Amarin ($AMRN) has been setting up a global network of contractors for manufacturing its fish oil product Vascepa so it is ready to go when it starts its hard push for the heart drug. It says today that it has forged two more links in the chain of manufacturing facilities.
The Irish company said the FDA has approved BASF ($BASF), one of the largest makers of omega-3, as an additional manufacturer of the Vascepa API. That followed FDA's recent sNDA approval to add Chemport as an API manufacturer as well. It already had Nisshin Pharma as an API supplier. It has used each FDA plant approval as a chance to further trumpet its intentions to move forward with its drug.
The FDA last year approved Vascepa but has yet to grant the omega-3 drug a New Chemical Entity (NCE) designation that would give it two years of additional exclusivity in the marketplace. It is believed its failure to get an NCE has hurt its chances to get a partner that could help it sell the drug. Some analysts have predicted that in the right hands, the product could reach blockbuster levels. Last year, the company borrowed $100 million it said it would use to move forward on its own, and approval for BASF is at least a small step down that road.
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. BASF has also invested €22 million ($29.2 million) to expand a plant in Isle of Lewis in the Hebrides, west Scotland, that it acquired last year from Equataq.
- here'e the release