Pfizer Inc. and Debiopharm Group (Debiopharm) announced that they have entered into a co-development agreement to conduct a phase-3 trial of tremelimumab (CP675,206), a fully human anti-CTLA4 monoclonal antibody for the treatment of patients with unresectable, Stage IV melanoma. A biomarker will be used to select patients considered likely to respond to tremelimumab.
Under the terms of the agreement, Debiopharm will assume responsibility for conducting the phase 3 trial of tremelimumab and Pfizer will retain responsibility for worldwide commercialization of the compound.
Melanoma, the deadliest form of skin cancer, occurs in about 69,000 patients in the United States each year, and results in about 9,000 deaths. The number of melanoma cases worldwide is increasing faster than any other cancer.
Pfizer’s investigational drug, tremelimumab (CP675,206), currently in phase-2, is a fully human igG2 monoclonal antibody which has been in development for the treatment of advanced melanoma. In April 2008, Pfizer announced that it had discontinued a phase-3 clinical trial for patients with advanced melanoma after the Data Safety Monitoring Board (DSMB) review of interim data showed that the trial would not demonstrate superiority to standard chemotherapy. Analysis of the data from this trial identified the biomarker which will be used in patient selection for the upcoming trial.
“The continuation of the clinical development of tremelimumab with our partner, Debiopharm, is a demonstration of our commitment to personalized medicine for cancer patients,” said Garry Nicholson, president and general manager of Pfizer’s Oncology Business Unit. “Debiopharm is a successful company which has achieved impressive results on a global scale. This co-development partnership is an opportunity to leverage the combined expertise of both companies in this innovative endeavour.”
Thierry Mauvernay, executive vice president, Debiopharm Group said, “Debiopharm and Pfizer share the same vision of personalized medicine for the benefit of patients and to enhance the effectiveness of medicine. We are proud to enter into a unique co-development partnership with Pfizer to address the unmet medical needs of melanoma patients.”
Financial terms of the co-development agreement between Debiopharm and Pfizer have not been disclosed.
Debiopharm Group is a Swiss-based global biopharmaceutical group of companies with a focus on the development of prescription drugs that target unmet medical needs. The group in-licenses and co-develops promising biological and small molecule drug candidates having reached clinical development phases-I, II or III. It develops its products for global registration and maximum commercial potential.