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Phenomix and Forest Laboratories to Collaborate on Development and Commercialization of Dutogliptin in Diabetes
23 / 10 / 2008
Forest Laboratories, Inc. (NYSE: FRX) and Phenomix Corporation today announced that they have entered into a definitive collaboration agreement to develop and commercialize dutogliptin (PHX1149) in North America. Dutogliptin is Phenomix' proprietary orally administered, small molecule dipeptidyl-peptidase-4 (DPP-4) inhibitor currently undergoing Phase 3 clinical development in Type 2 diabetes mellitus.
Under the terms of the agreement, Forest will make an upfront payment to Phenomix of $75 million. Phenomix and Forest will jointly develop and commercialize dutogliptin in the United States, and the companies will equally share profits and expenses. Upon commercialization, the parties will co-promote the product in the United States, with Phenomix promoting dutogliptin to endocrinologists and diabetologists and Forest promoting to primary care and specialty physicians. Forest has exclusive rights to develop and commercialize dutogliptin in Canada and Mexico, and Phenomix will receive a royalty on sales in these countries in exchange for the rights to use jointly funded trial data in those countries. Phenomix retains development and commercialization rights to the product outside of North America, and will pay Forest a royalty on net sales in these territories. Phenomix could receive up to $340 million in upfront and milestone payments for the successful development and commercialization of dutogliptin in the United States over the term of the collaboration.
"Diabetes is a widespread and growing disease. We have been eager to find a product with a promising and novel mechanism that we could acquire to develop and market. We believe that Phenomix' DPP-4 inhibitor is a valuable addition to the available treatments to help better control this serious condition," said Howard Solomon, Chairman and Chief Executive Officer of Forest. "Diabetes is treated to a large extent by primary care physicians, with whom the Forest sales force has been particularly successful. We are pleased to work with Phenomix, whose management and scientific team have demonstrated ingenuity and commitment in bringing dutogliptin from discovery into late-stage clinical development."
"Partnering with Forest is a very important next step for Phenomix in working towards commercialization of dutogliptin for the treatment of patients with Type 2 diabetes," said Laura K. Shawver, Ph.D., Phenomix'' Chief Executive Officer. "Forest has a demonstrated capability to develop and commercialize late-stage, large-market compounds, which will help ensure that dutogliptin will be a medically important and commercially successful drug. We are excited that Forest shares our vision and dedication to commercialize dutogliptin for the treatment of this devastating disease."
By comparison to placebo, dutogliptin demonstrated significant reductions in hemoglobin A1c (HbA1c) and fasting plasma glucose in a 12-week Phase 2b clinical study. The study also showed dutogliptin was well tolerated with a low incidence of adverse events. Dutogliptin was administered orally, once daily. Phenomix initiated a Phase 3 clinical development program in the third quarter of 2008. A composition of matter patent application has issued for dutogliptin, which provides protection to 2024, and is subject to extension.
Under the terms of the agreement, Forest will make an upfront payment to Phenomix of $75 million. Phenomix and Forest will jointly develop and commercialize dutogliptin in the United States, and the companies will equally share profits and expenses. Upon commercialization, the parties will co-promote the product in the United States, with Phenomix promoting dutogliptin to endocrinologists and diabetologists and Forest promoting to primary care and specialty physicians. Forest has exclusive rights to develop and commercialize dutogliptin in Canada and Mexico, and Phenomix will receive a royalty on sales in these countries in exchange for the rights to use jointly funded trial data in those countries. Phenomix retains development and commercialization rights to the product outside of North America, and will pay Forest a royalty on net sales in these territories. Phenomix could receive up to $340 million in upfront and milestone payments for the successful development and commercialization of dutogliptin in the United States over the term of the collaboration.
"Diabetes is a widespread and growing disease. We have been eager to find a product with a promising and novel mechanism that we could acquire to develop and market. We believe that Phenomix' DPP-4 inhibitor is a valuable addition to the available treatments to help better control this serious condition," said Howard Solomon, Chairman and Chief Executive Officer of Forest. "Diabetes is treated to a large extent by primary care physicians, with whom the Forest sales force has been particularly successful. We are pleased to work with Phenomix, whose management and scientific team have demonstrated ingenuity and commitment in bringing dutogliptin from discovery into late-stage clinical development."
"Partnering with Forest is a very important next step for Phenomix in working towards commercialization of dutogliptin for the treatment of patients with Type 2 diabetes," said Laura K. Shawver, Ph.D., Phenomix'' Chief Executive Officer. "Forest has a demonstrated capability to develop and commercialize late-stage, large-market compounds, which will help ensure that dutogliptin will be a medically important and commercially successful drug. We are excited that Forest shares our vision and dedication to commercialize dutogliptin for the treatment of this devastating disease."
By comparison to placebo, dutogliptin demonstrated significant reductions in hemoglobin A1c (HbA1c) and fasting plasma glucose in a 12-week Phase 2b clinical study. The study also showed dutogliptin was well tolerated with a low incidence of adverse events. Dutogliptin was administered orally, once daily. Phenomix initiated a Phase 3 clinical development program in the third quarter of 2008. A composition of matter patent application has issued for dutogliptin, which provides protection to 2024, and is subject to extension.