Akorn, Sofgen to develop, market anti-nausea drug

By Elaine Rigoli

Tampa, Fla., Aug. 10 - Akorn, Inc. and Sofgen Pharmaceuticals have signed an exclusive development and supply agreement to develop and commercialize a treatment for nausea and vomiting associated with cancer chemotherapy.

The drug, with a current market size of approximately $125 million, is also indicated for anorexia in patients with weight loss related to AIDS, according to a news release.

Akorn said it expects a product launch of the drug to occur in 2008.

Sofgen is responsible for the formulation and development of the drug, the manufacture of clinical product batches and the documentation necessary to support the chemistry, manufacturing and control section of an Abbreviated New Drug Application to be filed by Akorn with the Food and Drug Administration, according to the release.

Sofgen will supply the drug in finished dosage form to Akorn, who will fund the pivotal bioequivalency study, file the Abbreviated New Drug Application and, upon regulatory approval, market, distribute and sell the drug.

Akorn will own the Abbreviated New Drug Application and have exclusive marketing rights in the United States and Canada.

Akorn, based in Buffalo Grove, Ill., manufactures and markets sterile specialty pharmaceuticals.

Sofgen is a privately held pharmaceutical company located in Sunrise, Fla.

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