Gilead Sciences Inc. (GILD:US) failed to win U.S. regulatory approval to sell as separate products two HIV medicines that are part of its four-in-one pill Stribild.
The Food and Drug Administration cited “deficiencies in documentation and validation of certain quality testing procedures and methods,” Foster City, California-based Gilead said today in a statement. The company said it’s working with the FDA to address the agency’s questions.
The two drugs, elvitegravir and cobicistat, are intended to be used to help treat patients who have failed other medicines or to boost the potency of certain HIV-treatment regimens. The compounds are components of Stribild, a once-daily tablet approved by the FDA in August that combines four drugs into one pill. Two of the medications were already FDA-approved as Gilead’s Truvada.
Gilead fell less than 1 percent to $51.09 at the close in New York. The company almost doubled in the past 12 months.
Gilead’s Atripla, which combines three drugs in one pill, is the best-selling HIV treatment with $3.6 billion in sales last year. Elvitegravir and cobicistat individually may generate an estimated $363 million and $262 million in 2016, according to analysts’ estimates compiled by Bloomberg.
Elvitegravir interferes with an enzyme HIV needs to multiply. Gilead said in a July statement that its research found the drug works as well as Whitehouse Station, New Jersey-based Merck & Co.’s twice-daily Isentress, approved in 2007.
Cobicistat enhances the potency of widely prescribed protease inhibitors such as Bristol-Myers Squibb Co. (BMY:US)’s Reyataz and Johnson & Johnson (JNJ:US)’s Prezista. New York-based Bristol Myers and New Brunswick, New Jersey-based J&J each have licensing agreements with Gilead to develop pills containing combinations of their drugs and cobicistat.
Cobicistat worked as well in a clinical trial on adults who hadn’t taken HIV medication before as AbbVie Inc. (ABBV:US)’s boosting agent Norvir, Gilead said in July.
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