E-DRUG: big pharma finally also preparing FDC ARV
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[crossposted from IP-Health with thanks; WB]
http://home.businesswire.com/portal/site/google/index.jsp?ndmViewId=news_vie
w&newsId=20040516005051&newsLang=en
Bristol-Myers Squibb, Gilead Sciences and Merck & Co., Inc. Announce
Plans to Develop Fixed-Dose Combination of Three HIV Medicines
NEW YORK & FOSTER CITY, Calif. & WHITEHOUSE STATION, N.J.--(BUSINESS
WIRE)--May 16, 2004--
Companies Support U.S. Department of Health and Human Services' Call to
Increase Treatment Options for HIV in Developing World
Bristol-Myers Squibb Company (NYSE:BMY), Gilead Sciences, Inc.
(Nasdaq:GILD) and Merck & Co., Inc. (NYSE:MRK) announced today 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."
[snip]
Contacts
Bristol-Myers Squibb
David M. Rosen, 609-252-5675
david.m.rosen@bms.com
or
Gilead Sciences
Amy Flood, 650-522-5643
aflood@gilead.com
or
Merck & Co., Inc.
Anita Larsen, 908-423-6022
anita_larsen@merck.com
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