throbber
2010 ANNUAL REPORT
`
`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
`
`Page 4 of 128
`
`

`
`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
`
`Page 10 of 128
`
`

`
`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
`
`

`
`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.
`
`10
`
`Page 12 of 128
`
`

`
`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

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

Still Working On It

This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.

Give it another minute or two to complete, and then try the refresh button.

throbber

A few More Minutes ... Still Working

It can take up to 5 minutes for us to download a document if the court servers are running slowly.

Thank you for your continued patience.

This document could not be displayed.

We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.

Your account does not support viewing this document.

You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.

Set your membership status to view this document.

With a Docket Alarm membership, you'll get a whole lot more, including:

  • Up-to-date information for this case.
  • Email alerts whenever there is an update.
  • Full text search for other cases.
  • Get email alerts whenever a new case matches your search.

Become a Member

One Moment Please

The filing “” is large (MB) and is being downloaded.

Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.

Your document is on its way!

If you do not receive the document in five minutes, contact support at support@docketalarm.com.

Sealed Document

We are unable to display this document, it may be under a court ordered seal.

If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.


Access Government Site

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket