Sofgen will be responsible for development and manufacturing of the product. Akorn will be responsible for the regulatory submission, marketing and distribution in the US and Puerto Rico. Companies are expected to begin a pivotal bioequivalence study in October 2007 with a projected launch date in late 2009.
Arthur Przybyl, Akorn’s president and CEO, said: “We previously announced an abbreviated new drug application (ANDA) filing in collaboration with Sofgen. Building upon that success, we look forward to working together again. This soft gel oral drug product will be the second addition to our pipeline in women’s healthcare and potentially a significant revenue contributor for both companies.”
Ruben Minski, Sofgen’s president and CEO, said: “We felt great chemistry in working hand by hand with Akorn’s team in our previous ANDA filing, so we welcome this new opportunity with this soft gel oral development where we have put a great deal of resources. The drug is a specialty type niche pharmaceutical, with no current generic competitors and we are confident that with the combined energy and know-how between our Companies, the rewards will be gratifying.”