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BRISTOL-MYERS SQUIBB SEEKS TO EXPAND ACCESS TO ITS MOST RECENTLY APPROVED HIV/AIDS MEDICINE
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BMS distributed this press release today.
New Initiative is Part of Company's Broad Efforts to Address HIV/AIDS Crisis in Africa -- Enables Generics Companies to Manufacture and Sell a Generic Version of
Reyataz (atazanavir sulfate)
PRINCETON, NJ (February 15, 2006) Bristol-Myers Squibb (NYSE: BMY) today announced an agreement for technology transfer and voluntary license with generic manufacturers Aspen PharmaCare and Emcure Pharmaceuticals for atazanavir, the company's once-daily protease inhibitor for HIV/AIDS that was initially approved in the U.S. in June 2003 for use in combination therapy with other anti-HIV medicines. Bristol-Myers Squibb will grant a royalty-free license to Aspen and Emcure to manufacture and sell atazanavir in sub-Saharan Africa. A separate agreement has been concluded with Emcure covering India.
Under the agreement, Bristol-Myers Squibb will provide a royalty-free license to operate under relevant patents and will transfer to Aspen and Emcure its technical know-how related to the manufacturing, testing, packaging, storage and handling of the active pharmaceutical ingredient and the finished dosage form of atazanavir. Bristol-Myers Squibb staff will provide technical training at its manufacturing facilities for Emcure and Aspen, and will also travel to Aspen's and Emcure's facilities in South Africa and India to provide further hands-on training. In addition, Bristol-Myers Squibb will provide support for regulatory filings to the two companies.
"This agreement builds on Bristol-Myers Squibb's long-standing commitment to the global fight against AIDS," said Peter R. Dolan, Chief Executive Officer, Bristol-Myers Squibb. "In Sub-Saharan Africa, where the HIV/AIDS pandemic has been especially devastating, we've taken a broad-based approach to addressing the AIDS crisis, including providing our AIDS medicines at no profit prices and committing to ensure our patents do not prevent inexpensive treatment in the region. We've also sought to address the impact of HIV/AIDS on families and communities through our $150 million Secure the Future initiative, that now funds the largest network of pediatric AIDS treatment centers in the world. With this new agreement, we're taking our commitment to the next level, by expanding access to our most recently approved antiretroviral in sub-Saharan Africa, where HIV/AIDS is a significant and growing public health challenge."
"Aspen has remained committed to expanding access to HIV medicines in sub-Saharan Africa, where millions are suffering with the disease." said Stephen Saad, Aspen Group Chief Executive. "We are pleased to be part of this innovative agreement , and have already begun the steps needed to get atazanavir to the patients in sub-Saharan Africa who so desperately need it."
"We at Emcure support the fight against HIV/AIDS as part of our commitment to corporate social responsibility. We are proud of this agreement with Bristol-Myers Squibb and we are committed to do everything we can to bring this important medicine to patients in need," said Satish Mehta, Chief Executive Officer of Emcure.
"Initiatives such as voluntary licensing are critical to our ability to respond effectively to the AIDS crisis over time," said Dr. Mark Dybul , Deputy U.S. Global AIDS Coordinator. "This agreement represents the kind of innovative collaboration needed to increase access to antiretrovirals in the developing world."
Important Information about REYATAZ (atazanavir sulfate)
REYATAZ is a prescription medicine used in combination with other medicines to treat people who are infected with HIV and has been studied in 48-week trials in both patients who have taken or have never taken anti-HIV medicines. REYATAZ does not cure HIV or prevent passing HIV to others.
REYATAZ should not be taken with the following medicines: ergot medicines, Versed , Halcion , Orap , Propulsid , Camptosar , Crixivan , Mevacor , Zocor , rifampin, St. John's wort, AcipHex , Nexium , Prevacid , Prilosec or Protonix . Viagra , Levitra , Cialis , Vfend , Advair , Flonase , or Flovent should not be used while taking REYATAZ without first speaking with a healthcare provider. This list of medicines is not complete.
The use of all prescription and non-prescription medicines, vitamin and herbal supplements, or other health preparations should be discussed with a healthcare provider.
The following side effects or conditions should be reported to healthcare providers right away: a change in the way the heart beats may occur and could be a symptom of a heart problem; diabetes and high blood sugar may occur in patients taking protease inhibitor medicines like REYATAZ; yellowing of the skin and/or eyes may occur due to increases in bilirubin levels in the blood (bilirubin is made by the liver); rash (redness and itching) sometimes occurs in patients taking REYATAZ, most often in the first few weeks after the medicine is started, and usually goes away within two weeks with no change in treatment; in patients with liver disease, including hepatitis B or C, the liver disease may get worse when taking anti-HIV medicines like REYATAZ; and some patients with hemophilia have increased bleeding problems with protease inhibitor medicines like REYATAZ.
Changes in body fat have been seen in some patients taking anti-HIV medicines. The cause and long-term effects are not known at this time. Other side effects of REYATAZ taken with other anti-HIV medicines include: nausea, headache, stomach pain, vomiting, diarrhea, depression, fever, dizziness, trouble sleeping, numbness, and tingling or burning of hands or feet. REYATAZ should be taken once daily with food (a meal or snack). REYATAZ and other anti-HIV medicines should be taken exactly as instructed by healthcare providers. United States Full Prescribing Information for REYATAZ is available at www.REYATAZ.com.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global pharmaceutical and related healthcare products company whose mission is to extend and enhance human life. For more than a decade, Bristol-Myers Squibb Company has been a global leader in the science of HIV/AIDS and has invested consistently in innovative research leading to the development of important treatments for people with HIV/AIDS. Visit Bristol-Myers Squibb on the World Wide Web at www.bms.com.
About Aspen
Aspen is Africa's largest generics manufacturer and a major supplier of branded pharmaceutical and healthcare products to African and selected international markets. Aspen's extensive basket of quality, effective and affordable products is comprised of original, generic, over-the-counter (OTC), personal care, fast moving consumer goods (FMCG), nutriceutical and nutritional brands
About Emcure
Emcure, located in Pune, India, is a vertically integrated company offering end-to-end solutions to its strategic allies. Emcure's formulation manufacturing facility in Pune has been approved by various international regulators including USFDA, UKMHRA and WHO Geneva. Emcure has also been very active in dealing with HIV/AIDS through their "Let's
fight AIDS together" initiative. Emcure has been supplying Anti-retroviral products for
fighting HIV/AIDS in India and in other Asian and African countries. It was the first company, globally, to introduce three-drug combination for pediatric use.
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This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. Specifically, there can be no guarantee that the technology transfer to the generic companies will be successful and that the generic companies will be able to manufacture atazanavir. For further details and a discussion of this and other risks and uncertainties, please see the company's 2004 Annual Report on Form 10-K and the company's periodic reports on Form 10-Q. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.
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