Irish Times, Saturday edition. Get A Move On, Amarin
It is a tense time for Irish biopharma group Amarin, as it waits to get its first drug on to the shelves. Amarin delivered spectacular trial results for Vascepa, its highly purified omega-3 fish oil drug, in treating patients with high triglycerides – blood fats that are seen as increasing the risk of coronary disease.
The drug also avoided side effects that can occur in the only comparable therapy currently available for patients.
But since winning clearance from US regulators in July, the drug has failed to build on that momentum. Reporting third-quarter results on Thursday night, the Nasdaq-listed company said it continued to make significant progress in expanding the patent protection for the drug. It also confirmed again that it was on course for the commercial launch of Vascepa early in the first quarter of 2013.
However, many of the questions that have swirled around the drug since its approval remain. First among these is whether the US Food and Drug Administration (FDA) will grant exclusivity to the active ingredient in the drug, giving Vascepa key additional protection against competition. Second is the failure of Amarin to outline in detail how, as a small company, it expects to be able to handle the logistics involved in manufacturing, marketing and distributing what is expected to be a blockbuster drug.
The two are related. The failure to secure a ruling on exclusivity is seen as weighing on potential suitors waiting in the wings either to acquire Amarin or lend it sufficient muscle in a commercial partnership. Amarin and some observers argue that the portfolio of patents the company has secured over the past six months gives it sufficient protection to overcome any failure on the exclusivity front.
But doubters remain and Amarin’s shares are trading near six-month lows. The danger with such uncertainty was highlighted this week when another firm, Omthera Pharmaceuticals, announced that it had phase three clinical trial data for its drug candidate – also a purified fish oil – targeting the same patient group. Amarin needs to get moving, with or without the FDA’s grant of exclusivity.
Good well balanced post, we all know that this recent surge, means something is being cooked ? Hope this is for the good and that we all longs on AMRN can finally profit !, and then ... jump to our next run up.
Well said. The other danger is the current market situation. If the fiscal cliff happens and the market tanks so will amrn even further if there is no resolution to the nce. I agree get moving! You can't wait much longer for the FDA.
FDA has letter circulating with response with tgat knowledge is prudent to wait through next OB only a week. No BO will happen without ruling so will need to hire and prepare to launch if another delay but should know if there is a delay sometime next week, if not NCE decision is a game changer, not just in ST stock price but BO level and pretty much everything can move forward so at this point need to wait next week and hope the fact a letter is circulating will lead to a result, otherwise FDA takes chance another month with letter floating equals a whole month the contents could get leaked. Though FDA has strict rules and plans in place still, a while month to keep it quiet seems not worth the risk