Akorn, Inc. has signed an exclusive development and supply agreement with Sofgen Pharmaceuticals to develop and commercialize an ANDA drug product. Under the agreement, Sofgen is responsible for the formulation and development of the drug, the manufacture of clinical product batches, and the documentation to support the Chemistry, Manufacturing and Control (CMC) section of an ANDA, which will be filed by Akorn. Upon approval, Sofgen will supply finished dosage form product to Akorn. Akorn will be responsible for funding, the pivotal bio study, filing the ANDA and, upon approval, the marketing, distribution and sales of the drug. Akorn will have exclusive marketing rights in the U.S. and Canada.
The drug is indicated for the treatment of nausea and vomiting associated with cancer chemotherapy. The drug is also indicated for anorexia in patients associated with weight loss related to AIDS.
Arthur S. Przybyl, Akorn's president and chief executive officer, stated, "This agreement highlights several Akorn strategies. The drug is a specialty type niche pharmaceutical, with no current generic competitors and compliments our strategies in AIDS and cancer drug products. Drug products for these markets are being developed internally and externally through our business partners, Fidia, Natco and Serum. We are excited to join forces with Sofgen Pharmaceuticals."
Ruben Minski, Sofgen's president and chief executive officer, stated, "Our company is infused with a strong belief in the growing need for precisely the sort of generic drugs and advance delivery technologies like the one we are partnering with Akorn. The trends are clearly in our favor, with our development and manufacturing capabilities and Akorn marketing expertise, we are heading for success."