Epanova: Will the New Drug Save Struggling Pharma Giant AstraZeneca?

Hit by a stagnant pipeline, job cuts, Phase III failures, generics competition and looming patent cliffs, AstraZeneca has seen better days; but a new drug could potentially put the ailing company back on its feet, says an analyst with research and consulting firm GlobalData.

On 18 September 2013, AstraZeneca announced that the new drug application (NDA) for Epanova (omefas), a fish oil-based treatment for hypertriglyceridemia, was accepted by FDA. Epanova, a product developed by Omthera Pharmaceuticals, caught the attention of AstraZeneca during the last year, leading to the latter company’s $437 million take-over of Omthera in July.

According to the current 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.

Eric J. Dimise, PhD, GlobalData’s Analyst covering Cardiovascular and Metabolic Disorders, says: “If approved, Epanova would come into head-to-head competition with GlaxoSmithKline’s (GSK) Lovaza (omega-3-acid ethyl esters) and Amarin’s Vascepa (icosapent ethyl), both omega-3-acid ethyl ester fish oil-derived treatments for hypertriglyceridemia.”

Dimise says that even though Epanova is also prepared from fish oil omega-3s, it boasts two key innovations that Omthera and AstraZeneca believe will give it a leg up over the competition.

First, unlike the esterified GSK and Amarin compounds, Epanova consists of the omega-3 oils in their free acid form. Second, Omthera claims that a patent-protected capsule will further improve the delivery and the effect of the product’s active ingredients.

However, according to Dimise, AstraZeneca has been clear about where its sights are set for the long-term future of this drug: a Crestor-Epanova combination therapy.

“Statins are the true giants of the drug market, and AstraZeneca would very much like to prevent Crestor from drowning in the flood waters of the generic Lipitor (atorvastatin) deluge.

“Furthermore, if the acquisition of smaller companies and promising compounds during the last year turn out to be smart moves — as may well be the case with Epanova — AstraZeneca will be able to tout a short-term success whilst having crystalised a longer-term vision,” concludes Dimise.