Omega-3 to the rescue

I raised a quizzical eyebrow in September when GlobalData noted that: “AstraZeneca (AZ) had seen better days.” They cited the usual reasons — a stagnant pipeline, job cuts, Phase III failures, generic competition and looming patent cliffs — but speculated that a “new drug could potentially put the ailing company back on its feet.” In the run up to CPhI, with its Natural Extracts Trail being of particular interest to me (I’m a firm believer in the looming convergence of Big Pharma and the nutraceutical and functional food sectors), it seems that might be having similar thoughts.

On 18 September, the company announced that its new drug application (NDA) for Epanova (omefas), a fish oil-based treatment for hypertriglyceridemia, was accepted by the US Food and Drug Administration (FDA). According to the NDA, Epanova would be indicated to treat severe high blood levels of triglycerides, a condition that is marked by triglyceride levels equal to or exceeding 500 mg/dL and which afflicts some four million patients in the US, increasing their risk of heart disease and strokes.

A GlobalData analyst pondered: “If approved, Epanova would come into head-to-head competition with GSK’s Lovaza (omega-3-acid ethyl esters) and Amarin’s Vascepa (icosapent ethyl), both omega-3-acid ethyl ester fish oil-derived treatments for hypertriglyceridemia.” I’m not sure that’s the point, to be honest; there’s a bigger picture to look at. Not ignoring that fact that Epanova comprises non-esterified omega-3 oils in their free acid form and that a patent-protected capsule will further improve the delivery and the effect of the product’s active ingredients, giving the competition a run for its money, this could be another stab at the statin market.

The messages may be mixed, but they’re loud and resonant. End-users, be they patients or consumers, are taking a good look at the cardiovascular benefits of omega-3s … and tend to like what they see. AstraZeneca may well be stating that their sights for the long-term future are a Crestor-Epanova combination therapy, but watch this space. Sure, AZ would very much like to prevent Crestor from drowning in the flood waters of the generic Lipitor (atorvastatin) deluge, but statins aren’t the only way to approach cardiovascular disease. A raft of prescription-based omega-3 products may be coming our way.