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Gilead, With Two PRVs In Hand, Holds Options For Accelerating Late-Stage Pipeline

 
• By Joseph Haas

Likely candidates for use of Gilead's priority review vouchers include GS-4997, a Phase III candidate for NASH, and bictegravir, its second-generation integrase inhibitor for HIV. The virology specialist previously used a PRV successfully to accelerate approval of Odefsey.

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Sitting on a nest egg of $32.4bn in cash as of the end of 2016 and needing catalysts to boost sales while revenues from its industry-leading hepatitis C franchise decline steadily, Gilead Sciences Inc. has turned for a third time to the seller's market for priority review vouchers, obtaining Sarepta Therapeutics Inc.'s voucher for $125m.

Gilead's pipeline lists four Phase III programs with previously unapproved drug candidates, in a variety of therapeutic spaces – HIV, non-alcoholic steatohepatitis (NASH), gastric cancer and autoimmune indications, including rheumatoid arthritis, Crohn's disease and ulcerative colitis

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