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REYATAZ® (atazanavir sulfate) Granted Approval For Use With Low-Dose Ritonavir in Treatment-Experienced HIV-Infected Patients

PRINCETON, N.J., July 14 /PRNewswire-FirstCall/ -- Bristol-Myers Squibb Company announced today that REYATAZ® (atazanavir sulfate) has received approval from the U.S. Food and Drug Administration (FDA) to include new scientific data and dosing in its package insert, or labeling, from BMS Study AI424-045. With the approval of the supplemental New Drug Application (sNDA), the REYATAZ labeling now includes data indicating that combination HIV treatments containing REYATAZ/ritonavir and Kaletra® (lopinavir/ritonavir; Abbott Laboratories, Inc.) were similar for the primary efficacy outcome measurement of time-averaged difference in change from baseline in HIV RNA level in HIV-infected patients previously taking anti-HIV medicines.

However, Study 045 was not large enough to reach a definitive conclusion that REYATAZ/ritonavir and Kaletra are equivalent on the secondary efficacy outcome measure of proportions of HIV-1 RNA less than 400 or 50 copies/mL. There are no data regarding the use of REYATAZ/ritonavir in patients who have never taken anti-HIV medicines.

Addressing the primary efficacy outcome measurement of the study, Kathleen Squires, M.D., Keck School of Medicine of the University of Southern California said, "The expanded REYATAZ labeling enables physicians to provide their patients with a once-daily protease inhibitor that, in combination therapy, has been shown in a clinical trial to demonstrate efficacy in viral load reduction similar to Kaletra."

Another secondary endpoint of Study 045 was to compare changes from baseline in lipid values after 48 weeks of treatment. The observed magnitude of dyslipidemia was less with REYATAZ® (atazanavir sulfate)/ritonavir than with Kaletra. However, the clinical impact of such findings has not been demonstrated. At this time point, the percentage of patients who had total cholesterol greater than or equal to 240 mg/dL was 25 percent in the REYATAZ/ritonavir arm and 26 percent in the Kaletra arm. The percentage of patients with triglyceride levels greater than or equal to 751 mg/dL was 8 percent and 12 percent, respectively.

"Today's sNDA approval represents another strong step forward for REYATAZ and for BMS in the treatment of HIV/AIDS," said Anthony Hooper, president, U.S. Pharmaceuticals, Bristol-Myers Squibb Company. "Over 31,000 patients have received a HAART (highly-active antiretroviral therapy) regimen containing REYATAZ since it was approved in June 2003. With this approval, doctors have additional information for treating their HIV/AIDS therapy- experienced patients."

BMS Study AI424-045 is an ongoing, randomized, multi-center trial comparing REYATAZ/ritonavir (300 mg/100 mg) once daily to REYATAZ with saquinavir soft gelatin capsules (400 mg/1200 mg) once daily, and to Kaletra (400 mg lopinavir/100 mg ritonavir) twice daily, each in combination with tenofovir and one nucleoside reverse transcriptase inhibitor (NRTI), in 347 (of 358 randomized) patients who previously experienced virologic failure on at least two regimens containing PIs, NRTIs and non-nucleoside reverse transcriptase inhibitors (NNRTIs). In Study 045, coadministration of REYATAZ and saquinavir did not provide adequate efficacy.

In the study, selected treatment-emergent adverse events of moderate or severe intensity reported in greater than or equal to 2% of patients treated with REYATAZ/ritonavir were: yellowing of the skin and/or eyes (9% for REYATAZ/ritonavir, 0% for Kaletra), muscle pain (4%, 0%), diarrhea (3%, 11%), nausea (3%, 2%), fever (2%, 0%) and depression (2%,

On June 20, 2003, REYATAZ was the first once-daily protease inhibitor (PI) to receive FDA approval for the treatment of HIV in combination therapy. REYATAZ is a prescription medicine that 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 help 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® and Vfend® should not be used while taking REYATAZ® (atazanavir sulfate) without first speaking with a healthcare provider. This list of medications 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. Common 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.

Full prescribing information is available at http://www.reyataz.com/ or by calling 800-426-7644.

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

REYATAZ® is a registered trademark of Bristol-Myers Squibb Company.

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

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