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Focus on Serious Diseases with Significant Unmet Medical Needs

Context

Bristol-Myers Squibb’s primary focus is to discover and develop innovative, cost-effective medicines that address significant unmet medical needs. We invested approximately $3.3 billion on research and development in 2007.

The guiding principles and values behind our R&D strategy can be found in the Bristol-Myers Squibb mission—to extend and enhance human life—and in our Pledge. The Pledge sets forth our concern for the interests and expectations of our stakeholders and applies to our operations around the globe. Among other things, the Pledge is a formal commitment to conscientious citizenship. It supports policies and practices that fully embody the responsibility, integrity, and decency required of free enterprise if it is to merit and maintain the confidence of our society.

The company engages with scientists, academia, government, and other stakeholders to better understand areas of significant unmet medical needs. We foster communications and dialogue with stakeholders on our R&D strategy.

To build and sustain a robust pipeline of new medications now and well into the future, Bristol-Myers Squibb scientists work continuously to select the right targets and synthesize the right compounds to help enhance development success rates. The company’s Discovery group feeds a stream of novel compounds into the development pipeline in order to find innovative therapies in areas of significant unmet medical need. Selected for development in 2005, for example, were drug candidates in atherothrombosis, cancer, diabetes, HIV/AIDS, obesity and rheumatoid arthritis.

External alliances also provide potential development candidates. New collaborations in 2005 may one day lead to additional medications for atherosclerosis, autoimmune diseases, cancer, coronary artery disease and transplantation. Other partnerships provide enabling technologies to advance the company’s screening, biomarker, and pharmacogenomic efforts that help enable medications to target specific patient populations.

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Focus on Serious Diseases

Ten Disease Areas

Our R&D focus is on 10 critical disease areas: Alzheimer’s disease, atherosclerosis/thrombosis, cancer, diabetes, hepatitis, HIV/AIDS, obesity, psychiatric disorders, rheumatoid arthritis and solid organ transplantation. These 10 areas were selected with an emphasis on where there are opportunities to help patients, where we anticipate future medical need, and where there is a match to our core internal expertise and competencies.

 
Disease Areas
Discovery Programs
Exploratory Development Compounds
Full Development Compounds
Life Cycle Management Products
Oncology Cancer


Cardiovascular and Metabolic Diseases Atherosclerosis/ Thrombosis

Diabetes

Obesity
Neuroscience Psychiatric Disorders

Alzheimer’s Disease
Virology Hepatitis
HIV/AIDS
Immunology Rheumatoid Arthritis

Solid Organ Transplant Rejection

= Internal
= Alliance/In-licensed
Pipeline chart as of August 2006

Compounds and research programs in Discovery are at the earliest stages of research. Compounds in Exploratory Development are in preclinical or early clinical development. Full development compounds are investigational drugs that are in late-stage clinical development, have been submitted to regulatory agencies for approval, or have been approved in one major market and are pending approval in other major markets. Lifecycle Management products are among approved medicines that are driving current and future growth while continuing their clinical development to determine whether additional indications and formulations will benefit patients.

Like any other scientific endeavor, clinical testing of novel drug compounds is a complex, time-consuming, resource-intensive process with no guaranteed results. But, as described here, Bristol-Myers Squibb is committed to pursuing such clinical development and, in doing so, to brining new hope to patients.

In less than four years, eight Bristol-Myers Squibb medicines, each addressing a critical medical need, have been approved. This was among the best performances in the industry for the period.

Drug Approvals Since 2002
 
Key Market Approvals
Abilify® (aripiprazole)
Schizophrenia
U.S. - November 2002
E.U. - June 2004
Reyataz® (atazanavir sulfate)
HIV/AIDS
U.S. - June 2003
Japan - December 2003
E.U. - March 2004
Erbitux® (cetuximab)
Colorectal Cancer
U.S. - February 2004
Canada - October 2005
Baraclude® (entecavir)
Hepatitis B
U.S. - March 2005
China - November 2005
E.U. - June 2006
Japan - July 2006
Orencia® (abatacept)
Rheumatoid Arthritis
U.S. - December 2005
Canada - July 2006
EMSAM® (selegiline transdermal system)
Depression
U.S. - February 2006
SPRYCEL® (dasatinib)
Chronic Myelogenous Leukemia
U.S. - June 2006
ATRIPLA™ (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg)
HIV/AIDS
U.S. - July 2006

As of September 2006.

Please click on the product name to see the Full Prescribing Information for Abilify®, Reyataz®, Erbitux®, Baraclude®, Orencia®, EMSAM®, SPRYCEL® and ATRIPLA™ including boxed WARNINGS for Abilify®, Erbitux®, Baraclude®, EMSAM® and ATRIPLA™.

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Biologics – Targeting Cancer and Rheumatoid Arthritis

Most medicines today are compounds known as small molecules. But now a new kind of compound is delivering to patients an increasing number of novel and targeted treatments. They are called biologics and are known as large molecules, which can be 200 or more times the size of small molecules. Often designed to bind to specific cell surface receptors, biologics are generally more targeted than traditional small molecule drugs. The company recognizes the great potential for these compounds to treat a wide variety of diseases, and we are accelerating our biologics capabilities through technology acquisitions, licensing opportunities, and our own development programs. Erbitux, the company’s first marketed biologic, was developed by Bristol-Myers Squibb and ImClone Systems Incorporated. Orencia, approved in December 2005, is the first marketed biologic compound discovered by Bristol-Myers Squibb.

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HIV/AIDS

Reyataz® (atazanavir sulfate), the first protease inhibitor for the treatment of HIV/AIDS with once-a-day dosing, was introduced in the U.S. in July 2003 and approved for marketing in Europe in March 2004.

In October 2005, Bristol-Myers Squibb announced the signing of a license agreement with the International Partnership for Microbicides (IPM) to develop new antiretroviral compounds as potential microbicides to protect women from HIV. Bristol-Myers Squibb will grant the non-profit group a royalty-free license to develop, manufacture, and distribute our compounds for use as microbicides in resource-poor countries.

Hepatitis

On March 29, 2005, the FDA approved Baraclude® (entecavir). Baraclude, discovered by Bristol-Myers Squibb scientists, is indicated for the treatment of chronic hepatitis B infection.

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Heart Attack and Stroke

In 1997, a new medicines co-developed with Sanofi-Sythelabo received approval: Plavix® (clopidogrel bisulfate), an anti-platelet agent.

Schizophrenia and Major Depressive Disorder

In November 2002, the FDA approved Abilify® (aripiprazole) for the treatment of schizophrenia. It is jointly marketed in the U.S. by Bristol-Myers Squibb and Otsuka America Pharmaceutical, Inc. Bristol-Myers Squibb and Otsuka Pharmaceutical Co., Ltd., are also collaborative partners in the development and commercialization of aripiprazole in major European and Latin American countries.

On February 28, 2006, Bristol-Myers Squibb and Somerset Pharmaceuticals announced FDA approval of EMSAM® (selegiline transdermal system), the first transdermal patch for the treatment of major depressive disorder.

Please click on the product name to see the Full Prescribing Information for Abilify®, Reyataz®, Erbitux®, Baraclude®, Orencia®, EMSAM® including boxed WARNINGS for Abilify®, Erbitux®, Baraclude®, EMSAM®.

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Last updated August 3, 2008 . Italicized product names are registered trademarks of Bristol-Myers Squibb Company or one of its divisions or subsidiaries. Copyright © 1998-2006 Bristol-Myers Squibb Company. Your use of the information on this site is subject to the terms of our Legal Notices.

 

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