Amarin jumps on positive patent news for blockbuster hopeful

Posted under Amarin, AMR101, blockbuster, Blog, cardiovascular, Companies, Diagnostics, Funding, Medical Devices, Medical Supply, Patent news, Pharmaceuticals, Startups, triglyceride, Universities, Videos by Ryan McBride

Amarin ($AMRN) eased some jitters over the strength of its IP protection for its lead drug AMR101 yesterday with the announcement of a notice of allowance for a U.S. patent for the formulation of its potential blockbuster cardiovascular disease drug.

Amarin's shares jumped as much as 15% yesterday on the news of the notice of allowance, Reuters reported.

The patent issue has long been a hole in the AMR101 story and had stoked fears that the fish-oil-derived drug wouldn't survive IP attacks. Ireland-based Amarin has no other products on the market, and the fate of the drug, which is under FDA review, holds most of the company's fortunes. With the U.S. patent office's notice of allowance of a patent related to the drug, Amarin might be in a stronger position to get buyout offers or a strong partnership deal for marketing AMR101.

"Amarin's plan consists of continuing to pursue additional patent protection, seeking regulatory exclusivity, maintaining trade secrets and taking advantage of manufacturing barriers to entry, with the goal of protecting the commercial potential of AMR101 to 2030 and beyond," Joseph Zakrzewski, Amarin's chairman and CEO, stated yesterday. "This patent application is one of Amarin's over 16 pending U.S. patent applications across over 11 patent families."

The prescription-grade fish oil has shown in Phase III studies that it can significantly lower blood fat known as triglycerides that can lead to heart problems. Leerink Swann has estimated that the drug's peak sales could top $3 billion. The FDA is expected to decide whether to approve the drug by July 26, The Wall Street Journal reported.

- here's the company's release
- check out the Reuters story
- see the article from The Wall Street Journal

Special Report: AMR101 - 15 top blockbuster contenders

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FDA accepts Amarin’s NDA for heart drug

Posted under Amarin, AMR101, Blog, Companies, Diagnostics, Funding, GlaxoSmithKline, Medical Devices, Medical Supply, Pharmaceuticals, Startups, Universities, Videos by Maureen Martino

Dublin-based Amarin ($AMRN) says the FDA has accepted the company's NDA for AMR101, a prescription omega-3 drug for the treatment of high triglycerides. Triglycerides are fats in the blood that can cause heart disease. The FDA is expected to rule on Amarin's drug by July 26.

Amarin's NDA is based on two Phase III trials of AMR101, which showed that patients who took the 4g and 2g-per-day doses of the drug saw triglyceride levels drop 21.5% and 10.1% respectively. Additionally, AMR101 didn't raise bad cholesterol levels in trial subjects. If approved, AMR101 will compete with GlaxoSmithKline's ($GSK) Lovanza, with sales of Amarin's drug predicted to top $3 billion by 2021, according to a Leerink Swann projection.

"We are very pleased with the FDA's acceptance for filing of our AMR101 NDA submission as it is a significant achievement in the development of what we believe is a next generation Omega-3 based triglyceride lowering therapy," said Amarin CEO Joseph Zakrzewski in a statement.

Though the company's drug is on track for a 2012 launch, Amarin still has to wrestle with concerns about the intellectual property surrounding its fish oil drug. Patent officials have twice issued rejection notices for a filing on AMR101, causing analysts to worry that Amarin will have a shortened period of exclusivity for its drug. 

- check out Amarin's release

Special Report: AMR101 - 15 top blockbuster contenders

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