BEDMINSTER, N.J., DUBLIN, Ireland, and MONTGOMERY, Ala., March 31, 2014 (GLOBE NEWSWIRE) -- Amarin Corporation plc (Nasdaq:AMRN) and Kowa Pharmaceuticals America, Inc., two biopharmaceutical companies focused on the development and commercialization of therapeutics to improve cardiovascular health, today announced an agreement to co-promote Amarin's flagship product, Vascepa ® (icosapent ethyl) capsules, in the United States. Vascepa is approved for use in the United States as an adjunct to diet to reduce triglyceride levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia. In bringing together two companies focused on the primary care and cardiovascular health communities, the agreement is designed to benefit a greater number of patients.
"With the support of Kowa Pharmaceuticals America, we anticipate increasing the rate of Vascepa prescription and revenue growth as together we help educate physicians regarding the use of Vascepa as therapy for severe hypertriglyceridemia through promotion of its highly favorable efficacy and safety profile," stated John F. Thero, President and Chief Executive Officer of Amarin. "Kowa's commercial reach and customer base make it a valuable commercial partner for Amarin. Kowa Pharmaceuticals America has a highly motivated and talented sales force that complements Amarin's sales team and substantially increases its reach into our target market. Kowa Pharmaceuticals America has a strong and proven leadership team, a solidified presence in the cardiovascular and lipid-lowering marketplace and a track record of success. We look forward to a successful collaboration with Kowa Pharmaceuticals America and to creating significant value for both companies and their customers.""Our goal has been to help physicians address patient-care concerns by offering important medications and support programs," said Ben Stakely, Chief Executive Officer and President of Kowa Pharmaceuticals America, Inc. "We have been very impressed with Vascepa's favorable efficacy and safety profile and look forward to working with Amarin to significantly expand Vascepa promotional efforts in the United States. By entering into this agreement with Amarin, we can now speak to a range of important lipid-related issues that impact our target physicians' practices. We are proud of our current portfolio and excited about bringing new FDA-approved treatments, such as Vascepa, to more patients in need. With its favorable efficacy and safety profile, our team is excited about this opportunity to work with Amarin to help maximize the value of Vascepa." Vascepa commercialization progress Vascepa was launched by Amarin in early 2013. Sales of Vascepa in 2013 resulted in net revenues for Amarin of approximately $26.4 million. Vascepa labeling reflects a spectrum of favorable effects on lipid and lipoprotein parameters at 4 g/day, including statistically significant reductions in TG, Apo B, VLDL-C, and non-HDL-C, with no increase in LDL-C, also known as bad cholesterol, and a safety profile that is comparable to placebo. The most common reported adverse reaction (incidence > 2% and greater than placebo) was arthralgia (2.3% for Vascepa, 1.0% for placebo). With the benefit of this clinical profile, Amarin made significant progress throughout 2013 in multiple areas of the Vascepa commercialization plan. Vascepa is now available on formulary to over 200 million lives in the United States, including over 100 million with Tier 2 coverage. The conversion of these lives to Tier 2 status has helped enable Amarin to grow the Vascepa prescriber base to over 16,000 physicians since launch.
About Vascepa® (icosapent ethyl) capsulesVascepa ® (icosapent ethyl) capsules, known in scientific literature as AMR101, is a highly pure-EPA omega-3 prescription product in a 1 gram capsule. Indications and Usage
- Vascepa (icosapent ethyl) is indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia.
- The effect of Vascepa on the risk for pancreatitis and cardiovascular mortality and morbidity in patients with severe hypertriglyceridemia has not been determined.
- Vascepa is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to Vascepa or any of its components and should be used with caution in patients with known hypersensitivity to fish and/or shellfish.
- The most common reported adverse reaction (incidence > 2% and greater than placebo) was arthralgia (2.3% for Vascepa, 1.0% for placebo).
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CONTACT: Amarin contact information: Michael Farrell or Joseph Bruno Amarin Corporation In U.S.: +1 (908) 719-1315 firstname.lastname@example.org Kowa Pharmaceuticals America, Inc. contact information: Lisa Garman Kowa Pharmaceuticals America, Inc. Mobile: 334-296-1917 email@example.com