Amarin's omega-3 Vascepa. (Photo: Amarin/FIS)
Amarin gets ready to launch new fish oil drug
Monday, December 10, 2012, 05:00 (GMT + 9)
Irish company Amarin announced USD 100 million had been granted in private funding that will be used to push its fish oil product Vascepa in the US in 2013.
The firm plans to hire 250-300 sales representatives to prepare the launch of the product, and will subsequently look to sell itself to a bigger drugmaker, find a marketing partner or if unlucky will move the product alone.
Investors expressed their discontent with the fact that Amarin is going in debt worth USD 100 million (via non-equity financing with an investment fund managed by Pharmakon Advisors), and this caused shares to fall by 21 per cent, as it also indicated that the sale of the company to a larger drug business has become much less probable.
Vascepa was already approved by the Food and Drug Administration (FDA) in July 2012 as a prescription ultra-pure omega-3 fatty acid derived from fish oil designed to lower triglycerides, a type of fat in the blood, for patients with abnormally high triglycerides. It is meant to be used along with a low-fat and low-cholesterol diet, Benzinga reports.
But Amarin was hoping for the FDA to designate Vascepa a New Chemical Entity (NCE), which would grant the company two more years of exclusivity. However, the FDA has delayed that decision several times, FiercePharma reports.
Further, the FDA is still deciding whether to give Vascepa status as a first-of-a-kind drug, which would give the company five years of protection from competition, The Associated Press reports.
Such a status would also make Amarin more appealing to big pharma partners.
CEO and Chairman Joseph Zakrzewski said the USD 100 million-funding gives the firm "maximum flexibility" to prepare for the drug’s launch while it continues to negotiate potential partnerships.
Previously, there were rumours that several companies, including AstraZeneca and Pfizer, were interested in Amarin, but these rumours have since dissipated.
By Natalia Real