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news.Novacea and Pierre Fabre Medicament are to collaborate in the development and commercialization of oral vinorelbine, a chemotherapeutic agent, for the treatment of various tumor types. Novacea will focus on bringing the drug to the North American markets where it is not yet approved.
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Pierre Fabre has licensed the US and Canadian rights for oral vinorelbine 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 III clinical program to build upon existing safety and efficacy data from previous studies. Upon completion of the phase III program, Novacea will file a New Drug Application in the US and seek approval from Canadian regulatory agencies. Novacea will also commercialize and market the compound in those territories.
Financial terms of the 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.
Brad Goodwin, CEO of Novacea commented: “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.