Cappella, Inc. completed the first tranche of a €10.5 million Series D investment

Cappella, Inc. (Cappella) today announced that it has completed the first tranche of a €10.5 million Series D investment, from existing investors, Polytechnos Partners, ACT Venture Capital, Fountain Healthcare Partners, Mitsui & Co. Venture Partners (MCVP) and venture debt financing from Kreos Capital Limited and Silicon Valley Bank, the commercial banking division of SVB Financial Group (Nasdaq: SIVB).

"Silicon Valley Bank has been dedicated to helping entrepreneurs succeed for nearly 30 years. We are delighted to be in a position to support Cappella with its continued growth as it expands its global network and product pipeline."

Proceeds will be used to finance the expanded launch of Cappella's proprietary Sideguard™ Sidebranch stent for the treatment of Bifurcated Vascular Disease in Europe and South America, to provide additional manufacturing capacity and to advance key R&D programs in Galway on additional applications of Cappella's technology in Complex Coronary Artery Disease (CAD).

Commenting on this financing, Dr. Art Rosenthal, Cappella’s CEO, said "This funding will allow us to expand our direct Sales and Distribution network, expand our product pipeline, provide an additional 7,500 sq. ft. facility for manufacturing capacity and additional R&D laboratory space for our development programs. We believe our proprietary products will treat many types of bifurcation disease, including Left Main Bifurcation Disease and our innovative sheath delivery system for self expanding nitinol devices will give us a platform to expand our range of products and build on the positive market reception of the Sideguard launch."

During the recent Transcatheter Cardiovascular Therapeutics (TCT 2010) Congress Dr Farzin (Faz) Fath-Ordoubadi (Manchester Royal Infirmar, Manchester, UK) presented several cases where the benefit of protecting the ostium with the Sideguard device resulted in positive successful patient outcomes. "The Sideguard technology comes close to the ideal technology as it provides an easy-to-use solution that minimizes procedural time and number of steps. It protects the sidebranch vessel and ostium upon placement and secures access to the main branch at all times. Finally, the stent design is suitable for a variety of bifurcation lesions. Clinical practice with Sideguard indicates excellent acute results; however, I look forward to the 1-year data to confirm that this benefit is sustained with low target lesion revascularization (TLR)."

Phil Cox, Head of UK, Europe and Israel commented: "Silicon Valley Bank has been dedicated to helping entrepreneurs succeed for nearly 30 years. We are delighted to be in a position to support Cappella with its continued growth as it expands its global network and product pipeline."

Eamonn Hobbs, Chairman Cappella's Board stated, "This is a very exciting time for Cappella. The company’s commercial launch which began at the recent TCT meeting in Washington, D.C. is progressing very well and this latest round of funding is a key step that will allow the company to drive market penetration for its Sideguard™ Sidebranch stent product lines while continuing to broaden its product offerings to address what is a large market opportunity by providing an enhanced approach to the current provisional and other sidebranch treatment techniques."

 

About Cappella Inc

Cappella, Inc. (“Cappella” or the “Company”) is a medical device company that is developing novel solutions for the treatment of Complex Coronary Artery Disease (CAD) and specifically bifurcation vascular disease. The Company’s initial product is the Sideguard™ Sidebranch stent. This technology addresses an unmet medical need in CAD. The company was founded in 2004 by Antonio Columbo, M.D., Chief of Invasive Cardiology at San Raffaele Hospital in Milan, Italy, and Ascher Shmulewitz, M.D., Ph.D., a cardiologist, medical device entrepreneur and founder of NeoVision, Xcardia and Labcoat Ltd., and established its European headquarters in Galway in 2005.

The Sideguard™ Sidebranch stent is an anatomically shaped self-expanding coronary stent that utilizes a unique peel-away delivery system. Both the stent and this delivery system were developed by Cappella Medical Devices Ltd. The unique delivery technology overcomes a number of delivery problems associated with existing nitinol stents, including reduced profile and improved placement accuracy over traditional delivery systems.

Cappella continues to enjoy the support of its strong investor syndicate of Irish and Internationally active venture capital;Polytechnos Venture Partners, ACT Venture Capital, Mitsui & Co Venture Partners, Fountain Healthcare Partners and Enterprise Ireland all of whom remain enthusiastic on the opportunity that Cappella represents in the next generation technologies to treat heart disease.

 

About Kreos Capital Limited

Kreos Capital is Europe's largest and leading provider of specialty finance to growth companies from early- to late-stage. Since 1998, as the first provider of this kind of financing dedicated to early- to late-stage companies across Europe and Israel, Kreos has adapted the experience of the US model to the European market. Having completed over 250 transactions and committing over $1 billion in 15 countries across Europe and in Israel, Kreos has a proven track record of helping portfolio companies grow throughout their business cycle whilst supporting the objectives of both the portfolio company and their equity sponsors.

 

About Silicon Valley Bank

Silicon Valley Bank provides commercial banking services to emerging growth and mature companies in the technology, life science, private equity and premium wine industries. Through its focus on specialized markets and extensive knowledge of the people and business issues driving them, Silicon Valley Bank provides a level of service and partnership that measurably impacts its clients’ success. Founded in 1983 and headquartered in Santa Clara, Calif., the company serves clients around the world through 26 U.S. offices and five international operations. Silicon Valley Bank is a member of global financial services firm SVB Financial Group (Nasdaq: SIVB), along with SVB Analytics, SVB Capital, SVB Global and SVB Private Client Services. More information on the company can be found at www.svb.com.

Luis Malave Joins Palyon Corporation as CEO

NEW YORK, August 24, 2010 -- Palyon Corporation (Palyon), a New York-based medical device company focused on the treatment of chronic pain, spasticity and other acute and chronic diseases, has named Luis Malave as its new Chief Executive Officer. Malave was previously Chief Operating Officer of Insulet Corporation, a public company that develops pumps for insulin delivery. He succeeds David Present, M.D., who continues as Palyon’s Chairman.

“I am very excited to join Palyon and think this role is a natural next step in my career,” said Malave. “I believe the technology supporting Palyon’s platform for delivery of multiple drugs will lead to very meaningful benefits for patients and physicians, and I look forward to leading the company toward that potential.”

Palyon is developing a state-of-the-art Implantable Drug Delivery System (IDDS), which delivers therapeutics directly into the spinal canal. The initial application of the technology is in the treatment of patients suffering from chronic pain. Chronic pain, defined as pain lasting 6 months or longer, affects 76 million Americans (more than heart disease, diabetes and cancer combined). Up to 20 percent of chronic pain patients do not respond to conventional medical management, such as oral medications and physical therapy, and may become candidates for interventional pain management therapies such as Palyon’s IDDS.Due to its inherent flexibility as a delivery platform, the IDDS can be used to deliver therapeutics to treat both acute diseases, such as cancer, and chronic diseases including diabetes and multiple sclerosis.

“We are pleased to welcome Luis to Palyon,” said Dr. Present, Palyon Chairman. “His deep experience in this space, from R&D to operations, makes him the ideal candidate to guide Palyon to the next level. He will be a tremendous asset to our company.”

 

Biography – Luis Malave

Malave has more than 23 years in the medical device sector and served as Insulet’s Chief Operating Officer since January 2007. Previously, he was Insulet’s Senior Vice President of Research, Development and Engineering. He began his medical device career as a software engineer in the instrument division of Medtronic. From Medtronic, he moved to Minimed as one of its first employees and served in a number of positions, ultimately as Director of Engineering before moving to Insulet. Malave earned his bachelor’s degree from the University of Minnesota, and his MBA from the University of Maryland.

 

About Palyon Corporation

Palyon Corporation is a medical device company based in New York City developing technologies for the treatment of chronic pain, spasticity and other acute and chronic diseases.

For additional information, contact:
Doug Fechter, Chief Financial Officer
(212) 333-2082
dfechter@palyoncorp.com

Insulet Announces Departure of Chief Operating Officer

BEDFORD, MA--(Marketwire - August 17, 2010) - Insulet Corporation (NASDAQ: PODD), the leader in tubing-free insulin pump technology with its OmniPod® Insulin Management System, today announced that Chief Operating Officer Luis Malave has resigned effective August 31, 2010 to become the Chief Executive Officer of Palyon Medical. On an interim basis, Insulet's operations function will continue to be jointly managed by Ruthann DePietro, Insulet's Vice President of Quality & Regulatory Affairs and Kevin Schmid, Vice President of Operations and Engineering, both of whom will report directly to Duane DeSisto, the Company's Chief Executive Officer.

"We thank Luis for his eight years of commitment and guidance in helping to establish Insulet as a leader in the diabetes industry," commented Mr. DeSisto. "During his tenure at the Company, Luis formed a talented and experienced team that has been instrumental in scaling-up Insulet's manufacturing processes. Luis was responsible for building our partnership with Flextronics, which has driven our manufacturing capacity and efficiency such that we can now produce more than 1,000,000 pods per quarter. With the next generation OmniPod System nearing submission to the Food and Drug Administration, I am confident, given our experienced management team in place, that we are well positioned for continued revenue growth and gross margin expansion. We appreciate Luis' contributions and wish him success in his new role."

 

Forward-Looking Statement

This press release contains forward-looking statements concerning Insulet's expectations, anticipations, intentions, beliefs or strategies regarding the future, including those related to its expected revenue and gross margin, management structure, manufacturing capacity and new product launches. These forward-looking statements are based on its current expectations and beliefs concerning future developments and their potential effects on it. There can be no assurance that future developments affecting it will be those that it has anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond its control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to: risks associated with the Company's dependence on the OmniPod System; Insulet's ability to increase customer orders and manufacturing volumes; adverse changes in general economic conditions; impact of healthcare reform legislation; Insulet's inability to raise additional funds in the future on acceptable terms or at all; potential supply problems or price fluctuations with sole source or other third-party suppliers on which Insulet is dependent; international business risks; Insulet's inability to obtain adequate coverage or reimbursement from third-party payors for the OmniPod System and potential adverse changes in reimbursement rates or policies relating to the OmniPod; potential adverse effects resulting from competition with competitors; technological innovations adversely affecting the Company's business; potential termination of Insulet's license to incorporate a blood glucose meter into the OmniPod System; Insulet's ability to protect its intellectual property and other proprietary rights; conflicts with the intellectual property of third parties, including claims that Insulet's current or future products infringe the proprietary rights of others; adverse regulatory or legal actions relating to the OmniPod System; failure of Insulet's contract manufacturers or component suppliers to comply with FDA's quality system regulations, the potential violation of federal or state laws prohibiting "kickbacks" or protecting patient health information, or any challenges to or investigations into Insulet's practices under these laws; product liability lawsuits that may be brought against Insulet; reduced retention rates; unfavorable results of clinical studies relating to the OmniPod System or the products of Insulet's competitors; potential future publication of articles or announcement of positions by physician associations or other organizations that are unfavorable to Insulet's products; the expansion, or attempted expansion, into foreign markets; the concentration of substantially all of Insulet's manufacturing capacity at a single location in China and substantially all of Insulet's inventory at a single location in Massachusetts; Insulet's ability to attract and retain key personnel; Insulet's ability to manage its growth; fluctuations in quarterly results of operations; risks associated with potential future acquisitions; Insulet's ability to generate sufficient cash to service all of its indebtedness; the expansion of Insulet's distribution network; Insulet's ability to successfully maintain effective internal controls; and other risks and uncertainties described in its Annual Report on Form 10-K, which was filed with the Securities and Exchange Commission on March 9, 2010 in the section entitled "Risk Factors," and in its other filings from time to time with the Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should any of its assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. Insulet undertakes no obligation to publicly update or revise any forward-looking statements.

 

About Insulet Corporation

Insulet Corporation is an innovative medical device company dedicated to improving the lives of people with diabetes. The Company's OmniPod Insulin Management System is a revolutionary, discreet and easy-to-use insulin infusion system that features two easy-to-use parts with no tubing and fully-automated cannula insertion. Through the OmniPod System, Insulet seeks to expand the use of continuous subcutaneous insulin infusion (CSII) therapy among people with insulin-dependent diabetes. Founded in 2000, Insulet is based in Bedford, MA.

 

Contact:

Stephanie Marks for Insulet Corporation
Email: ir@insulet.com
877-PODD-IR1 (877-763-3471)

Amarin Corporation Appoints Colin W. Stewart as President and Chief Executive Officer

Dublin, Ireland and Mystic, Connecticut, USA, August 17, 2010 – Amarin Corporation plc (NASDAQ: AMRN), a clinical-stage biopharmaceutical company with a focus on cardiovascular disease, today announced that Colin W. Stewart has been appointed President, Chief Executive Officer (CEO) and a member of the Company’s Board of Directors effective August 16, 2010. Mr. Stewart will be responsible for driving forward the Company’s strategy to maximize the value of its lead product, AMR101, a new drug being studied in Phase 3 clinical trials for the treatment of high triglycerides. The Company announced last week that one of its Phase 3 trials, the MARINE trial, completed patient enrollment and randomization earlier than expected with top-line results now expected in early 2011.

Mr. Stewart has more than 30 years of experience in executive management and commercial positions for pharmaceutical companies, including five years as President and CEO of CollaGenex Pharmaceuticals, Inc. where he was responsible for the company’s growth leading to its successful sale in 2008.

In addition, Mr. Stewart served ten years with the ASTA Medica Group, where he managed several business units in the United States and internationally. He began his career in sales and marketing for Winthrop Laboratories, Ltd. in the United Kingdom, and subsequently held a number of positions of increasing responsibility within the Sterling-Winthrop Group.

Dr. Declan Doogan, who has been serving as the Company’s Interim CEO, will continue to support the Company as Chief Medical Officer providing Amarin access to the majority of his time.

Amarin’s Chairman of the Board, Joseph Zakrzewski, commented, “We are very excited by the addition of Colin Stewart to the Amarin team. He brings a wealth of commercial and executive management experience, which complements the already strong technical and financial functions within the Company. Colin is expected to play a key role as we weigh our various alternatives for commercialization of AMR101.” Mr. Zakrzewski went on to state that, “Declan Doogan deserves many thanks for his contributions as Interim CEO and we look forward to his continued contributions.”

Mr. Stewart added, “I am very impressed by the progress Amarin has made since being restructured and recapitalized late last year. This progress is a tremendous credit to the whole team at Amarin with which I really look forward to working. With Phase 3 studies of AMR101 for two indications advancing well and scheduled to report in 2011, we will continue to explore every opportunity to maximize the potential commercial value of this promising drug, including potentially through one or more collaborations with larger pharmaceutical companies.”

 

About AMR101

AMR101 is ultra pure ethyl icosapentate (ethyl-EPA). Significant scientific and clinical evidence supports the efficacy of ethyl-EPA in reducing triglyceride levels. Near the start of 2010, Amarin initiated two Phase 3 clinical trials to investigate the efficacy of AMR101 in reducing elevated triglyceride levels in two patient populations (the ANCHOR and MARINE trials). As separately reported, patient enrollment and randomization to dosing (2 grams, 4 grams and placebo) has been completed in the MARINE trial

and is over half completed in the ANCHOR trial. Amarin expects to report preliminary top-line results from both trials in 2011 with results from the MARINE trial expected in the beginning of 2011.

 

About Amarin

Amarin Corporation plc is a clinical-stage biopharmaceutical company with expertise in lipid science focused on the treatment of cardiovascular disease. The Company’s lead product candidate is AMR101 (ethyl icosapentate), which is presently being investigated in two Phase 3 clinical trials, one for the treatment of patients with very high triglyceride levels and the other for the treatment of patients with high triglycerides with mixed dyslipidemia on statin therapy. Both of these Phase 3 trials are conducted under Special Protocol Assessment (SPA) agreements with the U.S. Food and Drug Administration (FDA). Amarin also has next-generation lipid candidates under evaluation for preclinical development. For more information please visit www.amarincorp.com.

 

Investor Contact Information:

John F. Thero
Chief Financial Officer
In US: +1 (860) 572 4979
investor.relations@amarincorp.com

Lee M. Stern
The Trout Group
In U.S. +1 (646) 378-2922
lstern@troutgroup.com

 

International Media Contact Information:

Mark Swallow or David Dible
Citigate Dewe Rogerson
In UK: +44 (0)207 638 9571
mark.swallow@citigatedr.co.uk

AMARIN REPORTS Q2 2010 RESULTS -MARINE trial results due early 2011; ANCHOR trial >50% randomized - Conference call today

Dublin, Ireland and Mystic, CT, USA, August 10, 2010 – Amarin Corporation plc (NASDAQ: AMRN), a clinical-stage biopharmaceutical company with a focus on cardiovascular disease, today reports a financial update as of June 30, 2010.  In addition, the Company provides a progress update of its MARINE and ANCHOR trials, the two on-going Phase 3 clinical trials of its lead product candidate AMR101 for treating elevated triglyceride levels.

  • MARINE trial patient randomization completed with top-line results expected in early 2011
  • ANCHOR trial patient randomization now >50% complete with top line results expected in  2011
  • Financial resources sufficient to complete both Phase 3 clinical trials and submit an NDA for AMR101

 

Q1 Financial Update

Amarin’s cash balance as of June 30, 2010 was approximately $37.6 million.  The Company expects that its current financial resources are sufficient to cover planned operations through completion of the ongoing ANCHOR and MARINE Phase 3 clinical trials, the reporting of results from these trials and, assuming clinical trial success, the submission of an NDA.

During the three months ended June 30, 2010, net cash outflows were approximately $6.8 million, including approximately $5.3 million paid in connection with the Company’s two Phase 3 clinical trials.

The Company’s cash outflows during the quarter were partially offset by approximately $1.5 million in net proceeds received from the exercise of warrants. The warrants were exercised by three investors.  The warrant exercises, at exercise prices from $1.00 to $1.50 per share, resulted in the issuance of 1,044,937 new shares during the quarter ended June 30, 2010.

 

Clinical Trial Update

Around the beginning of 2010, Amarin initiated two Phase 3 clinical trials (MARINE and ANCHOR) to investigate the efficacy of AMR101 in reducing elevated triglyceride levels in two patient populations. As separately reported, patient enrollment and randomization to dosing (2 grams, 4 grams and placebo) has been completed in the MARINE trial.  Amarin expects to report preliminary top-line results from the MARINE trial early in 2011, towards the early part of the range of guidance provided previously.

As of the date of this release, over half of the 650 patients currently targeted for the ANCHOR trial have been enrolled and randomized to dosing.  Consistent with previous guidance, the Company anticipates completing enrollment and randomization of ANCHOR in 2011and also anticipates reporting top-line results from the ANCHOR trial in 2011.

“We are excited to be within approximately six months of being able to review and report the results of the MARINE study.  The progress that we have made in both pivotal trials is very encouraging. Being positioned to report results in 2011 for these trials is earlier than we initially expected. This acceleration is a tribute to the commitment, experience and enthusiasm of our employees, clinical investigators and CRO,” commented Dr. Declan Doogan, Interim Chief Executive Officer of Amarin Corporation.

 

Conference Call and Webcast Information

Amarin will host a conference call today, August 10, 2010 at 4:00 pm UTC/GMT + 1 hour (11:00 am Eastern Time).   To participate in the call, please dial (201) 689-8565 from outside the U.S. and (877) 407-0778 within the U.S.   For both dial in numbers please use account number is 286 and conference id 350729. The conference call can also be heard live via the investor relations section of the Company's website at www.amarincorp.com.

A replay of the call will be available via the Company's website.

 

About AMR101 Phase 3 Clinical Trials

The MARINE trial is a multi-center, placebo-controlled, randomized, double-blind, 12-week pivotal study to evaluate the efficacy and safety of 2 grams and 4 grams of AMR101 in patients with fasting triglyceride levels greater than or equal to 500 mg/dL.  Patients in this trial are characterized as having very high triglyceride levels.  Patient enrolment and randomization in this trial has been completed at 229 patients, which the Company expects will be sufficient to demonstrate statistical significance in accordance with the trial protocol. The primary endpoint in the trial is the percentage change in triglyceride level from baseline after 12 weeks of treatment.  Following completion of the 12-week double-blind treatment period, patients will be eligible to enter a 40-week, open-label, extension period.  Results from the extension period are not required for regulatory approval.  The Principal Investigator of the MARINE Study is Harold Bays, M.D., Medical Director Louisville Metabolic and Atherosclerosis Research Center, Kentucky.

The ANCHOR trial is a multi-center, placebo-controlled, randomized, double-blind, 12-week pivotal study to evaluate the efficacy and safety of 2 grams and 4 grams of AMR101 in patients with high triglyceride levels between 200 mg/dL and 500 mg/dL who are on statin therapy.  Patients in this trial are characterized as having high triglyceride levels with mixed dyslipidemia (two or more lipid disorders).  The trial aims to recruit approximately 650 patients into the study. The primary endpoint in the trial is the percentage change in triglyceride level from baseline after 12 weeks of treatment.    The Principal Investigator of the ANCHOR study is Christie M. Ballantyne, M.D., Methodist DeBakey Heart and Vascular Center, Houston, Texas.  No prescription omega-3 based drug, such as AMR101, is currently approved in the U.S. for treating high triglyceride levels in statin-treated patients who have mixed dyslipidemia.

In both the MARINE and ANCHOR trials, all patients undergo a six-to-eight week washout period of lipid altering drugs, as well as diet and lifestyle stabilization, prior to randomization into the 12-week double-blind treatment period.  Both the MARINE and ANCHOR trials received Special Protocol Assessment (SPA) agreements in 2009 from the U.S. Food and Drug Administration (FDA).

The Company expects to file an NDA for AMR101 in 2012.  The Company expects that its current financial resources are sufficient to finance its planned operations through the filing of this NDA for AMR101 seeking approval for the indication being studied in the MARINE trial while also seeking reference in the label to treatment of high triglyceride levels in statin-treated patients who have mixed dyslipidemia as studied in the ANCHOR trial. The Company expects that its current financial resources are sufficient to cover planned operations through the filing of an NDA for this indication.

In order to potentially obtain a broader indication for AMR101 based on the ANCHOR trial results, the Company’s SPA for the ANCHOR trial requires that the Company has a cardiovascular Outcomes study substantially underway at the time of the NDA filing.  If the Company elects to seek this separate indication in its initial NDA filing and commence an Outcomes study, the Company will need to seek additional financing, through a commercial partner or otherwise, to finance the study.  Importantly, the results of an Outcomes study are not required for FDA approval of this broader indication for AMR101. In addition, an outcome study is not required by the SPA covering the indication being studied in the MARINE trial.

 

About Amarin

Amarin Corporation plc is a clinical-stage biopharmaceutical company with expertise in lipid science focused the treatment of cardiovascular disease. The Company’s lead product candidate is AMR101 (ethyl icosapentate), which is presently being investigated in two Phase 3 clinical trials, one for the treatment of patients with very high triglyceride levels and the other for the treatment of patients with high triglycerides with mixed dyslipidemia. Both of these Phase 3 trials are conducted under Special Protocol Assessment (SPA) agreements with the U.S. Food and Drug Administration (FDA). Amarin also has next-generation lipid candidates under evaluation for preclinical development. For more information please visit www.amarincorp.com.

 

Contacts:

Investor Contact Information:

John F. Thero
Chief Financial Officer
In US: +1 (860) 572 4979
investor.relations@amarincorp.com

Lee M. Stern
The Trout Group
In U.S. +1 (646) 378-2922
lstern@troutgroup.com

International Media Contact Information:

Mark Swallow or David Dible
Citigate Dewe Rogerson
In UK: +44 (0)207 638 9571
mark.swallow@citigatedr.co.uk

Amarin’s Amr101 Pivotal Phase 3 Marine Clinical Trial Completes Patient Enrollment And Randomization - Trial Guidance Positively Updated

Dublin, Ireland and Mystic, CT, USA, August 10, 2010 – Amarin Corporation plc (NASDAQ: AMRN), a clinical-stage biopharmaceutical company with a focus on cardiovascular disease, today announced that its MARINE trial, a Phase 3 clinical trial of AMR101, has completed patient enrollment and randomization into the treatment phase of this trial. The Company indicated that top line results from this trial are expected early in 2011, towards the early part of the range of guidance provided previously.

The MARINE trial is a multi-center, placebo-controlled, randomized, double-blind, 12-week pivotal study to evaluate the efficacy and safety of 2 grams and 4 grams of AMR101 in patients with fasting triglyceride levels greater than or equal to 500 mg/dl.  Patients in this trial are characterized as having very high triglyceride levels according to the National Cholesterol Education Program Adult Treatment Panel III treatment guidelines.  The primary endpoint in the MARINE trial is the percentage change in triglyceride level from baseline after 12 weeks of treatment. Consistent with the protocol for this trial, the Company expects that the 229 patients randomized in this study will be sufficient to achieve statistical significance. The MARINE study is the largest controlled therapeutic trial ever conducted in this population.

As of the date of this release, over half of the 650 patients currently targeted for the ANCHOR trial, a separate on-going Phase 3 trial for AMR101, have been enrolled and randomized to dosing. Consistent with previous guidance, the Company anticipates completing patient enrolment and randomization for ANCHOR in 2011 and reporting top-line results from the ANCHOR trial in 2011. This trial is designed to evaluate the safety and efficacy of 2 grams and 4 grams of AMR101 in patients with high triglyceride levels (between 200 mg/dl and 500 mg/dl) who are also on statin therapy for elevated LDL cholesterol levels. No prescription omega-3 based drug, such as AMR101, is currently approved in the U.S. for this indication.

Dr. Declan Doogan, Amarin’s Interim CEO, said: “We are extremely pleased that the MARINE study has been able to complete recruitment faster than we initially expected and we very much look forward to reviewing and reporting the results of this trial early in 2011.” He added, “Elevated triglyceride levels are increasingly being recognized and treated as an independent modifiable risk factor for cardiovascular disease in much the same way as elevated LDL cholesterol levels were more than a decade ago. We believe that AMR101 represents an improved treatment alternative for patients with higher than normal triglyceride levels.”

 

About Amarin

Amarin Corporation plc is a clinical-stage biopharmaceutical company with expertise in lipid science focused the treatment of cardiovascular disease. The Company’s lead product candidate is AMR101 (ethyl icosapentate), which is presently being investigated in two Phase 3 clinical trials, one for the treatment of patients with very high triglyceride levels and the other for the treatment of patients with high triglycerides with mixed dyslipidemia. Both of these Phase 3 trials are being conducted under Special Protocol Assessment (SPA) agreements with the U.S. Food and Drug Administration (FDA). Amarin also has next-generation lipid candidates under evaluation for preclinical development. For more information please visit www.amarincorp.com.

 

Contacts:

Investor Contact Information:

John F. Thero
Chief Financial Officer
In US: +1 (860) 572 4979
investor.relations@amarincorp.com

Lee M. Stern
The Trout Group
In U.S. +1 (646) 378-2922
lstern@troutgroup.com

International Media Contact Information:

Mark Swallow or David Dible
Citigate Dewe Rogerson
In UK: +44 (0)207 638 9571
mark.swallow@citigatedr.co.uk

Eamonn Hobbs Accepts Appointment as Chairman of the Board of Directors of Cappella

BOSTON--(BUSINESS WIRE)--Cappella, Inc. (Cappella), a medical device company developing dynamic solutions for the treatment of coronary bifurcation disease, announced that Mr. Eamonn Hobbs has assumed the role of Chairman of the Board of Directors, effective immediately. Mr. Hobbs is President, CEO, & Director of Delcath Systems, Inc. and was previously, President and CEO of AngioDynamics (Nasdaq:ANGO), which he co-founded. Mr. Hobbs is an entrepreneurial senior executive with over 30 years of medical device experience and demonstrated outstanding success in growing profitable medical device businesses. Regarding his new position Mr. Hobbs states, “This is an exciting time for Cappella. Cappella is extremely well-positioned to grow its business and take the pole position in the emerging bifurcation market. I am impressed by the achievements of Cappella’s worldclass development team with Art Rosenthal at its helm and look forward to help transform this new medical practice which is now available to interventional cardiologists and their patients into a commercially highly successful company.”

Mr. Hobbs joined Cappella’s Board of Directors early this year and moves now into the Chairman position, previously held by Dr. Wolfgang Oster, MD, PhD, Managing Partner at PolyTechnos Venture-Partners GmbH who will remain a Director. Dr. Oster comments, “I am delighted that Eamonn elevates his presence in the leadership team by assuming the role of Chairman of Cappella. The company has arrived at a juncture which warrants emphasis on commercial objectives and I am certain that Eamonn’s strength and vision will create an eminent position for our technology in the market place.

 

About Cappella, Inc.

Cappella, Inc. is a medical device company, developing novel solutions for the treatment of complex Coronary Artery Disease (CAD), specifically bifurcation disease. Cappella’s initial product, the Sideguard® Coronary Sidebranch Stent & Delivery System offers interventional cardiologists a straightforward, effective solution that focuses on treating the sidebranch of diseased coronary arteries first, allowing the preferred stent of choice for the main vessel. Optimal self-expanding stent design specific to the anatomy of the sidebranch, combined with the proprietary delivery system provide a dynamic solution for treating sidebranch disease. Cappella Medical Devices Ltd., Galway, Ireland is the R&D and manufacturing subsidiary of Cappella, Inc. For more information, see: www.cappella-med.com

David Blossom joins Cappella as Vice President, Commercial Operations

Cappella, Inc. (Cappella), a medical device company developing dynamic solutions for the treatment of coronary bifurcation disease, announced the appointment of Mr. David Blossom as Vice President of Commercial Operations. Mr. Blossom is a seasoned sales and marketing executive with 20 years of medical device experience, most recently at Covidien/Aspect Medical Systems and previously at Boston Scientific. “David provides the exceptional skills and depth of experience needed to lead the commercial effort as we continue to transition from an R&D to a commercial enterprise,” said Dr. Art Rosenthal, CEO of Cappella, “David’s record of success in market development and commercialization of innovative medical devices will have a significant impact as we implement our commercialization plans of the Sideguard® Coronary Sidebranch Stent.”

 

About Cappella, Inc. 

Cappella, Inc. is a medical device company, developing novel solutions for the treatment of complex Coronary Artery Disease (CAD), specifically bifurcation disease. Cappella’s initial product, the Sideguard® Coronary Sidebranch Stent & Delivery System offers interventional cardiologists a straightforward, effective solution that focuses on treating the sidebranch of diseased coronary arteries first, allowing the preferred stent of choice for the main vessel. Optimal self-expanding stent design specific to the anatomy of the sidebranch, combined with the proprietary delivery system provide a dynamic solution for treating sidebranch disease. Cappella Medical Devices Ltd., Galway, Ireland is the R&D and manufacturing subsidiary of Cappella, Inc. For more information, see: www.cappella-med.com.

Amarin Reports Q1 2010 Results

AMARIN REPORTS Q1 2010 RESULTS

- Positively updates guidance for ANCHOR and MARINE trials - Conference call today

Dublin, Ireland and Mystic, CT, USA, May 13, 2010 – Amarin Corporation plc (NASDAQ: AMRN), a clinical-stage biopharmaceutical company with a focus on cardiovascular disease, today reported selected financial results for the fiscal quarter ended March 31, 2010 and provided a progress update of the Company’s ANCHOR and MARINE trials, the two pivotal Phase 3 clinical trials of its lead product candidate AMR101 for treating elevated triglyceride levels.

  • Progress in pivotal trials ahead of previously disclosed schedule: expect to report top line results in 2011, ahead of prior guidance of 2012
  • Financial resources sufficient to cover planned operations through to filing of an NDA

 

Q1 Financial Update

Amarin’s cash balance as of March 31, 2010 was approximately $44 million. The Company expects that its current financial resources are sufficient to cover planned operations through completion of the ongoing ANCHOR and MARINE Phase 3 clinical trials, the reporting of results from these trials and, assuming clinical trial success, the filing of an NDA.

During the three months ended March 31, 2010, net cash outflows were approximately $8 million, including approximately $5 million paid in connection with the ramp-up and support of the Company’s two Phase 3 clinical trials, including the commencement of enrollment for these trials which occurred near the start of 2010, as well as for support of general operations. First quarter net cash outflows also included approximately $3 million in payments associated with scaling-down Amarin’s operations in Europe, which action is consistent with the previously announced decision to consolidate Amarin’s R&D headquarters in the United States, and payment of U.K. stamp tax and registration costs associated with the financing completed in 2009.

Amarin Corporation plc is currently a foreign private issuer for U.S. Securities and Exchange Commission (SEC) reporting purposes. In accordance with SEC rules applicable to foreign private issuers, Amarin currently reports its financial results in accordance with International Financial Reporting Standards (“IFRS”) and is not required to file a quarterly report with the SEC on Form 10-Q. However, during fiscal 2010 the Company plans to transition to U.S. generally accepted accounting principles (U.S. GAAP) and in so doing provide more extensive financial reporting in future periods.

 

Clinical Trial Update

Near the start of 2010, Amarin initiated two pivotal Phase 3 clinical trials to investigate the efficacy of AMR101 in reducing elevated triglyceride levels in two patient populations (the ANCHOR and MARINE trials). Both trials have progressed well since then and the Company now expects to complete enrollment of these trials in 2011. As a result of this progress, Amarin expects to report preliminary top-line results of these trials in 2011, ahead of previously stated guidance of preliminary results reported in 2012.

As of the date of this release, nearly all of the targeted clinical sites for the ANCHOR trial (80 clinical sites, all in the U.S.) have been activated and over 150 of the 650 patients targeted for the trial have been randomized into the study. Additionally, over 75% of the targeted clinical sites for the MARINE trial (approximately 50 clinical sites located in India, Finland, The Netherlands, Russia, South Africa and the U.S.) have been activated and over 100 of the 240 patients targeted for the trial have been randomized into the study.

“We are very pleased with the progress being made in these two pivotal trials. We believe AMR101 has the potential to be a best-in-class prescription omega-3 drug for treating patients with very high triglycerides or high triglycerides with mixed dyslipidemia,” commented Dr. Declan Doogan, Interim Chief Executive Officer of Amarin Corporation. “Elevated triglycerides are increasingly being recognized as an important independent risk factor for cardiovascular disease. We are encouraged by the progress we are making and by the enthusiasm for these trials from the investigators. We believe this reflects a growing interest in the active management of elevated triglyceride levels and the expectation that AMR101 possesses an appropriate benefit-risk profile. Amarin is focused on completing patient enrollment into these trials as quickly as possible.”

 

Conference Call and Webcast Information

Amarin will host a conference call today, May 13, 2010 at 4:00 pm GMT (11:00 am Eastern Time). To participate in the call, please dial (201) 689-8565 from outside the U.S. and (877) 407-0778 within the U.S. The conference call can also be heard live via the investor relations section of the Company's website at www.amarincorp.com.

A replay of the call will be available via the Company's website.

 

About AMR101 Phase 3 Clinical Trials

The ANCHOR trial is a multi-center, placebo-controlled, randomized, double-blind, 12-week pivotal study to evaluate the efficacy and safety of 2 grams and 4 grams of AMR101 in patients with high triglyceride levels between 200 mg/dL and 500 mg/dL who are on statin therapy. Patients in this trial are characterized as having high triglyceride levels with mixed dyslipidemia (two or more lipid disorders). The trial aims to recruit approximately 650 patients into clinical sites in the United States. The primary endpoint in the trial is the percentage change in triglyceride level from baseline to week 12. The Company also seeks to demonstrate that AMR101 does not result in a statistically significant increase in LDL (low density lipoprotein) cholesterol compared to statins alone. The Principal Investigator of the MARINE Study is Harold Bays, M.D., Medical Director Louisville Metabolic and Atherosclerosis Research Center, Kentucky. No prescription omega-3 based drug is currently approved in the U.S. for treating high triglyceride levels in statin-treated patients who have mixed dyslipidemia.

The MARINE trial is a multi-center, placebo-controlled, randomized, double-blind, 12-week pivotal study to evaluate the efficacy and safety of 2 grams and 4 grams of AMR101 in patients with fasting triglyceride levels greater than or equal to 500 mg/dL. Patients in this trial are characterized as having very high triglyceride levels. The trial aims to recruit approximately 240 patients from clinical sites in multiple countries, including Finland, India, The Netherlands, Russia, South Africa and the United States. The primary endpoint in the trial is the percentage change in triglyceride level from baseline to week 12. Following completion of the 12-week double-blind treatment period, patients will be eligible to enter a 40-week, open-label, extension period. Results from the extension period are not required for regulatory approval. The Principal Investigator of the ANCHOR study is Christie M. Ballantyne, M.D., Methodist DeBakey Heart and Vascular Center, Houston, Texas.

In both the ANCHOR and MARINE trials, all patients undergo a six-to-eight week washout period of lipid altering drugs, as well as diet and lifestyle stabilization, prior to randomization into the 12-week double-blind treatment period. Both the ANCHOR and MARINE trials received Special Protocol Assessment (SPA) agreements in 2009 from the U.S. Food and Drug Administration (FDA).

The Company expects to file an NDA in 2012. The Company expects that its current financial resources are sufficient to finance its planned operations through the filing of an NDA for AMR101 seeking approval for the indication being studied in the MARINE trial with reference in label to treatment of high triglyceride levels in statin-treated patients who have mixed dyslipidemia as studied in the ANCHOR trial. The Company expects that its current financial resources are sufficient to cover planned operations through the filing of an NDA for this indication.

In order to potentially obtain a broader indication for AMR101 based on the ANCHOR trial results, the Company’s SPA for the ANCHOR trial requires that the Company have an outcome study substantially underway at the time of the NDA filing. If the Company elects to seek this separate indication in its initial NDA filing and commence an outcome study, the Company will need to seek additional financing, through a commercial partner or otherwise, to finance the study. The results of an outcome study are not required for FDA approval of the broader indication and an outcome study is not required for the indication being studied in the MARINE trial.

 

About Amarin

Amarin Corporation plc is a clinical-stage biopharmaceutical company with expertise in lipid science focused the treatment of cardiovascular disease. The Company’s lead product candidate is AMR101 (ethyl icosapentate), which has commenced patient enrollment in two pivotal Phase 3 clinical trials, one for the treatment of patients with very high triglyceride levels and the other for the treatment of patients with high triglycerides with mixed dyslipidemia. Both of these Phase 3 trials were designed under Special Protocol Assessment (SPA) agreements with the U.S. Food and Drug Administration (FDA). Amarin also has next-generation lipid candidates under evaluation for preclinical development. For more information please visit www.amarincorp.com.

 

Contacts:

Investor Contact Information:

John F. Thero
Chief Financial Officer
In US: +1 (860) 572 4979
investor.relations@amarincorp.com

Gitanjali Ogawa
The Trout Group
In U.S. +1 (646) 378-2949
gogawa@troutgroup.com

International Media Contact Information:

Mark Swallow or David Dible
Citigate Dewe Rogerson
In UK: +44 (0)207 638 9571
mark.swallow@citigatedr.co.uk

Amarin Corporation Appoints Industry Veteran Joseph Zakrzewski as Executive Chairman

Dublin, Ireland and Mystic, Connecticut, USA,  December 2, 2009 – Amarin Corporation plc (NASDAQ: AMRN), a clinical-stage biopharmaceutical company with a focus on cardiovascular disease, today announced Joseph S. Zakrzewski will join the Company’s Board of Directors as Executive Chairman effective January 1, 2010.  Mr. Zakrzewski has more than 20 years of industry experience, including significant contributions to Reliant Pharmaceuticals as Chief Operating Officer during the period when Omacor®/Lovaza® was successfully developed, launched, and marketed for reducing very high triglyceride levels, a cardiovascular health risk, leading to its 2007 acquisition by GlaxoSmithKline.   

In addition, Mr. Zakrzewski contributed 17 years of service to Eli Lilly & Company in a variety of capacities, including Vice President of Corporate Business Development where he had global responsibility for licensing activities.  Mr. Zakrzewski is currently the Chief Executive Officer of Xcellerex Inc, a Massachusetts-based biotechnology company. He serves on the board of directors of Insulet Corporation and is Chairman of the boards of directors for Promedior Inc. and Zelos Therapeutics.  Mr. Zakrzewski received a BS in Chemical Engineering and an MS in Biochemical Engineering from Drexel University, and received an MBA in Finance from Indiana University. 

Amarin’s current Chairman of the Board, Thomas Lynch, commented, “I am delighted that Joe Zakrzewski has agreed to become Executive Chairman of Amarin.  Joe’s experience is an ideal fit as the Company moves aggressively forward with its cardiovascular drug development program. We look forward to Joe’s contributions as we advance our lead drug candidate, AMR101, into Phase 3 clinical trials.” 

Mr. Zakrzewski added, “Having reviewed Amarin’s compelling business plan and cardiovascular development strategy, I am pleased to be joining the Company’s Board of Directors as Executive Chairman. With AMR101 poised to enter Phase 3 clinical trials, and the combination of the Company’s recent financing by top-tier investors, the composition of its Board and the high quality management team, I believe this is a unique opportunity to create value for Amarin shareholders.”   

Effective upon Mr. Zakrzewski joining the Board of Directors as Executive Chairman on January 1, 2010, Mr. Lynch will step down as Chairman but will continue to serve as a member of Amarin’s Board of Directors.   

 

Heightened Company Focus on Cardiovascular Disease

In October 2009, Amarin raised $70 million in a private placement.  The primary purpose of this financing is to fund Phase 3 clinical trials for AMR101. The Phase 3 clinical trials are designed to demonstrate that AMR101 is safe and effective at lowering high triglyceride levels.  High triglyceride levels have been associated with the increased risk of developing coronary artery disease.  More recently, the Company announced that it has contracted with Medpace, Inc., a contract research organization, to 

help execute the cardiovascular Phase 3 clinical trials.  The addition of Joe Zakrzewski as Executive Chairman of the Board further reflects the Company’s heightened strategic focus on these trials and preparations for commercialization of AMR101 to address cardiovascular disease.   

 

Clinical Trial Update

The Company anticipates commencing enrollment of patients in the Phase 3 trials in the first quarter of 2010 under Special Protocol Assessment agreements (SPAs) with the U.S. Food and Drug Administration. The Phase 3 clinical trials seek to build on the encouraging performance of AMR101 in earlier-stage clinical trials, as well as extensive additional scientific data, which support a positive correlation between the use of AMR101 and reduction in high triglyceride levels.  In addition, these Phase 3 clinical trials aim to confirm the excellent safety and tolerability profile achieved in previously completed clinical trials of AMR101 for Huntington’s disease.   

The Company indicated that, while the safety profile of AMR101 for Huntington’s disease remains very encouraging, feedback from European regulatory authorities indicates that additional study of AMR101 is required to establish efficacy of this product candidate in treating the motor symptoms of Huntington’s disease. As a result, the Company has elected to voluntarily withdraw its previously announced European marketing application for AMR101 relating to an Orphan Medicinal Product indication for a subset of Huntington’s disease patients.  Pursuant to this voluntary withdrawal, the Company will intentionally concentrate its resources on cardiovascular disease, initially directed at regulatory approval and commercial launch of AMR101 in the United States as quickly as possible.   

Amarin Board member, Joseph Anderson of Abingworth LLP, stated, “As a result of our recently completed financing, we believe Amarin now has the resources to execute a well-defined Phase 3 clinical program addressing cardiovascular disease with AMR101.  Clinical management of triglycerides is an exciting emerging market that has certain characteristics reminiscent of the early statin market for cholesterol control.  The addition of Joe Zakrzewski to the Amarin team, we believe, further positions us for success with this cardiovascular-focused strategy.” 

Dr. Anderson added, “On behalf of the Board, I would like to record our thanks to Tom Lynch for his service as Chairman and Chief Executive, in particular for the transformation of Amarin from a CNS company to a Company focused on cardiovascular disease.” 

 

About AMR101

AMR101 is prescription grade, semi-synthetic, ultra pure ethyl ester of eicosapentaenoic acid (ethyl-EPA). The Company believes that, with no DHA included, AMR101 is designed to be the most pure and potent EPA-based product in the U.S. market. Significant scientific and clinical evidence supports the efficacy of ethyl-EPA in reducing triglyceride levels. AMR101 has been studied in over 1,000 patients in double blind, placebo controlled studies, including over 100 patients studied for greater than twelve-months.   

 

About Amarin

Amarin is a clinical-stage biopharmaceutical company with a focus on cardiovascular disease. The Company’s lead product candidate is AMR101(ethyl icosapentate), which is entering Phase 3 clinical trials for the treatment of very high triglycerides and high triglycerides in patients with mixed dyslipidemia, under Special Protocol Assessment agreements with the U.S. Food and Drug Administration. Amarin also has next-generation lipid candidates under evaluation for preclinical development. Amarin recently established its research and development headquarters in Mystic, 

Connecticut and assembled a team of experienced research and development personnel with initial focus on developing AMR101 for cardiovascular disease.  Amarin’s programs capitalize on its lipid science expertise and the known therapeutic benefits of highly pure omega-3 products in treating cardiovascular disease. For more information please visit www.amarincorp.com.

 

Contacts:

Investor Contact Information: 

John F. Thero
Chief Financial Officer
Amarin Corporation plc
In US: +1 (860) 572 4979  
investor.relations@amarincorp.com

Media Contact Information: 

Mark Swallow or David Dible
Citigate Dewe Rogerson
+44 (0)207 638 9571
mark.swallow@citigatedr.co.uk

Cappella, Inc. Announces Initiation of Sideguard 3

GALWAY, Ireland-- Cappella, Inc. (Cappella), a medical device company developing dynamic solutions for the treatment of coronary bifurcation disease, announced the start of Sideguard 3, an IVUS/OCT evaluation of the Sideguard® Coronary Sidebranch Stent & Delivery System. This is a European multicenter study to evaluate the vascular response to Sideguard in de novo bifurcation lesions of native coronary arteries. The primary objective of the study is to determine the change in stent area (mm2) and corresponding change in vessel area (mm2) at the carina of the sidebranch during the 6-month follow-up period.

“The results from the initial CE mark pivotal studies documented positive remodelling. The Sideguard 3 study is intended to provide further certainty for those findings.” said Gary S. Mintz. Further, Akiko Maehara, who also completed the analysis for the initial study said, “We are looking forward to having more clinical proof of the mechanisms of the remodelling process of nitinol in coronary stents.” Gary S. Mintz, MD, & Akiko Maehara, MD, Cardiovascular Research Foundation, New York, USA, are the co-PIs for the study.

One of the primary German investigators in the Sideguard 3 study and pioneer in dedicated sidebranch bifurcation stenting, Karl-Eugen Hauptmann, MD, Krankenhaus der Barmherzigen Brueder in Trier, Germany, stated, “Sideguard is my stent of choice for the treatment of bifurcation lesions. I am very happy to continue my close collaboration with Cappella in this interesting clinical trial.”  Karl-Eugen Hauptmann has recently enrolled the first patients into the study.

 

About Cappella, Inc.

Cappella, Inc. is a medical device company, developing novel solutions for the treatment of complex Coronary Artery Disease (CAD) and specifically bifurcation vascular disease. Cappella’s initial product, the Sideguard® Coronary Sidebranch Stent & Delivery System offers interventional cardiologists a straightforward, effective solution that focuses on treating the sidebranch of diseased coronary arteries first, rather than the main vessel. More importantly, it allows the preferred stent of choice for the main vessel. An optimal stent design specific to the anatomy of the sidebranch, combined with the qualities of nitinol now provide a dynamic solution for treating sidebranch disease. Cappella Medical Devices Ltd., Galway, Ireland is the R&D and manufacturing subsidiary of Cappella, Inc.  For more information, see: www.cappella-med.com.

 

Contact:

Claire Marie Gigon
Cappella Medical Devices Limited
Tel: +41 (0) 79 374 57 65
Email: cmgigon@capella.ie

Amarin Appoints John F. Thero as Chief Financial Officer

DUBLIN, Ireland, November 6th, 2009 – Amarin Corporation plc (NASDAQ: AMRN) today announced the appointment of John F. Thero as the Company’s Chief Financial Officer. In this role, Mr. Thero will have broad responsibility for financial and administrative matters of the Company and be actively involved in corporate development and other strategic and operational matters. He will report directly to Dr. Declan Doogan, Amarin’s interim Chief Executive Officer.

Mr. Thero has more than 20 years of senior financial and operational management experience including over 15 years supporting the growth of life science companies. Previously, Mr. Thero was Chief Financial Officer at ViaCell, Inc., where he helped guide the company to its successful sale, and Abiomed, Inc., during its transition from a development-stage company into a commercial entity. Mr. Thero began his professional career at Arthur Andersen LLP, during which time he became a Certified Public Accountant.

“I am delighted to welcome John to Amarin,” said Dr. Doogan. “He brings a wealth of experience and will be a great addition to our management.”

Added Mr. Thero, “I am impressed with the clarity of the Company’s clinical path and the experience of the Company’s AMR101-focused development team. With resources from the Company’s recently completed $70 million financing, I look forward to helping move the Company expeditiously through its Phase 3 program.”

 

About Amarin

Amarin is a clinical-stage biopharmaceutical company focused on cardiovascular disease. The Company’s lead candidate is AMR101, a prescription grade omega-3 product comprising not less than 96% ultra-pure ethyl eicosapentaenoic acid (EPA-E). Amarin is preparing to commence two Phase 3 clinical trials for AMR101 targeting the treatment of hypertriglyceridemia. These trials will be conducted under Special Protocol Assessment (SPA) agreements with the U.S. Food and Drug Administration (FDA). It is estimated that as many as 28 million people in the U.S. alone have elevated blood triglyceride levels, a major risk factor for cardiovascular morbidity and mortality. In addition, Amarin has potential next-generation lipid candidates under evaluation for preclinical development. Amarin recently established its research and development headquarters in Mystic, Connecticut, USA and engaged Medpace as CRO for the Phase 3 trials. In addition to its cardiovascular development focus, Amarin has non-core programs available for partnering in the area of central nervous system (CNS) disorders, including Huntington’s disease, myasthenia gravis and Parkinson’s disease. Additional information about Amarin is available at www.amarincorp.com.

 

Disclosure Notice
The information contained in this document is as of November 6th, 2009. Amarin assumes no obligation to update any forward-looking statements contained in this document as a result of new information or future events or developments. Forward-looking statements about Amarin's products in development involve substantial risks and uncertainties. You can identify forward-looking statements by the use of words such as "will", "anticipate", "estimate", "expect", "project", "forecast", "intend", "plan", "believe" and other words and terms of similar meaning in connection with any discussion of future operating or financial performance or events. Among the factors that could cause actual results to differ materially from those described or projected herein are the following: the success of Amarin's research and development activities; the speed with which regulatory authorizations, pricing approvals and product launches may be achieved and the success with which developed products may be commercialized.  A further list and description of these risks, uncertainties and other matters can be found in Amarin's Form 20-F for the fiscal year ended December 31, 2008, filed with the U.S. Securities and Exchange Commission on October 22, 2009. 

 

Contact Information: 

Jonathan D. Rowe PhD
Investor Relations
860 572 4979x232 

or 

John F. Thero
Chief Financial Officer
860 572 4979
investor.relations@amarincorp.com

Amarin Announces Completion Of $70 Million Private Placement

DUBLIN, Ireland, October 19, 2009 – Amarin Corporation plc (NASDAQ: AMRN) today announced it has closed its $70 million private placement. The transaction was led by existing investor, Fountain Healthcare Partners, on behalf of funds affiliated with other existing investors Sofinnova Ventures, Orbimed Advisors and Longitude Capital. The new investor group was led by funds affiliated with Abingworth LLP and included APG Asset Management, Great Point Partners, Tavistock Life Sciences Company and RA Capital. Cowen and Company, LLC acted as the exclusive placement agent for the transaction. 

As previously announced, Mr. Thomas Lynch will step down as Chief Executive Officer (CEO) and maintain his position as Chairman. Commenting on his transition to the role of interim CEO, Dr. Declan Doogan said “I am pleased to accept the role of CEO at Amarin, taking over from my colleague Thomas Lynch. During his time as CEO, Thomas has very successfully guided Amarin through a clinical and corporate transition during challenging economic times. As a result, Amarin has emerged in a significantly stronger position with the financial resources to advance its focused clinical strategy. With the Phase 3 program fully funded we are now looking forward to the commencement of the trials.” 

Following the closing of the financing, certain corporate functions will be moved from Amarin’s Dublin office to its Connecticut office in the United States. In that regard, Alan Cooke, President, Chief Operating Officer and Chief Financial Officer, has decided to leave the Company later this year to pursue other interests but will remain through the transition of these functions to the U.S. 

Thomas Lynch, Chairman of Amarin, commented “On behalf of my colleagues at Amarin, I would like to thank Alan for the invaluable contribution he has made during his five years with the Company. Alan has played a key role helping to shape and execute Amarin’s strategy and in managing our fund raising activities. We are pleased that Alan will continue to work with Amarin to ensure a smooth transition of functions to the U.S.” 

Following the closing of this financing, Amarin has 98,801,974 Ordinary Shares in issue. 

As a result of the closing of the private placement announced today, pursuant to an agreement the Company entered into with the investors under the previously disclosed Securities Purchase Agreement dated May 13, 2008, the second tranche funding option and the preemptive, registration and board seat rights provided by that agreement have been cancelled and the eight preference shares granted to certain of the 2008 investors have been converted to eight ordinary shares in Amarin. 

The securities issued by the Company in the equity financing are not registered under the Securities Act of 1933, as amended (the "Securities Act"), may not be offered or sold in the United States and may not be resold by the purchasers thereof, in each case, absent registration or an applicable exemption from the registration requirements of the Securities Act. This press release does not constitute an offer to sell or the solicitation of an offer to buy any securities. The securities will not be sold in any jurisdiction in which such offering would be unlawful. 

 

About Amarin 

Amarin is a clinical-stage biopharmaceutical company with a focus on cardiovascular disease. The Company’s lead product candidate is AMR101, a prescription grade Omega­3 product comprising not less than 96% ultra-pure ethyl eicosapentaenoic acid (EPA), which is entering Phase 3 clinical trials for the treatment of hypertriglyceridemia and mixed dyslipidemia under Special Protocol Assessment (SPA) agreements with the U.S. Food and Drug Administration (FDA). Amarin also has next-generation lipid candidates under evaluation for preclinical development. Amarin recently established its research and development headquarters in Mystic, Connecticut with an experienced research and development team. Amarin’s programs capitalize on its lipid science expertise and the known therapeutic benefits of Omega-3 products in treating cardiovascular disease. 

Amarin has a number of non-core programs for partnering in the area of central nervous system (CNS) disorders, including Huntington’s disease, myasthenia gravis and Parkinson’s disease. Amarin is listed in the U.S. on the NASDAQ Capital Market (“AMRN”). For more information please visit www.amarincorp.com.

 

Contacts:
Amarin
+353 (0)1 669 9020 Thomas Lynch, Chairman Dr. Declan Doogan, Interim Chief Executive Officer Alan Cooke, President, Chief Operating Officer and Chief Financial Officer Darren Cunningham, EVP Strategic Development and Investor Relations investor.relations@amarincorp.com

Amarin Announces Changes to Its Board And Management Team

DUBLIN, Ireland, October 13, 2009 – Amarin Corporation plc (NASDAQ: AMRN) today announced changes to its board and management team, in conjunction with its separately announced $70 million private placement.

Following the closing of the financing, Mr. Thomas Lynch, Chairman and Chief Executive Officer of Amarin, has decided he will step down as CEO and will continue as Chairman. Dr. Declan Doogan, Amarin’s Head of Research and Development, has agreed to assume the role of Interim CEO.   

Mr. Lynch, who has served as Amarin’s Chairman since 2000, commented “I became CEO of Amarin two years ago in order to reposition the Company to take advantage of the multi-billion dollar cardiovascular opportunity represented by AMR101 and to ensure that we had the financial underpinnings to bring this program to fruition. Over the past 12 months, we have significantly de-risked the Phase 3 program with two Special Protocol Assessment agreements with the U.S. Food and Drug Administration and now, with the announcement of today’s financing, the program is funded through NDA filing. It is now my intention to step down as CEO on closing. On behalf of Amarin’s board of directors I would like to wish Dr. Doogan every success in the execution of the Phase 3 program.” 

The financing was led by existing investor, Fountain Healthcare Partners, on behalf of funds affiliated with other existing investors Sofinnova Ventures, Orbimed Advisors and Longitude Capital. The new investor group was led by funds affiliated with Abingworth LLP and included APG Asset Management, Great Point Partners, Tavistock Life Sciences Company and RA Capital. Dr. Manus Rogan of Fountain Healthcare Partners and Dr. Joseph Anderson of Abingworth LLP will join Amarin’s board of directors. 

Thomas Lynch, added “We are delighted to have signed for this substantial funding, to have the continuing support of our existing investors and the participation of new and well-recognised investors. The closing of the financing will enable Amarin to progress the Company’s two Phase 3 clinical trials with AMR101 in patients with very high triglyceride levels and mixed dyslipidemia through to an NDA filing, which is anticipated to occur not later than 2012.”  

Incoming director Dr. Manus Rogan, commented “On behalf of the existing investors I would like to thank Thomas Lynch for his critical role in leading Amarin through a remarkable transition over the past two years, culminating in today’s financing. He and his team have attracted a group of top tier international investors in an oversubscribed offering during a very challenging time in the financial markets.  I would also like to welcome Dr. Declan Doogan to his new role and look forward to working with him on advancing AMR101 successfully through Phase 3 clinical trials and onto the market.” 

Dr. Joseph Anderson, Partner at Abingworth, who will join the board on closing, added “We are delighted to join Amarin at such an exciting and crucial time in its development. We believe the Company has a tremendous asset in AMR101, with a clear route to regulatory approval and a highly experienced development team.  We believe AMR101 will be a successful drug and, with this financing in place, we believe Amarin has the necessary resources to progress the final stages of its development.” 

Following the closing of this financing, Amarin’s Board will comprise Mr. Thomas Lynch; Dr. Joseph Anderson; Dr. Lars Ekman; Dr. Carl Gordon; Dr. James Healy; and Dr. Manus Rogan. The Board intends to appoint two additional independent directors post closing. Dr. John Climax, Dr. William Mason and Mr. Anthony Russell-Roberts are retiring from the board on closing of this financing. 

Mr. Lynch further added “I would like to thank our retiring board members for their contribution especially over the last two years when their support to me was invaluable.” 

 

Biographies of the new directors follow: 

Manus Rogan, PhD, is a Co-founder and Managing Partner at Fountain Healthcare Partners. He began his career in product development at GlaxoSmithkline in the UK. He completed an MBA at Trinity College Dublin in 1996 and joined Elan Corporation’s business development group shortly thereafter. For four years he was responsible for licensing Elan’s products and drug delivery technologies in Europe and Japan. In 2001, Dr. Rogan joined Elan’s corporate VC group in the U.S. where he was involved in the sourcing, screening and management of investments in private and public biotechnology companies. In his seven years at Elan, Dr. Rogan concluded over twenty five investment and technology licensing transactions involving companies in the U.S., Europe and Japan. He has a PhD in chemistry. 

Joseph Anderson, PhD, is a Partner at Abingworth LLP, an international investment group dedicated to the life sciences and healthcare sectors. He leads private investments in public companies in the U.S. and Europe and manages open-market portfolios of small-cap public equities. He has more than 20 years experience as a Fund Manager and Analyst in the pharmaceutical and bioscience sectors.  Dr. Anderson was previously at First State Investments in London, part of the Commonwealth Bank of Australia, where he was Head of Global Healthcare Equities and Portfolio Manager. Prior to this, he was Pharmaceuticals Analyst at investment bank, Dresdner Kleinwort Benson. From 1990– 98, Dr. Anderson established and was Head of the Strategy Unit at the Wellcome Trust, one of the world’s largest medical foundations.  Dr. Anderson is currently a Director of Algeta ASA, a publicly quoted oncology company developing radiopharmaceuticals and a Director of Abingworth BioEquities, an offshore investment fund. He has a PhD in Biochemistry.   

The securities to be issued by the Company in the equity financing will not be registered under the Securities Act of 1933, as amended (the "Securities Act"), may not be offered or sold in the United States and may not be resold by the purchasers thereof, in each case, absent registration or an applicable exemption from the registration requirements of the Securities Act. This press release does not constitute an offer to sell or the solicitation of an offer to buy any securities. The securities will not be sold in any jurisdiction in which such offering would be unlawful. 

 

About Amarin 

Amarin is a clinical-stage biopharmaceutical company with a focus on cardiovascular disease. The Company’s lead product candidate is AMR101, a prescription grade Omega­3 product comprising not less than 96% ultra-pure ethyl eicosapentaenoic acid (EPA), which is entering Phase 3 clinical trials for the treatment of hypertriglyceridemia and mixed dyslipidemia under Special Protocol Assessment (SPA) agreements with the U.S. Food and Drug Administration (FDA). Amarin also has next-generation lipid candidates under evaluation for preclinical development. Amarin recently established its research and development headquarters in Mystic, Connecticut with an experienced research and development team. Amarin’s programs capitalize on its lipid science expertise and the known therapeutic benefits of Omega-3 products in treating cardiovascular disease.  

Amarin has a number of non-core programs for partnering in the area of central nervous system (CNS) disorders, including Huntington’s disease, myasthenia gravis and Parkinson’s disease. Amarin is listed in the U.S. on the NASDAQ Capital Market (“AMRN”). For more information please visit www.amarincorp.com.

 

Contacts: 

Amarin
+353 (0)1 669 9020
Thomas Lynch, Chairman and Chief Executive Officer
Dr. Declan Doogan, Head of Research and Development
Alan Cooke, President, Chief Operating Officer and Chief Financial Officer
Darren Cunningham, EVP Strategic Development and Investor Relations
investor.relations@amarincorp.com 

Fountain Healthcare Partners
+353 (0)1 5225100
Dr. Manus Rogan, Managing Partner
info@fh-partners.com 

Abingworth LLP
+44 (0)20 7534 1500
Dr. Joseph Anderson, Partner
anderson@abingworth.com

Cappella Inc. Secures $17.3 Million Series C Investment

Delaware, Us And Galway, Ireland - Cappella, Inc. (Cappella) announces today that it has completed a $17.3 million Series C investment, led by new investors, Fountain Healthcare Partners and Mitsui & Co. Venture Partners (MCVP). Enterprise Ireland also participated in this round alongside Cappella’s existing investors, Polytechnos Partners and ACT Venture Capital.

Proceeds will be used to finance the launch of Cappella’s proprietary Sideguard™ Sidebranch stent for the treatment of Bifurcated Vascular Disease in Europe and to advance key R&D programs in Galway on additional applications of Cappella’s technology in Complex Coronary Artery Disease (CAD).

Commenting on this financing, Dr. Art Rosenthal, Cappella’s recently appointed CEO, said “This funding will allow us to expand our pipeline, to supplement on-going clinical studies and to successfully launch our first product, the Sideguard™ Sidebranch stent. We believe our proprietary products will treat many types of bifurcation disease, including Left Main Bifurcation Disease. In 2008, this was a $1.0 billion worldwide market and it is growing annually”.

Dr Rosenthal previously served as Chairman and CEO of Labcoat Ltd. and as Chief Scientific Officer of Boston Scientific Corporation. Cappella has also appointed additional senior management to lead European sales and manufacturing activities.

Dr Ena Prosser of Fountain Healthcare Partners commented “We are delighted to invest in Cappella at a very strategic point in the company’s development. From our perspective, Cappella have a differentiated product offering for the treatment of coronary heart disease. Cappella’s impressive management team and top-class scientific advisory board will drive rapid adoption of the Sideguard™ Sidebranch stent in Europe and its successful clinical development in the US”.

Masashi Kiyomine, Principal at Mitsui & Co. Venture Partners, commented: “We are very pleased to have co-led this important round of financing for Cappella, to support the global commercial success of the Sideguard™ Sidebranch stent. With an experienced management team led by Dr. Rosenthal, we believe Cappella is ideally positioned to become the leading provider of innovative solutions for the treatment of bifurcation vascular disease – an area of high unmet medical need”.

Dr Wolfgang Oster, Managing Partner at Polytechnos Venture Partners and Chairman of Cappella’s Board, noted: “As founding investors of Cappella, we are delighted to close this substantial round of finance for a company which we believe has the potential to lead the field of bifurcation devices. The commercial expertise which the new investors bring to the table in Europe, US and Japan is reassuring and will help to accelerate the company’s marketing efforts of its device portfolio. Importantly, the continued participation of our syndicate partners, in particular ACT Venture Capital, in our common cause was a prerequisite to get the company to this exciting value inflection point. ”

In addition to Dr Wolfgang Oster, Dr Art Rosenthal and Dr Ena Prosser, other Board seats will be held by Masashi Kiyomine, MCVP, Dr Ascher Shmulewitz company co-founder, Cappella’s Vice Chairman Charlie Glass of ACT Venture Capital and Dirk Kanngiesser, Polytechnos Venture Partners.

 

About Cappella Inc

Cappella, Inc. (“Cappella” or the “Company”) is a medical device company that is developing novel solutions for the treatment of Complex Coronary Artery Disease (CAD) and specifically bifurcation vascular disease. The Company’s initial product is the Sideguard™ Sidebranch stent. This technology addresses an unmet medical need in CAD. The company was founded in 2004 by Antonio Columbo, M.D., Chief of Invasive Cardiology at San Raffaele Hospital in Milan, Italy, and Ascher Shmulewitz, M.D., Ph.D., a cardiologist, medical device entrepreneur and founder of NeoVision, Xcardia and Labcoat Ltd., and established its headquarters in Galway, with the backing of Polytechnos Venture Partners and ACT Venture Capital. The Sideguard™ Sidebranch stent is an anatomically shaped self-expanding coronary stent that utilizes a unique peel-away delivery system. Both the stent and this delivery system were developed by Cappella Medical Devices Ltd. The unique delivery technology overcomes a number of delivery problems associated with existing nitinol stents, including reduced profile and improved placement accuracy over traditional delivery systems. Cappella Medical Devices Ltd., Galway, Ireland is the R&D and manufacturing subsidiary of Cappella Inc.

For more information please see http://www.cappella-med.com/

 

About Fountain Healthcare Partners

Fountain Healthcare Partners (“Fountain”) is a life science focused venture capital fund headquartered in Dublin, Ireland with a second office in New York, US. Fountain specialises in making investments in biotechnology, medical device, specialty pharma and diagnostic companies and allocates the majority of its capital to Europe with a primary emphasis on Ireland. Fountain launched its inaugural fund (Fountain Healthcare Partners I) in May 2008 with €75M in committed capital. www.fh-partners.com

 

About Mitsui & Co. Venture Partners, Inc.

Mitsui & Co. Venture Partners (MCVP) is a provider of early stage venture capital with expertise in helping U.S. start-up companies build their businesses in global markets. Over the years, MCVP has invested in breakthrough technologies and accelerated the growth of companies across the life sciences, medical devices, communication, software, information technology and cleantech industries. Located in New York, Silicon Valley and Tokyo, MCVP currently manages over $280 million in capital. For more information about MCVP, visit www.mitsuiventures.com/en/

 

About Polytechnos Venture Partners

PolyTechnos Venture-Partners is an independent European Venture Capital firm focusing on early stage Information Technology and Life Science investments, predominantly in Europe. Areas of expertise comprise Information Technology (communications & networking, electronics & computer hardware, and semiconductors) and Life Science (drug development & medtech), as well as opportunities arising from the convergence of these fields. PolyTechnos currently advises funds totaling approximately EUR 200 million. www.polytechnos.com

 

About ACT Venture Capital

ACT Venture Capital is one of Ireland's leading venture capital firms. Founded as an independent operation in 1994, ACT has raised over €350m for investment in growing Irish companies, sourced from American, European, Irish and UK institutions and since then has completed over 70 investments, principally in technology based companies serving global markets. ACT’s current portfolio of more than 20 companies comprises many Irish success stories in the Information and Communications Technology and Healthcare sectors.

 

About Enterprise Ireland

Enterprise Ireland is the government agency responsible for the development of Irish industry. Its core mission is to accelerate the development of world - class Irish companies to achieve strong positions in global markets resulting in increased national and regional prosperity.

www.enterprise-ireland.com

 

Contact:

Niamh Lyons
Financial Dynamics
10 Merrion Square
Dublin 2, IRELAND
T +353 (0)1 66 33 602
F +353 (1) 6633 601
M +353 (0)87 7745000
www.fd.com

Nextech Venture participates in the $24m financing of Palyon Medical

Zurich, Switzerland - Palyon Medical, Inc., a New York-based medical device company, has raised $24m in Series A financing.

The proceeds will be used to finance a multi-site clinical study and to commercialise Palyon's programmable, implantable drug delivery system, which delivers targeted doses of pain medication directly to the spinal area. Baird Venture Partners led the round, with Hambrecht & Quist Capital Management. Fountain Healthcare Partners, BB Biotech Ventures, Cross Atlantic Partners, Arcus Ventures. Nextech Venture also participated in the transaction.

Palyon focuses on the treatment of chronic pain, spasticity and other neurological diseases. Chronic pain, which is defined as pain lasting six months or longer, affects 76 million Americans, according to the company.

David Present, MD, CEO of Palyon, said, "We are very excited to team up with Baird Venture Partners and this group of investors to take Palyon to the next level. We believe that our unique technology platform has led to the development of a next-generation device that will offer meaningful benefits to patients and physicians."

Michael Liang, principal at Baird Venture Partners, added, "There is a significant opportunity for Palyon to participate in and expand this underserved market. We are excited to help facilitate that progress by leading this successful financing syndicate, and believe that the oversubscribed demand for participation in this round speaks to the opportunity."

Palyon Medical Corporation Secures $21 Million Series A Investment

Palyon’s Programmable Implantable Drug Delivery System Intended for Management of Chronic Pain, Spasticity and other Neurological Diseases

NEW YORK, APRIL 29, 2009 – Palyon Medical Corporation (Palyon), a New York-based medical device company, announced today it has raised $21 million in Series A financing. The proceeds will be used to finance a multi-site clinical study and to commercialize Palyon’s programmable implantable drug delivery system, which delivers targeted doses of pain medication directly to the spinal area. Baird Venture Partners led the round, with Hambrecht & Quist Capital Management, Fountain Healthcare Partners, BB Biotech Ventures, Cross Atlantic Partners and Arcus Ventures also participating in the transaction.

Palyon focuses on the treatment of chronic pain, spasticity and other neurological diseases. Chronic pain, which is defined as pain lasting six months or longer, affects 76 million Americans -- more than heart disease, diabetes and cancer combined. Up to 20 percent of chronic pain patients do not respond to conventional medical management, such as oral medications and physical therapy, and may become candidates for interventional pain management therapies such as Palyon’s programmable implantable drug delivery system.

“We are very excited to team up with Baird Venture Partners and this group of investors to take Palyon to the next level,” said David Present, M.D., CEO of Palyon. “We believe that our unique technology platform has led to the development of a next-generation device that will offer meaningful benefits to patients and physicians.”

“There is a significant opportunity for Palyon to participate in and expand this underserved market,” said Michael Liang, Ph.D., Principal at Baird Venture Partners. “We are excited to help facilitate that progress by leading this successful financing syndicate, and believe that the oversubscribed demand for participation in this round speaks to the opportunity.”

In addition, Glen Kashuba will join as a new member of Palyon’s Board of Directors. Kashuba is President of Biomet Trauma and Biomet Spine and was previously President of Johnson & Johnson's Codman Neuroscience division, where he was responsible for overseeing the company’s neuromodulation efforts. Michael Liang, Ph.D, of Baird Venture Partners, Daniel Omstead, Ph.D., of Hambrecht & Quist Capital Management, and Aidan King of Fountain Healthcare Partners will also join the Board.

Rockport Venture Securities, LLC, a wholly-owned subsidiary of Rockport Venture Partners, acted as placement agent in connection with the offering.

 

About Palyon Medical Corporation

Palyon Medical Corporation is a medical device company developing technologies for the treatment of chronic pain, spasticity and other neurological diseases.

 

For additional information, contact:

David Present, M.D., CEO
212-333-2050
dpresent@palyonmedical.com

Opsona Therapheutics Closes €18M Funding

  • Novartis Venture Fund, Fountain Healthcare Partners, Inventages Venture Capital and Seroba Kernel Life Sciences invests in Opsona Therapeutics Series B Financing
  • Proceeds will Advance Lead Compound Targeting Inflammatory Diseases into Clinical Development
  • Opsona opens facility in Switzerland to complement Dublin team

DUBLIN, Ireland, 18 February 2009 - Opsona Therapeutics, a biotechnology company focused on novel therapeutic and preventative approaches to autoimmune and inflammatory diseases, today announced the completion of an €18M ($23M) Series B financing round which will enable it to expand both at an operational and clinical level. Novartis Venture Fund, Fountain Healthcare Partners, Inventages Venture Capital and Seroba Kernel Life Sciences all participated in the funding.

Proceeds will support the advancement of Opsona‘s clinical trials targeting inflammatory diseases, such as rheumatoid arthritis, lupus and transplantation. As a part of the financing, Opsona Therapeutics also announced the addition of Florent Gros, managing director at Novartis Venture Fund, and Dr. Manus Rogan, managing partner at Fountain Healthcare Partners, to the Board of Directors. Opsona expects to make a number of other key appointments in the corporate and clinical areas in the coming months.

Commenting on the announcement, Dr Mark Heffernan, Chief Executive Officer of Opsona Therapeutics, said: "Completion of this financing represents a significant milestone in the transition of Opsona into a product-focused company delivering key clinical development milestones. With the endorsement of our existing and new investors, including the Novartis Venture Fund, Fountain Healthcare Partners and Seroba Kernel Life Sciences. Opsona is positioned to deliver on proof of concept studies in patients by targeting inflammatory diseases through the innate immune system, with our ultimate aim being to uncover innovative therapies that combat diseases with significant unmet medical need.”

Opsona is developing biopharmaceutical and small molecule products which modulate the innate immune system, which is the key trigger in the inflammation cascade in many autoimmune and inflammatory diseases. Opsona’s lead product, a fully humanised monoclonal antibody (OPN-305) to a key toll-like receptor (TLR) target, has demonstrated efficacy in a number of animal models and will start pivotal clinical trials in 2010.

Florent Gros, managing director, Novartis Venture Fund added, "We are delighted to be working with Opsona Therapeutics and the other investors to assist Opsona in progressing the company’s highly innovative technology and approaches towards the clinic. The innate immune system represents a new frontier in targeting inflammatory diseases, and the caliber of the investors in this funding round is a demonstration of Opsona’s expertise and capabilities in this highly promising field."

Opsona has also announced the opening of a new facility in Switzerland. The Swiss laboratory will carry out pivotal assay development and biochemical work for new projects and therapeutics recently acquired by Opsona to expand its pipeline of immunomodulators. The expertise that it intends to grow in Switzerland will complement the existing team and activity in Dublin.

Dr Cormac Kilty, Chairman of Opsona and past Chairman of the Irish Bioindustry Association explains “This is major achievement for any biotechnology company in the current economic climate. Opsona’s R&D shows that emerging Irish companies can reach international recognition in biotechnology.” 

 

About Opsona Therapeutics

Opsona is a drug development company, focused on novel therapeutic and preventative approaches to autoimmune and inflammatory diseases. The company was founded in 2004 with three of Trinity College Dublin’s respected Immunologists (Professors Luke O’Neill, Kingston Mills and Dermot Kelleher). The company is specifically interested in drugs which modulate the innate immune system and its signalling, specifically Toll-Like Receptors (TLR). Opsona has a pipeline of therapeutics in advanced pre-clinical development which modulate the innate immune system, including biologics and small molecules. The company has signed some significant partnering and collaborative deals, such as with Wyeth (USA). The company is based in Dublin and also has laboratories in Lausanne, Switzerland. www.opsona.com

Amarin Proceeding to Phase 3 with AMR101 for Hypertriglyceridemia

FDA Meeting to Discuss Development Plan Completed Successfully

DUBLIN, Ireland, July 22, 2008 – Amarin Corporation plc (NASDAQ: AMRN) today announced that the Company recently met with officials at the U.S. Food and Drug Administration (FDA) to discuss the Company’s plans to develop AMR101 for the treatment of hypertriglyceridemia. Following these discussions, the Company is proceeding to Phase 3 with AMR101 in hypertriglyceridemia.

Dr. Declan Doogan, Head of Research and Development of Amarin, commented “The meeting with the FDA was very successful as it gives us a clear path forward for the program. We are particularly pleased that we can proceed to Phase 3”.

Thomas Lynch, Chairman and Chief Executive Officer of Amarin, added “Over the past year we have assembled a highly experienced team of cardiovascular experts to develop AMR101 for this significant indication. Our initial objective of designing the Phase 3 program and obtaining FDA feedback has been achieved. Having completed our recent financing, we now look forward to conducting the Phase 3 program”.

AMR101 is an ultra-pure ethyl ester of eicosapentaenoic acid (Ethyl-EPA). Amarin has collected a substantial body of data on AMR101 to date. Amarin has previously investigated AMR101 in central nervous system (CNS) disorders in several double-blind, placebo controlled studies, including Phase 3 trials in Huntington’s disease. Over 900 patients have received AMR101 in these studies, with over 100 receiving continuous treatment for a year or more. In all studies performed to date, AMR101 has shown a very good safety profile.

Hypertriglyceridemia refers to a condition in which patients have high blood levels of triglycerides and is associated with increased levels of heart disease. It is one component of a range of lipid disorders collectively referred to as dyslipidemia. The overall dyslipidemia population in the U.S. is believed to be in excess of 100 million, with over 10 million of those diagnosed with hypertriglyceridemia.

Numerous studies have demonstrated the safety, tolerability and efficacy of Ethyl-EPA in lowering plasma triglycerides in patients with high triglyceride levels of varying degrees of severity. In Japan, an Ethyl-EPA prescription product has been approved for the treatment of high triglycerides and has been on the market for seventeen years. Data from Amarin’s Huntington’s disease trials indicate that AMR101 lowers triglycerides in patients with elevated baseline levels.

 

About Amarin

Amarin is a biopharmaceutical company focused on improving the lives of patients suffering from cardiovascular and central nervous system (CNS) diseases. Amarin’s cardiovascular programs, including AMR101 for hypertriglyceridemia, capitalize on the known therapeutic benefits of essential fatty acids in cardiovascular disease. Amarin’s CNS development pipeline includes programs in myasthenia gravis, Huntington’s disease, Parkinson’s disease, epilepsy and memory. Amarin is listed in the U.S. on the NASDAQ Capital Market (“AMRN”).

 

Contacts:

Amarin +353 (0)1 669 9020
Thomas Lynch, Chairman and Chief Executive Officer
Alan Cooke, President and Chief Operating Officer
Darren Cunningham, EVP Strategic Development and Investor Relations
investor.relations@amarincorp.com

Amarin announces private placement for up to $60 million

DUBLIN, Ireland, May 14, 2008 – Amarin Corporation plc (NASDAQ: AMRN) today announced a private placement of American Depositary Shares (each representing one ordinary share) (“ADSs”) with several new institutional and accredited investors, and potentially certain directors of the Company, for up to $60 million funded over two equal tranches.

The new investors, who have entered into definitive agreements for gross proceeds of up to $56 million, comprise Sofinnova Ventures, OrbiMed Advisors LLC, Thomas, McNerney & Partners, Panorama Capital, Longitude Capital and Fountain Healthcare Partners. The first $28 million tranche is expected to close shortly, subject to customary closing conditions. The investors will have an option to provide up to $28 million in a second tranche upon completion of certain business milestones by the Company, potentially over the next 12 months.

Certain directors of Amarin have indicated an interest in investing up to an additional $4 million in the placement, also over two equal tranches, bringing the potential total of the placement up to $60 million. Cowen and Company LLC acted as the lead placement agent for the transaction.

Thomas Lynch, Chairman and Chief Executive Officer of Amarin, commented “This financing strengthens our balance sheet considerably, and allows us to accelerate our key clinical development programs. We are now well positioned to take advantage of the significant opportunities available to the Company.”

Alan Cooke, President and Chief Operating Officer of Amarin, added “We are delighted with the participation by well recognised biotech investors and by the continued support of our directors, which we believe reflects the attractive investment proposition Amarin represents.”

The Company intends to use the proceeds from this financing for progressing its cardiovascular and CNS research and development pipeline, for general corporate purposes, and the retirement of its $2.75 million convertible debentures issued in December 2007, after which the company will be debt free.

The first tranche of $28 million will be settled by the issuance of 12,173,914 new Ordinary Shares and the potential $2 million investment by directors would be settled by 869,565 new Ordinary Shares, all at $2.30 per share. The second tranche would be settled by the issuance of ADSs at a price equal to the lower of (i) $2.60, and (ii) 113% of the average of the volume weighted average prices of Amarin’s ADSs as reported on NASDAQ for each of the 30 trading days immediately prior to the date of the closing of the second tranche.

Following closing of the first tranche, the new investors will hold approximately 45% of the Ordinary Shares of the Company. Certain of the new investors will be entitled to join Amarin’s Board and will obtain various rights relating to the appointment of directors and pre-emption on further issues of shares by Amarin.

 

City Code and Regulatory Disclosures

Following the recent move of the place of central management of the Company to Ireland, the City Code on Takeovers and Mergers (the "Code") does not apply to Amarin, as the Company does not fall within paragraph 3(a)(ii) of the Introduction to the Code.

The securities offered in the private placement are not registered under the Securities Act of 1933, as amended (the "Act"), or any state securities laws, and may not be offered or sold in the United States absent registration, or an applicable exemption from registration, under the Act and applicable state securities laws.

Under an agreement with the investors, the Company is required to file a registration statement with the United States Securities and Exchange Commission covering the resale of the shares of common stock to be issued to the investors no later than sixty days after each closing and to use reasonable best efforts to have the registration statement declared effective as soon as practicable thereafter. Application has been made to list 12,173,914 ordinary shares on AIM and IEX respectively.

This press release does not constitute an offer to sell or the solicitation of an offer to buy any securities. There shall not be any sale of these securities in any jurisdiction in which such offering would be unlawful.

 

About Amarin

Amarin is a biopharmaceutical company focused on improving the lives of patients suffering from cardiovascular and central nervous system (CNS) diseases. Amarin’s cardiovascular programs capitalize on the known therapeutic benefits of essential fatty acids in cardiovascular disease. Amarin’s CNS development pipeline includes programs in myasthenia gravis, Huntington’s disease, Parkinson’s disease, epilepsy and memory. Amarin also has two proprietary technology platforms: a lipid-based technology platform for the targeted transport of molecules through the liver and/or to the brain, and a unique mRNA technology based on cholinergic neuromodulation. Amarin has its primary stock market listing in the U.S. on the NASDAQ Capital Market (“AMRN”).

 

Contacts:

Amarin +353 (0)1 669 9020
Thomas Lynch, Chairman and Chief Executive Officer
Alan Cooke, President and Chief Operating Officer
Darren Cunningham, EVP Strategic Development and Investor Relations
Investor Relation

Investors:

Lippert/Heilshorn & Associates, Inc.
Anne Marie Fields +1 212 838 3777
Bruce Voss +1 310 691 7100

Media:

Powerscourt
+44 (0) 207 250 1446
Rory Godson
Paul Durman

 

Disclosure Notice 

The information contained in this document is as of May 14, 2008. Amarin assumes no obligation to update any forward-looking statements contained in this document as a result of new information or future events or developments. This document contains forward-looking statements about Amarin's financial condition, results of operations, business prospects and products in research that involve substantial risks and uncertainties. You can identify these statements by the fact that they use words such as "will", "anticipate", "estimate", "expect", "project", "forecast", "intend", "plan", "believe" and other words and terms of similar meaning in connection with any discussion of future operating or financial performance or events. Among the factors that could cause actual results to differ materially from those described or projected herein are the following: risks relating to the Company’s ability to maintain its Nasdaq listing; Amarin's ability to maintain sufficient cash and other liquid resources to meet its operating and debt service requirements; the success of Amarin's research and development activities; decisions by regulatory authorities regarding whether and when to approve Amarin's drug applications, as well as their decisions regarding labeling and other matters that could affect the commercial potential of Amarin's products; the speed with which regulatory authorizations, pricing approvals and product launches may be achieved; the success with which developed products may be commercialized; competitive developments affecting Amarin's products under development; the effect of possible domestic and foreign legislation or regulatory action affecting, among other things, pharmaceutical pricing and reimbursement, including under Medicaid and Medicare in the United States, and involuntary approval of prescription medicines for over-the-counter use; Amarin's ability to protect its patents and other intellectual property; claims and concerns that may arise regarding the safety or efficacy of Amarin's product candidates; governmental laws and regulations affecting Amarin's operations, including those affecting taxation; general changes in International generally accepted accounting principles; and growth in costs and expenses. A further list and description of these risks, uncertainties and other matters can be found in Amarin's Form 20-F for the fiscal year ended December 31, 2006, filed with the SEC on March 5, 2007, Amarin’s statutory annual report for the year ended 31 December, 2006 furnished on a Form 6-K to the SEC on May 9, 2007, Amarin’s Report of Foreign Issuer (Updated and Additional Risk Factors) furnished on a Form 6-K to the SEC on January 8, 2008 and in Amarin’s other Reports of Foreign Issuer on Form 6-K furnished to the SEC.