Sanofi, Lexicon Pharmaceuticals team on diabetes drug in pipeline
PARIS and THE WOODLANDS, Texas — A new diabetes drug in the pipeline has Sanofi and Lexicon Pharmaceuticals working together as it goes through Phase 3 trials. The two companies on Friday announced a development and commercialization deal for sotagliflozin, which is currently undergoing Phase 3 trials for its efficacy treating type-1 diabetes and will enter Phase 3 trials for type-2 diabetes in early 2016.
“This agreement with Lexicon reinforces our commitment to helping people living with diabetes,” Sanofi EVP Pascale Witz said. “Adding sotagliflozin to our portfolio, which includes medicines at virtually every stage of the treatment pathway, highlights our focus on providing a large and diverse set of therapeutic options for people with this disease.”
Under the agreement, Lexicon will receive a $300 million up-front payment, with the ability to receive milestone payments up to $1.4 billion for development, regulatory and sales achievements. Sanofi will retain the license for manufacturing, developing and commercializing sotagliflozin.
“Lexicon firmly believes in the potential of sotagliflozin for patients living with diabetes,” Lexicon president and CEO Lonnel Coats said. “Sanofi's patient-centric focus in diabetes, and its rich history of innovation in diabetes, make it an exceedingly attractive partner which is well positioned to unlock the full potential of sotagliflozin for patients living with diabetes.”
FDA approves Gilead’s new HIV drug Genvoya
SILVER SPRING, Md. — The Food and Drug Administration announced that it had approved Gilead Sciences’ Genvoya (elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide, or E/C/F/TAF) to treat HIV. The drug, according to Gilead, is the first HIV treatment using a TAF-based regimen to get approval.
“Today’s approval of a fixed dose combination containing a new form of tenofovir provides another effective, once daily complete regimen for patients with HIV-1 infection,” said Dr. Edward Cox, M.D., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.
The drug can be used in adults and children 12 years of age and older who haven’t taken an HIV therapy before, and HIV-positive adults whose virus is suppressed. The drug uses a new form of tenofovir that keeps the drug’s levels in the bloodstream low, but high in the cells where the disease replicates, in an effort to reduce side effects.
Camber rolls out new website
BY DSN STAFF
PISCATAWAY, N.J. — Camber Pharmaceuticals on Thursday unveiled its revamped website, featuring responsive design for optimal viewing on any device. The new website is also tailored to its user, with a product section that customizes results based on who is searching — patients, pharmacists or partners.
“Our new website is a reflection of our commitment to provide the very latest product information available and to offer the highest level of service to patients and customers alike,” Camber’s marketing director Kirk Hessels said. “The content management system for the site allows us to make updates the same day a product is launched giving our customers immediate access to product and bottle images, medication guides, SDS sheets, case dimensions and much more.”
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