AstraZeneca wins FDA OK for another fish-oil heart pill, enters crowded market

AstraZeneca ($AZN) has won FDA approval for its new prescription-strength fish oil therapy for artery-clogging fats, but don't look for it to help much in its nascent effort to convince investors that its bright prospects should make them steer clear of Pfizer's ($PFE) takeover pitch. This drug is headed into a crowded field that now includes a low-priced generic competitor.

AstraZeneca's plan all along has been to get this drug and market it as a combo with Crestor, its $6.2 billion megablockbuster which loses patent protection in 2016. Crestor, meanwhile, has been steadily losing market share to generic copies of Lipitor.

AstraZeneca executed a $443 million deal a year ago--$323 million in cash along with up to $120 million in contingent value rights--to acquire Princeton, NJ-based Omthera, which developed Epanova. For AstraZeneca it was a shortcut to regulatory agencies, offering up a near-term product prospect for severe hypertriglyceridemia.

At least one analyst pegged potential annual sales at $1 billion, but Thomson Reuters' average projection among analysts was a far more modest $322 million. Still, any success is likely to be welcome at AstraZeneca as it tries to struggle free from Pfizer's $106 billion takeover offer.

The once-daily omega-3 therapy demonstrated its ability to lower triglycerides and non-HDL cholesterol from baseline after 6 months of treatment over the course of a Phase III study. Omthera will be poised to take on GlaxoSmithKline's ($GSK) Lovaza as well as Vascepa, which Amarin ($AMRN) has been struggling to launch. Troubles with Vascepa have created a cloud over Epanova's future, which has been further blighted by Teva's ($TEVA) recent announcement that it is now ready to launch the first generic of Lovaza in the U.S.

AstraZeneca R&D chief Briggs Morrison

"This approval is a significant milestone for AstraZeneca, as it strengthens our existing portfolio of cardiovascular medicines," says Briggs Morrison, one of three R&D chiefs at AstraZeneca. "We are committed to further assessing the clinical profile of Epanova and to identifying other patient groups it may benefit."

Omthera obtained Epanova under a license from Swizterland's Chrysalis Pharma. 

- here's the release from AstraZeneca
- get the report from Reuters