Gilead gains US approval for Complera, resolves manufacturing problem and buys Genentech facility

In what were a couple of busy news days for US biotech firm Gilead Sciences (Nasdaq: GILD), the company received US Food and Drug Administration approval for Complera (emtricitabine/rilpivirine/tenofovir disoproxil fumarate), a complete single-tablet regimen for the treatment of HIV-1 infection in treatment-naive adults.

Complera, which is partnered with Johnson & Johnson (NYSE: JNJ) subsidiary Tibotec Pharmaceuticals, combines three antiretroviral medications in one daily tablet - Gilead’s Truvada, which is a fixed-dose combination of the two nucleoside reverse transcriptase inhibitors emtricitabine and tenofovir disoproxil fumarate, and Tibotec’s non-nucleoside reverse transcriptase inhibitor, rilpivirine (marketed as Edurant in the USA by Janssen Therapeutics, another unit of J&J. Truvada and rilpivirine were approved by the FDA in August 2004 and May 2011, respectively, for use as part of HIV combination therapy.

“In the 30 years since the first AIDS cases were reported, we’ve made incredible strides in the treatment of this disease,” said Tony Mills, director of medical research at Anthony Mills MD Inc and a participating investigator in ongoing Complera studies. “The concept of a single-tablet regimen has become a goal in HIV drug development, and the standard of care in medical practice in the United States. However, no one therapy is appropriate for all patients. Given its efficacy, safety and convenience, the availability of Complera represents an exciting milestone in addressing the individual needs of patients new to HIV therapy,” he added.