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Omthera Pharmaceuticals, Inc. Closes a $6.5M Series A led by Sofinnova Partners to Advance Epanova™, a Prescription Omega 3 Therapy

08/03/2010

Dyslipidemia Experts Jerry Wisler and Michael Davidson, M.D. Co-Found New Pharmaceutical Company Developing a Prescription Omega 3 Treatment of High Triglycerides

NEW YORK – March 8, 2010 – Omthera Pharmaceuticals, Inc., an emerging specialty pharmaceutical company focusing on the clinical development of new dyslipidemia therapies, today announced commencement of operations in Bedminster, New Jersey.  Omthera’s lead product candidate, Epanova™, an Omega 3 fatty acid containing a novel formulation of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), has shown promising results in lowering triglycerides in earlier clinical trials, as well as an excellent safety and tolerability profile. The Omthera management team includes drug development and commercialization expert Jerry Wisler, president and chief executive officer, and cardiologist and clinical expert Michael Davidson, M.D., chief medical officer.

“Under the leadership of Mr. Wisler and Dr. Davidson, Omthera Pharmaceuticals is poised to elevate the treatment of dyslipidemia, beginning with its lead product candidate Epanova for the treatment of very high triglycerides,” said Graziano Seghezzi, member of Omthera’s board of directors and partner at Sofinnova Partners, a leading European venture capital firm who led the initial financing for Omthera. “Dr. Davidson’s clinical expertise in cardiovascular disease treatment along with Mr. Wisler’s track record of commercialization of cardiovascular therapies will help Omthera bring new and innovative therapies to the patients who need them.”

Jerry Wisler brings 25 years of pharmaceutical industry experience to Omthera, including his most recent role as co-founder, president and CEO of Aegerion Pharmaceuticals, Inc., a biopharmaceutical company 
focused on the development and commercialization of pharmaceuticals to treat dyslipidemia.  While at Aegerion he was actively involved in clinical trial design, fundraising, business development and general management.  Prior to his role at Aegerion, Mr. Wisler served as vice president of marketing for Novartis.  Mr. Wisler held numerous positions during his 20 years with Merck, including vice president of marketing with responsibility for the atherosclerosis franchise. He led Merck’s Zocor® team during a period of robust growth, with annual revenues growing from $1.8 billion in 1997 to $5.3 billion in 2002. Mr. Wisler was also involved in various lifecycle management activities for Zocor, providing commercial input into the decision to enter into a Joint Venture with Schering-Plough for Zetia® and Vytorin®. 

“The prescription Omega 3 market is already over $1.5 billion in annual worldwide revenues and is positioned for tremendous growth,” said Mr. Wisler.  “I am excited to be working with Dr. Davidson, whom I have collaborated with over the past 12 years.  We are assembling a strong team of employees and external consultants to develop Epanova and bring it to market over the next few years.”

Michael Davidson, M.D. has more than 20 years of experience in the development of drugs for the treatment of lipid disorders and continues to serve as clinical professor and director of Preventive Cardiology at the University of Chicago.  He was previously founder, president and CEO of the Chicago Center for Clinical Research, acquired by Pharmaceutical Product Development (PPD) in 1996, and later sold to Radiant Research.  His studies on statins, novel lipid-lowering drugs, and nonpharmacologic risk factor reduction have established him as a key opinion leader in this area.   A prolific author and lecturer on lipid disorders, nutrition, and atherosclerosis, Dr. Davidson has coordinated more than 700 clinical trials in the area of preventive cardiology and published more than 200 articles for leading medical journals.  Dr. Davidson earned his medical degree from The Ohio State University College of Medicine in Columbus and fulfilled his residency in internal medicine at Rush-Presbyterian-St. Luke’s Medical Center in Chicago, where he later completed a fellowship in cardiology. 

Epanova, Omthera’s lead product candidate, a free fatty acid form of Omega 3, is expected to provide unique absorption characteristics and bioavailability versus the ethyl ester form found in prescription Omega 3s currently available.  Absorption characteristics of Epanova are further enhanced via a proprietary capsule and capsule coating that delays absorption to the small intestine with superior release kinetics. The delivery of Omega 3 to the small intestine is also expected to result in improved GI tolerability for Epanova.

Omthera plans to initiate comparative bioavailability trials for Epanova in mid-2010 and begin Phase III trials of Epanova in patients with severe hypertriglyceridemia (TG >500 mg/dL) in late 2010 or early 2011.  The compound is also expected to enter Phase III trials in combination with statin therapy in 2011.

“An estimated five million people in the U.S. have triglyceride levels greater than 500 mg/dL and according to a recent National Health and Nutrition Examination Survey (NHANES) analysis, that number is growing,” said Dr. Davidson.  “Epanova has potential to provide these patients with a ’best in class’ therapy to get their triglyceride levels under control and reduce their risk of heart disease.  I am very pleased to be leading the clinical trial efforts for this important product.”

About Sofinnova Partners
Sofinnova Partners is an independent venture capital firm based in Paris, France. For over 35 years, the firm has backed nearly 500 companies at different stages of development – pure creations, spin-offs, as well as turnaround situations – and worked alongside Europe’s key entrepreneurs in the technology, life sciences and cleantech sectors. With €1.1 billion of funds under management, Sofinnova Partners’ experienced team and hands-on approach in building portfolio companies through to exit have created market leaders, from landmark historical investments including Genentech, Actelion and Vistaprint to more recent successes such as CoreValve, Novexel, Fovea and Sensitive Object. With a global mindset, the firm has a sister organization in San Francisco, California.

About Omthera Pharmaceuticals, Inc.
Omthera Pharmaceuticals, Inc. is a specialty pharmaceuticals company with an experienced team of experts in drug development focusing its efforts on the clinical development of new therapies for dyslipidemia.  The lead product candidate is Epanova™, an Omega 3 fatty acid containing a novel formulation of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA).   Omthera holds worldwide rights to Epanova.