Amarin supplier continues production of Omega-3s following US FDA panel decision

22-Oct-2013 - Last updated on 24-Oct-2013 at 08:58 GMT

BASF will continue to supply the API for Amarin's Vascepa

Related tags Omega-3 fatty acid Basf

Omega-3 supplier BASF will continue to produce the API for Amarin, as well as its competitor GlaxoSmithKline, despite an FDA panel saying that Amarin’s drug should not be approved for a broader population.

BASF SVP Scott Thompson told In-Pharmatechnologist.com at CPhI in Frankfurt, Germany on Tuesday that the panel decision from last week, which caused Amarin’s stock to drop by nearly 60%, is a “setback,” but that it’s still early and BASF will have to meet with Amarin to discuss what it will mean moving forward.

Thompson added that BASF is the world’s top Omega-3 supplier in terms of capacity and that even when the drugs become generics, BASF will still be well-positioned to supply the API (active pharmaceutical ingredient) of Vascepa and Lovaza. BASF also is supplying product for Amarin’s ongoing trial of Vascepa, as well as another for GSK.

Vascepa is already approved to reduce triglycerides in patients who are not taking statins such as Pfizer’s Lipitor, but Amarin had hoped to market the drug to a much broader patient population. The FDA panel last week voted 9-2 against approval of the drug for patients taking other statins.

The FDA’s panel also said approval should be withheld pending the results of an 8,000-patient trial from Amarin that is expected to offer more results on how Vascepa cuts cardiovascular risk in 2016, according to Reuters.

But Amarin’s CEO suggested the company may not even finish that trial, which spurred a flurry of reaction, according to Forbes. The trial is costing Amarin between $30m and $40m per year, but Amarin only has about $270m in cash.

Market for Omega 3 Suppliers

With its acquisition of Pronova in January of this year, BASF solidified its position as the top fatty acid supplier and seems well positioned to control that market in the near term.

South Korea’s Chemport and Japan’s Nisshin Pharma are also approved suppliers for Amarin, while the company also sought approval for Novasep to be a supplier. It’s unclear how many of these relationships might be severed because of Amarin’s drop and the expected uptake of Vascepa generics.