Pharmion Corporation and GPC Biotech AG have entered into a co-development and license agreement for satraplatin, the only oral platinum-based compound in advanced clinical development.
Satraplatin has shown promising safety and efficacy as demonstrated by significant improvement in progression-free survival (PFS) in a randomised study of first-line treatment of patients with hormone-refractory prostate cancer (HRPC) and is currently the subject of a phase 3 registrational trial as second-line chemotherapy treatment for patients with HRPC. Data from the pivotal phase 3 trial are expected to form the basis of a marketing authorisation application (MAA) in Europe and a new drug application (NDA) in the US for this indication. Based on data from this trial, Pharmion expects to file the MAA in Europe in 2007, pending concurrence with the EMEA, claims a company release.
Under the terms of the agreement, Pharmion gains exclusive commercialisation rights for Europe, Turkey, the Middle East, Australia and New Zealand, while GPC Biotech retains rights to the North American market and all other territories. Pharmion is to provide an upfront payment of $37.1 million to GPC Biotech, including an $18 million reimbursement for past satraplatin clinical development costs and $19.1 million for funding of ongoing and certain future clinical development to be conducted jointly by Pharmion and GPC Biotech.
The companies will pursue a joint development plan to evaluate development activities for satraplatin in a variety of tumour types and will share global development costs, for which Pharmion has made an additional commitment of $22.2 million, in addition to the $37.1 million in initial payments. Pharmion will also pay GPC Biotech $30.5 million based on the achievement of certain regulatory filing and approval milestones, and up to an additional $75 million for up to five subsequent EMEA approvals for additional indications. GPC Biotech will also receive royalties on sales of satraplatin in Pharmion's territories at rates of 26 to 30 per cent on annual sales up to $500 million, and 34 per cent on annual sales over $500 million. Finally, Pharmion will pay GPC Biotech sales milestones totaling up to $105 million, based on the achievement of significant annual sales levels in the Pharmion territories. Pharmion and GPC Biotech will lead regulatory and commercial activities in their respective territories, added the release.
"We believe that satraplatin has the potential to provide significant additional benefits in the well-characterised platinum treatment class, and we will work closely with GPC Biotech to get this vital therapy to physicians and patients as quickly as possible. Satraplatin represents an important addition to our product portfolio, complementing our existing products as well as the global regulatory, clinical development and commercial organisations that support them," said Patrick J. Mahaffy, Pharmion's president and chief executive officer.
Bernd R. Seizinger, chief executive officer of GPC Biotech, said: "We were very pleased with the significant interest in satraplatin shown by a large number of pharmaceutical and biotech firms in the US and Europe. We have selected Pharmion as a partner because we believe they are ideally suited to help us fully exploit the potential of satraplatin in Europe and are strongly committed to continued development of this important compound for a variety of cancers. The deal structure provides us with significant funding but still allows GPC Biotech to retain the full commercialisation rights to the US market and other key pharmaceutical markets."
Satraplatin, an investigational drug, is a member of the platinum family of compounds.
Pharmion is a pharmaceutical company focused on acquiring, developing and commercialising innovative products for the treatment of haematology and oncology patients in the US, Europe and additional international markets.
GPC Biotech AG is a biopharmaceutical company discovering and developing new anticancer drugs.