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.
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