Small Biopharma Amarin Wins FDA Approval of Triglyceride-Lowering Treatment

Vascepa expected to launch in early 2013

Thursday was a big day at Amarin Corp., a small biopharma company based in Dublin, Ireland, with U.S. offices in Bedminster, N.J.

The FDA on July 26 approved the company’s first drug, Vascepa, as an adjunct to diet in the treatment of very high triglycerides (which can lead to coronary artery disease, heart attack and/or stroke).  The approval also set in motion a likely battle for control of how the drug will be promoted, and whether Amarin will continue as a standalone company. (Its share price has traded in a 52-week range of $5.99 to $15.96, closing Thursday at $15.32.)

Vascepa (which quickly launched a website for both patients and HCPs following the FDA approval) is expected to launch in the first quarter of 2013 and the new drug will compete with GlaxoSmithKline’s Lovaza, a similar fish-oil based pill. (Here’s a link to the Amarin news release.)

Note that roughly 40 million people have elevated triglyceride levels in the U.S. The new drug is a prescription-grade omega-3 fatty acid.

Jon Lecroy, an analyst with MKM Partners, told Bloomberg News that Vascepa might have an advantage over Lovaza by virtue of the finding that it did not increase bad cholesterol levels, which is seen as a possible side effect of Lovaza. “Amarin’s drug has the potential to reach sales of $1.25 billion in 2017, which may lead to acquisition offers for the Dublin-based company from drugmakers, including AstraZeneca, Bloomberg reported (citing Lecroy).

“There will be interest from large pharmaceutical companies,” the securities analyst told Bloomberg “Any company with a large cardiovascular or diabetes sales force makes sense. That’s almost any.”

Other Big Pharma companies also are said to be interested in a deal with Amarin, including Pfizer and Abbott Labs. (The companies declined to comment on the speculation, Bloomberg reported.)

In its statement, the company said it is in the midst of “consider[ing] three potential paths for the marketing and sale of the product: an acquisition of Amarin, a strategic collaboration, or self-commercialization, the latter of which could include third-party support. We are now focused on continued commercial preparations for Vascepa which includes, but is not limited to, finalizing the introduction of Vascepa to managed care plans to gain formulary access, building-up inventory levels and coordinating other pre-launch marketing activities.”

Stay tuned, this story is going to get interesting.

 

 

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