash items arising out of the re-domicile of our parent company to Germany during the third quarter of 2013, and changes in the value of liabilities associated with options issued to pre-IPO investors outstanding during the third quarter of 2014, as well as foreign exchange gains in each quarter.

Although Innocoll options issued to investors are settled in stock and are included in our authorized capital, under IFRS accounting rules, they will continue to be valued on a quarterly basis, which is likely to result in significant non-cash finance expense or income going forward.

Proceeds from Investment, Cash Position: In the second and third quarters of 2014 the company received total net proceeds from the issuance of shares of €52.1 million ($69.9 million), consisting of €12.4 million ($17.2 million) net proceeds of pre-IPO equity issuance and €39.7 million ($52.7 million) net proceeds from the IPO.

As of September 30, 2014, cash, cash equivalents, and short-term investments totalled €47.3 million ($60.0 million), which is expected to be sufficient to fund our clinical programs and operational expenses through the first half of 2016.

Nine Month 2014 Financial Results

Net Profit/(Loss) Available to Ordinary Shareholders: For the nine months ended September 30, 2014 net loss attributable to ordinary shareholders was €16.4 million or €33.36 per share ($3.19 per ADS), compared to a profit of €6.7 million, or €142.70 per share, for the nine months ended September 30, 2013.

Non-GAAP diluted loss excluding stock-based compensation and certain non-cash finance and other income was €7.2 million or €14.70 per share ($1.41 per ADS), for the nine months ended September 30, 2014, compared to a loss of €4.4 million, or €6.00 per share, for the nine months ended September 30, 2013.

Weighted average shares outstanding increased from 0.05 million during the nine months ended September 30, 2013, to 0.49 million during the nine months ended September 30, 2014, primarily as a result of the conversion of preference shares into ordinary shares and pre-IPO and IPO equity issuance in 2014.

Revenues: Revenues for the nine months ended September 30, 2014 were 38% higher at €3.7 million, compared to €2.7 million for nine months ended September 30, 2013. This increase was primarily due to an increase in sales of CollatampG, CollaGUARD and RegenePro as described above.

General and Administrative (G&A) Expenses: G&A expenses were €7.4 million for the nine months ended September 30, 2014 as compared to €2.9 million for the nine months ended September 30, 2013. G&A expenses in the nine months ended September 30, 2014 included €2.8 million in non-cash charges for stock-based compensation, compared to €0.0 of such charges in the corresponding period in 2013.

Excluding such charges for stock-based compensation, G&A expenses were €4.6 million for the nine months ended September 30, 2014 as compared to €2.9 million for the nine months ended September 30, 2013. The increase in G&A was primarily due to accounting, legal and consulting professional fees, insurance costs and investor relations costs related to becoming a public company.

Research and Development (R&D) Expenses: R&D expenses were €2.0 million for the nine months ended September 2014 as compared to €1.2 million for the nine months ended September 30, 2013. The increase was primarily due to the commencement of our pharmacokinetics and safety study of XaraColl.

Operating Losses: Operating losses in the nine months ended September 30, 2014 and 2013 were €9.7 million and €4.4 million respectively. Excluding stock-based compensation, operating losses in the nine months ended September 30, 2014 were €6.9 million.

Finance and Other Income/(Expense): Finance and other income was an expense of €6.6 million for the nine months ended September 30, 2014 as compared to income of €11.2 million for the nine months ended September 30, 2013. Finance and other income or expense items in each period were non-cash items arising out of the re-domicile of our parent company to Germany during the third quarter of 2013, and changes in the value of liabilities associated with options issued to pre-IPO investors outstanding during the second and third quarter of 2014, as well as foreign exchange gains in each period.

For further financial information for the period ending September 30, 2014, please refer to the financial statements appearing at the end of this release. As the financial statements are in euros, all amounts shown in U.S. dollars are for the convenience of the reader only, exchanged at a rate of €1.2687 per euro, the exchange rate as of September 30, 2014.

Conference Call

Innocoll management will host a conference call today at 10 a.m. EST to discuss third quarter 2014 financial results and provide a business update.

To participate in the conference call, please dial 877-407-4018 (domestic) or 201-689-8471 (international) and ask for the "Innocoll third quarter financial results conference call." A live webcast of the call can be accessed under "Events and Presentations" in the News & Investors section of the Company's website at www.innocollinc.com

An archived webcast recording and telephone replay will be available on the Innocoll website beginning approximately two hours after the call. To access the telephone replay, please dial 877-870-5176 for domestic callers or 858-384-5517 for international callers and enter the conference code: 13594801. The telephone replay will be available until midnight EST on November 16.

About Innocoll AG

Innocoll is a global, commercial-stage, specialty pharmaceutical company. The Company develops and manufactures a range of pharmaceutical products and medical devices using its proprietary collagen-based technologies. The Company's late stage product pipeline is focused on addressing a number of large unmet medical needs, including: XaraColl® in Phase 3 development for the treatment of post-operative pain; Cogenzia® in Phase 3 for the adjuvant treatment of diabetic foot infections; and CollaGUARD®, a barrier for the prevention of post-surgical adhesions. The Company's approved products include: CollaGUARD (Ex-US), Collatamp® G, Septocoll®, RegenePro®, Collieva®, CollaCare®, Collexa®, and Zorpreva™, which are sold through strategic partnerships with various partners including Takeda, Biomet, and Jazz Pharmaceuticals. All of the Company's products are made using Type 1 collagen and are manufactured in-house at its facility in Saal, Germany.

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

CollaRx®, Collatamp®, CollaGUARD®, Collieva®, CollaCare®, Collexa®, Cogenzia® LidoColl®, LiquiColl®, Septocoll®, and XaraColl® are registered trademarks, and CollaPress™, DermaSil™, Durieva™, and Zorpreva™ are trademarks of the Company.

Mainstay Medical - Interim Management Statement

Continued progress towards commercialisation of ReActiv8®

Dublin – Ireland, 6 November 2014 – Mainstay Medical International plc (“Mainstay” or the “Company” listed on Euronext Paris: MSTY.PA and ESM of the Irish Stock Exchange: MSTY.IE) is issuing this Interim Management Statement covering the period from 1 July 2014 to today’s date.

Mainstay is an Irish medical device company with operations in Ireland, Australia and the United States. The Company is focused on the development and commercialisation of ReActiv8, an innovative implantable neurostimulation device designed to treat people with Chronic Low Back Pain (CLBP) by helping to restore control to the muscles that stabilise the lumbar spine.

Business Update

We continue to make progress in the ReActiv8-A clinical trial, with subjects being recruited the UK, Belgium, and Australia, (see http://clinicaltrials.gov/show/NCT01985230). The ReActiv8-A clinical trial is a prospective single arm clinical trial with up to 96 subjects at sites in Australia and Europe. The Company currently expects that data from 40 subjects could be sufficient to apply for a CE Mark. We are pleased to report that over 25 subjects have been implanted as part of the ReActiv8-A clinical trial to date.

In July 2014, the Company submitted an information package about ReActiv8 and the proposed US clinical trial to the US Food and Drug Administration (‘FDA’) under an Investigational Device Exemption (‘IDE’). We met with the FDA in September 2014 and obtained feedback and guidance. We currently anticipate making a submission to start the proposed US clinical trial under an IDE to the FDA in the first quarter of 2015.

Financial Update

There have been no significant changes in the financial position of the group since publication of the Half Year Results for the period ended 30 June 2014. Expenditure relating to clinical trial activities, ongoing research and development and general and administrative expenses is in line with expectations. The Company had $21.4 million cash on hand as at 30 September 2014.

Outlook

Mainstay looks forward to continuing progress with the ReActiv8-A clinical trial as it works towards obtaining CE Mark and commencing the commercialisation of ReActiv8.

About Mainstay

Mainstay is a medical device company which is developing an innovative implantable neurostimulation medical device, ReActiv8, for people with debilitating CLBP. Low Back Pain is a leading cause of activity limitation and work absence throughout much of the developed world, imposing a high economic burden on individuals, families, communities, industry, and governments.

The Company is headquartered in Dublin, Ireland. It has subsidiaries operating in Ireland, the United States and Australia, and is listed 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 stabilize the spine in the lower 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 spine stability, allowing the body to recover from CLBP.

People with debilitating 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 spinal 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 economies.

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

Media queries to:

Jonathan Neilan, FTI Consulting, Dublin Tel: +353 1 663 3686
Email: jonathan.neilan@fticonsulting.com

Jeanne Bariller, FTI Consulting, Paris
Tel: +33 1 47 03 6863 / +33 67 412 4452
Email: jeanne.bariller@fticonsulting.com

ESM Advisers:

Fergal Meegan / Barry Murphy, Davy
Tel: +353 1 6796363
Email: fergal.meegan@davy.ie / barry.murphy2@davy.ie

Acorda Therapeutics Completes Acquisition of Civitas Therapeutics

ARDSLEY, N.Y.--(BUSINESS WIRE)-- Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced it has completed its acquisition of Civitas Therapeutics and obtained global rights to CVT-301, a Phase 3 treatment candidate for OFF episodes of Parkinson’s disease. The acquisition also included rights to the proprietary ARCUS® pulmonary delivery technology, and a manufacturing facility with commercial-scale capabilities based in Chelsea, MA. Under the terms of the acquisition agreement, Acorda paid $525 million in cash to acquire Civitas.

About Acorda Therapeutics

Founded in 1995, Acorda Therapeutics is a biotechnology company focused on developing therapies that improve the lives of people with neurological disorders.

Acorda markets three FDA-approved therapies, including AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg, a treatment to improve walking in patients with multiple sclerosis (MS), as demonstrated by an increase in walking speed. The Company has one of the leading pipelines in the industry of novel neurological therapies. Acorda is currently developing seven clinical-stage therapies and one preclinical stage therapy. This pipeline addresses a range of disorders including chronic post-stroke walking deficits, Parkinson’s disease, epilepsy, neuropathic pain, stroke, peripheral nerve damage, spinal cord injury, and heart failure.

For more information, please visit the Company’s website at: www.acorda.com.