GPC Pharmion Co-Development and License Agreement
Dec. 20, 2005:
Pharmion Corporation (Nasdaq: PHRM) and GPC Biotech AG (Frankfurt Stock Exchange: GPC; TecDAX index; Nasdaq: GPCB) today announced that the companies 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 randomized 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 Authorization Application (MAA) in Europe and a New Drug Application (NDA) in the U.S. for this indication. Based on data from this trial, Pharmion expects to file the MAA in Europe in 2007, pending concurrence with the EMEA. Under the terms of the agreement, Pharmion gains exclusive commercialization 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 tumor 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 percent on annual sales up to $500 million, and 34 percent 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."
As of the date of posting, the full text of the agreement is not available.
Pharmion Corporation (Nasdaq: PHRM) and GPC Biotech AG (Frankfurt Stock Exchange: GPC; TecDAX index; Nasdaq: GPCB) today announced that the companies 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 randomized 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 Authorization Application (MAA) in Europe and a New Drug Application (NDA) in the U.S. for this indication. Based on data from this trial, Pharmion expects to file the MAA in Europe in 2007, pending concurrence with the EMEA. Under the terms of the agreement, Pharmion gains exclusive commercialization 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 tumor 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 percent on annual sales up to $500 million, and 34 percent 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."
As of the date of posting, the full text of the agreement is not available.
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