NeoTherapeutics Inc has signed an agreement with GPC Biotech to co-develop NeoTherapeutics'' lead anti-cancer drug, satraplatin. Under the co-development and licensing agreement, NeoTherapeutics may receive up to $22 million in license fees and milestone payments. The license fee consists of a payment of $2 million within 10 days of signing, and a payment of $1 million plus a $1 million equity investment within 30 days after the first dosing of a patient in a registrational study.

GPC Biotech has agreed to make additional payments totaling up to $18 million upon achieving agreed upon milestones, the first of which is anticipated to be the acceptance of the NDA (New Drug Application) filing by the U.S. Food and Drug Administration. Furthermore, GPC Biotech will fully fund development and commercialization expenses for satraplatin. Upon commercial sale of satraplatin, NeoTherapeutics will receive royalty payments based upon net sales, and may co-promote satraplatin in the United States.

"GPC Biotech''s and NeoTherapeutics'' partnership to develop satraplatin is a natural fit for many reasons," stated Luigi Lenaz, President of the oncology division of NeoTherapeutics. "Members of senior management and clinical development from both companies have worked well together in the past. The development team has strong knowledge on platinum derivate compounds based on their former involvement in the development of cisplatin and carboplatin. I also look forward to collaborating again with a leader in oncology like Marcel Rozencweig, Senior Vice President, Drug Development at GPC Biotech. His expertise in worldwide drug development will contribute greatly to our potential success."

Satraplatin is an orally-administered platinum derivative licensed from Johnson-Matthey to NeoTherapeutics. Platinum derivatives are one of the most active classes of cytotoxic anti-cancer agents and are currently used to treat a wide range of cancers. A large phase 2 program has shown efficacy in the treatment of hormone-resistant prostate cancer as well as several other tumor types. NeoTherapeutics and GPC Biotech expect to begin phase 3 clinical development of satraplatin in 2003 with clinical trials to be conducted in both the U.S. and Europe. First- and second-generation agents, cisplatin and carboplatin, are widely used in treating cancer and generate annual sales in excess of $800 million. Neither drug is approved to treat prostate cancer.