Healthcare Industry News:  Protonix 

Biopharmaceuticals HIV/AIDS FDA

 News Release - October 20, 2006

FDA Approves REYATAZ(R) (atazanavir sulfate) 300 mg Single Capsule Formulation in Combination Therapy for Adults With HIV-1 Infection

Formulation Marks The First One Capsule, Once Daily Protease Inhibitor Dosing Option for Use With Ritonavir In Appropriate Patients

PRINCETON, N.J., Oct. 20 (HSMN NewsFeed) -- Bristol-Myers Squibb Company (NYSE: BMY ) today announced that the U.S. Food and Drug Administration (FDA) has granted approval of a new 300 mg single capsule formulation of REYATAZ® (atazanavir sulfate) for the treatment of HIV-1 infection in adults as part of combination therapy. Taken once daily along with ritonavir and food as part of a anti-HIV drug regimen, the REYATAZ 300 mg single capsule formulation can replace two REYATAZ 150 mg capsules for: patients who have previously received anti-HIV medicines, patients who will be receiving tenofovir disoproxil fumarate, and patients who have never taken anti-HIV medicines that require SUSTIVA® (efavirenz) as part of their anti-HIV drug regimen. The REYATAZ single capsule formulation will be available in the United States within seven business days.

"Bristol-Myers Squibb is committed to helping lead the development and production of innovative once-daily HIV medicines," said Anthony Hooper, president, U.S. Pharmaceuticals, Bristol-Myers Squibb Company. "With the REYATAZ 300 mg single capsule formulation approval, Bristol-Myers Squibb now has one pill, once-daily HIV medicine options available in three drug classes, as part of combination therapy."

REYATAZ is an anti-HIV drug that blocks the action of the HIV protease enzyme, which is needed for the virus to multiply. REYATAZ is a prescription medicine used in combination with other medicines to treat people who are infected with HIV. REYATAZ 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, a serious disease, or help prevent passing of HIV to others. Since REYATAZ was initially approved by the FDA in 2003, approximately 129,000 patients in the United States have been treated with the drug. Bristol-Myers Squibb will continue to produce the currently available REYATAZ 200 mg, 150 mg, and 100 mg once-daily capsules.

Important Safety Information About REYATAZ® (atazanavir sulfate) 300 mg Capsules:

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®, 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 prescriptions and non-prescription medicines, vitamins, herbal supplements, or other health preparations should be discussed with a healthcare provider.

The following side effects or conditions should be reported to a healthcare provider 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 (atazanavir sulfate).

* 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.

* 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 a healthcare provider.

Important Information About SUSTIVA® (efavirenz) 600 mg Tablets:

Indication:

SUSTIVA is a prescription medicine used in combination with other medicines to treat people who are infected with the human immunodeficiency virus type 1 (HIV-1).

SUSTIVA does not cure HIV or help prevent passing HIV to others.

Important Safety Information:

SUSTIVA should not be taken with the following medicines: Hismanal® (astemizole), Propulsid® (cisapride), Versed® (midazolam), Halcion® (triazolam), ergot medicines (for example, Wigraine® and Cafergot®), or Vfend® (voriconazole). This list of medicines is not complete. The use of all prescriptions and non-prescription medicines, vitamins, herbal supplements (particularly St. John's wort), or other health preparations should be discussed with a healthcare provider.

The following side effects or conditions should be reported to a healthcare provider right away:

* Severe depression, strange thoughts, or angry behavior have been reported by a small number of patients taking SUSTIVA. There have been a few reports of suicide but it is not known if SUSTIVA was the cause.

* Dizziness, trouble sleeping or concentrating, drowsiness, and/or unusual dreams are common. These feelings tend to go away after taking SUSTIVA for a few weeks.

* Pregnancy: Women should not become pregnant or breastfeed while taking SUSTIVA. Serious birth defects have been seen in children of women treated with SUSTIVA during pregnancy. Women must use a reliable form of barrier contraception, such as a condom, even if they also use other methods of birth control.

* If the patient has ever had mental illness or is using drugs or alcohol.

* Rash is a common side effect that usually goes away without any change in medicines. Rash may be a serious problem in some children.

* If a patient has liver disease, has ever had seizures, or is taking medicine for seizures, the healthcare provider may want to do tests to check the liver or check drug levels in the blood.

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 common side effects of SUSTIVA taken with other anti-HIV medicines include: tiredness, upset stomach, vomiting, and diarrhea.

SUSTIVA should be taken on an empty stomach, preferably at bedtime, which may make some side effects less bothersome.

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global pharmaceutical and related healthcare products company. Visit Bristol-Myers Squibb on the World Wide Web at www.bms.com.

Forward-Looking Statements

Bristol-Myers Squibb Forward-Looking Statement

This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding product development. 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. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that the product will be commercially successful. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb's business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2005 and in our Quarterly Reports on Form 10-Q. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

Full prescribing information for REYATAZ is available at www.reyataz.com.

Full prescribing information for SUSTIVA is available at www.sustiva.com.

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

SUSTIVA is a registered trademark of Bristol-Myers Squibb Pharma Company. The other brands listed are trademarks of their respective owners and are not trademarks of Bristol-Myers Squibb Company.


Source: Bristol-Myers Squibb

Issuer of this News Release is solely responsible for its content.
Please address inquiries directly to the issuing company.



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