Important note: Information in this article was accurate in 2002. The state of the art may have changed since the publication date.
PRNewswire - December 20, 2002
Atazanavir, currently in Phase III clinical development, is an azapeptide viral protease inhibitor of HIV-1. It is the first protease inhibitor to be submitted with pharmacokinetic data supporting the potential for once-daily administration. The NDA includes data from more than 2,400 patients enrolled in clinical trials comparing atazanavir to widely prescribed drugs for HIV infection.
"Bristol-Myers Squibb is committed to bringing new treatments to patients with HIV/AIDS," said Peter R. Dolan, Chairman and CEO, Bristol-Myers Squibb. "Should atazanavir gain FDA approval, the Company will be the first to provide once-daily HIV medications in all three drug classes -- a testament to Bristol-Myers Squibb's leadership in the development of therapies that provide a range of treatment options for people in need."
In the United States, Bristol-Myers Squibb is currently enrolling patients in an Early Access Program (EAP) to provide atazanavir to eligible patients infected with HIV. An EAP provides medicines to patients in need of alternative therapy prior to the medicine's approval.
HIV-infected patients who have experienced treatment failure with other available antiretroviral agents and who require an alternative antiretroviral agent in order to construct a new treatment regimen may be eligible to participate in the EAP. Reasons for treatment failure include a sufficient degree of antiretroviral resistance, intolerance or adherence problems. Physicians must use atazanavir in combination with two or more new or recycled antiretroviral agents. In addition, patients must meet other protocol- specified eligibility criteria.
Patients may be enrolled in the EAP through physicians only. Physicians may call 1-877-7BMSEAP (1-877-726-7327) or visit http://www.ATVEAP.com for more information about the program.
Bristol-Myers Squibb is a global pharmaceutical and related health care products company whose mission is to extend and enhance human life.
This press release contains certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that may be identified by terminology such as "expects" and other words or terms of similar expression or meaning. 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. These factors include, among other things, uncertainties relating to product development, unexpected regulatory delays and government regulation generally. For further details and a discussion of these and other risks and uncertainties, see the Company's Securities Exchange and Commission filings, including the Company's 2001 Annual Report on Form 10-K. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.
CONTACT: David M. Rosen of Bristol-Myers Squibb, +1-609-897-4763, Pager +1-866-308-4484, david.m.rosen@bms.com , or Nikki Levy of Golin-Harris International, +1-312-729-4248, nlevy@golinharris.com .
SOURCE Bristol-Myers Squibb Company
Web Site: http://www.ATVEAP.com
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Always watch for outdated information. This article first appeared in 2002. This material is designed to support, not replace, the relationship that exists between you and your doctor.
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