Gilead and J&J’s combination pill Complera receives FDA approval for HIV treatment

In an announcement earlier on Wednesday, Gilead said that Complera, the once-per-day combination treatment for HIV, has been approved by the United Sates Food and Drug Administration.

Complera is a combination pill of Gilead Sciences Inc.’s drug Truvada and Johnson & Johnson’s drug Edurant, and is approved for use in treatment-naïve HIV patients. While Gilead’s Truvada (a combination of the drugs emtracitabine and tenofovir) was approved in Aug 2004, Edurant, or rilpivirine (developed by Johnson & Johnson’s Tibotec unit) was approved in May.

Marketed by Gilead and Bristol-Myers Squibb Co., Atripla is the first once-per-day drug and Complera is the second once-per-day drug intended for treatment naïve HIV patients, said Gilead.

In the US, European Union, Canada, Brazil, Australia, and New Zealand, Complera will be developed, manufactured, and marketed by Gilead and co-marketed by Tibotec. According to the new terms of the expanded agreement by the companies on Wednesday, Gilead will take over manufacturing, development, and marketing responsibilities in Latin America, the Caribbean, and in some European countries while these functions will be catered to by Tibotec in the rest of the countries.

With a steep decline in the markets on Wednesday, Gilead shares plunged 7.3 percent to $35.34, although the stock recovered 90 cents, or 2.6 percent, to $36.24 in aftermarket trading. During the day, Johnson & Johnson shares plummeted 3.2 percent to $60.20 while in after-hours trading, they spiked 7 cents to $60.27.