Novacea Inc., and Pierre Fabre Medicament S.A., will partner on the development and commercialization of oral vinorelbine, a chemotherapeutic agent, for the treatment of various tumour types. Pierre Fabre has licensed the US 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, release from Novacea said.
"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.
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.
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.
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).