Thursday, April 25, 2013

Bristol Myer initates a bioequivalence study to evaluate a fixed dose combination of Reyataz and Cobicistat

The trial has been initiated as result of an agreement between Bristol-Myers Squibb and Gilead to collaborate on the development of a new once-daily fixed-dose coformulation containing the widely used HIV protease inhibitor atazanavir (Reyataz) plus Gilead's novel pharmacoenhancer cobicistat. Currently atazanavir is typically boosted with a low dose of ritonavir (Norvir) taken as a separate pill.  Cobocistat is yet not approved by the USFDA. The PDUFA is on April 28, 2013. 


Bristol-Myers Squibb will be responsible for the formulation, manufacturing, development, registration, distribution, and commercialization of the Reyataz and cobicistat fixed-dose combination worldwide. Under the terms of the agreement, Bristol-Myers Squibb will pay Gilead an undisclosed royalty based on annual net sales of the product. Gilead retains sole rights for the manufacture, development and commercialization of cobicistat as a stand-alone product and for use in combination with other agents.


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