Gilead Sciences, Inc., Johnson & Johnson Expand Existing HIV R&D Pact
December 29, 2014
By Krystle Vermes, BioSpace.com Breaking News Staff
Janssen R&D Ireland announced today that it has agreed to a deal with Gilead Sciences, Inc. for the development of an HIV treatment that will develop a once-a-day, darunavir-based, single-tablet regimen. Darunavir is marketed as Prezista, and the drug is in a class of HIV medicines known as protease inhibitors.
"Janssen has vast experience in developing and making innovative HIV treatments available to patients and we have engaged in several successful collaborations with Gilead,” said Paul Stoffels, chief scientific officer and worldwide chairman of Pharmaceuticals at Johnson & Johnson . “We are proud to be extending our collaboration and leading the development of this darunavir-based single-tablet regimen. Our ultimate goal is to offer new treatment options for people living with HIV. If approved, this STR has the potential to provide additional choice in the form of another one pill, once a day, as a new and simplified regimen."
If the drug is eventually approved by regulators, it would be the first protease inhibitor-based STR. Janssen and Gilead have also announced that they have expanded upon a 2009 agreement for Complera, a once-daily prescription drug designed for patients who have never taken HIV-1 medication before and have no more than 100,000 copies or milliliters of the virus in their blood.
The Approval of Complera
The Food and Drug Administration approved of Complera back in December 2013 for use in certain virologically suppressed adult patients on a stable antiretroviral regimen. Complera was initially approved for patients new to therapy back in 2011. The drug is a combination of emtricitabine, rilpivirine and tenofovir disoproxil fumarate.
“Complera is an effective single-pill therapy with a demonstrated safety profile, and has rapidly become an important option for appropriate HIV patients who are initiating antiretroviral treatment,” said Calvin Cohen, research director at the Community Research Initiative of New England and an investigator on clinical trials of Complera. “The data supporting today’s approval demonstrate Complera has the potential to help a broader range of HIV-infected patients who have achieved virologic control on another regimen.”
The approval was supported by clinical data from the Phase 3 SPIRIT study, which looked at patients who were on a multi-tablet HIV therapy. They were either switched to Complera or remained on their regiment over the course of 48 weeks. Researchers found that 89 percent of Complera patients had a viral load of less than 50 copies.