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BRISTOL-MYERS SQUIBB FILES NEW DRUG APPLICATION FOR ANTI-AIDS DRUG ZERIT (STAVUDINE, d4T)

 NEW YORK, Jan. 5 /PRNewswire/ -- Bristol-Myers Squibb Company (NYSE: BMY) today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval to market ZERIT(TM) (stavudine, d4T), an experimental antiretroviral agent which is being studied for use in treating patients with HIV infection. ZERIT belongs to the nucleoside family of compounds that includes VIDEX(R) (didanosine, ddI), AZT (zidovudine) and ddC (zalcitabine), the three drugs currently marketed for this disease.
 The application for ZERIT capsules and oral solution includes extensive, long-term, follow-up safety and efficacy data accumulated from over 4,400 patients treated with ZERIT in several clinical studies. These include: preliminary data from a randomized, double-blind trial comparing ZERIT vs. continued zidovudine and a randomized, double-blind, large simple trial comparing two stavudine doses (U.S. Parallel Track Program); and final data from an open-label randomized dose-comparative trial and three Phase I trials.
 As of the NDA submission date, nearly 14,000 patients worldwide have received ZERIT in clinical trials of the drug and/or through a Parallel Track Program initiated by the company.
 Through the U.S. Parallel Track Program, Bristol-Myers Squibb makes ZERIT available at no charge to patients with advanced HIV infection who have failed, are intolerant of or who have major contraindications to therapy with VIDEX and AZT. Nearly 11,000 patients have received free drug via this program.
 If and when approved, ZERIT would be the second nucleoside antiretroviral agent to be developed and brought to market by Bristol- Myers Squibb. VIDEX was originally introduced to the U.S. market on Oct. 9, 1991 for use in treating adult and pediatric patients with advanced HIV infection who were intolerant of AZT therapy or who had demonstrated significant clinical or immunologic deterioration during AZT therapy. On Sept. 28, 1992, the FDA cleared an amendment of the labeling to include adult patients with advanced HIV infection who have received prolonged prior AZT therapy.
 In addition to VIDEX, the company's HIV-related products portfolio includes Megace(R) (megestrol acetate) Oral Suspension, which is indicated for treatment of anorexia, cachexia, or an unexplained weight loss in patients with AIDS. Also, the company's Mead Johnson Enteral Nutritionals makes Lipisorb(R), a nutritional supplement which improves fat absorption in persons with AIDS. In early 1993, the company's Apothecon Division re-introduced NYDRAZID(R) INJECTION (Isoniazid Injection USP), an anti-infective agent indicated for treatment of all susceptible forms of tuberculosis, a disease that had been in decline through the mid-1980s, until its resurgence associated with the AIDS epidemic.
 Bristol-Myers Squibb is a research-based, diversified health care company whose principal businesses are pharmaceuticals, consumer products, nutritionals and medical devices.
 -0- 1/5/94
 /CONTACT: Susan J. Yarin of Bristol-Myers Squibb, 212-546-5709/
 (BMY)


CO: Bristol-Myers Squibb Company ST: New York IN: MTC SU:

GK -- NY061 -- 9428 01/05/94 15:18 EST
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Date:Jan 5, 1994
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