PARIS and SOUTH SAN FRANCISCO, Calif., July 25 /PRNewswire/ -- Novacea Inc. and Pierre Fabre Medicament S.A. announced today that they will partner on the development and commercialization of oral vinorelbine, a chemotherapeutic agent, for the treatment of various tumor types. Pierre Fabre has licensed the U.S. and Canadian rights to Novacea, while Pierre Fabre will continue to develop and commercialize oral vinorelbine in Europe and other countries, where it is approved for the treatment of breast and lung cancer.
As part of the licensing agreement, it is anticipated that Novacea will conduct a Phase 3 clinical program to build upon existing safety and efficacy data from previous studies. Upon completion of a Phase 3 program, Novacea will be responsible for filing a New Drug Application in the United States and seeking approval from Canadian regulatory agencies. Novacea will also be responsible for the commercialization of the compound in those territories. Financial terms of the agreement were not disclosed, but include an upfront payment, milestone fees, reimbursement for manufacturing costs and royalty payments on future net sales. Pierre Fabre will manufacture the product for clinical trials and any subsequent commercial sales.
"We look forward to building on the strong platform of research experience and clinical knowledge that Pierre Fabre has developed in support of their clinical work and commercialization of oral vinorelbine in Europe and we are pleased that Pierre Fabre has recognized our clinical and development teams as strong and capable partners. Oral vinorelbine provides a perfect fit for the Novacea model to in-license, develop and commercialize clinical stage cancer therapeutics that offer important advantages over current forms of therapy," said Brad Goodwin, chief executive officer of Novacea. "As few oral chemotherapies have been approved in North America, we believe that patients appreciate both the clinical benefit and convenience aspects of oral cancer therapy. We are excited to play an important role in accelerating North American registration of this product and to bring this needed therapy to patients," continued Goodwin.
"We are pleased to partner with Novacea and we expect that Novacea's enthusiasm, dedication, and clinical expertise will benefit oral vinorelbine and many cancer patients in the U.S. and Canada. With approximately 1,000,000 patients treated with vinorelbine, both in its oral and I.V. forms, since the product was put on the market in 1989, we know that this drug is an important addition to the treatment of breast and lung cancer," said Jean-Pierre Couzinier, M.D., Pierre Fabre Medicament's Chief Operating Officer. "This partnership further illustrates our commitment to partnerships, both for product development and for global marketing, that allow for patients worldwide to have access to the best possible options for their care."
Vinorelbine I.V. is a semi-synthetic derivative of a vinca alkaloid and a well-studied and long utilized therapy for the treatment of breast and non- small cell lung cancer (NSCLC). Oral vinorelbine is an innovative advance for cancer patients. As studies have shown that 89% of cancer patients express a clear preference for oral chemotherapy assuming equal efficacy and side effects (Journal of Clinical Oncology, January 1997), Pierre Fabre has worked toward the goal of improving quality of life for cancer patients with an effective and better tolerated anti cancer agent. To this end, clinical studies have demonstrated that oral vinorelbine has similar clinical results and tolerance when compared to I.V. delivery of vinorelbine. Additionally, oral delivery of vinorelbine avoids the stress of hospitalization and the possible damage to the patient's venous system while improving patients' comfort and reducing the cost of treatment. Oral vinorelbine is registered and launched in most European countries for NSCLC and breast cancer.
About Pierre Fabre Medicament
The Pierre Fabre Group, the second-largest independent laboratory in France, employs about 9,300 people and achieved sales of 1.47 billion euros in 2004. Operating in the areas of ethical medicine, health products and dermo-cosmetics with the brands Avene, Ducray, A-derma, Galenic, Klorane and Rene Furterer, it achieves 43 percent of its business abroad. With more than 1,100 researchers, Pierre Fabre Medicament dedicates 23 percent of its annual sales to research and development in five major therapeutic areas in terms of public health: oncology (the priority R&D area of Pierre Fabre Medicament with 50% of all R&D expenses), central nervous system, cardiology, internal medicine/urology and dermatology. Pierre Fabre currently markets, directly or through its licensees, oral and I.V. vinorelbine in over 80 countries throughout the world.
The Pierre Fabre group has taken several actions that will reinforce its role as major actor in French Research on Cancer: In 2004, Pierre Fabre signed partnership agreements with two major American drug companies, which confirms the expertise of the R&D in our group and the relevance of its approach in Oncology: An agreement with Bristol-Myers Squibb on the clinical and commercial development of Javlor(R) (vinflunine), a new generation anti- cancer agent; An R&D partnership agreement and a licensing agreement with Merck Sharp and Dohme on F50035, a monoclonal antibody against the IGF 1 growth factor.
The Pierre Fabre Group is also participating to the Canceropole project in Toulouse, where the company will bring together in 2007 on this site a number of its R&D units, particularly those involved in oncology.
For more information, visit www.pierre-fabre.com
Novacea is a privately held biopharmaceutical company focused on the licensing, development and commercialization of novel products to revolutionize the treatment of cancer. The Company currently has two products in clinical development: DN-101 and banoxantrone (AQ4N). DN101 recently completed Phase 2/3 clinical studies in advanced prostate cancer and is also being studied in a Phase 1/2 study in advanced non-small cell lung cancer. Banoxantrone, a tissue-targeting cytotoxic prodrug, has shown preclinical activity in both solid tumors and lymphoid malignancies and currently is being tested in Phase 1/2 clinical studies to determine safety and dosing. The Company plans to expand its product portfolio by in-licensing other compounds that leverage its development expertise in oncology and hematology. For more information, visit www.novacea.com.
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