AstraZeneca Buys Omthera

AstraZeneca has entered into a definitive agreement to acquire Omthera Pharmaceuticals, a specialty pharmaceutical company based in Princeton, NJ. Omthera is focused on the development and commercialization of new therapies for dyslipidemia.

Omthera’s lead product, Epanova, for the potential treatment of patients with very high triglycerides, is a novel omega-3 free fatty acid composition that has been shown to bolster levels of eicosapentaenoic acid and docosahexaenoic acid significantly in the blood.

AZ’s total potential acquisition cost is approximately $443 million, including $323 million in cash — a premium of 88% on Omthera’s stock price — and Contingent Value Rights (CVRs) of as much as $120 million in total, if specified milestones related to Epanova are achieved, or if a milestone related to global net sales is achieved. The transaction is expected to close in 3Q13.

Omthera has completed pharmacokinetic and Phase III studies to investigate the safety and efficacy profile of Epanova, a coated soft gelatin capsule containing a complex mixture of polyunsaturated free fatty acids derived from fish oils. In 2012, Omthera reported positive results from two Phase III trials examining the effectiveness of Epanova in lowering very high triglycerides, and in reducing non-HDL cholesterol in combination with a statin for patients with high triglycerides. Both trials were conducted under a Special Protocol Assessment with the FDA.

Omthera is expected to file an NDA in the U.S. for Epanova in mid-2013 for patients with severe hypertriglyceridemia (triglyceride levels greater than or equal to 500mg/dL), with regulatory filings in other markets to follow. AZ aims to file a supplemental NDA as soon as possible for Epanova as a treatment for patients with mixed dyslipidemia (triglyceride levels of 200-499mg/dl), as well as in a fixed dose combination with Crestor for those mixed dyslipidemia patients at high risk of a cardiovascular event. AstraZeneca intends to pursue a large-scale CV outcomes trial for Epanova in combination with statins.

Pascal Soriot, chief executive officer of AstraZeneca, commented, “The number of people with elevated triglyceride levels is rising rapidly across the world, due in part to the increasing prevalence of obesity and diabetes. There is a clear need for effective and convenient alternatives to some of the existing treatments. Epanova offers real potential both as a distinctive monotherapy for the treatment of hypertriglyceridemia and in combination with Crestor for patients at high risk of adverse cardiovascular events. This is an exciting acquisition that clearly complements our existing portfolio in cardiovascular and metabolic disease, one of our core therapy areas.”