January 20, 2015
By Krystle Vermes, BioSpace.com Breaking News Staff
Strides Arcolab Limited announced today that it has entered a licensing agreement with Gilead Sciences, Inc. to market HIV drugs in developing countries. Through the licensing agreement, Strides will manufacture and distribute Tenofovir Alafenamide, a nucleotide reverse transcriptase inhibitor.
TAF has shown high antiviral efficacy at a dose that is 10 times lower than Viread, also known as tenofovir disoproxil fumarate, from Gilead Sciences. The product also has an improved renal and bone safety profile.
With approval from the U.S. Food and Drug Administration, Strides will receive a technology transfer from Gilead. Currently, TAF has not been deemed safe in humans.
An approval will allow it to manufacture low-cost versions of TAF for countries around the world. Strides will have a license that extends across 112 countries, which account for 30 million people living with HIV.
Gilead’s Progression with TAF
In December 2014, Gilead announced that it would be furthering the development and commercialization of its once-daily single tablet regimen containing TAF through an agreement extension with Janssen R&D Ireland. The tablet, known as Complera, combines TAF, emtricitabine, and Janssen’s rilpivirine. The agreement between the two companies was struck in 2009, and it has been extended to initiate Phase III studies.
“We believe that TAF’s efficacy and safety advantages may make it a strong backbone of new fixed-dose combinations and single tablet regimens,” said Norbert Bischofberger, executive vice president of Research and Development and chief scientific officer at Gilead Sciences, at the time of the announcement. “Gilead is pleased to continue its collaboration with Janssen to bring improved treatment options to patients living with HIV.”
A Closer Look at TAF
TAF is considered to be an investigational drug by the FDA, and it has not been approved for sale. Clinical trials could potentially determine the safety and efficacy of TAF over time.
TAF belongs to a group of HIV drugs called nucleoside reverse transcriptase inhibitors, which block an HIV enzyme known as reverse transcriptase. The product itself is an inactive drug, and it does not work until the body converts it into its active form, tenofovir diphosphate. TAF is being looked at in studies in three different fixed dose combinations for the treatment of HIV infection.
BioSpace Temperature Poll
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