Amarin, which 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, has forged two more links in the chain of manufacturing facilities.
Omthera Pharmaceuticals is heading to Wall Street in search of $75 million of IPO cash to support a prospective launch of an omega-3 drug, soon after the biotech reported positive Phase III data and laid out plans to file for an approval within months.
The future of Amarin ($AMRN) and its fish oil product Vascepa got a little more slippery Thursday. The Irish company said it had obtained $100 million in private financing to move forward with the drug come what may.
Amarin today tossed another deadline on the bonfire of management vanities, scrapping a self-imposed decision date on hiring a sales force for the recently approved Vascepa. The new deadline is mid-December, when it will get another shot at an FDA decision on new chemical entity status, which has gradually swelled into a major catalyst for the company.
This might not be the big fish-oil drug acquisition industry watchers were anticipating. BASF, the German chemicals giant, plans to gobble up Norway's Pronova BioPharma, maker of the active ingredient in GlaxoSmithKline's blockbuster omega-3 drug Lovaza, in a cash buyout valued at NOK 4,845 million or $844 million.
Months of waiting anxiously for a key decision from the FDA on its newly-approved fish-oil therapy Vascepa has created an unsettling aroma of uncertainty over the future of Amarin. And it's spurring some dyspeptic reactions in the biotech investor community.
Omthera Pharmaceuticals is touting a new batch of Phase III data on its cardiovascular drug for patients with very high triglycerides. And the Princeton, NJ-based developer says its omega-3 drug, Epanova, has shown comparable efficacy to rival therapies in a lower 2-gram dose in two late-stage studies.
New Amarin ($AMRN) buyout gossip: The U.K. newspaper The Daily Mail has reported speculation that Pascal Soriot, AstraZeneca's ($AZN) new chief executive, has set his sights on a purchase of Ireland-based Amarin and the biotech company's newly approved Vascepa, a prescription strength fish oil for combatting blood fats that could become a blockbuster seller.
Shares of Amarin took a hit overnight after the company filed papers noting that the FDA had yet to decide whether its industrial-strength fish oil product Vascepa warranted approval as a new chemical entity, a classification that carries 5 years of marketing exclusivity with it.
Amarin has nailed down an FDA approval for its heart drug AMR101, which will now be called by its branded name Vascepa.