Gilead Sciences subpoenaed in USA over HIV and other drugs

US biopharmaceutical company Gilead Sciences (Nasdaq: GILD) revealed late Friday that it has received a subpoena from the UDS Attorney’s Office for the Northern District of California requesting documents related to the manufacture, and related quality and distribution practices of its leading and investigational HIV/AIDS drugs as well as other products. News of the subpoena saw the firm’s shares drop 2.4% to $39.25 in after-hours trading that day.

Gilead says it is cooperating in this civil and criminal investigation. The AIDS drugs in question, which generated sales of some $6.3 billion last year, are Atripla (efavirenz tenofovir emtricitabine), Emtriva (emtricitabine), Viread (tenofovir) and Truvada (tenofovir emtricitabine), as well as Hepsera (adefovir dipivoxil) for hepatitis B and Letairis (ambrisentan) for arterial pulmonary hypertension, and Gilead’s investigational fixed-dose combination of Truvada and Edurant (rilpivirine). The latter drug from Johnson & Johnson was approved by the Food and Drug Administration last month for use in combination with other antiretroviral agents (ARVs) in the treatment of human immunodeficiency virus type 1 (HIV-1) in adults who have never taken HIV therapy (The Pharma Letter May 23).

Gilead has previously received federal subpoenas - in December 2006 regarding the marketing of Truvada, Viread and Emtriva and in August 2009 focused on angina drug Ranexa (ranolazine), noted Mark Schoenebaum, an analyst at ISI Group quoted by Bloomberg. He said that the company told him that both were resolved without penalty. The current investigation may take years to resolve with the “worst-case outcome” a substantial fine, he added.