Amarin asks FDA to approve Novasep as Vascepa partner

Irish drugmaker Amarin ($AMRN) continues to stack up manufacturing partners for the API for its fish oil drug Vascepa. While its decision to launch the drug without a partner has meant slow going in getting it to market, Amarin has pushed ahead with deals with contract manufacturers, hoping to get FDA approval for a fourth API maker.

The company said Monday it had filed a Supplemental New Drug Application (sNDA) to the FDA seeking approval for Novasep, which would make the API through its Finorga subsidiary. It claims Novasep is building the world's largest chromatography plant in Mourenx, France, which it expects to have up and running sometime next year.

The company has already gotten approval for Nisshin Pharma, BASF and Chemport as API suppliers for Vescepa. "(T)he continued addition of these suppliers will potentially lead to API cost reductions of up to 50% or more," Amarin CEO Joseph Zakrzewski said.

Some contract manufacturers have decided that making omega-3 is a good play. BASF made a number of acquisitions last year to position itself prominently in the market for manufacturing ultrapure omega-3. The company paid €684 million ($910 million) to buy Pronova BioPharma in Norway. Pronova makes the API for GlaxoSmithKline's ($GSK) blockbuster omega-3 drug, Lovaza. Pronova has manufacturing facilities in Norway and Denmark.

The FDA approved Vascepa last year, but Amarin has not found a partner that could help it sell the drug. Some analysts have predicted that in the right hands, the product could reach blockbuster levels. In December, the company borrowed $100 million and said it would use the money to move forward with the drug on its own.

- here's the release