Dr. Leon Hooftman Appointed Chief Medical Officer As Opsona Therapeutics Transitions Into The Clinic

-    Prof. Luke O’Neill extends role to become Chief Scientific Officer

-    Ms. Mary Reilly assumes broader role as VP Pharmaceutical Development and Operations

06 May, 2011 – DUBLIN, Ireland - Opsona Therapeutics, a drug development company focused on novel therapeutic and preventative approaches to autoimmune and inflammatory diseases, today announced that Leon Hooftman, M.D., has joined the company as Chief Medical Officer, with responsibility for leading the company’s clinical development initiatives.  Dr. Hooftman who will be based at Opsona Therapeutics’ headquarters in Dublin will be a member of the company’s Executive Management Team.

Commenting on Dr. Hooftman’s 18 years of experience in the industry, Bernd R. Seizinger, M.D., Ph.D., Executive Chairman said, “During his successful career Dr. Hooftman has provided extensive clinical development leadership in a variety of therapeutic areas including transplantation and oncology, designing and overseeing numerous multi-center clinical trials.  His credibility and experience as a leading clinical scientist will be invaluable as we move OPN-305, our first-in-class monoclonal antibody against Toll-like-Receptor-2 into clinical development this year.”

Leon Hooftman, M.D., joins Opsona Therapeutics following a high-profile career in clinical development where he was most recently Chief Medical Officer at Chroma Therapeutics (UK).  Previously, Leon was Head of Clinical Development at Celltech (U.K.); Director of Clinical Science for Oncology and Immunology and prior to that International Medical Manager in Immunology at Hoffmann La-Roche.  Dr. Hooftman also served as the Senior Clinical Research Physician at Syntex, U.K.

Dr. Hooftman obtained his medical degree at University of Utrecht (Netherlands) and underwent specialist training in transplantation surgery at Addenbrooke’s Hospital in Cambridge, U.K.

To further strengthen the Executive Management team, one of the Company’s founding scientists and Directors, Professor Luke O’Neill, a world-renowned leader in innate immunity and Professor at Trinity College in Dublin will assume the additional role of Chief Scientific Officer at Opsona.  

Opsona’s VP of Pharmaceutical Development, Ms Mary Reilly, will assume a broader role within the company as Vice President of Pharmaceutical Development and Operations.  Together with the Company’s CFO David Hurley, Dr. Hooftman, Prof. O’Neill and Ms. Reilly will constitute the Company’s Executive Management Team, reporting to Dr. Bernd Seizinger.

Opsona Therapeutics Executive Chairman, Dr. Bernd Seizinger, went on to say, “as Opsona looks forward to an exciting new chapter in its corporate evolution, we have aligned a highly experienced team of senior professionals who will help us to further solidify our position as an international leader in the development of a new generation of therapeutics targeting the innate immune system.” 

For further information: Niamh Lyons for Opsona Therapeutics - +353 1 6633602

European Commission Awards Eur 5.9m To Opsona Therapeutics For Clinical Development Of Lead Drug Candidate Opn-305

-    Trans-European Consortium to start clinical development of OPN-305this year

-    Clinical trials to target solid organ transplantation

06 May,  2011-- DUBLIN, Ireland -- Opsona Therapeutics, a drug development company focused on novel therapeutic approaches to treat autoimmune and inflammatory diseases today announced that it has been awarded€5.9 million from the European Commission to lead a European framework 7 (FP7) consortium of research and clinical groups (termed MABSOT*) in the advancement of clinical trials for its lead drug candidate OPN-305 in solid organ transplantation.  A phase 1 trial in healthy volunteers is due to start this summer. 

Commenting on today’s announcement, Bernd R. Seizinger, M.D., Ph.D., Executive Chairman of Opsona Therapeutics said, “We are very excited to have the opportunity to coordinate this important trans-European consortium.  Improvement of graft function, specifically in renal transplantation, continues to be an area of unmet medical need, requiring truly innovative therapeutic approaches such as OPN-305.”

The specific focus of the Consortium will be the development of OPN-305 as a therapeutic agent for the prevention of Delayed Graft Function (DGF), a serious complication of the immediate postoperative period in renal transplantation.  OPN-305 is a monoclonal antibody inhibitor of Toll-like-receptor-2 (TLR-2). Data generated by Opsona, its collaborators and independent scientists has provided solid scientific evidence for a link between TLR-2 and DGF. The consequences of DGF can be prolonged hospitalisation of patients, additional invasive procedures and transplant rejection.   There is currently no specific therapeutic treatment for DGF.  Following successful completion of the Phase 1 trial this year, the consortium plans to conduct a prospective randomized placebo-controlled Phase 2 trial in the prevention of DGF to be initiated in 2012. 

Dr. Seizinger went on to comment on the broader potential of OPN-305, “Since OPN-305 targets TLR-2, a key component of innate immunity, this first-in-class antibody against TLR-2 may have even greater medical and commercial potential for the novel treatment of a broad range of human diseases including cancer and cardiovascular disease.”

The Monoclonal Antibody Solid Organ Transplantation (MABSOT)* consortium which has been partially funded by the European Commission Seventh Framework Program (FP7) consists ofKings College London (UK),  Katholieke Universiteit Leuven (Belgium),  Fundacio Privada Institut D'Investigacio Biomedica De Bellvitge (Spain), Academisch Ziekenhuis Groningen (Netherlands), Institut Klinické a Experimentální Medicin(Czech Republic), University of Newcastle Upon Tyne (UK), Euram Ltd (UK) and Almac Diagnostics Ltd (UK), together with Opsona Therapeutics Ltd. (Ireland).

“We are proud, particularly as a Small/Medium Enterprise, to lead and coordinate this important collaborative effort which brings together many outstanding scientists, transplant surgeons and medical opinion leaders in the field of immunology and transplantation from across Europe” said Mary Reilly, VP Pharmaceutical Development and Operations, and MABSOT coordinator with the European Commission. 

Further information on the objectives of the MABSOT consortium can be found on the projects website, www.mabsot.eu.

For further information: Niamh Lyons for Opsona Therapeutics - +353 1 6633602

Opsona Therapeutics Appoints Chairman Dr. Bernd R. Seizinger As Executive Chairman; Dr. Mark Heffernan Resigns As Ceo But Remains As Non-Executive Director

06 May, 2011 – DUBLIN, Ireland - Opsona Therapeutics, a drug development company focused on novel therapeutic approaches to target autoimmune and inflammatory diseases today announced that its Board of Directors has appointed Chairman Bernd Seizinger M.D., Ph.D., as Executive Chairman, following the resignation of founding CEO Mark Heffernan, Ph.D.  Dr. Heffernan who has stepped down for personal reasons to return to Australia is joining Opsona’s Board of Directors as a Non-Executive Director of the Board. 

A CEO search committee has been formed.  The committee is led by Dr. Seizinger who also has assumed additional oversight responsibilities of the Company’s operations during this period of transition.

Speaking about Dr. Heffernan’s departure, Dr Seizinger said, “As our founding CEO, Mark, in his seven years with the company has established Opsona as one of Europe’s leading early-stage biotech companies. He successfully managed the company through a number of fundraisings, built collaborations and partnerships with some of the best in the business and ultimately led the company to the door of clinical development.  As we move into our next stage of corporate evolution we are happy that Mark will maintain his association with Opsona as a Non-Executive Director.”

"Opsona has gained considerable product and financial momentum and is evolving into a clinical development company capable of translating key scientific discoveries on the innate immune system into novel therapeutics.   Our roadmap for the year includes moving into Phase I clinical trials with our first-in-class antibody OPN-305 targeting Toll-like-receptor 2 (TLR2).  TLR2 has

been associated with a variety of human diseases including complications in solid organ transplantation, cancer, cardiovascular disease, as well asautoimmune-  and inflammatory diseases.  This is a pivotal and exciting time for the Company," continuedDr. Seizinger.

For more information – Niamh Lyons for Opsona Therapeutics - +353 1 6633602

 

About Opsona Therapeutics

Opsona is a drug development company, focused on novel therapeutic approaches to key targets of the innate immune systemassociated with a wide range of major human diseases, including autoimmune and inflammatory diseases, transplant rejection, cancer, diabetes, Alzheimer’s disease and atherosclerosis. The company was founded in 2004 by three world-renowned immunologists at Trinity College in Dublin.  Opsona has two lead programs that modulate the innate immune system, including biologics and small molecules.  Opsona’s lead product, a fully humanized monoclonal antibody (OPN-305) against Toll-like-receptor-2 (TLR-2) has demonstratedactivityin a number of animal models and will start clinical trials in 2011 Opsona has also signed significant partnering and collaborative deals, with Pharmaceutical companiessuch asPfizer (USA). Headquartered in Dublin, Opsona most recently completed a €21.3m financing round with an international investor consortium including: Inventages Venture Capital, Novartis Venture Fund,  Roche Venture Fund, Seroba-Kernel Life Sciences, Fountain Healthcare Partnersand Enterprise Ireland.  www.opsona.com

Amarin’s AMR101 Phase 3 ANCHOR Trial Meets all Primary and Secondary Endpoints

Amarin’s AMR101 Phase 3 ANCHOR Trial Meets all Primary and Secondary Endpoints with Statistically Significant Reductions in Triglycerides at Both 4-Gram and 2-Gram Doses and Statistically Significant Decrease in LDL-C

- Triglyceride levels decreased 21.5% and 10.1% from baseline versus placebo at 4 grams and 2 grams doses, respectively

- LDL-C decreased at both doses within the predefined non-inferiority boundary with a statistically significant 6.2% decrease in LDL-C from baseline versus placebo at 4 gram dose

- All results were incremental to background statin therapy

- Safety profile similar to placebo and similar to MARINE trial results

- Results position AMR101 to be first-in-class product for treatment of high triglycerides

MYSTIC, Conn. and DUBLIN, April 18, 2011 – Amarin Corporation plc (Nasdaq: AMRN), a clinical-stage biopharmaceutical company with a focus on cardiovascular disease, today reported positive, statistically significant top-line results from its ANCHOR trial for the Company’s lead product candidate, AMR101. The Phase 3 trial met its primary and secondary efficacy endpoints for both the 4 gram and 2 gram daily doses.

The purpose of the ANCHOR trial was to demonstrate that AMR101 is effective in reducing triglyceride levels in patients with high triglycerides without increasing LDL-C (“bad cholesterol”) levels in patients on background statin therapy. The ANCHOR trial investigated AMR101 as a treatment for high triglycerides (≥200 and <500mg/dL) in 702 patients with mixed dyslipidemia (two or more lipid disorders) on background statin therapy at LDL-C (low-density lipoprotein cholesterol) goal who were at high risk of cardiovascular disease. The majority of these patients were diabetic (73%). This is the largest trial with omega-3 therapy conducted in this important patient population. All patients were on background statin therapy with simvastatin, atorvastatin or rosuvastatin. Despite the benefits of statin therapy, patients in this population have significant residual risk for cardiovascular events. The trial’s primary endpoint was defined as the percentage change in triglyceride levels from baseline compared to placebo after twelve weeks of treatment. In addition, the study was powered to demonstrate a lack of LDL-C elevating effect with AMR101 compared to placebo. The trial was conducted under a Special Protocol Assessment (SPA) agreement with the FDA.

 

Triglyceride Reduction Levels Exceeded Company Expectations

The primary endpoint for triglyceride change was achieved at both 4 grams and 2 grams per day with median placebo-adjusted reductions in triglyceride levels of 21.5% and 10.1% for the 4 grams and 2 grams per day dose groups, respectively.  These reductions were both statistically significant (p<0.0001 and p = 0.0005, respectively). The median baseline triglyceride levels were 259 mg/dL, 265 mg/dL and 254 mg/dL for the patient groups treated with placebo, 4 grams and 2 grams of AMR101 per day, respectively.  Even greater reductions in triglycerides were noted with higher potency statin regimens. Results were positive and statistically significant in both the diabetic and non-diabetic patient groups.

 

LDL-C Reductions Surpass Target of LDL-C Neutrality

The trial’s key secondary endpoint was to demonstrate a lack of elevation of LDL-C in order to avoid offset to the primary target of cholesterol lowering therapy. The trial’s non-inferiority criterion for LDL-C was met at both AMR101 doses.  The upper confidence boundaries for both doses were below the pre-specified +6% LDL-C threshold limit.  In fact, at the 4 gram dose the upper confidence boundary was below zero (-1.7%) and at the 2 gram dose the upper confidence boundary was close to zero (0.05%). Moreover, for the 4 grams per day AMR101 group, LDL-C decreased significantly by 6.2% from baseline versus placebo, demonstrating superiority over placebo (p=0.0067). For the 2 grams per day group, LDL-C decreased by 3.6% from baseline versus placebo (p=0.0867).

 

Additional Findings and Safety Profile were Positive

In addition, the ANCHOR trial demonstrated statistically significant decreases in all predefined secondary endpoints at both doses studied. These endpoints were non-HDL-C, Apo B (Apolipoprotein B), Lp-PLA2 (lipoprotein phospholipase A2) and VLDL-cholesterol. Non-HDL-C decreased in the 4 grams per day group by 13.6% (p<0.0001) and in the 2 grams per day group by 5.5% (p=0.0054) compared to placebo. These are important lipid biomarkers as they represent predictors of cardiovascular risk. Apo B is a sensitive index of residual cardiovascular risk and is generally considered to be a better predictor than LDL-C.  Lp-PLA2 is an enzyme found in blood and atherosclerotic plaque; high levels have been implicated in the development and progression of atherosclerosis. The safety profile of AMR101 was similar to placebo and there were no treatment-related serious adverse events in the trial. These results confirm and build upon the positive results for the MARINE Phase 3 trial announced in November 2010. The Company expects to present more details of these results at an upcoming scientific meeting.

 

Principal Investigator and Company Very Encouraged by Results

“The design and execution of the ANCHOR trial were robust and the trial results were very clearly positive,” said Christie M. Ballantyne, M.D., Methodist DeBakey Heart and Vascular Center, Houston, and principal investigator of the ANCHOR trial.  “I am very impressed with the performance of AMR101. In particular, whereas current triglyceride-lowering drugs may raise LDL-C and causes patient treatment concerns, AMR101 demonstrated a decrease in LDL-C beyond the decrease created by statin therapy. Furthermore, it is very encouraging for patient care that AMR101 caused reductions in significant markers of cardiovascular risk such as Apo B and non-HDL-C. The greater triglyceride reduction in patients with higher potency statin regimens is also very encouraging.”

Commenting on the ANCHOR trial results, Joseph S. Zakrzewski, Chief Executive Officer and Executive Chairman of Amarin, stated, “We are delighted by the results of the ANCHOR trial. In November we announced MARINE trial results which position AMR101 to be best-in-class for treating patients with very high triglycerides. The ANCHOR trial results are even more remarkable than the broadly positive MARINE trial results. We believe these results clearly differentiate AMR101 from other triglyceride lowering therapies and position AMR101 to be both first-in-class and best overall therapy for treating the high triglyceride population. We thank the ANCHOR team, including our investigators, for their many contributions to this outstanding study design and execution.”

 

Large Market Potential

In the U.S. alone, approximately 40 million people have triglyceride levels above 200 mg/dL. The majority of these patients have high triglyceride levels of ≥200 and <500mg/dL as studied in the ANCHOR trial with approximately 4 million of these people having very triglyceride levels >500 mg/dL as studied in the MARINE trial.  Currently, no omega-3 based product is approved for the indication studied in the ANCHOR trial.  In the seven largest pharmaceutical markets (U.S., Japan and five largest European markets), it is estimated that over 100 million people have mixed dyslipidemia.

 

Investor Contact Information:

Stephen D. Schultz
Investor Relations and Corporate Communications
Amarin Corporation
In U.S.: +1 (860) 572-4979 x292
investor.relations@amarincorp.com

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

Amarin Corporation announces the pricing of an underwritten public offering

MYSTIC, Conn. and DUBLIN, Jan. 6, 2011 /PRNewswire/ -- Amarin Corporation plc (Nasdaq:AMRN - News) (the "Company"), a clinical-stage biopharmaceutical company with a focus on cardiovascular disease, today announced the pricing of an underwritten public offering of 12,000,000 American Depositary Shares ("ADSs") at a price to the public of $7.60 per ADS. The net proceeds to the Company from this offering are expected to be approximately $87.1 million, after deducting underwriting discounts and commissions and other estimated offering expenses. The offering is expected to close on or about January 11, 2011, subject to customary closing conditions.

Jefferies & Company, Inc. and Leerink Swann LLC are acting as joint book-running managers in the offering, and Canaccord Genuity Inc. is acting as co-lead manager for the offering. Amarin has granted the underwriters a 30-day option to purchase up to an aggregate of 1,800,000 additional ADSs solely to cover over-allotments, if any. Amarin anticipates using the net proceeds from the offering to prepare for the commercialization of AMR101, its filing of a New Drug Application and for working capital and general corporate purposes.

The securities described above are being offered by Amarin pursuant to a shelf registration statement previously filed with and declared effective by the Securities and Exchange Commission (the "SEC") on November 23, 2010. A preliminary prospectus supplement related to the offering has been filed with the SEC and is available on the SEC's website at http://www.sec.gov. Copies of the final prospectus supplement relating to these securities may be obtained from Equity Syndicate Prospectus Department, Jefferies & Company, Inc., 520 Madison Avenue, 12th Floor, New York, NY, 10022, at 877-547-6340, and at Prospectus_Department@Jefferies.com. This news release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

Cappella Medical Systems Announces First Placements of its New Dual Marker Sideguard® System

GALWAY, Ireland--(BUSINESS WIRE)--Cappella Medical Systems has announced the successful initial placements of its new dual-marker Sideguard® coronary sidebranch stent system by Dr. Antonio Colombo and Dr. Azeem Latib at San Raffaele Hospital in Milan, Italy.

“The additional reference marker is a nice addition to the Sideguard system. The angiographic view that produces the least amount of foreshortening between the two reference markers is helpful and ensures proper placement of the Sideguard system.”

The Cappella Sideguard system is a self-expanding trumpet shaped nitinol stent designed to optimize treatment of bifurcation lesions. The novel, low-profile balloon-catheter delivery system includes proprietary split-sheath technology that helps ensure precise placement. Now, with the introduction of the new dual-marker system, clinicians will have an additional reference point to help visualize the position of the Sideguard system under angiography prior to deployment.

Commenting on the new dual marker Sideguard placement, Dr. Azeem Latib stated, “The additional reference marker is a nice addition to the Sideguard system. The angiographic view that produces the least amount of foreshortening between the two reference markers is helpful and ensures proper placement of the Sideguard system.”

The new Sideguard system with dual reference markers is CE mark approved and available for sale outside of the US. For additional information please visit www.cappella-med.com.

 

About Cappella Medical Systems

Cappella, Inc. develops novel solutions for the treatment of complex coronary artery disease (CAD) - specifically bifurcation disease. Cappella’s Sideguard® coronary sidebranch technology offers interventional cardiologists a straightforward, effective, solution that focuses on treating the sidebranch of diseased coronary arteries first, rather than the main vessel. Clinicians can then use their preferred stent of choice in the main vessel. The Sideguard delivery system features an innovative split-sheath, balloon released, technology that ensures precise placement on the ostial borderline. The Sideguard self-expanding, nitinol, stent promotes continuous wall apposition and positive remodeling and its’ unique trumpet-shaped design conforms to varying characteristics of the sidebranch ostium. Cappella Medical Devices Ltd., Galway, Ireland is the R&D and manufacturing subsidiary of Cappella, Inc. For more information, please visit the Cappella Medical Systems website at www.cappella-med.com.

Amarin Completes Patient Randomization in Phase 3 ANCHOR Trial

Study Designed to Position AMR101 as First-in-Class Drug for Treating High Triglyceride Levels in Statin-Treated Patients with Mixed Dyslipidemia;
ANCHOR Trial Studies a Separate Indication for AMR101 than Studied in Recently Reported Phase 3 MARINE Trial

MYSTIC, Conn., and DUBLIN, Dec. 15, 2010 – Amarin Corporation plc (Nasdaq: AMRN), a clinical-stage biopharmaceutical company with a focus on cardiovascular disease, today reported the completion of patient randomization for its ANCHOR trial, a pivotal Phase 3 trial of AMR101. The Company indicated that it anticipates reporting top-line results from this trial by the end of Q2 2011 (the Company’s previous guidance for the timing of such results was mid-2011).

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 (ethyl-EPA) in patients with high triglyceride levels from 200 mg/dL to less than 500 mg/dL who are also on statin therapy. Patients in this trial are characterized as having high triglyceride levels with mixed dyslipidemia (two or more lipid disorders) and are at significant risk of cardiovascular disease. No omega-3 based therapy is approved by the FDA for treating this patient population.

The ANCHOR trial is being conducted under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA). The trial recruited and randomized 702 patients. Prior to randomization into the 12-week treatment period, all patients underwent a six-to-eight week washout period of lipid altering drugs, as well as diet and lifestyle stabilization. The Company expects that the 702 patients randomized will be sufficient to demonstrate statistical significance in accordance with the trial protocol. All of the clinical sites in the trial are in the U.S. The primary endpoint in the trial is the percent change in triglyceride level from baseline to week 12. An important secondary endpoint in the ANCHOR trial is to show that the addition of AMR101 to statin therapy does not increase LDL-cholesterol (LDL-C or “bad cholesterol”) compared to placebo in this population.

“We are pleased that the ANCHOR study has been able to complete the patient randomization process before the end of 2010,”said Joseph S. Zakrzewski, Executive Chairman and Chief Executive Officer of Amarin. “Following the very positive results of the recently reported MARINE study in whichAMR101 demonstrated that it reduced triglyceride levels without increasing LDL-C in patients with very high triglycerides (>500 mg/dL), the ANCHOR study evaluates AMR101 in a different and larger patient population. AMR101 is designed to be first-in-class for this indication. In the U.S. alone, there are 36 million patients with triglyceride levels in the range being studied in the ANCHOR trial.”

On November 29, 2010, the Company reported positive top-line data for its pivotal Phase 3 MARINE study. In that study, AMR101 was shown to effectively lower triglyceride levels in patients with very high triglycerides (>500mg/dl) without increasing LDL-C. AMR101 is the first omega-3 based product outside of Japan to demonstrate statistically significant triglyceride reduction without an increase in LDL-C. The Company believes that this is because AMR101, like a similar product in Japan, consists of >96% ethyl-EPA (ethyl icosapentate) and no DHA (Docosahexaenoic acid). DHA has been linked to increases in LDL-C. The MARINE study results also included favorable findings with respect to significant reductions in total cholesterol, non-HDL-C, Apo B, and Lp-PLA2 levels together with a safety profile for AMR101 that appears to be both comparable to placebo and more favorable compared to other triglyceride lowering therapies.. The MARINE study was conducted in a population representative of millions of people with very high triglyceride levels, including more than 3.8 million in the U.S. Amarin believes that AMR101 is positioned to be best-in-class for this indication.

Cappella Medical Systems Wins Top Medical Technology Industry Awards

GALWAY, Ireland--(BUSINESS WIRE)--Cappella Medical Systems has received two prestigious medical device awards for 2010. It was honored with the prestigious Medical Technology Company of the Year 2010 award at the fourth annual Medical Technology Industry Excellence Awards, jointly hosted by Enterprise Ireland, IDA Ireland and the Irish Medical Devices Association (IMDA). The IMDA represents over 140 medical devices companies that reside within Ireland. Cappella Medical also won the overall Emerging Company of the Year 2010 award.

Established in Galway in May 2005 and now employing more than 30 staff, Cappella Medical won both awards for creating an innovative solution for the treatment of complex coronary artery disease. Cappella’s Sideguard® is a next-generation, self-expanding ostial protection stent with unique delivery system which offers cardiologists a straightforward, effective solution that focuses on treating the sidebranch of diseased coronary arteries. The CEO of Cappella Medical Systems, Dr. Art Rosenthal, stated, “These awards are confirmation of the unique benefits of our technology. The proprietary Sideguard® balloon activated split-sheath design overcomes the historical problem of implanting self expanding stents. The cardiologist only needs to activate the balloon in customary fashion resulting in quick and precise deployment of the Sideguard® stent. The combined innovations of the Sideguard® delivery catheter and stent design redefine the use of self expanding nitinol stents for cardiology.”

Commenting on the awards, Cappella VP of Engineering, Clinical and Regulatory Affairs, Michael Gilmore said: "I am delighted and honored to accept this award on behalf of the Cappella team. The design and testing of a medical stent is a complex process and I commend each member of the team that brought Sideguard from concept to reality. This award is a wonderful recognition of our work as we look to applying the technology we have created in the development of Sideguard to additional stents for the treatment of coronary artery disease."

The IMDA director Sharon Higgins said: "Despite the current economic climate, we are very much witnessing the fruits of Ireland’s strong and dynamic national innovation strategy. As a young innovative company, Cappella is making an outstanding contribution towards establishing Ireland as ‘Innovation Ireland’ and is a perfect example of how we can retain and grow our position as a world leader in the medical technology sector. It is our pleasure to pay tribute to this up-and-coming medical devices company, and we also warmly commend the other very worthy finalists who each play a vital role in ensuring that Ireland continues to compete on the world stage."

 

About Cappella Medical Systems

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. It allows the clinician’s preferred stent of choice to then be placed in the main vessel. The Sideguard® system combines a proprietary split-sheath technology delivery system that ensures precise placement with a unique trumpet-shape self expanding nitinol design that protects the ostium and promotes continuous wall apposition and positive remodeling. In addition, a new second radio-opaque marker has been added to the catheter as a reference point when visualizing under angiography to help facilitate proper positioning on the ostial borderline. Cappella Medical Devices Ltd., Galway, Ireland is the R&D and manufacturing subsidiary of Cappella, Inc. For more information, please visit the Cappella Medical Systems website at www.cappella-med.com

Amarin’s AMR101 Meets Pivotal Phase 3 Study Endpoints

Amarin’s AMR101 Meets Pivotal Phase 3 Study Endpoints with Highly Statistically Significant Reductions in Triglycerides at 4 Gram and 2 Gram Doses in MARINE Trial with No Statistically Significant Increase in LDL-C and Safety Profile Similar to Placebo

• Largest controlled therapeutics trial in patients with very high triglycerides

• Trial conducted in accordance with Special Protocol Assessment with FDA

• NDA submission moved forward to 2011

MYSTIC, Conn., and DUBLIN, Nov. 29, 2010 – Amarin Corporation plc (Nasdaq: AMRN), a clinical-stage biopharmaceutical company with a focus on cardiovascular disease, today reported positive, statistically significant top-line results from the MARINE study, its first Phase 3 clinical trial of lead drug candidate AMR101. The MARINE study, investigating AMR101 as a treatment for very high triglycerides (>500 mg/dL), met its primary efficacy endpoints as defined in the clinical trial protocol and demonstrated a positive safety profile. The Company believes that AMR101 has the potential to be the best-in-class product for this indication and that the MARINE study results may support additional patentable claims that could further protect the Company’s rights to this product through 2030.

The study’s primary endpoint, the percent change in triglyceride (TG) levels from baseline to week 12, was met for both the 4 gram and 2 gram dose groups. The MARINE study was required to meet a stringent level of statistical significance of 1% (p < 0.01), as agreed in the Company’s SPA (Special Protocol Assessment) with the FDA. Twenty-five percent of patients were on background statin therapy. The patient group treated with 4 grams of AMR101 showed a significant median TG decrease of 33 % (P < 0.0001) compared to placebo, and the patient group treated with 2 grams of AMR101 showed a significant median TG decrease of 20 % (P = 0.0051) compared to placebo. The median baseline triglyceride levels were 703 mg/dL, 680 mg/dL and 657 mg/dL for the patient groups treated with placebo, 4 grams of AMR101 and 2 grams of AMR101, respectively.

In a pre-specified secondary analysis in the subgroup of patients with baseline TG > 750 mg/dL, representing 39% of all patients, the effect of AMR101 in reducing TG levels was even more pronounced. In this group, the median decrease in TG levels from placebo was 45% for 4 grams and 33% for 2 grams, both statistically significant (P= 0.0001 for 4 grams and P= 0.0016 for 2 grams, respectively). The median baseline TG levels in this subgroup were 1052 mg/dL, 902 mg/dL and 948 mg/dL for placebo, 4 gram and 2 gram groups, respectively. In addition, the subgroup of patients on background statin therapy had much greater median reductions in TG, which were also statistically significant, than those not on statin therapy.

Importantly, AMR101 did not result in an increase in median LDL-C compared to placebo at either dose (-2.3% for the 4 gram group and +5.2% for the 2 gram group [p=NS]). This is the first and only triglyceride-lowering therapy studied in this population with very high triglyceride levels to show a lack of elevation in LDL-C. Furthermore, there was a statistically significant decrease in median non-HDL-C (total cholesterol less “good cholesterol”) compared to placebo with both of the AMR101 treated groups (-18% for the 4 gram group [p < 0.001] and -8% for the 2 gram group [p < 0.05]).

There were also statistically significant reductions in several important lipid markers, including Apo B, Lp-PLA2 (Lipoprotein-phospholipase A2), VLDL-C and Total Cholesterol. These results are particularly encouraging given that no other TG-lowering therapy studies have shown such results. For these achieved endpoints, p-values were <0.01 for most and <0.05 for all. Apo B (Apolipoprotein B) is a sensitive index of residual cardiovascular risk and is generally considered to be a better predictor than LDL-C. Lp-PLA2 is an enzyme found in blood and atherosclerotic plaque; high levels have been implicated in the development and progression of atherosclerosis. Furthermore, AMR101 appeared to be very well tolerated with a safety profile that appears to be both comparable to placebo and more favorable compared to other triglyceride lowering therapies. There were no treatment-related serious adverse events in the MARINE study. The Company will present more details of these results at an upcoming scientific meeting.

Commenting on the results of the study, Harold Bays, M.D., Medical Director, Louisville Metabolic and Atherosclerosis Research Center, and Principal Investigator of the study, said, “The MARINE trial included a study population of patients with very high TG levels (i.e. > 500 mg/dl). In this study, AMR101 reduced TG levels to within the range observed with common approved triglyceride-lowering drugs. Clinicians are aware, and some may have concerns, that common TG-lowering agents may raise LDL-C by 40 – 50% in patients with very high TG levels. In the MARINE trial, AMR101 did not significantly increase LDL-C levels. Another surprise to me was the degree of TG-lowering efficacy in the statin-treated group, which exceeded the TG lowering in the non-statin treated group. It was also reassuring that the safety and tolerability of AMR101 was similar to placebo. Adding these favorable findings to the significant reductions in total cholesterol, non-HDL-C, Apo B, and Lp-PLA2 levels, this suggests that AMR101 may prove to represent an effective, and safe alternative treatment option to improve cardiovascular risk factors in patients with very high triglycerides. In summary, the results of the MARINE trial suggest that AMR101 may prove to represent a “first in class” EPA TG-lowering agent that not only represents a new chemical entity, but a potential novel therapy with favorable lipid efficacy effects that differ from common TG-lowering agents, such as fibrates and previously approved prescription omega-3 drugs. We very much look forward to presenting the full dataset at a scientific meeting.”

Joseph S. Zakrzewski, Executive Chairman and Chief Executive Officer of Amarin, added, “The MARINE study was conducted in a population representative of millions of people with very high triglyceride levels, including more than 3.8 million in the U.S. alone. We believe that these results and the overall profile of AMR101 position the drug candidate to be best in class in this market. Furthermore, the MARINE study results are encouraging, especially the positive outcomes with respect to LDL-C and other lipids, as we await the results of the ongoing ANCHOR study. This separate Phase 3 study is designed to investigate AMR101 in patients with high triglycerides (¬>200 and <500mg/dL) with mixed dyslipidemia treated with statins, a patient population for which no drug in this class is currently approved. While the market for a drug labeled for treatment of triglycerides of >500 mg/dL is already proven to be a billion dollar market, there are ten times the number of patients with triglycerides of >200 and <500 mg/dL.”

Based on the timing and nature of these results, Amarin intends in 2011 to submit a New Drug Application (NDA) seeking approval to market and sell AMR101 in the U.S. Previous Company guidance projected 2012 for the NDA submission. The Company further added that, based on the positive results of the MARINE trial, Amarin has advanced additional patent claims to add to its growing portfolio of U.S. and international intellectual property claims related to AMR101.

Amarin Corporation Appoints Kristine Peterson to Board of Directors

Dublin, Ireland and Mystic, CT, USA, November 18, 2010 – Amarin Corporation plc (Nasdaq: AMRN), a clinical-stage biopharmaceutical company with a focus on cardiovascular disease, today announced the appointment of Kristine Peterson to its board of directors.  

Ms. Peterson has more than 27 years of pharmaceutical industry experience, including 20 years at Bristol-Myers Squibb, where she was responsible for sales, marketing and general management in a variety of therapeutic areas, including leading the cardiovascular and metabolic disease business unit. She is currently Chief Executive Officer at Valeritas Inc., a medical technology company committed to the development and commercialization of innovative drug delivery solutions, with its lead product for the treatment of diabetes. Prior to joining Valeritas, Ms. Peterson was Chair for the biotech business at Johnson & Johnson, and was Senior Vice President of commercial operations and President at Biovail Corporation.   

“Kristine’s expertise in cardiovascular and metabolic disease, combined with her track record of success in commercializing products, will be invaluable to Amarin as we move our programs and our lead candidate AMR101 forward,” said Joseph S. Zakrzewski, chief executive officer.  

“I am thrilled to join Amarin’s board of directors at this exciting time,” said Ms. Peterson. “I am looking forward to working with the rest of the board and Amarin’s management team as we anticipate the pivotal results from two Phase 3 clinical trials that may position AMR101 as a best-in-class prescription medicine for treating patients with elevated triglycerides.” 

The appointment of Ms. Peterson increases the Company’s board of directors to eight members.  

 

About AMR101 

AMR101 is primarily comprised of 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 distinct patient populations (the ANCHOR and MARINE trials). As separately reported, patient screening has been completed in both trials with top-line results expected for the MARINE trial before the end of 2010 and for the ANCHOR trial in mid-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  
President  
In U.S.: +1 (860) 572-4979  
investor.relations@amarincorp.com
 

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

 

Media Contact Information:  

David Schull or Martina Schwarzkopf, Ph.D.  
Russo Partners  
In U.S.: +1 (212) 845-4271 or +1 (212) 845-4292 (office)  
+1 (347) 591-8785 (mobile)  
david.schull@russopartnersllc.com
martina.schwarzkopf@russopartnersllc.com 

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

Amarin Corporation Announces Senior Management Changes

DUBLIN and MYSTIC, Conn., Nov. 10, 2010 - Amarin Corporation plc (Nasdaq: AMRN), a clinical-stage biopharmaceutical company with a focus on cardiovascular disease, today announced that, effective November 10, 2010, Joseph S. Zakrzewski has been appointed Chief Executive Officer. Mr. Zakrzewski has served as the Chairman of the Board of Amarin since January 2010 and will continue to serve in that capacity. 

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, approved, launched, and marketed for reducing very high triglyceride levels, leading to its 2007 acquisition by GlaxoSmithKline. Mr. Zakrzewski, until recently, was Chief Executive Officer of Xcellerex Inc, a private Massachusetts-based biotechnology company. Although Mr. Zakrzewski currently serves on the boards of directors and in other advisory roles for various companies, Amarin is his primary business commitment.

Additionally, John F. Thero has been appointed President of Amarin. Since November 2009, Mr. Thero had been the Company's Chief Financial Officer, a role in which he has been responsible for a significant portion of the Company's operations. Mr. Thero has more than 20 years of senior management experience, including broad responsibilities in finance, business development and commercial operations. Prior to joining Amarin, 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. Colin Stewart, who has been serving as the Company's President and CEO and a director of the Company, resigned effective November 10, 2010 to address personal matters.

In connection with these changes, Mr. Frederick Ahlholm, Vice President Finance, will be the Company's Principal Accounting Officer. Mr. Ahlholm joined Amarin in March 2010 and has approximately 20 years of financial and management experience at public and private companies. He began his professional career at Ernst & Young LLP and is a Certified Public Accountant.

Mr. Zakrzewski commented, "This is a very exciting time at Amarin as we move closer to pivotal results from our MARINE and ANCHOR Phase 3 clinical trials. Our R&D team has done an impressive job in advancing Amarin to this stage and their contributions will continue to be essential as we move forward. I look forward to leading Amarin beyond its current clinical trials, including increased focus on commercial opportunities for AMR101. The promotion of John to President reflects both his strong record of performance and his experience in managing later-stage companies like Amarin."

Mr. Thero commented, "I am honored to assume this broader role in working with the Amarin team to create value with Amarin's technology and resources. With potential best-in-class positioning for AMR101 and key clinical milestones approaching, this is an opportunity for increased visibility for Amarin and a time for continued execution. The Company has made tremendous progress over the past year in executing on its mission. Assuming favorable Phase 3 study results for AMR101, we plan to move aggressively forward to an NDA submission while seeking to exploit every opportunity to maximize the potential commercial value of this promising drug, including potentially through collaboration with one or more 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 distinct patient populations (the ANCHOR and MARINE trials). As separately reported, patient screening has been completed in both trials with top line results expected for the MARINE trial before the end of 2010 and for the ANCHOR trial in mid-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. 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
President
In U.S.: +1 (860) 572-4979
investor.relations@amarincorp.com

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

 

Media Contact Information: 

David Schull or Martina Schwarzkopf, Ph.D. 
Russo Partners
In U.S.: +1 (212) 845-4271 or +1 (212) 845-4292 (office)
+1 (347) 591-8785 (mobile) 
david.schull@russopartnersllc.com
martina.schwarzkopf@russopartnersllc.com

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

Amarin Reports Third Quarter 2010 Financial Results and Positively Updates Phase 3 Guidance

-Phase 3 milestones moved ahead into 2010 for report of top line results of MARINE trial and completion of ANCHOR trial randomization-

DUBLIN, Ireland and MYSTIC, Conn., Nov. 10, 2010 -Amarin Corporation plc (Nasdaq: AMRN), a clinical-stage biopharmaceutical company focused on cardiovascular disease, today reported its financial and operational results for the three-month period ended September 30, 2010. In addition, the Company provided an update regarding its MARINE and ANCHOR trials, the two on-going Phase 3 clinical trials of its lead product candidate AMR101 for treating elevated triglyceride levels, including a positive update regarding the timing of key future milestones for these trials. In summary:

  • MARINE trial top-line results are now expected before the end of 2010
  • ANCHOR trial patient screening is complete and randomization is now expected to be complete by the end of 2010 with top-line results expected in mid-2011
  • The above revised guidance is months ahead of previous guidance for both trials
  • Financial resources remain sufficient to complete both Phase 3 clinical trials and submit the NDA for AMR101

The MARINE and ANCHOR trials are pivotal Phase 3 studies designed to evaluate the efficacy and safety of AMR101 in two separate populations of patients with elevated triglyceride levels. According to current treatment guidelines established by NCEP ATPIII, patients with these levels of triglyceride elevation should be treated with triglyceride lowering therapy.

Q3 Financial Update

Amarin's cash balance as of September 30, 2010 was approximately $31.4 million. During the three months ended September 30, 2010, net cash outflows were approximately $6.2 million, including approximately $5.5 million paid in connection with the Company's two ongoing Phase 3 clinical trials.

The Company's net cash outflows during the quarter were partially offset by approximately $2.0 million in net proceeds received from the exercise of warrants. These warrant exercises, at exercise prices from $1.00 to $1.50 per share, resulted in the issuance of 1.5 million new shares during the quarter ended September 30, 2010.

As of September 30, 2010, the Company had 101.3 million shares outstanding, 38.7 million warrants outstanding at an average exercise price of $1.77 and 12.3 million stock options outstanding at an average exercise price of $2.47.

The Company expects that its current financial resources are sufficient to finance its planned operations through the filing of the NDA pending positive clinical results. 

 

Clinical Trial Update

Amarin's two ongoing Phase 3 clinical trials (MARINE and ANCHOR) were initiated near the beginning of 2010 to investigate the efficacy of AMR101 in reducing elevated triglyceride levels in two patient populations. As reported on August 10, 2010, randomization to dosing has been completed in the MARINE trial. Amarin now expects to report top-line results from the MARINE trial before the end of 2010, ahead of previously stated guidance of such report in early 2011.

In addition, at the date of this release, Amarin has screened all of the patients needed to complete the ANCHOR trial and, accordingly, has ceased screening additional patients. Most of the patients screened have been randomized to dosing cohorts of 2 grams, 4 grams or placebo of AMR101. Additional patients have been screened and are currently progressing through the six-to-eight week run-in period prior to randomization. Amarin now anticipates that it will complete randomization of the 650 patients targeted for the ANCHOR trial before the end of 2010, ahead of previously stated guidance of completing randomization in 2011. The company now expects to report top-line results from the ANCHOR trial in mid-2011.

"With less than two months remaining before we expect to learn the results of the MARINE trial, it is a very exciting time at Amarin," commented Joseph Zakrzewski, Chairman and Chief Executive Officer. "This can be attributed to the tremendous progress made by our Clinical Development and Operations group as well as the outstanding clinical investigators involved in both the ANCHOR and MARINE studies." 

 

SEC Filing Status

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. Effective January 1, 2011, Amarin will no longer be a foreign private issuer and for SEC purposes will report its financial results in accordance with generally accepted accounting principles in the United States (US GAAP). 

 

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 as per NCEP ATPIII guidelines. Patient randomization in this trial has been completed at 229 patients. The single 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 randomize 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. This study will also evaluate whether AMR101 is devoid of the LDL-C elevating effects commonly seen in patients with mixed dyslipidemia on statin therapy who take concomitant prescription omega-3 therapies. 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). Because the trials address separate and important patient populations the results from one trial may not be indicative of the results of the other trial. 

 

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. 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
President
In U.S.: +1 (860) 572-4979
investor.relations@amarincorp.com

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

Media Contact Information: 

David Schull or Martina Schwarzkopf, Ph.D.
Russo Partners
In U.S. +1 (212) 845-4271 or +1 (212) 845-4292 (office)
+1 (347) 591-8785 (mobile) 
david.schull@russopartnersllc.com
martina.schwarzkopf@russopartnersllc.com

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

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.