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AZ target Omthera files blood fat drug in US

FDA submission for Epanova in severe hypertriglyceridemia

Omthera Pharmaceuticals said yesterday it had submitted its drug Epanova for US approval in the treatment of patients with high levels of the blood fat triglyceride.

The company, which is the subject of a $443m takeover by AstraZeneca (AZ), filed the drug with the Food and Drug Administration (FDA) for use in the severe hypertriglyceridemia.

This condition means triglyceride levels in the blood are greater than or equal to 500mg/dL, and can be caused by several factors, including high fat diet, excessive alcohol intake, certain medications and medical conditions, as well as a genetic predisposition for people with familial hypertriglyceridemia.

High levels of triglyceride, which store excess calories after a meal, can cause problems, such as  coronary artery disease, skin disorders, pancreatitis and enlargement of the liver.

Omthera said the submission was based on two phase III trials named EVOLVE and ESPRIT, which demonstrated that the omega-3 free fatty acid composition Epanova was able to lower very high triglycerides and reduce non-HDL cholesterol when used in combination with a statin for patients with high triglycerides.

The drug is Omthera's lead product candidate, and the submission is good news for AZ, which has faced high key trial failures in recent years for both internal and acquired drug candidates.

AZ is looking to take full advantage of the drug's potential, and has previously said it plans to file supplemental marketing applications "as soon as possible" for Epanova in mixed dyslipidaemia and as a fixed-dose combination with its $6bn-plus statin drug Crestor (rosuvastatin).

There is competition in the hypertriglyceridemia area, however, and if approved, Epanova would compete in the marketplace against BASF/Pronova's Omacor/Lovaza, an omega-3 fatty acid product that achieved end-user sales of around $1.4bn in 2011 and is sold by Abbott Laboratories in the US and various companies including GlaxoSmithKline, Grupo Ferrer and Pierre Fabre in Europe.

Epanova has one potential advantage over Omacor in that it does not need to be taken with meals, and can be dosed at either 2g or 4g once a day. Labelling for Omacor indicates it should be dosed at 4g per day, either in a single dose or two 2g doses.

10th July 2013

From: Research

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