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.
About Bristol-Myers
Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose
mission is to discover, develop and deliver innovative medicines
that help patients prevail over serious diseases. For more
information, please visit http://www.bms.com or follow us on
Twitter at http://twitter.com/bmsnews.
About Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers,
develops and commercializes innovative therapeutics in areas of
unmet medical need. The company’s mission is to advance the care of
patients suffering from life-threatening diseases worldwide.
Headquartered in Foster City, California, Gilead has operations in
North America, Europe and Asia Pacific. For more information,
please visit www.gilead.com.
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 the research, development and commercialization of
pharmaceutical products. 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 compound described in this release will move from early
stage development into full product development, that clinical
trials of this compound will support a regulatory filing, or that
the compound will receive regulatory approval or become a
commercially successful product. Nor is there any guarantee that
the transaction described in this release will receive the
necessary regulatory approvals to close. Forward-looking statements
in the 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, 2010, its Quarterly Reports on Form 10-Q, and
Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no
obligation to publicly update any forward-looking statement,
whether as a result of new information, future events, or
otherwise.
Gilead Sciences Forward Looking Statement
This press release includes forward-looking statements, within
the meaning of the Private Securities Litigation Reform Act of
1995, that are subject to risks, uncertainties and other factors,
including risks related to whether ongoing clinical trials for
cobicistat will be successful and the ability to formulate
cobicistat with other agents, including atazanavir sulfate. In
addition, safety and efficacy data from additional clinical trials
may not warrant further development of cobicistat or the fixed-dose
combination product, regulatory authorities may not approve
cobicistat as a stand-alone product or in any combination product,
and marketing approval, if granted, may have significant
limitations on its use. As a result, cobicistat and the fixed-dose
combination product may never be successfully commercialized. The
parties may make a strategic decision to discontinue development of
the fixed-dose combination product if, for example, Bristol-Myers
Squibb is unable to successfully formulate the fixed-dose
combination product or the market for the product fails to
materialize as expected. These risks, uncertainties and other
factors could cause actual results to differ materially from those
referred to in the forward-looking statements. These and other
risks are described in detail in Gilead's Quarterly Report on Form
10-Q for the quarter ended June 30, 2011, as filed with the U.S.
Securities and Exchange Commission. All forward-looking statements
are based on information currently available to Gilead, and Gilead
assumes no obligation to update any such forward-looking
statements.
REYATAZ is a registered trademark of Bristol-Myers Squibb
Company. SUSTIVA is a registered trademark of Bristol-Myers Squibb
Pharma Company. All other trademarks are the property of their
respective owners and not of Bristol-Myers Squibb.
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