Plans for once-daily, fixed-dose combination of three anti-HIV drugs

May 16 2004

Bristol-Myers Squibb Company, Gilead Sciences, Inc. and Merck & Co., Inc. have announced that they are in discussions on the development of a once-daily, fixed-dose combination of three anti-HIV drugs and are also considering certain co-packaging options for the individual products. The three companies welcome today's comments by U.S. Secretary of Health and Human Services Tommy Thompson on the need for increased treatment options for people with HIV/AIDS in the developing world.

This collaboration -- a multi-company effort to create a fixed-dose product with three patented HIV/AIDS medicines -- would be the first partnership of its kind in the field of HIV. The parties agree on the importance of the task -- to support the need for simplified treatment regimens, particularly in resource-constrained settings.

Fixed-dose combinations contain multiple medicines co-formulated in a single tablet, potentially simplifying combination therapy for HIV treaters and patients. This potential three-drug, fixed-dose combination would include two Gilead drugs, Viread(R) (tenofovir disoproxil fumarate) and Emtriva(TM) (emtricitabine). In March, Gilead filed regulatory applications in the United States and Europe for approval of a single-tablet fixed-dose combination of these two drugs. The third drug in the proposed combination, efavirenz, is marketed in the United States, Canada and certain European countries by Bristol-Myers Squibb as Sustiva(R) (efavirenz) and elsewhere by Merck under the brand name Stocrin(R) (efavirenz).

The companies plan to seek regulatory review and approval of the three-drug fixed-dose combination. The companies also are exploring a co-packaged version that would include the three products as an interim step until a fixed-dose combination product could be made available.

"We are pleased to be part of this pioneering initiative with Gilead and Merck and commend the Administration for their efforts to help bring new and better ways to fight the global HIV/AIDS pandemic," said Peter R. Dolan, Chairman and Chief Executive Officer of Bristol-Myers Squibb. "Given the complexities of this disease, and the unique challenges in delivering care and treatment in resource limited settings, we recognize the need to work together and combine our expertise to find innovative solutions. At Bristol-Myers Squibb, HIV/AIDS continues to be a major area of focus for our research, and we are committed to making our medicines available at no-profit in those countries hardest hit by this epidemic. In addition, in Africa, we are working with local communities through our $115 million Secure the Future(R) program to help strengthen their ability to fight this disease."

"While we have made progress in the fight against HIV with new therapies that offer significant advances, further efforts are needed to deliver the benefits of these advancements to those patients most in need," commented John C. Martin, PhD, President and Chief Executive Officer, Gilead Sciences. "Gilead has initiated a program to provide our antiretrovirals at no profit to developing world countries, and we have been evaluating options for partnerships that will allow us to expand these efforts. We're very pleased with the support we have received from the U.S. government, and we look forward to working with partners from industry, governments and NGOs to increase treatment and treatment options for those affected by HIV and AIDS."

"We welcome the Administration's support for the expedited development of new combinations of HIV medications for use in the President's Emergency Plan for AIDS Relief (PEPFAR) and look forward to working with the FDA on this critical issue," said Raymond V. Gilmartin, Chairman, President and Chief Executive Officer of Merck & Co., Inc. "Merck has worked closely for some time with representatives of the WHO, UNAIDS, the Global Fund and the Administration to explore ways to accelerate the development of fixed-dose combinations. We are delighted to be part of this new initiative. The proposed triple combination is expected to be an important new tool offering once-a-day treatment in the fight against the AIDS epidemic."