Combination Regimen Shows Similar Viral Load Suppression Through 48 Weeks of Treatment

Based on a virologic response treated analysis (ITT analysis for treated subjects), data from BMS Study 099 show that 80 percent of the 392 patients in the arm containing ZERIT extended release+ SUSTIVA(r) (efavirenz)+lamivudine (3TC) achieved viral load suppression below 400 copies/mL after 48 weeks of treatment compared to 75 percent of the 391 patients in the arm containing ZERIT immediate release+SUSTIVA+ 3TC.

In addition, 59 percent of patients in the arm containing ZERIT extended release achieved a viral load of less than 50 copies/mL compared to 57 percent in the arm containing ZERIT immediate release.

"We are encouraged by the results of this potential once-a-day formulation of ZERIT(r) (stavudine)," said Richard Pollard, MD, Professor of Internal Medicine, UC Davis Medical Center, University of California, Davis, Sacramento, California. "One of the goals of HIV treatment is to create regimens that are effective and convenient for the patient to take."

BMS Study 099 is a Phase III multinational, prospective, randomized, double-blind, placebo-controlled study to evaluate the antiviral activity, safety and tolerability of ZERIT extended release compared to ZERIT immediate release when used in combination with SUSTIVA(r) (efavirenz) (a non nucleoside reverse transcriptase inhibitor or NNRTI) and lamivudine (a NRTI) in antiretroviral naive patients at 24 and 48 weeks -- 24 week data was presented at the 2002 Retroviruses Conference in February. Median plasma HIV-RNA and CD4 cell count at baseline was 4.8 log10 copies/mL in both arms and 285 cells/mm3 in the extended release arm and 272 cells/mm3 in the immediate release arm.

Of the 797 randomized subjects in the study, 783 began treatment. All patients enrolled in the trial received 600 mg of SUSTIVA once-daily and 150 mg of lamivudine twice-daily. In the extended release arm, patients received 100 mg of ZERIT extended release once-daily if the patient's weight was greater than or equal to 60 kg or 75 mg if the weight was less than 60 kg. Patients also received ZERIT immediate release placebo twice-daily. In the immediate release arm, patients received 40 mg of ZERIT immediate release twice-daily if the patient's weight was greater than or equal to 60 kg or 30 mg twice-daily if the weight was less than 60 kg. Additionally, patients received ZERIT extended release placebo once-daily.

At 48 weeks, four percent of subjects discontinued therapy in each group due to an adverse event. Grade 3/4 clinical adverse events occurred in 11% of patient in the ZERIT(r) (stavudine) extended release arm compared to 10% in the ZERIT immediate release arm. Events of hepatotoxicity, pancreatitis, or symptomatic hyperlactatemia/lactic acidosis syndrome occurred in less than 1% of patients in the ZERIT extended release arm as compared to 1.5% of patients in the ZERIT immediate release arm. Grade 2-4 peripheral neurologic symptoms related to therapy occurred in 3% of patients in the ZERIT extended release arm and 5% of patients in the ZERIT immediate release arm. Marketing applications for the extended release formulation of ZERIT is currently under review by regulatory agencies in the United States and Europe.

ZERIT in combination with other antiretroviral agents is indicated for the treatment of HIV-1 infection.

An increase of lactic acid in the blood (lactic acidosis), an enlarged liver and liver failure, which can cause death, have been reported. Fatal lactic acidosis has occurred in pregnant women receiving the combination of didanosine and stavudine.

Fatal and non-fatal pancreatitis (inflammation of the pancreas) has occurred with ZERIT when taken in combination with didanosine and other HIV drugs. ZERIT may cause numbness, tingling or pain in the hands or feet (neuropathy). This risk is increased in patients with advanced HIV disease or a history of neuropathy. If you are taking ZERIT in combination with other medicines that may cause similar side effects, you may have a higher chance of developing these effects.

Frequent side effects reported in ZERIT-containing triple combination regimens are nausea, headache, diarrhea, rash, vomiting and neuropathy. Tell your doctor if you become pregnant while taking ZERIT. ZERIT should be used during pregnancy only after discussion with your doctor. ZERIT does not cure HIV infection or prevent passing HIV to others.

SUSTIVA(r) (efavirenz) in combination with other antiretroviral agents is indicated for the treatment of HIV-1 infection. In February, the FDA approved a new formulation of SUSTIVA -- a 600 mg tablet once-daily, an option to three 200 mg capsules once-daily (as SUSTIVA has been used since it was approved in September 1998).

In February 2002, the U.S. Department of Health and Human Services (DHHS) continued, for the third year in a row, to list SUSTIVA as the only NNRTI "strongly recommended" for use in first-line combination with NRTIs for the treatment of HIV-infected individuals. It is recommended that SUSTIVA be taken on an empty stomach, preferably at bedtime.

Many patients have dizziness, trouble sleeping, drowsiness, trouble concentrating, and/or unusual dreams when taking SUSTIVA. These feelings tend to go away after taking SUSTIVA for a few weeks. A small number of patients taking SUSTIVA have reported severe depression, strange thoughts, or angry behavior. There have been occasional reports of suicide but SUSTIVA has not been established as the cause. One of the most common side effects is rash which is usually mild and goes away in a few weeks.

SUSTIVA should not be taken with Hismanal(r) (astemizole), Propulsid(r) (cisapride), Versed(r) (midazolam), Halcion(r) (triazolam) or ergot derivatives. Tell your doctor about any medication or herbal products (particularly St. John's wort) that you are taking. Women should not become pregnant or breastfeed while taking SUSTIVA. SUSTIVA does not cure HIV or prevent passing HIV to others.

Bristol-Myers Squibb Company is a $19 billion pharmaceutical and related health care products company whose mission is to extend and enhance human life.

For full ZERIT and SUSTIVA prescribing information, please visit the company's website at www.BMSVirology.com or call 1-800-426-7644.

###

ZERIT(r) is a registered trademark of Bristol-Myers Squibb Company.SUSTIVA(r) is a registered trademark of Bristol-Myers Squibb Pharma Company.

The other brands listed are the registered trademarks of their respective owners and are not the trademarks of Bristol-Myers Squibb Company.

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.