PHARMACY

J&J to acquire Novira Therapeutics

BY David Salazar

NEW BRUNSWICK, N.J. — Johnson and Johnson is looking to grow its pharmaceutical arm’s specialty portfolio, announcing this week the acquisition of Novira Therapeutics. Novira focuses on development of chronic hepatitis B treatment, and the acquisition includes the company’s novel antivirals, among them its lead candidate NVR 3-778.
 
We are excited about the prospect this acquisition offers to accelerate the development of curative treatments for people affected by chronic hepatitis B,” said William N. Hait, M.D., Ph.D., Global Head, Research & Development, Janssen Pharmaceutical Companies of Johnson & Johnson. “NVR 3-778 offers the potential for efficient suppression of virus production and replication, which could help address the remaining unmet medical needs.”
 
The acquisition is expected to close in the fourth quarter of 2015. Financial terms have not been disclosed. 
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PHARMACY

Sanofi, Lexicon Pharmaceuticals team on diabetes drug in pipeline

BY David Salazar

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.”
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FDA approves Gilead’s new HIV drug Genvoya

BY David Salazar

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.
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