12:00 AM
Aug 08, 2011
 |  BioCentury  |  Emerging Company Profile

Omthera: Fishing expedition

Omthera's omega-3 fatty acid to take on Lovaza in lipid-lowering competition

Omthera Pharmaceuticals Inc. believes superior bioavailability and greater dosing flexibility will enable its Epanova omega-3 fatty acid to compete in the $1 billion market for lipid-lowering drugs now occupied by Lovaza.

Epanova is a mixture of the free fatty acid forms of the omega-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), both of which lower triglycerides by mechanisms that are not well understood.

According to CMO Michael Davidson, a "free fatty acid is already 'digested' so to speak, so it's more easily absorbed" than an ethyl ester fatty acid like Lovaza, which is the only approved prescription omega-3 product.

This means Epanova does not need to accompany a high-fat meal for better absorption and bioavailability. According to Davidson, Lovaza, an ethyl esterized combination of EPA and DHA, is more effective when taken with a high-fat meal.

In the Phase I/II ECLIPSE trial of Epanova vs. Lovaza in healthy volunteers, Lovaza's bioavailability was about 3,954 nmol*hour/mL with a high-fat diet vs. only about 735 nmol*hour/mL on a low-fat diet (p<0.001).

By contrast, 4 g Epanova produced plasma levels of EPA...

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