Under the terms of the deal, 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 (CMC) section of an abbreviated new drug application (ANDA) to be filed by Akorn.
Upon regulatory approval, Sofgen will supply finished dosage form product to Akorn. Akorn will fund and is responsible for a pivotal bio study, filing the ANDA and upon regulatory approval, the marketing, distribution and sales of the drug. Akorn will own the ANDA and has exclusive marketing rights in the US and Canada.
The drug is indicated for the treatment of nausea and vomiting associated with cancer chemotherapy. It is also indicated for anorexia in patients associated with weight loss related to AIDS. The current market size of the drug is approximately $125 million, according to Akorn, and the company hopes to launch the drug in 2008.
“We are excited to join forces with Sofgen Pharmaceuticals,” noted Arthur Przybyl, Akorn’s president and CEO. “The drug is a specialty type niche pharmaceutical, with no current generic competitors and complements our strategies in AIDS and cancer drug products.”