AstraZeneca offers $443M to bolster drug pipeline

AstraZeneca will pay up to $443 million to acquire Omthera Pharmaceuticals, a drug company that specializes in treatments for patients with elevated triglyceride levels.

The deal will allow AstraZeneca to add Epanova to its pipeline. Epanova is a novel omega-3 free fatty acid composition that in two phase III clinical trials has been shown to lower very high triglycerides and reduce non-HDL cholesterol in combination with a statin. The drug is taken as a coated soft gelatin capsule in two and four gram once-a-day doses with or without meals.

AstraZeneca will pay Omthera $12.70 per share, or approximately $323 million, plus $120 million if Omthera meets specified milestones or global net sales, for a total potential acquisition cost to $443 million.

Princeton, N.J-based Omthera is expected to file a new drug application (NDA) this year with the FDA for Epanova for patients with severe hypertriglyceridemia (triglyceride levels greater than or equal to 500mg/dL). AstraZeneca plans to file a supplemental NDA 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 rosuvastatin calcium (Crestor, AstraZeneca) for mixed dyslipidemia patients at high risk of a cardiovascular event.

AstraZeneca also plans to seek a large-scale cardiovascular outcomes trial for Epanova in combination with statins.

AstraZeneca and Omthera’s boards approved the agreement and Omthera’s board recommended shareholders approve the deal. Subject to the approval of Omthera’s shareholders as well as other conditions including customary regulatory approvals, the transaction is expected to close in the third quarter of 2013.

AstraZeneca is headquartered in London.