|AstraZeneca CEO Pascal Soriot|
AstraZeneca ($AZN) today said that the FDA has accepted its application for its omega-3 drug Epanova, newly added to the struggling giant's pipeline after striking a $437 million deal to buy Omthera ($OMTH). New AstraZeneca CEO Pascal Soriot engineered the deal, a top exhibit in AstraZeneca's campaign to change the narrative about the company as it tries to put a record of R&D defeat and retreat behind it and move confidently into a future ripe with new product potential.
But it's still just as much of a hard sale as ever. AstraZeneca took years to achieve a reputation for being star-crossed, pursuing bad projects and flunking out repeatedly when it comes to pivotal data. This time, though, even winning an approval isn't likely going to win over the skeptics.
Timothy Anderson at Bernstein noted recently that the Omthera buyout--along with the bolt-on deals to acquire Pearl and Amplimmune--had filled some strategic gaps at the company but had done little to excite wary investors.
Where the analysts are looking for new standards of care, AstraZeneca is looking to start shopping a fish-oil pill alongside GlaxoSmithKline's ($GSK) billion-dollar drug Lovaza and Amarin's ($AMRN) Vascepa, which has been struggling to gain traction after failing to find a Big Pharma champion to sell it. In another example of AstraZeneca's penchant for bad timing, an appeals court just knocked down barriers to a generic of Lovaza. And while that fight is far from over, the prospect of a generic coming into the market is likely to further cloud expectations for AstraZeneca.
AstraZeneca sees big potential in marketing the fish-oil pill alongside its cholesterol drug Crestor and is investigating a fixed-dose combo that could extend the Crestor franchise beyond a 2016 patent expiration. That may help, but once again leaves AstraZeneca on the defensive. And that's no way to change a narrative.
Omthera, now a subsidiary of AstraZeneca, filed the NDA, looking for an approval to market the drug for severe hypertriglyceridaemia. The PDUFA date for Epanova in May 5. On Monday, AstraZeneca also filed its application for naloxegol, an opioid-induced constipation drug in-licensed from Nektar Therapeutics. If the FDA accepts that application, Nektar will earn a $70 million milestone, according to the San Francisco Business Times.
- here's the press release
- see the San Francisco Business Times report on naloxegol