Bristol-Myers Squibb and Gilead Sciences announce licensing agreement

Bristol-Myers Squibb Company (NYSE: BMY) and Gilead Sciences, Inc. (Nasdaq: GILD) today announced a licensing agreement for Bristol-Myers Squibb to develop and commercialize a fixed-dose combination containing Bristol-Myers Squibb’s protease inhibitor REYATAZ® (atazanavir sulfate) and Gilead’s cobicistat, a pharmacoenhancing or “boosting” agent that increases blood levels of certain HIV medicines to potentially allow for one pill once daily dosing. Gilead is currently studying atazanavir and cobicistat in Phase 2 and 3 studies in HIV-1 treatment-naïve patients.

REYATAZ is a prescription medicine used in combination with other medicines to treat people 6 years of age and older who are infected with the human immunodeficiency virus (HIV). REYATAZ should not be taken if patients are allergic to REYATAZ or to any of its ingredients.

Bristol-Myers Squibb will be responsible for the formulation, manufacturing, development, registration, distribution, and commercialization of the REYATAZ and cobicistat fixed-dose combination worldwide. Under the terms of the agreement, Bristol-Myers Squibb will pay Gilead an undisclosed royalty based on annual net sales of the product. Gilead retains sole rights for the manufacture, development and commercialization of cobicistat as a stand-alone product and for use in combination with other agents.

“This collaboration with Gilead builds on Bristol-Myers Squibb’s longstanding commitment to develop medicines that have the potential to provide meaningful benefit to HIV patients, specifically aiming to enhance treatment options,” said Elliott Sigal, M.D., Ph.D., Executive Vice President, Chief Scientific Officer & President, R&D, Bristol-Myers Squibb. “A REYATAZ and cobicistat fixed-dose combination has the potential not only to help simplify HIV therapy but also to address an unmet medical need in HIV for additional, innovative treatment options.”

“Cobicistat provides us with the potential to co-formulate with a variety of commercially available HIV medicines that require boosting for optimal efficacy, such as the protease inhibitor atazanavir,” said Norbert Bischofberger, Ph.D., Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences. “This agreement represents a shared commitment between Gilead and Bristol-Myers Squibb to develop multiple treatment options that can address individual patient needs.”

Cobicistat is Gilead’s proprietary potent mechanism-based inhibitor of cytochrome P450 3A (CYP3A), an enzyme that metabolizes drugs in the body. Cobicistat is an investigational product and has not yet been determined to be safe or efficacious in humans.

IMPORTANT INFORMATION About REYATAZ® (atazanavir sulfate)

INDICATION: REYATAZ® is a prescription medicine used in combination with other medicines to treat people 6 years of age and older who are infected with the human immunodeficiency virus (HIV). REYATAZ has been studied in a 48-week trial in patients who have taken anti-HIV medicines and a 96-week trial in patients who have never taken anti-HIV medicines.

REYATAZ does not cure HIV or lower your chance of passing HIV to others. People taking REYATAZ may still get opportunistic infections or other conditions that happen with HIV infection.

IMPORTANT SAFETY INFORMATION:

Do not take REYATAZ if you are allergic to REYATAZ or to any of its ingredients.

Do not take REYATAZ if you are taking the following medicines due to potential for serious, life-threatening side effects or death:

Versed® (midazolam) when taken by mouth, Halcion® (triazolam), ergot medicines (dihydroergotamine, ergonovine, ergotamine, and methylergonovine such as Cafergot®, Migranal®, D.H.E. 45®, ergotrate maleate, Methergine®, and others), Propulsid® (cisapride), or Orap® (pimozide).

Do not take REYATAZ (atazanavir sulfate) with the following medicines due to potential for serious side effects: Camptosar® (irinotecan), Crixivan® (indinavir), Mevacor® (lovastatin), Zocor® (simvastatin), Uroxatral® (alfuzosin), or Revatio® (sildenafil).

Do not take REYATAZ with the following medicines as they may lower the amount of REYATAZ in your blood, which may lead to increased HIV viral load and resistance to REYATAZ or other anti-HIV medicines: rifampin (also known as Rimactane®, Rifadin®, Rifater®, or Rifamate®), St. John’s wort (Hypericum perforatum)-containing products, or Viramune® (nevirapine).

Serevent Diskus® (salmeterol) and Advair® (salmeterol with fluticasone) are not recommended with REYATAZ®.

Do not take Vfend® (voriconazole) if you are taking REYATAZ and Norvir® (ritonavir).

The above lists of medicines are not complete. Taking REYATAZ with some other medicines may require your therapy to be monitored more closely or may require a change in dose or dose schedule of REYATAZ or the other medicine. Discuss with your healthcare provider all prescription and non-prescription medicines, vitamin and herbal supplements, or other health preparations you are taking or plan to take.

Tell your healthcare provider if you are pregnant or plan to become pregnant. REYATAZ (atazanavir sulfate) use during pregnancy has not been associated with an increase in birth defects. Pregnant women have experienced serious side effects when taking REYATAZ with other HIV medicines called nucleoside analogues. After your baby is born, tell your healthcare provider if your baby’s skin or the white part of his/her eyes turns yellow. You should not breast-feed if you are HIV-positive.

Also tell your healthcare provider if you have end-stage kidney disease managed with hemodialysis or severe liver dysfunction.

Tell your healthcare provider right away if you have any side effects, symptoms, or conditions, including the following:

• Mild rash (redness and itching) without other symptoms sometimes occurs in patients taking REYATAZ, most often in the first few weeks after the medicine is started, and usually goes away within 2 weeks with no change in treatment.
• Severe rash may develop with other symptoms that could be serious and potentially cause death. If you develop a rash with any of the following symptoms, stop using REYATAZ and call your healthcare provider right away:
• Shortness of breath
• General ill-feeling or “flu-like” symptoms
• Fever
• Muscle or joint aches
• Conjunctivitis (red or inflamed eyes, like “pink-eye”)
• Blisters
• Mouth sores
• Swelling of your face
• Yellowing of the skin and/or eyes may occur due to increases in bilirubin levels in the blood (bilirubin is made by the liver).
• A change in the way your heart beats may occur. You may feel dizzy or lightheaded. These could be symptoms of a heart problem.
• Diabetes and high blood sugar may occur in patients taking protease inhibitor medicines like REYATAZ (atazanavir sulfate). Some patients may need changes in their diabetes medicine.
• If you have liver disease, including hepatitis B or C, it may get worse when you take anti-HIV medicines like REYATAZ.
• Kidney stones have been reported in patients taking REYATAZ. Signs or symptoms of kidney stones include pain in your side, blood in your urine, and pain when you urinate.
• 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.
• Immune reconstitution syndrome has been seen in some patients with advanced HIV infection (AIDS) and a history of opportunistic infection. Signs and symptoms of inflammation from previous infections may occur soon after starting anti-HIV treatment, including REYATAZ® (atazanavir sulfate).
• Gallbladder disorders (including gallstones and gallbladder inflammation) have been reported in patients taking REYATAZ.

Other common side effects of REYATAZ taken with other anti-HIV medicines include: nausea; headache; stomach pain; vomiting; diarrhea; depression; fever; dizziness; trouble sleeping; numbness, tingling, or burning of hands or feet; and muscle pain.

You should take REYATAZ once daily with food (a meal or snack). Swallow the capsules whole; do not open the capsules. You should take REYATAZ and your other anti-HIV medicines exactly as instructed by your healthcare provider.

Available REYATAZ. capsule strengths include 200 mg and 300 mg.

Please see accompanying Full Prescribing Information, or click here.