Two-year deal assumes FDA will ratify recent advisory committee’s recommendation to approve the drug.
Cubist Pharmaceuticals negotiated an exclusive two-year agreement to co-promote Optimer Pharmaceuticals’ Dificid™ (fidaxomicin) antibiotic in the U.S. Just yesterday FDA’s advisory committee voted unanimously in favor of approving the drug for the treatment of Clostridium difficile infection (CDI). A final decision by the agency on whether to sanction Dificid is expected by the PDUFA goal date of May 30.
Under terms of the co-promotion deal, and once the first sales have been made (assuming FDA approval), Cubist will receive quarterly service fees of $3.75 million over the two years, relating to the provision of specified levels of resources and activities. The firm will also be eligible for another $5 million in the first year after the first commercial sale, $12.5 million in the second year – if mutually agreed sales targets are achieved – and a portion of Optimer’s gross profits from any sales above the specified annual sales targets. Optimer will be responsible for manufacturing and distributing Dificid in the U.S., and for recording product revenue. It will retain ownership of the NDA.
The two firms will jointly promote Dificid to physicians, hospitals, and other healthcare institutions in the U.S., with Optimer building up its sales force and medical affairs team to complement Cubist’s existing teams, which are already geared to marketing the antibiotic Cubicin®.
“Optimer plans to hire 100 sales representatives to target the 1,100 hospitals, which comprise about 70% of U.S. hospital CDI cases,” comments Pedro Lichtinger, Optimer’s president and CEO. “We also believe this collaboration with Cubist will allow us to accelerate formulary adoption, expand our market reach and penetration to up to 2,000 hospitals, comprising over 90% of U.S. hospital CDI cases. In addition, this provides the opportunity to capture the undiagnosed CDI market segment, which some estimate to be as many as three million cases per year.”