Tibotec Pharmaceuticals today announced that it has entered into a license agreement with Gilead Sciences, Inc., for the development and commercialization of a new once-daily single tablet fixed-dose antiretroviral combination product containing Tibotec's protease inhibitor PREZISTA® (darunavir) and Gilead's cobicistat, an investigational pharmacoenhancing or "boosting" agent.
PREZISTA, co-administered with ritonavir (PREZISTA/ritonavir), and with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV-1) infection. In the United States of America, once daily dosing of PREZISTA is indicated for treatment-naive adult patients and treatment-experienced adult patients with no darunavir resistance associated substitutions. In the European Union, once daily dosing of PREZISTA is recommended for treatment-naive adult patients and may be used in treatment-experienced adult patients with no darunavir resistance associated substitutions and who have plasma HIV-1 RNA < 100,000 copies/ml and CD4+ cell count greater than or equal to 100 cells x 10(6)/l.
"We are excited to be able to study and develop PREZISTA with an alternative boosting agent in a combination product which has the potential to reduce the number of tablets patients take. Tibotec is committed to developing new and innovative HIV treatment options, especially those which provide simplified treatment regimens that may help patients to better manage their HIV treatment. PREZISTA is one of the leading protease inhibitors and co-formulating it with cobicistat in a new combination product demonstrates our commitment to HIV and innovations that will provide new options for patients," said Johan Van Hoof, MD, Global Therapeutic Area Head, Infectious Diseases and Vaccines, Janssen Pharmaceutica N.V.
Subject to regulatory approval, Tibotec will be responsible for the formulation, manufacturing, registration, distribution and commercialization of the PREZISTA and cobicistat fixed-dose combination worldwide. Gilead retains sole rights for the manufacture, development and commercialization of cobicistat as a stand-alone product and for use in combination with other agents.
In connection with this agreement, the companies are also negotiating terms for the development and commercialization of a future single-tablet regimen (STR) combining PREZISTA with Gilead's Emtriva® (emtricitabine), and its investigational agents GS 7340 and cobicistat. Gilead would be responsible for the development and commercialization of the new STR on a worldwide basis. The agreement to develop the fixed-dose combination of cobicistat and PREZISTA is contingent upon the signing of an agreement on the Emtriva, GS 7340, cobicistat and PREZISTA STR.