`
`Significant Changes. Significant Results.
`OUR BIOPHARMA
`TRANSFORMATION
`
`Bristol-Myers Squibb
`345 Park Avenue • New York, NY 10154-0037
`212-546-4000 • www.bms.com
`
`Get the free mobile app at
`http://gettag.mobi
`
`AstraZeneca Exhibit 2112
`Mylan v. AstraZeneca
`IPR2015-01340
`
`Page 1 of 128
`
`
`
`We stand today as a global
`
`company deeply committed
`
`to a single Mission: to discover,
`
`develop and deliver innovative
`
`medicines that help patients
`
`prevail over serious diseases.
`
`Chief Executive Officer Lamberto Andreotti (front center) with members
`of the Senior Management Team. See page 103.
`
`FRONT COVER
`
`Jennifer Lowinger is a research scientist in Applied Genomics at Bristol-Myers Squibb.
`She is part of an R & D team exploring the use of chemical genetics to identify new
`disease targets, one of the first steps in drug discovery and development.
`
`Produced by the Bristol-Myers Squibb Public Affairs Department.
`Copyright © 2011 Bristol-Myers Squibb. All rights reserved.
`
`In 2004, just two weeks before her wedding, Sharon
`Belvin learned that what she thought was a bad case
`of bronchitis was in fact melanoma. Despite chemo-
`therapy, the tumors spread to her lungs, lymph nodes
`and brain. “I was only 22,” she says, “and it seemed
`like my life was over.” But Sharon didn’t give up. She
`enrolled in a clinical trial for ipilimumab, an investi-
`gational treatment for metastatic melanoma, now
`being developed by Bristol-Myers Squibb as Yervoy.
`Since entering the trial, Sharon appears to be doing
`well. Now, she and her husband, Rob, live happily
`with their rambunctious 3-year-old, Lillybeth, and
`the latest addition to the family, James Michael. “I’m
`exhausted just trying to keep up with the kids,” she
`laughs. “Life is good.”
`
`BACK COVER
`
`Janice Henn, pictured with her Yorkshire terrier, Killer, was
`diagnosed with rheumatoid arthritis when she was 35 years
`old. That was 28 years ago. “No matter what I did for 25 years
`I didn’t find anything to stop it,” she says. Arthritis took its toll
`on everything she enjoyed doing: gardening, walking the dog,
`family vacations and playing with her grandchildren. “When I
`walked, it felt like my bones were frozen, like they were going to
`break every step I took,” says Janice. In 2008, at the recommen-
`dation of her doctor, Janice entered a clinical trial for Orencia
`(abatacept) subcutaneous formulation. Since entering the trial,
`her condition has improved. “I feel like I’m a participant in life
`again, rather than just an observer,” she says. “I’m so grateful.”
`
`Page 2 of 128
`
`
`
`TO OUR STOCKHOLDERS
`
`MESSAGE FROM THE CHIEF EXECUTIVE OFFICER
`
`Three years ago, we set out on a journey to become the
`benchmark BioPharma company.
`
`In effect, last year’s success proves that our BioPharma
`transformation is both very real and very promising.
`
`We evolved our Mission. We developed our strategy.
`We headed in a new direction. In effect, we made several
`significant changes, while maintaining our steadfast
`commitment to the patients and communities we serve.
`
`Today, our BioPharma transformation is well under way
`and near completion. Our portfolio is focused exclusively
`on medicines. Our operations have been streamlined and
`simplified. And our company now combines the global
`experience, established commercial infrastructure and
`development capabilities of a major pharmaceutical
`company with the agility, biologics expertise and entre-
`preneurial spirit of a biotechnology firm.
`
`
`
`As a result, Bristol-Myers Squibb is now stronger and
`better equipped to deliver meaningful results – a fact
`clearly demonstrated over the past year:
`
`• We achieved 4 percent sales growth;
`
`• We had a groundbreaking year with respect
`to clinical data;
`• We received key regulatory approval of
`products across the world;
`• We acquired ZymoGenetics, a renowned
`cutting-edge biotechnology company; and
`• We increased our dividend for the second
`consecutive year.
`
`
`
`
`
`2010: A Year of Impressive Results
`
`Granted, 2010 was a challenging year across the board.
`The global financial crisis had reached into every sector
`and affected every company. For those in the pharma-
`ceutical and biotechnology industries, the challenges
`were even greater, due to pricing pressures in Europe
`and the financial impact of health care reform in the
`United States.
`
`Bristol-Myers Squibb, however, not only weathered
`the storm; our company actually had a good year. This
`is true from both a short-term and long-term perspec-
`tive. Our financials were strong – with sales up and
`expenses down – and our pipeline of products became
`even more robust.
`
`This balance between short-term and long-term is
`absolutely essential. To be a successful differentiated
`BioPharma company, we must drive results today, while
`strengthening our company for the future. It is what we
`have done, and it is what we plan to continue to do.
`
`Financial Performance
`
`With respect to financial performance, we continued
`to drive shareholder value. In fact, with an 8.8 percent
`increase, our total shareholder return (including divi-
`dends) was one of the best in the industry.
`
`Bristol-Myers Squibb 2010 Annual Report 1
`
`Page 3 of 128
`
`
`
`THE THREE PILLARS OF
`OUR BIOPHARMA STRATEGY
`
`Innovation
`
`Selective
`Integration
`
`Continuous
`Improvement
`
`Net sales from continuing operations were $19.5 billion –
`up 4 percent over the previous year. That includes a
`6 percent increase in U.S. sales, with double-digit growth
`from Plavix, Sprycel, Sustiva, Baraclude and Orencia as
`well as initial sales of Onglyza.
`
`Meanwhile, efficiencies were realized throughout the
`organization, including from the 50 percent reduction in
`manufacturing plants brought about by the three-year
`network rationalization effort completed last year. With
`a focus on state-of-art technology, only 12 of the original
`27 manufacturing plants remain.
`
`Our strategic focus on capital management led to strong
`yields. We ended the year with $10 billion in cash and
`marketable securities, while completing our strategic
`acquisition of ZymoGenetics, a cutting-edge biotechnol-
`ogy firm, as part of our ambitious, albeit focused String of
`
`Pearls strategy. We retired $750 million principal amount
`of outstanding debt, increased our dividend by 3 percent
`and initiated a $3 billion share repurchase program.
`
`Products and Pipeline
`
`In 2010, we obtained several significant regulatory
`approvals. Sprycel was approved in the U.S. and Europe
`for use as a first-line treatment in newly diagnosed
`adults with Philadelphia chromosome-positive chronic
`phase chronic myeloid leukemia. Kombiglyze XR was
`approved in the U.S. as the first once daily, extended
`release, fixed dose combination of a DPP4 inhibitor and
`metformin for adults with type 2 diabetes. And Orencia
`gained approval in Japan for rheumatoid arthritis and in
`Europe for second-line use in rheumatoid arthritis, while
`a subcutaneous formulation was filed in the U.S.
`
`With respect to clinical data, 2010 was a very positive
`year. We reported important Phase III data for three of
`our new molecular entities. Yervoy (ipilimumab) showed
`an unprecedented survival benefit in second-line meta-
`static melanoma patients; Eliquis (apixaban) showed
`a significant decrease in the risk of stroke without an
`increase in bleeding for warfarin-unsuitable, atrial fibril-
`lation patients; and dapagliflozin, a novel first-in-class
`SGLT2 inhibitor, continued to show a significant glucose
`lowering effect with additional reductions observed in
`secondary endpoints of weight loss and blood pressure
`lowering in type 2 diabetes patients.
`
`We completed six regulatory submissions for new
`medicines in the U.S. and Europe. And with another
`year of positive benefit/risk data on Nulojix (belatacept)
`
`Our BioPharma Progress
`
`October 2007
`
`December 2007
`
`June 2008
`
`String of Pearls strategy launched with
`acquisition of Adnexus Pharmaceuticals.
`
`Ixempra (ixabepilone) approved by the
`U.S. Food and Drug Administration
`(FDA) for advanced breast cancer.
`
`Bristol-Myers Squibb unveiled the
`BioPharma strategy supported by three
`pillars: innovation, selective integration
`and continuous improvement.
`
`January 2008
`
`Sale of Bristol-Myers Squibb Medical
`Imaging.
`
`Bristol-Myers Squibb acquired Kosan
`Biosciences, a cancer therapeutics company.
`
`July 2008
`
`Bristol-Myers Squibb expanded the Productiv-
`ity Transformation Initiative, expected to result
`in $2.5 billion in annual productivity savings
`and cost avoidance by 2012.
`
`Erbitux (cetuximab) approved in Japan.
`
`2
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`Page 4 of 128
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`
`
`This is our way forward.
`This is our way of
`becoming and remaining
`the benchmark
`BioPharma company.
`
`Chief Executive Officer Lamberto Andreotti held a number of global town hall meetings
`in 2010 to update employees on the company’s progress to become the benchmark
`BioPharma company. He is pictured here at the company’s Shanghai office.
`
`for patients with kidney transplants, we completed our
`resubmission to the U.S. Food and Drug Administration.
`
`To ensure sustainability of our pipeline, we moved 15
`new high-quality compounds into preclinical develop-
`ment and achieved a record number of proof-of-concept
`transitions, with six more compounds now progressing
`toward Full Development.
`
`Corporate Responsibility
`
`As in years past, our commitment to the patients and the
`communities we serve extended well beyond our core
`business markets and into the lives of millions of people
`who generally do not have access to quality health care.
`
`In 2010, we continued our work to help reduce health
`disparities in various therapeutic areas and in various
`places throughout the world. Cancer in Europe. Hepatitis
`
`in Asia. HIV/AIDS in Africa. Mental health and well-being
`in the U.S. In January, when Haiti was struck by a cata-
`strophic earthquake, Bristol-Myers Squibb, our Founda-
`tion and employees lent a helping hand, contributing
`nearly $7 million in cash and product. And later in the
`year, the Bristol-Myers Squibb Foundation launched an
`ambitious program, Together on Diabetes – a new five-
`year, $100 million initiative to improve health outcomes
`of people living with type 2 diabetes in the U.S.
`
`We took our commitment to sustainability to the next
`level. We approved our Sustainability 2015 Goals, which
`lays out a plan to address social, economic and environ-
`mental challenges in the communities we serve; we also
`joined the United Nations Global Compact, the world’s
`largest voluntary corporate citizenship initiative.
`
`Our BioPharma Progress
`
`August 2008
`
`December 2008
`
`March 2009
`
`Partnership with PDL BioPharma (since trans-
`ferred to Abbott Laboratories) announced
`to develop elotuzumab, an investigational
`treatment for multiple myeloma.
`
`Sale of ConvaTec completed.
`
`September 2008
`
`Initial public offering for subsidiary
`Mead Johnson Nutrition announced.
`
`Oncology collaboration with Exelixis
`announced.
`
`Agreement with AstraZeneca expanded
`to develop and commercialize dapagliflozin
`in Japan.
`
`January 2009
`
`Collaboration with ZymoGenetics announced
`to develop novel treatment for hepatitis C.
`
`Global collaboration with Nissan
`Chemical Industries and Teijin Pharma
`announced for the development of a
`treatment for atrial fibrillation.
`
`April 2009
`
`Commercialization agreement with
`Otsuka extended for Abilify (aripiprazole).
`
`Bristol-Myers Squibb 2010 Annual Report 3
`
`Page 5 of 128
`
`
`
`2011 – The Way Forward
`
`In 2011, we expect the external challenges to persist.
`But we also expect to build on the momentum created
`last year as we continue to position our company
`for long-term success as a focused, differentiated
`BioPharma company.
`
`To be sure, it will be a year of transition – the last full
`year of exclusivity for Plavix and Avapro, but also a
`period of potential significant product launches and
`regulatory submissions.
`
`We have several new molecular entities under regula-
`tory review, including Yervoy for second-line metastatic
`melanoma, Nulojix for kidney transplantation, Eliquis
`for thrombosis prevention and dapagliflozin for type
`2 diabetes. We expect to receive additional important
`clinical data for Yervoy (first-line metastatic melanoma)
`and Eliquis (stroke prevention in atrial fibrillation),
`which may lead to regulatory submissions.
`
`In 2011, we are also anticipating four significant
`Phase III transitions in hepatitis C, Alzheimer’s disease
`and oncology.
`
`Taken together – the product launches, the regulatory
`actions, the clinical data – all of this should keep us on
`track to achieve our 2013 goals and position us well
`for sustained growth for 2014 and beyond.
`
`Our BioPharma Future
`
`When I became CEO in 2010, I set out to accomplish
`a few key goals during my first year. Bring together a
`
`strong management team. Build on the firm foundation
`established by my predecessor, Jim Cornelius. Take our
`BioPharma transformation to the next level.
`
`As the record makes clear, we succeeded in every respect.
`
`Bristol-Myers Squibb has an absolutely first-rate senior
`management team – one that clearly stands out with
`respect to experience, skill, passion and global diver-
`sity. We have navigated through an often challenging
`external environment to increase sales, reduce costs,
`and grow our promising pipeline. We have continued to
`streamline our operations, develop our people, and pro-
`duce the innovative science that helps patients prevail
`over serious diseases.
`
`This year, we will continue this transformation, and we
`will continue working to deliver results, while positioning
`Bristol-Myers Squibb for longer-term growth. We will over-
`come obstacles. We will seize opportunities. We will strive
`to exceed expectations. And guided by our firm commit-
`ment to the highest business standards and ethics, we
`will continue “to discover, develop and deliver innovative
`medicines that help patients prevail over serious diseases.”
`
`This is our way forward. This is our way of becoming and
`remaining the benchmark BioPharma company.
`
`Lamberto Andreotti, Chief Executive Officer
`March 8, 2011
`
`Our BioPharma Progress
`
`July 2009
`
`November 2009
`
`March 2010
`
`FDA approved Onglyza (saxagliptin)
`for treatment of type 2 diabetes in
`adults. European Union approval
`followed in October.
`
`August 2009
`
`Acquisition of Medarex, Inc., announced,
`expanding our oncology and immunology
`pipelines and our biologics capabilities.
`
`Entered global collaboration with Alder
`Biopharmaceuticals to develop a novel
`treatment for rheumatoid arthritis.
`
`Global agreement with Allergan, Inc.,
`announced for development of an oral
`treatment for neuropathic pain.
`
`December 2009
`
`Strategic split-off of Mead Johnson
`Nutrition holdings completed,
`focusing Bristol-Myers Squibb solely
`on our biopharmaceutical business.
`
`June 2010
`
`Ipilimumab first agent to improve overall
`survival in previously treated patients with
`advanced melanoma, in data presented
`at annual meeting of American Society of
`Clinical Oncology.
`
`4
`
`Page 6 of 128
`
`
`
`MESSAGE FROM THE CHAIRMAN
`
`This is an exciting time at
`Bristol-Myers Squibb. Our
`BioPharma transformation
`is driving organizational
`change and delivering
`meaningful results.
`We have streamlined
`operations and deci-
`sion-making. We have
`increased sales, while
`cutting costs. We have
`focused resources on our core competency – making
`innovative medicines that help patients prevail.
`Simply stated, we have fundamentally changed the way
`we do business, and by all accounts, this transformation
`is having a positive impact across the board:
`
`• Our employees work in an exciting environment
`conducive to personal growth;
`• Our shareholders receive solid returns and are
`confident about our promising future; and
`• Our patients are getting the medicines they need
`and the hope they deserve.
`When we first launched this effort, we made some
`assumptions. We assumed that the external environ-
`ment would become more challenging – that a new U.S.
`President would likely mean a new emphasis on health
`care reform. We assumed that filling the void left by the
`impending loss of Plavix exclusivity would necessitate
`a change in our business model. And to that end, we
`assumed that focused was better than diversified – that
`we should shrink our footprint, sell off our non-pharma-
`ceutical businesses, and target our resources.
`
`
`
`
`
`In other words, we assumed it was best to swim against
`the tide and challenge the conventional wisdom with
`respect to scale and breadth.
`Now, three years later, we no longer make such assump-
`tions … because we can already see the positive results.
`In fact, we see them every day – in the faces of the people
`who work here and in the lives of the patients we serve.
`We also read about them in the pages of industry reports.
`This was particularly true over this past year. Despite a
`demanding external environment, we had a very suc-
`cessful year. From strong sales in the U.S. to significant
`advances in the laboratory, we made great progress in
`2010 and set the stage for a strong 2011 and beyond.
`Needless to say, as Chairman of the Board, I am pleased
`with the direction of our company and grateful to all of
`those who have made it possible – our Directors for their
`vision, Lamberto Andreotti and the Senior Managers for
`their practical leadership, and our 27,000 employees for
`their passion, hard work and commitment to excellence.
`Since “retiring” as CEO last year, I have been able to step
`back and take a more holistic view of the company. I have
`been able to remove myself from the day-to-day manage-
`ment and look at the proverbial forest – observing the
`company, studying the industry and analyzing the trends.
`My conclusion – Bristol-Myers Squibb has never been
`stronger.
`
`James M. Cornelius, Chairman
`March 8, 2011
`
`Our BioPharma Progress
`
`July 2010
`
`Orencia (abatacept) approved in Japan.
`
`October 2010
`
`Acquisition of ZymoGenetics completed,
`securing full ownership of pegylated inter-
`feron lambda, other pipeline assets and an
`existing product, Recothrom (recombinant
`thrombin).
`
`Sprycel (dasatinib) approved in U.S. for
`newly diagnosed patients with chronic
`myeloid leukemia. In December, Sprycel
`was also approved in Europe for use in a
`first-line setting.
`
`November 2010
`
`Kombiglyze XR (saxagliptin and metformin
`HCl extended release) approved in the U.S.
`for the treatment of type 2 diabetes in adults.
`
`Entered into an agreement with Simcere Phar-
`maceutical Group to develop an early-stage
`oncology compound in China.
`
`December 2010
`
`Acquired exclusive worldwide rights for
`festinavir, an investigational compound
`for HIV, from Oncolys BioPharma.
`
`Bristol-Myers Squibb 2010 Annual Report 5
`
`Page 7 of 128
`
`
`
`OUR BIOPHARMA TRANSFORMATION
`
`DISCOVERING
`
`Novel Compounds
`
`Bristol-Myers Squibb’s revved-up Discovery engine is delivering more investiga-
`tional compounds into the development pipeline, across all therapeutic areas, than
`ever before. In 2010, 15 new compounds entered preclinical development, and six
`transitioned to mid-stage clinical testing.
`
`Being BioPharma has many advantages.
`
`Large and Small Molecules … and Some in Between
`
`“We’re the optimum size for a research organization,”
`says Francis Cuss, MB BChir, FRCP, senior vice president,
`Research. “Large enough to take advantage of our oppor-
`tunities, small enough to move quickly and decisively.”
`
`Avoiding a traditional research organizational structure
`based on fixed therapeutic areas, Cuss has divided the
`Drug Discovery organization into two integrated parts:
`Disease Sciences and Molecular Sciences.
`
`“Our approach is, I believe, unique,” says John Houston,
`Ph.D., senior vice president, Disease Sciences and Biolog-
`ics. “And the result is we’ve built a really strong discovery
`and early clinical pipeline.”
`
`Carl Decicco, Ph.D., senior vice president, Molecular Sciences
`and Candidate Optimization, agrees. “We set the bar high
`early in the process by putting a lot of effort into identifying
`the right targets,” he says, “and then we set up stringent
`hurdles at various pipeline decision points.”
`
`As part of our BioPharma strategy, we’ve sized our internal
`Discovery groups to be smaller than industry norms.
`What makes us effective is our size, our experience and
`our agility, which improves our ability to execute rapidly
`and decisively.
`
`To accelerate the discovery and development of new
`therapies, we are complementing and enhancing our
`internal capabilities with a suite of innovative alliances,
`partnerships and acquisitions with small and large com-
`panies. This is our String of Pearls strategy. “We take an
`integrated, global approach to these transactions, each
`of which is designed to enhance and accelerate our
`overall BioPharma strategy,” says Jeremy Levin, D.Phil.,
`MB BChir, senior vice president of Strategy, Alliances
`and Transactions.
`
`Historically, pharmaceutical companies have relied on
`small molecules for most of their marketed products.
`Small molecules are usually less expensive and less com-
`plicated to manufacture, and most can be taken orally.
`Bristol-Myers Squibb has a library of more than 2 million
`such molecules stored in a robotic retrieval and screening
`platform. Greater than 75 percent of the targets we screen
`against get hits that advance into development from this
`system. It’s our strongest, most reliable starting point for
`discovering potential new medicines.
`
`Large molecules, or biologics, derived from recombinant DNA
`technologies, are becoming increasingly important. They are
`often more difficult and expensive to manufacture than small
`molecules and must usually be administered by injection.
`Yet they are often more specifically disease targeted. Cur-
`rently, greater than one in three of our pipeline compounds
`are biologics, as are two of our key marketed products.
`
`Now, we’re pioneering a new drug modality – millamole-
`cules, which are midsize between small and large mol-
`ecules. Potentially, millamolecules combine advantages
`of both small and large molecules, affecting cell surface
`targets as well as protein interactions inside cells. We are
`synthesizing a millamolecule library, and novel types of
`millamolecular compounds are nearing development.
`
`Now we have three choices. Having multiple modalities
`gives us the capability to go after the most important
`scientific and medical disease targets.
`
`Turning Up the Heat Across Our Therapeutic Areas
`
`Through our knowledge of the human genome and our
`much-improved safety screens, we are discovering more
`new drugs with new mechanisms of action and better
`safety profiles than ever before.
`
`6
`
`Page 8 of 128
`
`
`
`REDEFINING
`Bristol-Myers Squibb’s flexible-design laboratory at our research facilities in Princeton, New Jersey, houses innovative drug candidate purification technology.
`Spectrix Analytical Services scientists Michael Appiah, foreground, and Tamara Shekunov, background, log samples and queue up purification experiments.
`At center, Harold Weller, Ph.D., senior research fellow, Bristol-Myers Squibb, analyzes data and monitors work flow. Key to our selective integration and
`continuous improvement BioPharma pillars, consolidating operations and using service providers such as Spectrix improve efficiency and reduce cost.
`And importantly, they free up our scientists to perform critical functions and to pioneer new discovery approaches.
`THE SCIENTIFIC PROCESS.
`
`Bristol-Myers Squibb 2010 Annual Report 7
`
`Page 9 of 128
`
`
`
`DISCOVERING NOVEL COMPOUNDS
`
`Our robust pipeline of small molecules and biologics – and
`some millamolecules – is driven by internal Discovery efforts and
`enhanced by String of Pearls transactions. Now, our Discovery
`teams have built up a reservoir of expertise, consistency and
`focus. As a result, we’re having a productive run across all of
`our therapeutic areas as our scientists see their work steadily
`advance into clinical development.
`
`Often, there is no clear dividing line between one therapeutic
`area and the next, as the science that drives one area may also
`inform another.
`
`Cancer
`Our goal is to shrink the tumor and then keep the disease in
`check. Currently, there are 15 compounds in Exploratory Devel-
`opment, representing a broad range of approaches to fight the
`disease across multiple tumor types. One innovative approach is
`immuno-oncology. We have both small molecules and biologic
`programs that are designed to enhance the cancer-killing power
`of the immune system or increase the visibility of the tumor to
`the immune system. Another pioneering area is antibody drug
`conjugates, in which a cancer-killing drug is linked to a monoclo-
`nal antibody. The antibody specifically targets a particular cancer
`cell antigen, thus delivering the drug directly to the cancer cell.
`A drug conjugate, anti-CD70, has entered the clinic, and others
`will follow.
`
`Cardiovascular
`Bristol-Myers Squibb’s long leadership in this therapeutic area,
`driven largely by in-licensed products, is now backed by a strong
`and growing pipeline. Atherosclerosis and thrombosis remain
`significant unmet medical needs, and so we’re taking a broad-
`based approach with multiple points of intervention, focusing
`on areas of innovation. Among those approaches is a first-in-class
`small-molecule modulator of the liver X receptor, for athero-
`sclerosis, and a biologic, PCSK9 inhibitor, designed to drastically
`and rapidly lower LDL cholesterol. Our goal is to treat athero-
`thrombosis at the vessel wall by directly attacking the underlying
`disease mechanism that results in clot formation.
`
`Immunology
`In the past few years, we’ve built up our Discovery and early
`development capabilities in this area. Now, we have a number
`of small molecules and biologics in the pipeline. Among the
`compounds in clinical development for rheumatoid arthritis are
`an interleukin-6 inhibitor and a small-molecule CCR1 antagonist.
`Other compounds are targeted against Crohn’s disease, ulcer-
`
`ative colitis and lupus. We have a wide breadth of unique targets,
`multiple technologies and a growing wealth of experience in this
`therapeutic area.
`
`Metabolics
`Diabetes is a complex, multifaceted disease. Our focus is dis-
`covering novel compounds to treat the broader abnormalities
`associated with diabetes – such as dyslipidemia and hyperten-
`sion – and the complications of diabetes, which include heart
`attack and stroke. Several agents, small molecules and biologics,
`are advancing into the clinic for diabetes, in addition to others
`for obesity, which represents a significant risk factor for diabetes.
`
`Neuroscience
`We’ve also built a robust neuroscience portfolio, and now we
`have drugs in the clinic or nearing the clinic for schizophrenia,
`neuropathic pain, depression, migraine and Alzheimer’s disease.
`Particularly interesting are compounds designed to address the
`two leading pathologies of Alzheimer’s disease – amyloid plaques
`and neurofibrillary tangles. Among our approaches is a first-in-
`class program to determine whether we can delay the onset of
`Alzheimer’s by preventing the formation of amyloid plaques
`in patients at risk for Alzheimer’s. Another industry-leading
`approach to the disease is designed to prevent a breakdown
`of neuronal cell microtubules and the formation of tangles.
`
`Virology
`Bristol-Myers Squibb has been a leader in virology research for
`20 years. Now, we’ve turned up the heat and are reinvesting in
`this critical therapeutic area. Bristol-Myers Squibb’s hepatitis C
`virus (HCV) pipeline is one of the broadest portfolios of clinical
`assets and programs of any company. We have a number of small
`molecules and biologics in clinical development and entering
`the clinic, representing new targets and mechanisms of action
`targeting HCV. In HIV/AIDS, we acquired festinavir from Oncolys
`BioPharma, have a novel HIV attachment inhibitor in the clinic
`and five new Discovery programs.
`
`In short, 2010 proved to be a year of significant results for
`Bristol-Myers Squibb Research. In fact it’s been one of the most
`productive on record. “It’s been a year of excellence,” says Francis
`Cuss. “We’ve made significant contributions to the discovery of
`new drugs, to the progression of our early development portfolio
`into mid-stage clinical trials and to the support of our late-stage
`portfolio. 2011 may indeed be even more productive.”
`
`8
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`Page 10 of 128
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`
`
`Our Pipeline
`Bristol-Myers Squibb is dedicated to discovering and developing
`innovative medicines that address serious unmet medical needs
`in key disease areas. In doing so, we believe we can better help
`patients prevail.
`Compounds in Exploratory Development are in preclinical or
`early clinical development. Full Development compounds are
`investigational drugs that are in later-stage clinical development
`or have been submitted to regulatory agencies for approval.
`Finally, medicines in Marketed Product Development are driving
`current and future growth while also undergoing continued
`clinical development to determine whether additional indications
`and formulations would benefit patients.
`
`DISEASE AREAS
`Cancer
`
`Cardiovascular
`
`Immunology
`(including Rheumatoid Arthritis and
`Solid-Organ-Transplant Rejection)
`
`Metabolics
`(including Diabetes and Obesity)
`
`Neuroscience
`(including Psychiatric Disorders
`and Alzheimer’s Disease)
`
`Virology
`(including HIV/AIDS and Hepatitis)
`
`Exploratory Development
`Full Development
`Marketed Product Development
`
`Pipeline chart as of December 31, 2010.
`
`Biologics Discovery California – formerly Medarex,
`acquired by Bristol-Myers Squibb in 2009 – is now fully
`integrated into the company. Here at our facility in
`Milpitas, scientists discovered and developed Yervoy
`(ipilimumab), currently under regulatory review for the
`treatment of patients with metastatic melanoma. Now,
`researchers are developing the next wave of leading-edge
`immuno-oncology therapies that enhance the cancer-
`killing power of the body’s immune system or deliver
`anticancer drugs directly into tumor cells. In photo top to
`bottom: Mark Selby, Ph.D., director, Discovery Research;
`Alan Korman, Ph.D., vice president, Discovery Research;
`and Changyu Wang, Ph.D., senior scientist.
`
`Bristol-Myers Squibb 2010 Annual Report 9
`
`Page 11 of 128
`
`
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`COMMITTED
`The Eliquis (apixaban) core clinical team in action. Running Bristol-Myers Squibb’s largest clinical trial program – with more than 57,000 patients enrolled in 16
`clinical trials in 41 countries – requires integrated cross-functional teams directing the program’s strategy, design and conduct. Eliquis is being studied for a range
`of cardiovascular indications. Jack Lawrence, M.D., vice president and development lead, at right, confers with his colleagues. Seated, left to right, Lorraine Rossi,
`associate director and operations lead, and Michael Hanna, M.D., group medical director. Standing, left to right, Robert Knabb, Ph.D., group director, and Puneet
`Mohan, M.D., Ph.D., executive director and medical lead. This core team meets frequently with an extended team – including colleagues in Pharmaceutical Devel-
`opment, Regulatory Sciences, Biometric Sciences, Pharmacovigilance and Clinical Pharmacology – as well as their counterparts at our alliance partner, Pfizer.
`TO SCIENTIFIC EXCELLENCE.
`
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`Page 12 of 128
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`
`
`OUR BIOPHARMA TRANSFORMATION
`
`DEVELOPING New Therapies
`
`As a BioPharma leader, we are unleashing the power of innovation through
`internal integration and external collaboration. One result: a record number of
`new product submissions.
`
`“2010 was an extraordinary year for our R&D organization,”
`says Elliott Sigal, M.D., Ph.D., executive vice president, chief
`scientific officer and president, R&D. “Across our develop-
`ment programs, our clinical and regulatory teams have
`applied innovative approaches to our trials, have allowed
`the science to lead the way and have executed programs
`efficiently and successfully. Overall, in my 13 years with
`Bristol-Myers Squibb, I don’t remember any other year
`in which we’ve had such groundbreaking clinical data.”
`
`Our strategy is simple: Develop innovative medicines
`backed by extraordinary teams. Each of our medicines
`in development requires high-performing matrix teams
`and a terrific amount of intellectual capital.
`
`We’re driving down an entrepreneurial and biotech mind-
`set. Each team member contributes technical expertise
`but also takes an enterprise perspective. This allows
`individuals and teams to be significantly more innovativ