Biopharmaceutical company Gilead Sciences, Inc. (GILD) said Wednesday that the U.S. Food and Drug Administration has approved Complera, a complete single-tablet regimen for the treatment of HIV-1 infection in treatment-naïve adults.
The approval marks Gilead's second successful collaboration to develop a complete single-tablet regimen for HIV/AIDS following its collaboration with Bristol-Myers Squibb for Atripla, that combines efavirenz 600 mg, emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg.
"Complera is the second complete single-tablet regimen that Gilead has introduced, and it represents a collaboration between two organizations that share a vision of simplifying HIV therapy for patients," Chairman and CEO John Martin said in a statement.
For Complera, Gilead first entered into a license and collaboration agreement with healthcare giant Johnson & Johnson's (JNJ) Tibotec Pharmaceuticals in July 2009 for the development and commercialization of the new fixed-dose combination for the treatment of HIV infection.
The Foster City, California-based drug maker noted that Complera combines the most-prescribed HIV product in the U.S. with the newest antiretroviral agent approved by the FDA. Complera combines three antiretroviral medications in one daily tablet, Gilead's Truvada, and Tibotec's non-nucleoside reverse transcriptase inhibitor, rilpivirine.
Truvada is a fixed-dose combination of the two nucleoside reverse transcriptase inhibitors emtricitabine and tenofovir disoproxil fumarate. Truvada was approved by the FDA in August 2004, and rilpivirine was approved by the FDA in May 2011 for use as part of HIV combination therapy.
Under the agreement with Tibotec, Gilead will be responsible for the manufacturing, registration, and commercialization of Complera in the U.S., Canada, Brazil, the European Union, Australia and New Zealand. Meanwhile, Tibotec will be responsible for the commercialization of rilpivirine as a stand-alone product and will hold rights to co-detail Complera in these territories.
Gilead noted that a marketing application for this combination of emtricitabine, rilpivirine, and tenofovir disoproxil fumarate single-tablet regimen is currently pending in the European Union.
For the rest of world, Gilead will be responsible for the registration, distribution and commercialization of the single-tablet regimen in certain European countries, Latin America and the Caribbean. Meanwhile, Tibotec will be responsible for all countries outside of the Gilead territories, the most significant of which include Asia Pacific, including Japan, the Middle East, Eastern Europe and all of Africa.
"Tremendous progress has been made in the field of HIV, but we recognize new therapies are still needed, and we continue to work to advance options that address the needs of patients," Martin added.
With the FDA approval for triple-drug combination Complera, Gilead currently has three combination drugs for HIV treatment, including double-drug Truvada and triple-drug Atripla. It is also in the process of developing a four-drug pill, now called the Quad, which Gilead plans to file for approval in early 2012.
As per a data from the Joint United Nations Programme on HIV/AIDS, in 2009, about 2.6 million people were estimated to suffer from HIV, and more than 1.8 million people succumbed to AIDS-related causes.
GILD closed Wednesday's regular trading session at $35.34, down $2.80 or 7.34 percent on a volume of 15.56 million shares. However, the stock rose $1.04 or 2.94 percent in after-hours trading.
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