Lausanne, Switzerland and New York, N.Y., January 7, 2010 – Debiopharm Group™ (Debiopharm) and Pfizer Inc. (Pfizer) announced today 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. 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 endeavor.”
– Garry Nicholson, president and general manager of Pfizer’s Oncology Business Unit.
“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.”
– Thierry Mauvernay, Executive Vice President, Debiopharm Group™
Financial terms of the co-development agreement between Debiopharm and Pfizer have not been disclosed.
About Pfizer Oncology
Pfizer Oncology is committed to the discovery, investigation and development of innovative treatment options to improve the outlook for cancer patients worldwide. Our strong pipeline, one of the most robust in the industry, is studied with precise focus on identifying and translating the best scientific breakthroughs into clinical application for patients across a wide range of cancers, including breast, lung, prostate, sarcoma, melanoma, and various hematologic cancers. Pfizer Oncology has more than 25 biologics and small molecules in clinical development and more than 200 clinical trials underway.
By working collaboratively with academic institutions, individual researchers, cooperative research groups, governments, and licensing partners, Pfizer Oncology strives to cure or control cancer with breakthrough medicines, to deliver the right drug for the right patient at the right time.
For more information please visit www.pfizer.com
Pfizer Inc: Working together for a healthier world™
At Pfizer, we apply science and our global resources to improve health and well-being at every stage of life. We strive to set the standard for quality, safety and value in the discovery, development and manufacturing of medicines for people and animals. Our diversified global health care portfolio includes human and animal biologic and small molecule medicines and vaccines, as well as nutritional products and many of the world’s best-known consumer products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as the world’s leading biopharmaceutical company, we also collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. To learn more about our commitments, please visit us at www.pfizer.com
About Debiopharm Group™
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. The products are out-licensed to pharmaceutical partners for sales and marketing.
Debiopharm independently funds the worldwide development of all of its products while providing expertise in pre-clinical and clinical trials, manufacturing, drug delivery and formulation, and regulatory affairs.
Founded in 1979 and headquartered in Lausanne, Switzerland, Debiopharm has developed four products with global combined sales of $2.6 billion in 2008.
For more information on Debiopharm Group™, please visit: www.debiopharm.com
PFIZER DISCLOSURE NOTICE: The information contained in this release is as of January 7, 2010. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
This release contains forward-looking information that involves substantial risks and uncertainties about a product candidate, tremelimumab, including its potential benefits. Such risks and uncertainties include, among other things, the uncertainties inherent in drug research and development, including whether and when such product candidate will advance to Phase 3; decisions by regulatory authorities regarding whether and when to approve any drug applications that may be filed for such product candidate, as well as their decisions regarding labeling and other matters that could affect its availability or commercial potential; and competitive developments.
A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2008 and in its reports on Form 10-Q and Form 8-K.