Gilead Sciences, Inc. announced that the company has entered into a licensing agreement with Japan Tobacco Inc. (JT), under which JT has granted to Gilead exclusive rights to develop and commercialise a novel HIV integrase inhibitor (JTK-303) in all countries of the world, excluding Japan, where JT will retain rights.
Under the terms of the agreement, Gilead will pay to JT an upfront payment of $15 million and additional cash payments of up to $90 million upon the achievement of certain milestones. Gilead will also pay to JT a royalty based on future product sales in the territories where Gilead will market the drug. The agreement announced today is subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act.
As a result of the financial impact of this agreement, Gilead is providing an update on its financial guidance for research and development (R&D) expenses for 2005. Gilead's revised guidance for full year R&D expenses is now in a range of $250 to $270 million, up from the guidance of $240 to $260 million provided on the January 27, 2005 earnings conference call.
"We are very pleased to partner with JT to develop this compound, which is from a novel class of drugs that target the integrase enzyme," said John C. Martin, PhD, president and CEO, Gilead Sciences. "HIV has been and continues to be a leading research and development priority at Gilead, and our efforts are focused on identifying compounds in established classes of HIV drugs and also exploring therapies with new mechanisms of action. We believe this particular compound has a profile that is complementary to our existing HIV products, and we look forward to advancing it forward in clinical trials later this year."
"JT has long been committed to the exploration of anti-HIV drugs, and our efforts are gaining significant momentum. Today we are extremely pleased to announce our partnership with Gilead, an ideal partner in the field of anti-HIV drug development," said Noriaki Okubo, president of JT's Pharmaceutical Business. "Together, we're going to make every effort to advance this therapy into clinics as quickly as possible with the goal that it will someday benefit patients suffering from HIV."
Integrase is one of the key enzymes required for HIV to replicate. By inhibiting this enzyme, the integration of HIV DNA into the DNA of immune system cells (the process by which infection occurs) is disabled. JT's compound has previously been evaluated in a Phase I study in Japan to assess bioavailability and pharmacokinetics in healthy volunteers. Gilead plans to initiate Phase I/II clinical studies in HIV-positive patients by mid-year.
Gilead and JT first partnered in July 2003, when the companies announced an agreement granting JT commercialisation rights for Truvada (emtricitabine and tenofovir disoproxil fumarate), Viread (tenofovir disoproxil fumarate) and Emtriva (emtricitabine) in Japan.