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Yesterday, Amarin (Nasdaq: AMRN ) said it had completed the remaining studies needed to submit its marketing application for is triglyceride-fighting AMR101 to the Food and Drug Administration. The final studies required Amarin to confirm that AMR101 didn't affect the metabolism of other drugs that might be taken concurrently. It seems to have passed with flying colors.
With the pharmacology studies complete, Amarin expects to submit the application by the end of next month. Assuming a standard 10-month wait, AMR101 could be on the market this time next year.
An approval seems pretty likely. AMR101 reduced triglycerides in patients with high triglyceride levels, and in a second phase 3 trial, the drug helped patients with medium triglyceride levels that were already taking statins such as Pfizer's (NYSE: PFE ) Lipitor, AstraZeneca's (NYSE: AZN ) Crestor, and Merck's (NYSE: MRK ) Zocor.
Who will be selling AMR101 when it's approved is a little less certain.
Amarin's shares dropped 2.4% yesterday, and while we could probably blame it on debt-ceiling anxiety, I think it's probably from the reminder that Amarin is closer to regulatory approval but hasn't found a buyer yet. Shares are well off the highs set after positive results from the second phase 3 trial.
What is big pharma waiting for? The risk of rejection is fairly minimal, so I don't see a point in waiting for the FDA's thumbs-up. My guess is potential acquirers are taking their time evaluating the patent protection of AMR101 and the potential impact of generic versions of GlaxoSmithKline's (NYSE: GSK ) Lovaza, a competing -- albeit inferior -- drug.
Amarin could launch the drug on its own, but I think most investors hope and expect that it'll get bought out entirely. Unfortunately, the timing and price are still unknown, and investors hate uncertainty.
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