Global Pharmaceutical R&D Pipeline

Corporates
Healthcare Global Special Report
Global Pharmaceutical R&D Pipeline

First-Quarter 2010
Introduction
Fitch Ratings global pharmaceutical team is presenting its Global Pharmaceutical R&D Pipeline report for the first quarter of 2010. This report includes the most current, key late-stage R&D brand-name pharmaceutical projects, as well as up-to-date financial measures that reflect the risks facing pharmaceutical developers. Recent market introductions of innovative and generic drug products are highlighted as well. The intent of the regular update is to keep investors informed of the dynamics of the brandname pharmaceutical portfolios of the major U.S. and European participants in the industry. Fitch issues this report on a quarterly basis following earnings reporting.
Analysts
Michael Zbinovec +1 312 368-3164
michael.zbinovec@fitchratings.com
Britta Holt (Europe) +00 44 020 7862-4022

britta.holt@ffitchratings.com
Related Research
U.S. Healthcare Stats Quarterly First-Quarter 2010, June 17, 2010 Healthcare Reform Update: Early Results, May 12, 2010 Global Pharmaceutical R&D Pipeline (Fourth-Quarter 2009), April 16, 2010 Healthcare Reform Update: Potential for Increased Utilization and Margin Compression Remains, March 24, 2010 U.S. Healthcare: 2010 Credit Outlook, Jan. 19, 2010 Fitch: Economic Pressure & Event Risk will Drive U.S. Healthcares Negative Outlook in 2010, Dec. 2, 2009 Fitch: Negative Outlook for Global Pharmaceuticals in 2010, Dec. 2, 2009 Applicable Criteria Corporate Rating Methodology, Nov. 24, 2009 Liquidity Considerations for Corporate Issuers, June 12, 2007
Data Presentation
This report incorporates three-year periods as it looks forward to calculate revenues potentially subject to generic competition, as well as a historical presentation of sales from the point of market introduction. The figures are presented in quarterly and yearly formats. The broader key statistics are calculated yearly for European companies and both yearly and quarterly for U.S.-based companies due to the timing of financial reporting in the different regions. The Appendix beginning on page 16 contains the latest detailed late-stage R&D portfolios, reflecting changes since the publication of Fitchs Special Report, Global Pharmaceutical R&D Pipeline (Fourth-Quarter 2009), on April 16, 2010, available at www.fitchratings.com.
Late-Stage R&D Pipeline Developments

In the first quarter, the U.S. Food & Drug Administration (FDA) approved six new molecular entities (NMEs) and one vaccine, while the European Medicines Agency (EMEA) authorized marketing of five NMEs and two vaccines. Fitch-covered drug developers were responsible for five of the total pharmaceutical and vaccine approvals by the FDA and EMEA during the quarter. Further back in the drug approval process, the regulatory applications of only four NMEs were filed to regulatory agencies during the quarter, including the dossier of one drug candidate that was accepted for review by the European drug regulator. Reviewing the targets for drug product registrations laid out at year-end conference calls or analyst meetings by the 13 pharmaceutical companies rated by Fitch, a total of 23 new drug filings may be made to drug authorities by the end of the year. An updated table on page 3 reflects changes made to the original goals, including a new accelerated goal for a current late-stage drug project as well as a minor delay to a planned filing. Since the start of the year, 10 NMEs have been added to the late-stage research portfolios of the Fitch-rated pharmaceutical companies six through internal research programs and the remainder derived from business development activities. Fitch still anticipates that licensing arrangements for drug candidates will be favored over industry consolidation during 2010.
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June 21, 2010
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Recent Regulatory Registration
Proving to be a rather spartan quarter, only four NMEs were registered with regulatory agencies during the first quarter of the year, including one drug candidate that was accepted for review by the European drug regulator. The regulatory applications for another experimental medicine were filed to the FDA and EMEA in the second quarter. Resulting from licensing activities, Eli Lilly & Co. (Eli Lilly) gained worldwide rights in March to Axiron, a late-stage drug candidate for the treatment of male testosterone deficiency in a novel delivery method. The developer, Acrux Ltd. (Acrux), registered the new pharmaceutical, an underarm formulation for the delivery of testosterone, to the FDA in late January 2010. Current testosterone delivery systems include injections; patches such as Watson Pharmaceuticals, Inc.s (Watson) Androderm; and gels like Abbott Laboratories (Abbott) Androgel, and the putty-like Striant from Columbia Laboratories, Inc. Another late-stage molecule arising from business development was Abbotts DM-1796, a potential medicine to treat postherpetic neuralgia, a complication of shingles. The drug compound comes from the first-quarter acquisition of Solvay Pharmaceuticals (Solvay), which licensed DM-1796 from Depomed Inc. (Depomed) for the U.S., Canada, Mexico, and Puerto Rico. Phase III investigation was completed in October 2009 and subsequently filed to the FDA at the end of March. A variety of medicines, often used in combination, are used by physicians to control the pain associated with the condition and include opioid-based medications, anti-seizure therapies such as Pfizer Inc.s (Pfizer) Lyrica, moderate dosages of antidepressants, and localized pain treatments like lidocaine patches. Also in the first quarter, Sanofi-Aventis SA (Sanofi-Aventis) filed the oncology drug Jevtana (cabazitaxel) to European drug authorities for advanced prostate cancer treatment. A rolling submission to the FDA had already finished up in December 2009 and a priority review had been granted. The chemotherapy is used in men whose cancer has spread to other parts of their bodies. Patients in this advanced stage are typically treated by reducing testosterone levels through drug therapy (eg, Abbotts Lupron, AstraZeneca plcs [AstraZeneca] Casodex) possibly in conjunction with radiation or through chemotherapy, including Sanofi-Aventis Taxotere, and Dendreon Corporations novel immunotherapy Provenge. Bristol-Myers Squibb Co.s (Bristol-Myers Squibb) belatacept, a novel therapy for organ transplant rejection prevention, was accepted for review in the first quarter by the EMEA for the prevention of kidney transplant rejection. The application for the drug candidate is currently under review with U.S. drug authorities and had been issued a complete response letter in early May. Other transplant drugs are Pfizers Rapamune, Novartis AGs (Novartis) Certican, and a host of other immunosuppressant medicines, including cyclosporine and generic versions of Hoffman-La Roche AGs (Roche) Cellcept. GlaxoSmithKline plc (GlaxoSmithKline) and Human Genome Sciences Inc. (Human Genome Sciences) successfully achieved their target of registering Benlysta for the treatment of systemic lupus erythematosus to drug regulators in the second quarter of 2010. GlaxoSmithKline submitted the marketing application to the EMEA on June 4, while Human Genome Sciences filed the biologics license application to the FDA on June 10. The regulatory filings were made despite study data that showed the lupus dug candidate worked no better than the standard treatment and placebo after a year and a half. The therapeutic class is vastly underserved as only older medicines exist to treat the condition, ranging from anti-inflammatory drugs (like aspirin) for mild forms of the disease to immunosuppressants (such as generic CellCept) for severe cases.
June 21, 2010
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Potential Near-Term Regulatory Registration
Below, Fitch discusses any variations to the original drug product registration estimates detailed in the table Expected Novel Drug Filings Full Year 2010, found in Fitchs previous quarterly report dated April 16, 2010. If no changes are mentioned, the time frames will remain consistent with those derived from year-end conference calls or analyst meetings of the Fitch-rated pharmaceutical developers. Novel drug and vaccines that are successfully filed with drug regulators are mentioned in the section above, Recent Regulatory Registration. The original late-stage pipeline information specified 22 new pharmaceuticals and vaccines that are planned to be registered with drug regulatory agencies throughout 2010. The number of NMEs may increase or decrease as the year progresses due to project delays into 2011 or accelerated progress.
Expected NME Filings Tracker 2010

Company Abbott AstraZeneca Project Briakinumab Ceftaroline Dapagliflozin Recentin Motavizumab Zactima Ipilimumab Apixaban Dapagliflozin Benlysta Nimenrix Dacogen Telaprevir TMC-278 Ridaforolimus Boceprevir MenB Pasireotide Patupilone Panobinostat AIN457b Apixaban Aprela Roche Sanofi-Aventis
a
Bristol-Myers Squibb
GlaxoSmithKline Johnson & Johnson
Merck Novartis
Pfizer
Trastuzumab-DMI Cabazitaxel
Lead Indication Psoriasis Antibiotic Type 2 Diabetes Recurrent Glioblastoma/ Colorectal Cancer Respiratory Syncytial Virus Infection Prevention Medullary Thyroid Cancer Metastatic Melanoma Venous Thrombotic Event Prevention Type 2 Diabetes Lupus Meningitis Vaccine Acute Myeloid Leukemia/ Myelodysplastic Syndromes Hepatitis C HIV Metastatic Sarcomas Hepatitis C Meningitis Vaccine Cushings Disease Ovarian Cancer Non-Hodgkins Lymphoma Uveitis Venous Thrombotic Event Prevention Menopausal Symptom Relief HER+ Metastatic Breast Cancer Prostate Cancer
FDA Registration First Half N.A. Fourth Quarter Fourth Quarter Filed Third Quarter 2010 2010 Fourth Quarter Filed N.A. N.A. 2010 Late 2010 or 2011 2010 2010 2010 2010 2010 2010 2010 Second Half 2010 Filed
EMEA Registration First Half Third Quarter Fourth Quarter Fourth Quarter Fourth Quarter Third Quarter 2010 First Halfa Fourth Quarter Filed Second Halfa 2010 2010 2010 Fourth Quarter 2010 2010 2010 2010 First Halfa Filed
Represents movement to a later date from prior company estimate. bRepresents new earlier estimate. N.A. Not applicable. Source: Company reports.
A slight slippage of the expected timing for the regulatory registration recently occurred for Bristol-Myers Squibb and Pfizers apixaban as the companies moved out the anticipated filing date into the first half of 2010 from the first quarter. Overlooking the minor delay, a recent announcement by the companies indicates the potential for the promising experimental anticoagulant. Specifically, a late-stage trial investigating the drug candidate in patients with atrial fibrillation was stopped early as an analysis by an Global Pharmaceutical R&D Pipeline June 21, 2010
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independent monitoring board determined the benefit of stroke reduction compared to aspirin in patients intolerant to warfarin. Novartis recently added AIN457 for uveitis to its basket of NMEs that is expected to be registered in 2010. The drug compound is being developed for various autoimmune disorders and is expected to be filed to the drug regulatory agencies this year for treating uveitis in patients with Behcets disease. AstraZeneca recently evaluated data from the HORIZON II and HORIZON III clinical trials investigating the oncology drug candidate Recentin in treating metastatic colorectal cancer patients. Based on the study information, the company decided in late May that an indication for metastatic colorectal cancer will no longer be pursued. Data from late-stage studies looking at clinical utility of the drug candidate in recurrent glioblastoma is expected in the near term.
Late-Stage Pipeline Additions

Since the start of the year, 10 NMEs were added to the late-stage R&D portfolios of the Fitch-rated pharmaceutical companies, including six through internal research programs. The remainder of new drug projects was derived from business development activities, either by licensing or acquisition. Four of these drug developers were able to increase the size of their Phase III programs by two new entities each. Abbott struck two deals since the start of the year with the acquisitions of Solvay and Facet Biotech Corp. (Facet) which increased the companys late-stage drug portfolio by two projects. Early in the year, Abbott completed the previously announced purchase of the pharmaceutical business of Solvay SA. The acquisition brought with it a potential neuropathic pain treatment, DM-1796, that had been licensed from Depomed for the U.S., Canada, Mexico, and Puerto Rico. The new drug compound finished Phase III testing in October 2009 and was filed to the FDA at the end of March. In the second quarter, Abbott also bought Facet, a developmental research firm whose portfolio included daclizumab, a multiple sclerosis drug candidate which recently entered late-stage trials in May. The potential medicine is being developed in partnership with Biogen Idec Inc. (Biogen). Eli Lilly added two more late-stage projects to its R&D program GLP-1Fc (LY2189265) and Axiron in the first quarter. The internally developed diabetes drug candidate, GLP-1Fc, moved into Phase III investigation in the AWARD-1 study in February. The new project adds to a string of late-stage advancement from internal research over the past 12 months that includes the Alzheimers disease treatment solanezumab, and the cancer drugs necitumumab and tasisulam. The companys second late-stage compound, Axiron, a treatment of male testosterone deficiency in novel delivery formulation, was licensed globally from the Australian drug developer Acrux in March. A regulatory filing had already been made to the FDA in late January 2010. Roche also saw successful progression of its internal R&D program during the first quarter. Two new molecular entities the cancer drug candidate RG7204 and cardiovascular drug aleglitazar moved into late-stage investigation for first indications, while another cancer project, RG7159, progressed to Phase III testing for a second indication. Resulting from a partnership with Plexxikon Inc. dating back to 2006, the potential oncology therapy RG7204 advanced in January into Phase III clinical trials studying the drugs efficacy in metastatic melanoma patients. In February 2010, Roche started late-stage work investigating aleglitazar for the management of cardiovascular disease in high-risk patients, including diabetics. Finally, a second indication is being pursued for non-Hodgkins lymphoma for the oncology drug candidate RG7159, which began Phase III clinical trials in March. The potential cancer therapy is already in latestage testing for chronic lymphocytic lymphoma.
June 21, 2010
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Novartis also saw progression of its mid-stage pipeline into late-stage clinical studies as the drug compounds panobinostat and SBR759 moved into Phase III testing. Panobinostat entered late-stage testing for a new lead indication for non-Hodgkins lymphoma in March, after being set back last year when the compound failed to show efficacy for cutaneous T-cell lymphoma. In February, the company started Phase III testing of SBR759, a phosphate binder, to be used mainly for dialysis patients to reduce the amount of dietary phosphorus absorbed by the kidneys. Novartis plans to file regulatory dossiers for panobinostat and SBR759 in 2010 and in 2011, respectively. Sanofi-Aventis anticoagulant otamixaban progressed into late-stage clinical investigation in March for potential use for moderate- to high-risk patients with acute coronary syndrome. The drug project is in a race to market with other Factor Xa inhibitors, specifically the registered drug products, Bayer AG (Bayer) and Johnson & Johnsons (J&J) Xarelto (rivaroxaban) and Boehringer Ingleheim GmbHs (Boehringer Ingleheim) Pradaxa, as well as Bristol-Myers Squibb and Pfizers late-stage apixaban. Another drug project arising from business development is Merck & Co. Inc.s (Merck) Daxas (roflumilast) for chronic obstructive pulmonary disease (COPD) which was licensed in April 2010 for certain European countries from Nycomed International Management GmbH. Merck will market Daxas to the U.K. and co-promote the drug in France, Germany, Italy, Spain, Portugal, and Canada. The marketing application was previously submitted to European drug regulators in 2009 and the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion favoring approval in April of this year.
Late-Stage Pipeline Setbacks

Since the beginning of 2010, there have been negative events to the late-stage R&D portfolios of pharmaceutical developers covered by Fitch, leading to delays or terminations of 16 new drug projects. Half of these represented the cancellation of late-stage development programs and dissolution of licensing partnerships. In the first quarter, Pfizer saw the discontinuation of two research programs and the withdrawal of a regulatory filing of three experimental medicines. Beyond the stoppage of a clinical trial in late 2009 for the oncology drug candidate figitumumab for the treatment of non-small cell lung cancer (NSCLC), the company halted further study investigating the potential medicine in combination with Tarceva in NSCLC patients in March. Earlier-stage research continues in other cancer types, including breast and prostate. Also in March, Pfizer and its partner Medivation Inc. discontinued the clinical studies for Dimebon looking at efficacy in treating mild-to-moderate Alzheimers disease. Indications in moderate-to-severe Alzheimers disease and Huntingtons disease are still under investigation in late-stage clinical trials. Finally, Pfizer withdrew the regulatory applications that sought approval for Fablyn for osteoporosis treatment and prevention and vaginal atrophy treatment. The company continues to explore strategic options for the potential therapeutic, including out-licensing. Novartis suffered two major setbacks to its late-stage R&D program and one relatively minor delay since the start of the year. In March, the company announced intentions to focus on the current development of ASA404, developed in collaboration with Antisoma plc, toward second-line use in patients with NSCLC. Late-stage study data released in late March showed little efficacy in the previously untreated patient population. The drug candidate also failed in late-stage clinical trials in ovarian cancer patients back in 2007. Additionally, the company withdrew the marketing application for Joulferon (also known as Zalbin) from the EMEA in April, as new data requested by the agency needed for full approval of the Hepatitis C treatment would not be provided within the standardized time frame allotted by the EMEA. Novartis and Human Genome Sciences are developing the potential infectious Global Pharmaceutical R&D Pipeline June 21, 2010
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disease medicine under an exclusive global arrangement established in 2006. Recently, approval of the multiple sclerosis therapy Gilenia may be somewhat delayed as the FDA extended its review by three months, setting a new action date of September 21; however, full approval is supported by an unanimous recommendation by an expert panel held on June 10 that favored approving the new therapy. Novartis licenses the potential novel medicine from Mitsubishi Tanabe Pharma Corp. During the first quarter, J&J terminated two research and commercialization agreements following the issuance of complete response letters by the FDA or the adoption of a negative opinion from the EMEA. Early in the quarter, J&J stopped all clinical progress toward approval of Comfyde (carisbamate), a potential treatment of partial onset seizures in patients 16 and older, developed in partnership with SK BioPharmaceuticals. The decision in January followed receipt of a complete response letter in August 2009. The second agreement dissolved in the quarter regarded the antiinfective Zevtera (ceftobiprole), under a development and marketing arrangement with Basilea Pharmaceutical Ltd. A variety of issues surrounded the drug approval process of the anti-infective candidate including a CHMP negative opinion adopted on Feb. 18; receipt of a second complete response letter on Dec. 30, 2009 requiring additional clinical trials; and an FDA warning letter issued in August 2009 citing improper monitoring of the clinical studies as well as deficiencies in study conduct. GlaxoSmithKline and its partner Xenoport Inc. experienced two delays in the first quarter to the approval of its potential restless leg treatment Horizant. After addressing a concern from the FDA regarding a risk evaluation and mitigation strategy (REMS) for the drug candidate, the user fee review deadline was extended by three months until February 9 to encompassed time needed to review the new data. Shortly after the Prescription Drug User Fee Act (PDUFA) date passed, the FDA issued a complete response letter on February 17 pertaining to the application, stating that the incidence of pancreatic cancer in rats found in preclinical trials outweighed the benefits of the indication being sought. The partners are considering the next steps for the drug candidate. In the first quarter, Abbott returned the U.S. rights for the potential asthma treatment Flutiform to its development and marketing partner SkyePharma plc (SkyePharma). The decision to terminate the agreement was derived from the receipt of a complete response letter from the FDA requesting information that would necessitate additional clinical work. Earlier in the quarter, Abbott had already transferred responsibility for the marketing application back to SkyePharma. Late in the first quarter, Abbott and AstraZeneca had seen a bump in the approval process for Certriad, a product line extension for AstraZenecas Crestor and Abbotts TriLipix, for the treatment of dyslipidemia. Approval of the fixed-dose combination pill in the U.S. awaits a company response to a complete response letter issued by the FDA in late March. The companies are working with the FDA to determine subsequent actions needed prior to approval. Moreover, the registration of the combination pill to the European drug regulator that had been planned last year has still not been achieved. In the second quarter, AstraZeneca suffered a serious blow to the approval of Numax, a potential agent for the prevention of respiratory syncytial virus in high-risk infants. The monoclonal antibody developed by the companys MedImmune subsidiary was not recommended for approval by a FDA advisory panel on June 2, as the committee needed more study data in sicker patients and clarity pertaining to increased incidence of serious skin infections versus the current standard of care. As mentioned above, AstraZeneca will not pursue an indication for metastatic colorectal cancer for the oncology drug candidate Recentin.
June 21, 2010
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The FDA issued a complete response letter pertaining to the licensing application for Bristol-Myers Squibbs belatacept, a novel therapy for organ transplant rejection prevention, on the PDUFA date of May 1. Additional clinical studies have not been requested for approval of the drug candidate; however, the agency asked for longerterm data lasting 36 months compared to the two-year data included in the original regulatory dossier. Approval of the drug for the prevention of kidney transplant rejection is supported by a vote of confidence on March 1 from an FDA advisory committee. In the first quarter, the EMEA accepted for review the marketing authorization application for belatacept. In the second quarter, Roche and its partner Biogen canceled the clinical development of ocrelizumab for use in rheumatoid arthritis, citing lessened commercial prospects from the overall risk-to-benefit profile of the drug candidate. The May decision followed a recommendation in March by an independent safety monitoring board to halt further treatment of patients in rheumatoid arthritis, as the risks of the medicine outweighed its benefits. Earlier studies continue for the treatment of relapsingremitting multiple sclerosis. So far, no word has been heard pertaining to a company response to a complete response letter issued by the FDA in May 2009 for Bayer and J&Js potential new anticoagulant, Xarelto. Last year, the companies expected to refile data requested for full approval sometime in early 2010.
Potential Near-Term Regulatory Approvals

Considering the wave of recent setbacks in the drug approval processes of Fitchcovered pharmaceutical developers, the number of potential marketing clearances of new drug candidates in the U.S. or Europe over the next two quarters appears modest. Looking over the near term, seven NMEs could gain full regulatory approval by the end of the third quarter. Two companies lead the list with three and two near-term NME approvals, respectively Merck and GlaxoSmithKline. Mercks drug portfolio includes three drug projects nearing full approval by drug regulators Sycrest, Brinavess (vernakalant), and Daxas (roflumilast) which were all obtained through business development activities. Merck inherited from Schering-Plough Corp. (Schering-Plough) the schizophrenia drug, Sycrest, which had been accepted for review by the EMEA back in early June 2009. The quickdissolve tablet, also known as Saphris in the U.S., is being reviewed by European drug authorities for the treatment of schizophrenia and manic episodes associated with bipolar disorder. Last year in late August, the company announced that the EMEA accepted for review the marketing authorization application for vernakalant. The drug candidate to treat acute atrial fibrillation has been licensed for territories outside of the U.S. from Cardiome Pharma Corp. (Cardiome). Finally, Mercks newest addition to its late-stage R&D portfolio, Daxas (roflumilast), was acquired in April and had already been registered with the FDA and EMEA during 2009. Recently, the CHMP adopted a positive opinion on April 23 favoring full approval for use in COPD treatment. GlaxoSmithKlines slate of near-term commercial opportunities is the oncology therapy Votrient (pazopanib), and the meningitis vaccine Menhibrix. The companys potential treatment of renal cell carcinoma, Votrient, was granted a revised positive opinion favoring conditional approval on April 22 despite the voluntary removal by GlaxoSmithKline of the orphan drug status for the drug candidate. The CHMP previously adopted a positive opinion for conditional approval on Feb. 18, 2010. Nonetheless, the new cancer drug may soon follow in the footsteps of the companys recently approved oncologic Arzerra, which was favored for conditional approval at the January CHMP monthly meeting. Additionally, the potential combination meningitis vaccine Menhibrix Global Pharmaceutical R&D Pipeline June 21, 2010
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may see full marketing clearance in the U.S. in the near term considering that the regulatory filing was made to the FDA back in August 2009. Despite the recent delay to the review process for Novartis novel multiple sclerosis drug candidate Gilenia, the new FDA action date was extended only until the end of September. The potential new medicine was filed to the EMEA and the FDA in December 2009 with the FDA granted a six-month priority review. Moreover, the potential therapy received a unanimous recommendation for approval from an FDA advisory panel held on June 10. The regulatory dossier for Sanofi-Aventis oncology drug Jevtana (cabazitaxel) was granted fast-track approval status which allowed for a rolling submission to FDA that was completed in December 2009. If a priority review to the application is granted, the potential chemotherapy for advanced prostate cancer could be approved within the next two quarters.
Recent Commercialization
Brand-Name Pharmaceuticals
In the first quarter of the year, the FDA approved six NMEs and one vaccine, while the EMEA recorded marketing clearance of five NMEs and two vaccines. Fitch-covered drug developers were responsible for five of the total pharmaceutical and vaccine approvals during the quarter, as noted below. Japanese drug regulators approved Novartis renal cancer treatment Afinitor in the same period. Starting in the first quarter, Roche received full FDA approval for its rheumatoid arthritis therapy, Actemra, in early January, meeting the review deadline timeframe following a refiling in July 2009 of the marketing application that included new information to address a complete response issued in September 2008. The novel monoclonal antibody is indicated for the treatment of moderate-to-severe rheumatoid arthritis and will enter a crowded therapeutic class dominated by the anti-tumor necrosis factors Abbotts Humira, Pfizer and Amgen Inc.s (Amgen) Enbrel, and J&J and Mercks Remicade.
Approvals of Novel Drugs per Geography First-Quarter 2010

Product
Actemra Scintimum Afinitor Ampyra Elonva Victoza Silodex Xiaflex Prevnar-13 Vpriv Revolade Menveo Tepadina ImmunoGam Carbaglu
Company
Roche CIS Bio Novartis Accorda Merck NovoNordisk Recordati Auxiliam Pfizer Shire GlaxoSmithKline Novartis Adienne Cangene R&R Registrations
Indication
Rheumatoid Arthritis Imaging Agent Renal Cancer Multiple Sclerosis Improved Functioning Fertility Diabetes Benign Prostate Hyperplasia Dupuytrens Contracture Streptococcus Vaccine Gauchers Disease Idiopathic Thrombocytopenic Purpura Meningitis Vaccine Stem Cell Mobilizer Hepatitis B Vaccine Acute Hyperammonemia
FDA Approval
1/8/10 1/22/10 1/25/10 2/2/10 2/24/10 2/26/10 3/18/10
EMEA Approval
1/11/10 1/25/10 1/29/10 3/11/10 3/15/10 3/15/10 3/16/10
MHLW Approval
1/20/10
MHLW Japans Ministry of Health, Labor and Welfare. Source: FDA, EMEA, MHLW, and company reports.
June 21, 2010
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Also in January, the EMEA granted marketing clearance to Elonva (corifollitropin-alfa), Mercks infertility treatment. Full regulatory approval came after a recommendation by the CHMP on Nov. 20, 2009, favoring approval of the marketing application and acceptance of the regulatory dossier for review by the EMEA back in December 2008. Commercialization of the new drug, the first long-acting stimulating agent allowing for less frequent injections than the current fertility drug regimens, builds on the expertise in fertility treatments present at Organon Biosciences N.V. Possibly the most significant drug product approved by the FDA in the quarter was Pfizers promising next generation pneumococcal vaccine, Prevnar-13. In February, the U.S. drug regulatory agency cleared the new vaccine for U.S. marketing after an advisory panel that recommended approval in November 2009 and a delay caused by a three-month extension of the user fee goal to the end of 2009. European drug authorities cleared the vaccine in December 2009. The vaccine extends the protection offered by the companys current seven-strain Prevnar vaccine to 13 different variations of Streptococcus pneumoniae. The new 13-valent vaccine is anticipated to replace the older vaccine as well as compete with GlaxoSmithKlines Synflorix. In the quarter, Novartis achieved marketing clearance in both the U.S. and Europe for its meningitis vaccine, Menveo. On Feb. 22, the FDA approved the new vaccine to protect patients aged 11 to 55 against infections from four strains of Neisseria meningitis. Moreover, the European drug regulatory body cleared the vaccine for marketing in Europe to patient ages 11 and older on March 17 after the CHMP adopted a positive opinion in December 2009. Sanofi-Aventis presently markets the Menactra vaccine, which protects against the identical strains of the bacteria as Menveo.
Approvals of Major Product Extensions and New Formulations FirstQuarter 2010

Product Orencia Herceptin Tykerb Norvir Rituxin DuoCover Xeloda Company Bristol-Myers Squibb Roche GlaxoSmithKline Abbott Roche Bristol-Myers Squibb/ Sanofi-Aventis Roche Indication Juvenile Rheumatoid Arthritis Stomach Cancer First-Line Breast Cancer Treatment HIV heat-stable formulation First-Line chronic lymphocytic leukemia Anti-Thrombotic combination of Plavix and aspirin Adjuvant Treatment of Early Colon Cancer FDA Approval 1/29/10 2/11/10 2/19/10 EMEA Approval 1/20/10 1/28/10 2/17/10 3/15/10 3/30/10 MHLW Approval
MHLW Japans Ministry of Health, Labor and Welfare. Source: FDA, EMEA, MHLW, and company reports.
Over the past few months, the R&D program at GlaxoSmithKline has been successful at obtaining marketing access for three novel drug candidates, all through licensing arrangements. In March, Revolade (known as Promacta in the U.S.) was cleared by the EMEA for marketing in Europe for the treatment for chronic idiopathic thrombocytopenic purpura after the CHMP adopted a positive opinion in December 2009. The molecule is licensed from Ligand Pharmaceuticals Inc. (Ligand) and will now compete with Amgens niche treatment, Nplate. Into the second quarter, GlaxoSmithKline and its development partner Genmab A/S (Genmab) achieved EMEA Global Pharmaceutical R&D Pipeline June 21, 2010
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approval of the oncology drug Arzerra (ofatumumab) on April 19 for the treatment of refractory chronic lymphocytic leukemia. The CHMP adopted a positive opinion favoring approval of the marketing application of the new cancer drug on January 21. Other monoclonal antibody therapies used to treat the same cancer type are Bayers Campath and Roches Rituxan. GlaxoSmithKline shares with Amgen in the successful regulatory approval of the promising biological drug for the treatment of osteoporosis, Prolia (denosumab), during the second quarter. The drug product was cleared by the EMEA in late May for the treatment of post-menopausal osteoporosis (PMO) and bone loss associated with hormone ablation in men with prostate cancer subsequent to the CHMP adopting a positive opinion in December 2009. Amgen granted co-promotion rights for the PMO indication to GlaxoSmithKline in specific areas outside of the U.S, including Europe. Amgen also received FDA approval for Prolia for PMO treatment in the U.S. on June 1, surprisingly ahead of an extended review deadline of July 25. Back in August 2009, an FDA advisory panel recommended that Prolia be used only for treatment of PMO and bone loss in prostate cancer patients, not for prevention for any of the conditions. The novel pharmaceutical competes in a therapeutic class dominated by the bisphosphonates, including Novartis Reclast, Roches (and GlaxoSmithKlines) Boniva, and generic versions of Mercks Fosamax, as well as the selective estrogen receptor modulators, primarily Eli Lillys Evista. Lastly, AstraZeneca and Pozen Inc. received full FDA approval of their line extension for Nexium, the combination pain pill with naproxen, Vimovo, in early May. The pain pill includes Nexium in order to reduce the gastrointestinal side effects of the pain medication. The pain pill enters a highly crowded market space with a variety of overthe-counter, generic, and brand-name medications.
Generic Pharmaceuticals
In the first quarter of 2010, the brand-name drug manufacturers mentioned in this report did not experience first-time generic challenges to any significant medicines. During the period, however, Merck did reach agreement with Teva Pharmaceutical Industries Ltd. (Teva) pertaining to the brain cancer therapy Temodar, avoiding a potential at-risk market launch. The settlement followed a decision by the U.S. District Court, which determined in January 2010 that a key patent was unenforceable due to inequitable conduct by the patent filer and licensor to Merck, Cancer Research Technologies, Ltd. Merck appealed the decision, but the FDA approved Barr Pharmaceuticals Inc.s abbreviated new drug application (ANDA) on March 1. Teva can now launch its generic product in August 2013, during Mercks pediatric exclusivity period, or earlier if the decision is upheld upon appeal. Into the second quarter, Teva launched its generic versions of Mercks hypertension drugs, Cozaar and Hyzaar, following the method-of-use patent expiration for losartan (Cozaar) on April 6. Teva was not alone, as other generic drug developers including Mylan Inc., Torrent Pharmaceuticals Ltd., and Roxane Laboratories Inc. received full approval of their ANDAs for the 100mg/12.5mg strength only of Hyzaar on the same day. However, only Teva is allowed to market its three drug dosages due to 180-day marketing exclusivity granted by a favorable court ruling in early March 2010. Tevas generic drugs compete with authorized versions launched by Sandoz Inc. Combined sales of Cozaar and Hyzaar were $1.31 billion in the U.S. and $2.20 billion outside of the U.S for the LTM period ending March 31, 2010. Also, in the second quarter, Boehringer Ingelheims Flomax, a drug for the treatment of benign prostatic hyperplasia, experienced generic competition ahead of its U.S. patent expiration on April 27. Impax Laboratories Inc. (Impax) launched its generic copy of
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June 21, 2010
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Flomax on March 2 after securing full approval of its ANDA from the FDA, despite a prior agreement between Ranbaxy Pharmaceuticals Inc. (Ranbaxy) and Astellas Pharma Inc., which assured Ranbaxy of marketing exclusivity as the first-to-file applicant. Ranbaxy was unable to achieve final approval of its ANDA, opening the door for Impax. Six more generic firms entered the market upon the compound patents lapse in late April.
Significant Near-Term Patent Expirations

Before the end of 2010, six more blockbuster-level drug products could potentially see generic competition. Beyond the two above-mentioned medicines currently competing with generic drug entrants starting in April, AstraZenecas adjuvant breast cancer treatment Arimidex is next on the list and may face generic competition in late June. Global sales of the oral medication nearly reached $2.0 billion for the LTM period at the end of the first quarter of 2010. Sanofi-Aventis could have seen generic versions of its oncology treatment as early as May, but the FDA recently approved the companys application for pediatric exclusivity providing six additional months of market protection until November 2010. Taxotere generated sales in the U.S. close to $1.0 billion for the LTM period ending March 31, 2010.
Near-Term Key Patent Expirations

Product Cozaar/Hyzaar Flomax* Arimidex Effexor-XRa Advair Taxotere Gemzar Aricepta Company Merck Boehringer Ingelheim AstraZeneca Pfizer GlaxoSmithKline Sanofi-Aventis Eli Lilly Pfizer/Eisai LTM 1Q10 Sales ($ Mil.) U.S. Sales ROW Sales 1,308 2,195 1,441 903 1,066 2,294 510 4,086 3,901 994 1,606 739 901 1,886 1,424 Potential U.S. Patent Expiry Expired 4/6/10 Expired 4/27/10 6/27/10 with PE 7/1/2010 Sept. 2010 11/14/10 with PE 11/15/10 with PE 11/25/10 with PE
a Sales are Fitch estimates. PE Six-month pediatric exclusivity extension. Source: FDA and company reports.
In the third quarter, two significant medicines face patent expiration Pfizers extended release formulation of the antidepressant Effexor, and GlaxoSmithKlines asthma inhaler Advair. Generic drug competition for Effexor-XR is virtually assured by an October 2005 patent litigation settlement that will allow Teva to launch its generic versions of Effexor-XR on July 1, 2010. The depression medicine generated an estimated $2.29 billion of U.S. sales for the LTM period ending March 31, 2010. Much more uncertain is the potential launch of generic copies of the medical device and drug combination for asthma, Advair, upon loss of patent life of the drug compound in September. Despite the loss of the base patent, the therapy is still offered some protection through a device patent on the Diskus inhaler as well as undefined approval requirements from the FDA for generic inhaled respiratory pharmaceuticals. Further complicating generic drug competition is a Citizens Petition filed by GlaxoSmithKline requesting that the patient instructions for any generic drug follow those of the original medicine, which uses the proprietary Diskus inhaler. Later in the year, potential generic drug competition could be introduced to Eli Lillys chemotherapy Gemzar, and to Aricept, the Alzheimers disease medicine from Eisai Inc. (Eisai) and its co-promotion partner Pfizer. Eli Lilly is already contending with generic versions of Gemzar outside of the U.S. and could see generic drug entrants appear in November when the compound patent lapses. Currently, the company is litigating the Global Pharmaceutical R&D Pipeline June 21, 2010
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validity of a method-of-use patent for the pharmaceutical and, if successful, this would extend the product life until 2013. In the U.S., sales of Gemzar totaled $739 million for the LTM period ending March 31, 2010. The patent maturing near the end of November for Eisais Aricept pertains to an oral once-daily immediate-release formulation of the Alzheimers disease medication. Eisai and Pfizer filed an application for an extended-release tablet, which was accepted for review by the FDA in late November 2009. The current formulation of Aricept garnered $1.89 billion of revenues in the U.S. for the LTM period at the end of the first quarter.
First-Quarter 2010 Review

Sales Trends
The positive sales trend from the end of 2009 continued into the first quarter of 2010 given signs of recovery from the global recession in various countries. The Fitch-rated pharmaceutical companies mentioned in this report generated weighted average revenue growth of 6.2% in the first quarter, adjusting for currency changes and a major consolidation in the fourth quarter of 2009 involving Pfizer and Merck. Twelve of the 13 European and U.S. drug marketers listed in this report achieved net sales growth of their pharmaceutical portfolios in the quarter. The first-quarter growth rate compares to that of the fourth quarter of 2009 when net sales increased approximately 7.0% year over year. The revenue increase in the first quarter was also boosted by an easy comparison to the worst-performing period in 2009. However, net sales derived in the U.S. were somewhat dampened in the first quarter due to the first impact from recently enacted healthcare reform legislation, the Patient Protection and Affordable Care Act. Rebates for drugs sold through the Medicaid program increased retroactive to the start of the year, to 23.1% from 15.1%. Later in 2010, industry participants can expect additional Medicaid rebates as an adjustment is made to the reimbursement calculation in October.
First-Quarter Pharmaceutical-Only Sales Growth
16.0 14.0 12.0 10.0 8.0 6.0 4.0 2.0 0.0 (2.0) (4.0) (%)
Br Ba ist ol ye -M r ye rs Sq ui bb
Ab bo tt
No va rt is
ith Kl in e
El iL
As tr aZ
oS m
Note: Pfizer and Merck sales adjusted for fourth-quarter acquisitions; European company sales are at constant currency. Source: Company reports.
U.S. Pharmaceuticals
All the U.S. pharmaceutical corporations listed in this report (with the exception of J&J), generated revenue growth for their drug portfolios in the first quarter, with notable sales performances at Abbott and Bristol-Myers Squibb.
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Corporates
Abbott led the drug developers in the U.S. with 12.9% growth in sales of its worldwide pharmaceutical business in the first quarter of the year. The superior sales performance was underpinned by continued strong demand for the companys top-selling drug product, Humira, which generated a sales increase of 36.5% and represented 18% of total company revenues in the quarter. Solid growth is also supported by the wash-out of the impact from generic competition to Abbotts anti-epileptic Depakote, which dragged down growth in 2009. The biopharmaceutical portfolio at Bristol-Myers Squibb, which now represents the companys entire product offering, produced a sales increase of 11.2% for the first quarter. As expected, the company experienced attractive growth prior to the start of its patent cliff next year, supported by demand for its top five drug products Plavix, Avapro, Abilify, Reyataz, and Sustiva. Collectively these products, representing 68.8% of total sales, grew 12.4%, driving overall company growth. Bristol-Myers Squibbs bestselling pharmaceutical Plavix grew 16.1% and generated nearly 35% of total company revenues in the quarter. Revenue growth derived from Eli Lillys human drug product offering continued to exceed that of the overall market in the first quarter despite the beginning of a period of key patent expiration that started internationally with Gemzar in the second half of 2009. Sales pressure could mount in the fourth quarter given the potential loss of market exclusivity of Gemzar in the U.S. Globally, the 8.6% sales performance of the human drug portfolio resulted primarily from volume gains versus price increases given strong uptake of the companys top five pharmaceuticals Zyprexa, Cymbalta, Humalog, Cialis, and Alimta. Combined sales of the best-selling drugs, representing 63% of total revenues, increased 15.0% in the quarter, mitigating a 22% decline in worldwide Gemzar revenues. Amgen also generated an 8.6% revenue gain from its human medicine portfolio in the first quarter, boosted by an 11.1% global sales increase from the companys current lead drug franchise, Neulasta. Supporting overall growth was the stabilization of Aranesp sales after more than three years of dramatic decreases in revenues of the long-acting erythropoiesis-stimulating agent. However, a REMS was recently initiated for Aranesp which may hinder sales growth due to a potential moderation in dosing. Amgens top five pharmaceuticals, representing 90% of overall company revenues, generated a 7.0% rise in sales in the quarter. Strong sales growth rates for the first quarter at Merck and Pfizer were bolstered by the addition of the first full-quarter revenues generated by the consolidated entities, Schering-Plough and Wyeth, respectively. Accounting for the effect of consolidation activity, Mercks first-quarter revenue growth of 81.9% dropped to approximately 6%. The companys present top five selling drugs Singulair, Cozaar/Hyzaar, Remicade, Zetia, and Januvia collectively grew 9.3% for the quarter on a pro forma basis. Mercks top human drug product, Singulair, generated a sales increase of 10.1%. Sales performance will be pressured starting in the second quarter due to the U.S. patent lapse in April of the hypertensives, Cozaar and Hyzaar, which garnered $3.5 billion of sales in the LTM period at the end of the first quarter. Pfizers stellar sales growth of 43.6% in the quarter came back down to Earth and was about 3% after adjusting for incremental revenues from the Wyeth human medicine portfolio. Pfizers new five top-selling drugs Lipitor, Celebrex, Lyrica, Enbrel, and Effexor-XR had a combined sales decrease of 1.5% when utilizing sales figures reported by Wyeth last year. Sales of the companys top drug product, Lipitor, are still increasing prior to the U.S. patent expiration next year and rose 1.3% in the first quarter. Future sales performance will be challenged by generic versions of Effexor-XR that are expected to hit pharmacy shelves in early July. Global Pharmaceutical R&D Pipeline June 21, 2010
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J&J was the only U.S.-based drug manufacturer to experience a sales decrease from its pharmaceutical portfolio in the first quarter, driven downward by a 12.7% drop in U.S. revenues. The company is still suffering the negative effect of generic competition to Risperdal and Topamax, which together pressured sales by 11% in the quarter. The impact had been partially mitigated by impressive sales growth of J&Js leading drug product, Remicade, which increased 15.6% year over year.
European Pharmaceuticals
In the first quarter of the year, all six European pharmaceutical companies covered by Fitch achieved positive sales growth in their pharmaceutical portfolios, with the growth rates of three of them (GlaxoSmithKline, Novartis, and Sanofi-Aventis) significantly boosted by flu pandemic-related vaccine sales. GlaxoSmithKline generated an impressive 14% revenue increase at constant currency driven by pandemic-related products, including H1N1 vaccine and Relenza. Excluding these revenues, the underlying sales growth at constant currency was 4%, supported by the respiratory drug division (up 6%), cardiovascular and urogenital (up 9%), oncology and emesis (up 23%), and dermatologicals (up more than 100%). The company generated attractive sales growth despite the challenge of continued generic competition to several mature products in the U.S., particularly in its central nervous system division (down 13%) and in antivirals (down 44%). At 10% sales growth year-over-year in constant currency, Roches pharmaceuticals division grew also at a fast pace during the quarter. The groups key oncology products, Avastin, MabThera/Rituxan, Herceptin, and Xeloda, as well as the virology drugs Tamiflu and Pegasus and the ophthalmology drug Lucentis, all grew at double-digit paces and were able to offset lower sales of Cellcept (down 28%) and Neorecormon (down 8%). Novartis pharmaceuticals local currency sales growth was 7%, led by the oncology portfolio (up 14%) and neuroscience and ophthalmics (up 19%). Moreover, the vaccines and diagnostics division grew dramatically by 436%, bolstered by the pandemic flu vaccines and adjuvants. These four treatment areas together accounted for 66% of pharmaceutical sales in the first quarter of 2010. AstraZeneca also achieved sales growth of 7% at constant exchange rates in the first quarter, as the company benefited from a solid sales performance year over year of four of its top five best-selling drug products Seroquel (up 13%), Crestor (+27%), Symbicort (+29%), and Arimidex (+7%). The company is in the midst of demand and pricing pressures for Nexium (flat) in light of new over-the-counter and generic versions of a rival product, Prevacid. AstraZenecas revenue growth was also supported by demand increases for Seloken/Toprol-XL (+24%) following the withdrawal of two generic manufacturers for generic Toprol-XL from the U.S. market; however, Watson recently entered the market with generic Toprol-XL for limited dosage strengths (25mg and 50mg). AstraZeneca also suffered during the quarter from U.S. generic competition for Pulmicort, sales of which were down 20% in the quarter, as a result of the relaunch of the Teva generic budesonide inhaled suspension product in December 2009. Sanofi-Aventis pharmaceuticals and vaccines operations recorded 5.8% sales growth at constant exchange rates in the first quarter, driven by the companys flagship product, Lantus (+10.4%), and by its vaccines business (+56%). Revenue growth was dampened by generic competition to Eloxatin that arose in the U.S. in the third quarter of 2009, as well as by generic competition for Plavix in some European countries. Bayer recorded first-quarter 2010 revenue growth of 0.6% (adjusted for foreign currency) in its pharmaceuticals division, as Yasmin sales in the U.S. were held back by
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the discussion surrounding the thrombosis risk resulting from use of contraceptives containing drospirenone. Yasmin/Yaz/Yasminelle franchise sales were down by 10.2% during the quarter. Sales were further dampened by generic competition for the multiple sclerosis drug Betaferon in Europe (franchise sales were down 5% in the quarter). During the same time period, the oncology drug Nexavar (up 16.0%), mainly for used against primary liver cancer, as well as the hormone-releasing intrauterine device Mirena (up 16.5%), continued to exhibit double-digit sales growth.
Shareholder Return
The same story from 2009 continued into 2010 as Fitch-rated pharmaceutical developers still favor dividends as the means to return value to shareholders. In the first quarter, share repurchases totaling nearly $3.0 billion paled in comparison to $9.4 billion of dividend payments. Amgen was most active in share repurchasing in the first quarter having bought back $1.5 billion, while Pfizer led all drug manufacturers covered by Fitch with $1.4 billion of dividends to shareholders.
Shareholder Returns
($ Mil.) 1Q10 Share Repurchases 861 1,527
a
Company Abbott Amgen AstraZeneca Bayer Bristol-Myers Squibb Eli Lilly GlaxoSmithKline Johnson & Johnson Merck Novartis
1Q10 Dividends 621 N.A. 2,237 None 551 539 GBP763 1,350 1,189 4,468
a
214 None None None None 383 None None
Pfizer Roche Sanofi-Aventis
1,441 CHF4,215 None

a
None None None
Repurchase Program Authorization (End of 1Q10) Approximately $2.5 billion remained of a $5 billion program authorized in October 2008. Around $4.3 billion remained, including $5 billion authorized in December 2009. Board announced $1 billion of share repurchases in 2010. N.A. N.A. Approximately $420 million remained under a $3 billion program. In July 2007, announced a two-year GBP12 billion program to be completed after July 2009. Approximately $0.7 billion remained under a $10 billion program. The Board authorized a new $3 billion program in November 2009. A CHF10 billion program was established in Feb. 2008. The share repurchase program was suspended in April 2008 after Novartis announced the Alcon agreement. A total of $5.0 billion remains; will resume share repurchasing in 2010. Approximately $3.5 billion remains from a $10 billion program from April 2008. Authorization for the company to repurchase its own shares up to a maximum of EUR3 billion, valid until the next AGM.
a Represents annual amount announced at AGM (annual group meeting). N.A. Not applicable Source: Company reports.
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Appendix
Current New Molecular Entities by Company
Company Abbott Laboratories Brand or Generic Name Flutiform DM-1796 Briakinumab (ABT-874) ABT-869 Daclizumab Amgen Prolia (Denosumab) Motesanib Diphosphate (AMG-706) AstraZeneca Vimovo (PN400) Numax (motavizumab) Brilinta/Brilnique (AZD6140) Zactima Ceftaroline Dapagliflozin Recentin (cediranib, AZD2171) Zibotentan (ZD4054) Bayer Xarelto (rivaroxaban) Indication Asthma Pain Management Autoimmune Diseases Cancer Multiple Sclerosis Osteoporosis Cancer Internally Developed or Licensed? Licensed, SkyePharma Licensed, Depomed Internally Developed Partnered with Roche Partnered with Biogen Internally Developed Internally Developed, Partnered with Takeda Licensed, Pozen Internally Developed, from MedImmune Internally Developed Internally Developed Licensed, Forest Licensed, BristolMyers Squibb Internally Developed Status U.S. rights returned to SkyePharma in the first quarter of 2010 after FDA issued a complete response letter on 1/22/10 asking for additional clinical information, including dosing information. Phase III in postherpetic neuralgia started in 3/08 and completed in 10/09; FDA filing on 3/30/10, accepted for review on 6/7/10. Phase III for psoriasis initiated in 12/07; global filing for psoriasis expected in first half of 2010. Phase III started in hepatocellular carcinoma in 10/09. Phase III initiated in 5/10. EMEA approved for PMO and bone loss treatment following a CHMP positive opinion adopted on 12/17/09; FDA approved on 6/1/10 after an advisory panel voted in favor of approval of PMO treatment on 8/13/09. Phase III for advanced NSCLC started in 7/07; trial resumed in 2/09 for only nonsquamous NSCLC patients. FDA approved on 4/30/10; EMEA filing announced on 10/16/09. FDA filing on 1/30/08, received a complete response letter on 11/28/08 to which company responded on 12/24/09, advisory panel held on 6/2/10 did not recommend approval of vaccine; EMEA filing is expected in the fourth quarter of 2010. Filed to the EMEA on 10/26/09; filed to the FDA on 11/19/09. Phase III data from medullary thyroid cancer trial met progression-free survival endpoint with filings planned in the third quarter of 2010. Phase III began in 1/07; FDA filing planned in 2009; EMEA filing expected in the third quarter of 2010. Phase III initiated in 9/07; EMEA filing expected in the fourth quarter of 2010; FDA filing depends on number of cardiovascular events and agency discussions. Phase III for metastatic CRC in 11/06, and recurrent glioblastoma in 10/07; did not meet primary endpoint in HORIZON III trial, based on data from both HORIZON II and III trials, an indication on metastatic CRC will not be pursued; data in recurrent glioblastoma expected in the first half of 2010. Phase III for prostate cancer initiated in 11/07; FDA and EMEA filings expected in first half of 2011. Filed to FDA on 7/30/08, advisory committee recommended approval on 3/19/09; a complete response letter was issued on 5/28/09 which did not require additional clinical studies but may take until early 2010 to address the concerns. Phase III began in 8/07; Phase III for retinal vein occlusion began in 4/09. Phase III started in PAH in 12/08, and in chronic thromboembolic pulmonary hypertension in 2/09. Phase III for bone metastases in hormone-refractory prostate cancer initiated in 6/08. Phase III began in 11/09. Received FDA complete response letter on 5/1/10 which did not ask for additional clinical work; FDA advisory committee voted in favor of approval on 3/1/10; EMEA filing accepted in the first quarter of 2010. Granted FDA fast-track approval status for second line monotherapy and first-line metastatic melanoma treatment in combination with chemotherapy; FDA and EMEA filings expected in 2010.
Pain Management Respiratory Syncytial Virus Infection Prevention Arterial Thrombosis Cancer Antibiotic Diabetes Cancer
Cancer Prevention of VTE
Internally Developed Internally Developed, Partnered with J&J Licensed, Regeneron Internally Developed Licensed, Algeta Internally Developed Internally Developed Internally Developed
VEGF-Trap Eye Riociguat Alpharadin Florbetaben Bristol-Myers Squibb Belatacept Ipilimumab (MDX-010)
Wet Age-Related Macular Degeneration PAH Bone Metastases Imaging Agent for Alzheimers Disease Prevention of Solid Organ Transplant Rejection Cancer
AML Acute myeloid leukemia. COPD Chronic obstructive pulmonary disease. CABG Coronary artery bypass graft. CRC Colorectal cancer. CV Cardiovascular. DVT Deep Vein Thrombosis. HCC Hepatocellular carcinoma. MACE Major adverse cardiovascular events. NSCLC Non-small cell lung cancer. PAH Pulmonary Arterial Hypertension. PMO Postmenopausal osteoporosis. PDUFA Prescription Drug User Fee Act. RA Rheumatoid arthritis. REMS Risk evaluation and mitigation strategy. VMS Vasomotor symptoms. VTE Venous thromboembolism. Source: Company reports. Continued on next page.
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Current New Molecular Entities by Company (Continued)
Company Bristol-Myers Squibb (Cont.) Brand or Generic Name Dapagliflozin Apixaban Indication Diabetes DVT and Prevention of Stroke Internally Developed or Licensed? Internally Developed; Partnered with AstraZeneca Internally Developed; Partnered with Pfizer Status Phase III initiated in 9/07; EMEA filing expected in the fourth quarter of 2010, while FDA filing depends on number of CV events and discussions with the agency. Phase III (stroke in atrial fibrillation) study started in 12/06; Phase III DVT study started in 11/06; Phase III for VTE treatment started in 5/08; received FDA fast track designation for stroke, trial stopped early due to benefits; may file for stroke prevention to the FDA in 2011; may file to EMEA for VTE prevention in first half of 2010. Phase III studies for metastatic CRC began in 5/08 and HCC started in 2/09; filings for HCC expected in 2011. Phase III investigations started in thyroid cancer in 6/08. Phase III in NSCLC began in 11/09. Filed in Japan in 12/07. Filed to FDA on 1/27/10. Phase III for diffuse B-cell lymphoma began in 6/06. Phase II/III for recent onset type 1 diabetes started in 10/06. Phase III initiated for mild-to-moderate disease in 3/08. Phase III studies started for breast cancer in 8/08. Phase III for mild-to-moderate disease began in 5/09. Phase III work in NSCLC began in 11/09. Phase III investigation for metastatic melanoma initiated in 12/09; FDA granted orphan drug status. Phase III AWARD-1 trial started in 2/10. EMEA approved on 3/12/10 after a CHMP positive opinion was adopted on 12/17/09; filed in Japan in 9/09; in Phase III for Hepatitis C and chronic liver disease. EMEA approved on 4/19/10 after CHMP favored conditional approval on 1/21/10. EMEA approved on 5/28/10 for PMO treatment and bone loss treatment following a CHMP positive opinion adopted on 12/17/09. FDA issued a complete response letter on 2/17/10 after PDUFA was extended three months until 2/9/10 to review REMS, Phase III studies in COPD and asthma initiated in 2/10 Filed to the EMEA on 3/4/09; CHMP adopted a revised positive opinion favoring conditional approval on 4/22/10 after removal of orphan drug designation; Phase III in ovarian cancer started in 6/09. FDA and EMEA filings on 10/30/09; EMEA accepted for review on 11/17/09; FDA accepted for review on 12/30/09. Phase III initiated in 12/06, filed to the FDA on 6/10/10 and to the EMEA on 6/4/10. Phase III started in 3/08. Phase III began in 8/08. Phase III started in 10/09; Phase III asthma trial began in 3/10. Phase III trials began in 12/08; second Phase III study began in 12/09. Phase III studies started in 2/09; enrollment completed for five studies. Phase III for NSCLC started in 10/07 and for multiple myeloma in 11/03. Phase III. Phase III; EMEA filing planned for second half of 2010. FDA filing occurred on 8/12/09.
Brivanib XL184 Necitumumab (IMC11F8) Ixempra (Ixabepilone) Axiron Enzastaurin Teplizumab Semagacestat (LY450139) Ramucirumab (IMC1121B) Solanezumab (LLY2062430) Necitumumab (IMC11F8) Tasisulam GLP-1Fc (LY2189265) Revolade (Promacta) Arzerra (Ofatumumab) Prolia (Denosumab) Horizant (Solzira, GSK 1838262) Votrient/Patorma (Pazopanib) Retigabine Benlysta (Belimumab) Almorexant Otelixizumab Revolair (Horizon) Tyrisa (Darapladib) Syncria (Albiglutide) MAGE-A3 (GSK1572932A) Simplirix Nimenrix (MenACWY) Menhibrix (Hib-MenCY-TT) Mosquirix Prepandrix
Cancer Cancer Cancer Cancer Hypogonadism Cancer Diabetes Alzheimer's Disease Cancer Alzheimer's Disease Cancer Cancer Diabetes Thrombocytopoietin Agonist Cancer, Autoimmune Diseases Osteoporosis Restless Leg Syndrome Cancer Epilepsy Lupus Erythematosus Insomnia Type-1 Diabetes Chronic Obstructive Pulmonary Disease Atherosclerosis Diabetes Cancer Vaccine Genital Herpes Neisseria Meningitis A, C, W &Y Vaccine Neisseria Meningitis C&Y, Haemophilus Influenzae b Vaccine Malaria Vaccine H5N1 Influenza Vaccine
Internally Developed Licensed, Exelixis Licensed, Eli Lilly Internally Developed Licensed, Acrux Internally Developed Licensed, MacroGenics Internally Developed Internally Developed, from ImClone Internally Developed Internally Developed, from ImClone Internally Developed Internally Developed Licensed, Ligand Licensed, Genmab Licensed (EU only), Amgen Licensed, XenoPort Internally Developed Licensed, Valeant Licensed, Human Genome Sciences Licensed, Actelion Licensed, Tolerx Licensed, Theravance Licensed, Human Genome Sciences Licensed, Human Genome Sciences Internally Developed Internally Developed Internally Developed Internally Developed
Eli Lilly
GlaxoSmithKline
Internally Developed Internally Developed
Phase III started in 5/09. Phase III.
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Corporates
Company Johnson & Johnson Brand or Generic Name Zevtera (Ceftobiprole) Xarelto (Rivaroxaban) Indication Anti-Infective Prevention of VTE Internally Developed or Licensed? Licensed, Basilea Pharmaceutica Licensed, Bayer Status Agreement terminated in 2/10 following a negative opinion from the CHMP on 2/18/10 in addition to receipt of a second FDA complete response letter on 12/30/09 requesting additional data from new clinical trials. Filed to FDA on 7/30/08; advisory committee recommended approval on 3/19/09; a complete response letter was issued on 5/28/09 which did not require additional clinical studies but may take until early 2010 to address the concerns. Discontinued project in 1/10 after receipt of a complete response letter on 8/21/09; EMEA filing withdrawn in 1/10. Phase III (U.S.) for acute myeloid leukaemia and myelodysplastic syndromes initiated 11/05; EMEA filing expected in 2010. Phase III started in 3/08; EMEA filing planned for 2010. Phase III started in 5/08; regulatory filings expected in 2010. Phase III trials initiated in 12/07; granted FDA fast-track designation for mild-to-moderate Alzheimers disease; North American trial to complete in mid-2012. Phase III in prostate cancer initiated in 4/08. First Phase III trial initiated in 8/09. Non-approvable letter received by FDA in 10/05. Phase III trials started in 7/06; EMEA approved on 1/25/10 after a CHMP positive opinion was adopted on 11/20/09; FDA filing expected in 2012. Filed to EMEA in 2009, CHMP adopted a positive opinion on 4/23/10. EMEA accepted filing for review on 6/2/09. Phase III trials started in 9/06; EMEA accepted for review on 8/26/09; FDA filing anticipated in 2010. Phase III started in 8/08; received FDA fast-track status; expected trial completion in mid-2010 and filing for treatment-experienced and nave patients in 2010. Phase III for sarcoma began in 9/07; granted orphan drug status in U.S. and EU; possible filing in late 2010 or 2011 pending review of interim analysis of SUCCEED trial. Endpoint was met in new Phase III trial that began in early 2008, announced in 2/10; FDA filing expected in 2010 or 2011. Phase III started in 3/07; based on discussion with the FDA, another Phase III safety study will be conducted; registration expected in 2011. Phase III initiated in 1/08; FDA filing expected in 2011; already approved by EMEA. FDA issued a non-approvable letter despite an advisory committee recommending approval on 3/11/08; a new clinical study protocol currently under FDA review; refiling expected in 2011. Two Phase III studies for MACE prevention initiated in 10/07; received FDA fast-track status; expected filings in 2011. Phase III began in 9/07; expected filings in 2012. Phase III started in 9/07; filings expected in 2012. Phase III (DEFINE) began in 4/08 for patients with coronary heart disease; FDA filing expected beyond 2015. Phase III studies for intravenous formulation began in 6/04, EMEA accepted for review on 8/26/09; Phase II for oral formulation. New Phase III initiated for prevention of complications during CABG surgery in high-risk patients in 4/09, expected registration in 2012. Received non-approvable letter from FDA on 4/28/08; FDA has requested data from HPS-2 THRIVE study expected to be completed in 2012; FDA filing expected in 2012. Phase III; FDA filing pending complete response to Tredaptive application. Phase III trial began in 12/09; filing expected in 2012. Phase III initiated in 9/07, received FDA fast-track status; will not pursue therapy for treatment-experienced patients as data from two trials did not meet primary efficacy endpoints; the treatment-nave indication is still under study. Phase III started in 3/07.
Comfyde (Carisbamate) Dacogen Telaprevir TMC278 Bapineuzumab (AAB-001) Abiraterone acetate Canagliflozin Priligy (Dapoxetine) Elonva (Corifollitropin alfa) Daxas (Roflumilast) Sycrest (Asenapine) Nomac/E2 Boceprevir Ridaforolimus (MK-8669 or AP-23573) Sublingual Tablet-Based Immunotherapy Telcagepant (MK-0974) Saflutan (Tafluprost, MK-2452) Bridion (Sugammadex) Vorapaxar (Thrombin Receptor Antagonist) Odanacatib (MK-0822) V503 Anacetrapib (MK-0859) Brinavess (Vernakalant, MK-6621) Acadesine
Epilepsy Cancer Chronic Hepatitis C HIV Alzheimer's Disease Cancer Type 2 Diabetes Premature Ejaculation Fertility COPD Schizophrenia Oral Contraceptive Hepatitis C Cancer Grass Pollen Allergy Vaccine Migraine Pain Glaucoma Anesthesia Adjuvant Anti-thrombotic Osteoporosis 9-Valent HPV Vaccine Cholesterol-Lowering Atrial Fibrillation Prevention of IchemiaReperfusion injury during CABG Surgery Cholesterol-Lowering Cholesterol-Lowering Insomnia HIV
Licensed, SK BioPharmaceuticals Licensed for EU, Eisai Licensed, Vertex Internally Developed Partnered with Pfizer Internally Developed Licensed, Mitsubishi Tanabe Licensed, PPD-GenuPro Internally Developed, from Schering-Plough Licensed for EU, Nycomed Internally Developed, from Schering-Plough Licensed, Merck KGaA Internally Developed, from Schering-Plough Licensed, Ariad Pharmaceuticals Licensed, ALK-Abello Internally Developed Licensed, Santen Internally Developed, from Schering-Plough Internally Developed, from Schering-Plough Internally Developed Internally Developed Internally Developed Licensed, Cardiome Licensed, PeriCor
Merck
Tredaptive (MK-0524A) MK-0524B (Simvastatin/ MK-0524A) MK-4305 Vicriviroc
Internally Developed Internally Developed Internally Developed Internally Developed, from Schering-Plough Internally Developed
MK-0507A (Trusopt/Timolol)
Glaucoma
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June 21, 2010
Corporates
Company Novartis Brand or Generic Name Menveo Indication Meningitis (Serotypes A, C, W-135, Y) Vaccine COPD Multiple Sclerosis Internally Developed or Licensed? Internally Developed Status FDA approved vaccine for ages 1155 on 2/22/10; filing for ages 211 expected in 2010, and ages two monthstwo years in 2011; EMEA approved on 3/15/10 after CHMP adopted a positive opinion on 12/17/09. Received a FDA complete response letter in 10/09 requesting additional dosage information; refiling planned in 2010. Phase III began in 6/06; data from FREEDOM I trial published in 9/09; FDA and EMEA filings occurred in 12/09; granted FDA priority review; advisory panel held 6/10/10 has unanimously favored approval; PDUFA extended three months to 9/21/10. Phase III began in 2/07; FDA and EMEA filings occurred in fourth quarter of 2009; EMEA filing withdrawn in 4/10 as new data requested could not be generated within the standardized time frame. EMEA filing for use in infants and children expected in the fourth quarter of 2010; Phase III discussions with FDA expected in the third quarter of 2010. Phase III started in 12/06; filing expected in 2010. Phase III in fallopian, ovarian cancer started in 11/05; filing for ovarian cancer expected in 2010. Phase III started in 11/09, expected filing in 2010 Lead indication changed to non-Hodgkins lymphoma which entered Phase III testing in 3/10; filings expected in 2010. Phase III trials initiated in 2/10; filings expected in 2011. Phase III trials began in 7/09; filings expected in 2011. Phase III for NSCLC began in 4/08; first-line indication studies discontinued in 3/10 while second-line treatment trials continue; filing now expected in 2012. New Phase III trials began in 6/08; filing expected in 2011. Phase III started in 6/09; filing expected in 2011. Phase III started in 12/06; expected FDA filing timeline moved out to 2012 from 2009 due to additional clinical trial work. Phase III began in 4/09; filing expected in 2012. Phase III trials investigating AML began in 4/08; filing for AML expected in 2013. Phase III began in 12/09; granted fast-track review status; expected EMEA and FDA filings in 2013. EMEA recommendation against approval received in 3/07 due to manufacturing concerns, resubmission planned after 2013. FDA approved on 2/24/10 for infants and toddlers after an advisory committee voted in favor of approval on 11/18/09; FDA and EMEA filings for adults expected in 2010. Withdrawing regulatory applications for osteoporosis treatment and prevention, and vaginal atrophy treatment; exploring strategic options for the drug compound, including out-licensing. Phase III studies completed in 10/09, filed to FDA on 12/20/09; granted fast-track approval and orphan drug status; FDA asked for additional non-clinical data and a response is expected in the second quarter of 2010; EMEA also granted orphan drug status. Received third FDA approvable letter in 6/07; additional clinical trials investigating combination use with sildenafil (Revatio) began in 10/08 and 3/09. Phase III (stroke in atrial fibrillation) study started in 12/06; Phase III (DVT) study started in 11/06; Phase III for VTE treatment started in 5/08; received FDA fasttrack designation for stroke, trial stopped early due to benefits; may file for stroke prevention to the FDA in 2011; may file to EMEA for VTE prevention in first half of 2010. Phase III trials for metastatic renal cell carcinoma began in 6/08. FDA approved for Dupuytrens Contracture on 2/22/10; EMEA filing occurred in 12/09. Phase III for NSCLC cancer began in 3/08, trial in combination with paclitaxel halted on 12/29/09 after an increase in morbidity in the treatment arm; refractory NSCLC trial testing drug with Tarceva discontinued on 3/12/10 due to ineffectiveness; earlier trials continue in breast, prostate and other cancers. Phase III initiated in 5/08 and complete enrollment in 6/09; clinical trials for mildto-moderate disease halted, while late-stage investigation into moderate-tosevere disease and Huntingtons disease continue. Phase III trials began for osteoarthritis pain in 11/08. Phase III trials started in the U.S. for rheumatoid arthritis in 2/09. Phase III in advanced NSCLC started in 9/09; FDA filing expected in first half of 2011.
Breezhaler (Indacaterol, QAB149) Gilenia (Fingolimod, FTY720) Zalbin/Joulferon (ABF656) MenB Pasireotide (SOM230) Patupilone (EPO906) AIN457 Panobinostat SBR759 INCB018424 ASA404 SMC021 NVA237 Agomelatine (AGO178) PTK-0796 Midostaurin (PKC412) Relaxin (RLX030, LCZ696) Mycograb Pfizer Prevnar 13 Valent
Internally Developed Licensed, Mitsubishi Tanabe Licensed, Human Genome Sciences Internally Developed Internally Developed Internally Developed Internally Developed Internally Developed Internally Developed Licensed outside U.S., Incyte Licensed, Antisoma Licensed, Nordic Biosciences Licensed, Vectura Licensed, Servier Licensed, Paratek Internally Developed Internally Developed, from Cothera Internally Developed, from NeuTec Internally Developed, from Wyeth Licensed, Ligand Licensed, Protalix
Hepatitis C Meningitis (serotype B) Vaccine Cushings Disease Cancer Uveitis Cancer Hyperphosphatamia Myelofibrosis Cancer Osteoporosis COPD Major Depression Disorder Antibiotic Cancer Heart Failure Severe Fungal Infections Pneumococcal Pneumonia Vaccine for Infants and Adults Osteoporosis Gauchers Disease
Fablyn (Lasofoxifene) Taliglucerase alfa
Thelin (Sitaxsentan) Apixaban
Pulmonary Arterial Hypertension DVT and Prevention of Stroke
Internally Developed, from Encysive Licensed, Bristol-Myers Squibb
Axitinib Xiaflex Figitumumab (CP751871) Dimebon Tanezumab Tasocitinib (CP-690550) Crizotinib (PF-2341066)
Cancer Dupuytrens Contracture Cancer
Internally Developed Licensed (EU only), Auxilium Internally Developed
Alzheimers Disease Pain Management Rheumatoid Arthritis Cancer
Licensed, Medivation Internally Developed Internally Developed Internally Developed
June 21, 2010
19
Corporates
Company Pfizer (Cont.) Brand or Generic Name Bapineuzumab (AAB-001) Bosutinib (SKI-606) Viviant (Bazedoxifene) Indication Alzheimer's Disease Cancer Osteoporosis Prevention and Treatment Relief of VMS due to Menopause Relief of VMS due to Menopause Cancer Cancer Rheumatoid Arthritis Osteoporosis Autoimmune Diseases Cancer Cancer Diabetes Cancer Cancer Dyslipidemia Cardio-protection in Diabetes Cancer Cancer Peripheral Arterial Disease Multiple Sclerosis Anticoagulant Cancer Diabetes Cancer Anticoagulant DTaP, Polio, and Influenza Type H Vaccine DTaP, Hep B, Polio, and Influenza Type H Vaccine Internally Developed or Licensed? Partnered with J&J Internally Developed, from Wyeth Licensed, Ligand Status Phase III trials initiated in 12/07; granted FDA fast track designation for mild to moderate Alzheimers disease; North American trial to complete in mid-2012 and Pfizer trials to end in 2014. Phase III trials started for chronic myelogenous leukemia in 12/07. Received second FDA approvable letter for prevention indication on 12/24/07, and received an approvable letter for treatment indication on 5/23/08; expected to file a complete response to both in the second half of 2009, with the expectation that a FDA Advisory Committee would have been held thereafter; Japan filing for treatment in 12/07. Phase III completed, FDA filing expected in second half of 2010; must first successfully complete additional work including a proposed formulation change and linking it to that used in clinical trials; additional clinical work may be necessary; plans currently contemplate an initial filing for only a lower dose. Received FDA approvable letter 7/07 for VMS necessitating a new clinical trial that is expected to be completed in the first half of 2010, plan to submit to the FDA in 2010; data may be used to refile to the EMEA after voluntarily withdrawing the application in 3/08. Phase III studies for HER-2 positive breast cancer started in 11/08. Phase III started in advanced NSCLC in 9/09. FDA approved on 1/8/10 after an FDA advisory panel voted in favor of approval on 7/29/08. Phase III started 9/04; Japanese filing on 10/29/09. Phase III (STAGE) for RA started in 12/06 for lupus nephritis in 2/08; both RA and lupus trials suspended in 3/10 as risks outweighed benefits; Phase II trials continue in multiple sclerosis. Phase III trials in second-line metastatic breast cancer started in 2/09; filing planned in 2010. Phase III for HER-2+ metastatic breast cancer started in 12/07; filing expected in 2011. Phase III trials started in 7/08, filings expected in 2011. Phase III trials in metastatic melanoma initiated in 1/10; filings expected in 2012. Phase III trials in chronic lymphocytic leukemia started in 12/09 and in nonHodgkins lymphoma in 3/10; filings expected in 2012. Phase III trials started in 4/08; filing expected in 2013. Phase III trials began in 2/10; filing planned after 2013. Phase III studies in prostate (began 8/07), colorectal (11/07), NSCL (9/07) cancers. Phase III for prostate cancer started 12/06; granted FDA fast-track status and rolling submission completed in 12/09 with a priority review; EMEA occurred in early 2010. Phase III started in 11/07; FDA and EMEA filings planned for 2011. Phase III started 9/04, another Phase III comparing drug vs. placebo began in 2/08. Phase III began in 6/08 for the prevention of VTE in cancer patients undergoing chemotherapy; now only pursuing oncology setting. Phase III in advanced sarcoma started in 6/08, expected filing in 2011. Phase III started in 6/08, study completion in 2010; EMEA filing expected in second half of 2011 and FDA filing planned for second half of 2012. Phase III studies in breast cancer began in 7/09; granted fast-track status, filing expected in the first quarter of 2011. Phase III started in 3/10. Phase III; filed to EMEA in the fourth quarter of 2009. Phase III.
Aprela (Bazedoxifene/ Conjugated Estrogens) Pristiq (Desvenlafaxine)
Licensed, Ligand
Internally Developed, from Wyeth Internally Developed, from Wyeth Internally Developed Partnered with Chugai Partnered with Chugai Partnered with Biogen Partnered with Immunogen Partnered with Chugai Licensed, Ipsen Licensed, Plexxikon Internally Developed Licensed, Japan Tobacco Internally Developed Licensed, Regeneron Pharmaceuticals Internally Developed Internally Developed Internally Developed Internally Developed Licensed, Ajinimoto Licensed, Zealand Pharma Internally Developed Internally Developed Internally Developed Internally Developed
neratinib (HKI-272) PF-299804 Actemra Eldecalcitrol (ED-71) Ocrelizumab Trastuzumab-DMI Omnitarg (Pertuzumab) Taspoglutide RG7204 (PLX4032) RG7159 (GA101, RO50772759) Dalcetrapib (JTT-705) Aleglitazar Sanofi-Aventis Aflibercept (VEGF-Trap) Jevtana (cabazitaxel, XRP6258) Temusi (XRP0038, NV1FGF) Teriflunomide Semuloparin (AVE5026) AVE8062 Lixisenatide (AVE0010) BSI-201 Otamixaban Pedicel (Second gen. Pentacel) Hexaxim
Roche
AML Acute myeloid leukemia. COPD Chronic obstructive pulmonary disease. CABG Coronary artery bypass graft. CRC Colorectal cancer. CV Cardiovascular. DVT Deep Vein Thrombosis. HCC Hepatocellular carcinoma. MACE Major adverse cardiovascular events. NSCLC Non-small cell lung cancer. PAH Pulmonary Arterial Hypertension. PMO Postmenopausal osteoporosis. PDUFA Prescription Drug User Fee Act. RA Rheumatoid arthritis. REMS Risk evaluation and mitigation strategy. VMS Vasomotor symptoms. VTE Venous thromboembolism. Source: Company reports.
20
June 21, 2010
Corporates
Key Statistics
Pharmaceutical Comparisons U.S. Quarterly Statistics
($ Mil.) Abbott Laboratories Amgen 3,592.0 8.6 (5.7) 3,592.0 100.0 8.6 (5.7) 863.0 24.0 11.1 (9.1) 3,233.0 90.0 7.0 (6.7) 1,163.0 32.4 646.0 18.0 7,027.0 47.1 39.4 0.0 1.7 (2,032.0) 0.0 3,809.0 1.6 (0.1) 3,809.0 100.0 1.6 (0.1) 949.0 24.9 3.9 2.7 3,465.0 91.0 0.6 (0.5) Bristol-Myers Squibb Co. 4,807.0 (4.2) (4.5) 4,807.0 100.0 11.2 (4.5) 1,666.0 34.7 16.1 3.0 3,305.0 68.8 12.4 (3.1) 1,980.0 41.2 910.0 18.9 39.0 0.8 (83.5) 21.9 8,157.0 39.4 4.8 (1,703.0) 0.8 (487.0) (2,418.0) 5,033.0 1.5 (8.3) 5,033.0 100.0 10.8 5.1 1,618.0 32.2 10.1 4.1 3,410.0 67.8 12.9 6.2 Eli Lilly & Co 5,485.5 8.7 (7.6) 5,195.9 94.7 8.6 (6.9) 1,215.0 22.2 8.2 (11.1) 3,460.3 63.1 15.0 (6.3) 1,744.4 31.8 1,039.1 18.9 8.8 0.2 131.6 7,992.4 35.9 10.4 (122.3) 0.8 1,923.0 (2,154.5) 5,934.2 13.9 6.7 5,581.1 94.1 14.3 6.4 1,366.5 23.0 19.2 11.7 3,691.1 62.2 18.8 9.5 Johnson & Johnson 15,631.0 4.0 (5.6) 5,638.0 36.1 (2.5) (5.9) 1,188.0 7.6 15.6 4.4 2,790.0 17.9 (5.4) (5.3) 371.0 2.4 1,557.0 10.0 108.0 0.7 (49.3) (62.1) 20,239.0 32.4 15.5 (1,701.0) 0.6 (5,907.0) (5,404.0) 16,551.0 9.0 9.8 5,993.0 36.2 5.4 14.2 1,138.0 6.9 28.4 9.9 2,946.0 17.8 3.2 16.6 Merck & Co., Inc. 11,422.2 112.1 13.2 9,793.4 85.7 81.9 8.0 1,165.3 10.2 10.2 (7.5) 3,665.7 32.1 29.5 1.7 1,946.8 17.0 2,026.7 17.7 443.0 3.9 (62.0) (55.0) 8,015.3 24.0 (4.1) (8,973.9) 2.4 9,326.2 (3,864.2) 10,093.5 67.3 66.8 9072.0 89.9 50.4 50.0 1,260.1 12.5 12.3 16.1 3,603.0 35.7 19.3 19.1 Pfizer Inc. 16,750.0 54.1 1.3 14,506.0 86.6 43.6 (0.7) 2,757.0 16.5 1.3 (13.2) 5,568.0 33.2 13.5 (2.3) 5,836.0 34.8 2,226.0 13.3 22,135.0 39.6 1.7 (43,123.0) 2.1 28,788.0 (4,856.0) 16,537.0 34.0 42.3 14,606.0 88.3 29.9 36.8 3,175.0 19.2 0.9 11.3 5,698.0 34.5 2.6 11.4
Three Months Ended March 31, 2010

Total Revenues YOY Quarterly Revenue Growth (%) Sequential Quarterly Revenue Growth (%) Total Pharmaceutical Sales % of Sales YOY Quarterly Revenue Growth (%) Sequential Quarterly Revenue Growth (%) Top-selling Product % of Sales YOY Quarterly Revenue Growth (%) Sequential Quarterly Revenue Growth (%) Top Five Products % of Sales YOY Quarterly Revenue Growth (%) Sequential Quarterly Revenue Growth (%) Sales "At-risk" % of Sales R&D Expense % of Sales New Drug Product Sales % of Sales YOY Quarterly Revenue Growth (%) Sequential Quarterly Revenue Growth (%) Operating LTM EBITDA Operating EBITDA Margin (%) Free Cash Flow Margin (%) Net Acquisitions and Divestitures Total Debt with Equity Credit/ Operating LTM EBITDA (x) Net Debt LTM Dividends 7,698.4 14.6 (12.4) 4,103.0 53.3 12.8 (15.4) 1,397.0 18.2 36.4 (15.9) 2,357.0 30.6 21.6 (19.5) 291.0 3.8 730.4 9.5 9,356.9 29.5 14.3 (7,294.1) 1.9 15,505.0 (2,476.2) 8,790.1 10.6 13.3 4,849.0 55.2 5.2 19.6 1,662.0 18.9 23.0 11.5 2,928.0 33.3 9.5 13.3
Three Months Ended Dec. 31, 2009

Total Revenues YOY Quarterly Revenue Growth (%) Sequential Quarterly Revenue Growth (%) Total Pharmaceutical Sales % of Sales YOY Quarterly Revenue Growth (%) Sequential Quarterly Revenue Growth (%) Top-selling Product % of Sales YOY Quarterly Revenue Growth (%) Sequential Quarterly Revenue Growth (%) Top Five Products % of Sales YOY Quarterly Revenue Growth (%) Sequential Quarterly Revenue Growth (%) Source: Company reports. Continued on next page.
June 21, 2010
21
Corporates
Pharmaceutical Comparisons U.S. Quarterly Statistics (Continued)
($ Mil.) Abbott Laboratories Amgen 1,272.0 33.4 891.0 23.4 66.0 1.7 43.5 13.8 6,873.0 46.9 39.7 0.0 1.5 (2,841.0) 0.0 3,812.0 (1.6) 2.7 3,812.0 100.0 (1.6) 2.7 924.0 24.2 3.5 2.8 3,482.0 91.3 (2.3) 2.8 566.0 14.9 647.0 17.0 58.0 1.5 41.5 3.6 6,946.0 47.6 36.7 (6.0) 1.7 (2,477.0) 0.0 Bristol-Myers Squibb Co. 1,957.0 38.9 1,057.0 21.0 32.0 0.6 (86.7) (79.4) 7,940.0 38.0 4.1 (1,675.0) 0.8 (2,153.0) (2,483.0) 5,487.0 4.4 1.9 4,788.0 87.3 6.2 2.6 1,554.0 28.3 8.0 11.6 3,211.0 58.5 8.0 7.3 1,883.0 34.3 838.0 15.3 155.0 2.8 (31.4) 14.0 6,144.0 29.5 (1.0) (1,868.0) 1.1 (76.0) (2,473.0) Eli Lilly & Co 1,939.7 32.7 1,216.7 20.5 3.8 0.1 (83.2) 8,036.3 36.8 6.5 (72.3) 0.8 2,164.5 (2,152.1) 5,562.0 6.8 5.1 5,247.2 94.3 6.4 4.6 1,223.0 22.0 2.8 1.7 3,372.5 60.6 6.9 6.3 1,814.3 32.6 1,122.1 20.2 22.6 0.4 8,075.6 38.3 8.5 (6,012.9) 0.9 3,463.1 (2,127.6) Johnson & Johnson 452.0 2.7 2,213.0 13.4 285.0 1.7 14.9 20,065.0 32.4 14.3 (2,316.0) 0.7 (4,884.0) (5,327.0) 15,081.0 (5.3) (1.0) 5,249.0 34.8 (14.1) (4.5) 1,036.0 6.9 5.9 (6.0) 2,526.0 16.8 (17.5) (6.7) 572.0 3.8 1,617.0 10.7 248.0 1.6 3.8 19,650.0 32.5 12.2 (2,410.0) 0.6 (2,737.0) (5,248.0) Merck & Co., Inc. 2,215.1 22.0 1,971.5 19.5 984.4 9.8 (22.9) 13.6 7,012.7 25.6 (5.6) (8,972.6) 2.5 7,849.6 (3,479.1) 6,049.7 1.8 2.5 6,049.7 100.0 1.8 2.5 1,085.0 17.9 5.4 (13.7) 3,024.4 50.0 (0.9) (4.6) 1,945.9 32.2 1,254.0 20.7 866.3 14.3 (23.8) (21.5) 7,713.8 33.0 (10.2) (130.0) 1.2 (13,184.8) (3,219.7) Pfizer Inc. 5,208.0 31.5 2,800.0 16.9 176.0 1.1 (56.0) 13.6 21,115.0 42.2 19.7 (43,123.0) 2.3 22,693.0 (5,548.0) 11,621.0 (2.9) 5.8 10,677.0 91.9 (2.7) 6.1 2,853.0 24.6 (9.2) 6.3 5,117.0 44.0 (7.2) 6.5 4,168.0 35.9 1,627.0 14.0 155.0 1.3 (62.0) (19.3) 21,685.0 47.3 22.2 (210.0) 1.8 (13,117.0) (6,400.0)
Three Months Ended Dec. 31, 2009 (Cont.)

Sales "At-risk" % of Sales R&D Expense % of Sales New Drug Product Sales % of Sales YOY Quarterly Revenue Growth (%) Sequential Quarterly Revenue Growth (%) Operating LTM EBITDA Operating EBITDA Margin (%) Free Cash Flow Margin (%) Net Acquisitions and Divestitures Total Debt with Equity Credit/ Operating LTM EBITDA (x) Net Debt LTM Dividends 418.0 4.8 747.0 8.5 8,861.7 28.8 12.3 (2,370.6) 1.9 6,523.9 (2,414.5) 7,761.3 3.5 3.6 4,055.0 52.3 (1.6) 2.8 1,491.0 19.2 23.8 12.0 2,584.0 33.3 4.9 7.9 330.0 4.3 675.7 8.7 8,447.9 28.2 11.9 (1,518.9) 1.9 6,959.2 (2,354.3)
Three Months Ended Sept. 30, 2009

Total Revenues YOY Quarterly Revenue Growth (%) Sequential Quarterly Revenue Growth (%) Total Pharmaceutical Sales % of Sales YOY Quarterly Revenue Growth (%) Sequential Quarterly Revenue Growth (%) Top-selling Product % of Sales YOY Quarterly Revenue Growth (%) Sequential Quarterly Revenue Growth (%) Top Five Products % of Sales YOY Quarterly Revenue Growth (%) Sequential Quarterly Revenue Growth (%) Sales "At-risk" % of Sales R&D Expense % of Sales New Drug Product Sales % of Sales YOY Quarterly Revenue Growth (%) Sequential Quarterly Revenue Growth (%) Operating LTM EBITDA Operating EBITDA Margin (%) Free Cash Flow Margin (%) Net Acquisitions and Divestitures Total Debt with Equity Credit/ Operating LTM EBITDA (x) Net Debt LTM Dividends Source: Company reports. Continued on next page.
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June 21, 2010
Corporates
Pharmaceutical Comparisons U.S. Quarterly Statistics (Continued)
($ Mil.) Abbott Laboratories Amgen 3,713.0 (1.4) 12.2 3,713.0 100.0 (1.4) 12.2 899.0 24.2 4.3 15.7 3,388.0 91.3 (2.9) 12.1 561.0 15.1 693.0 18.7 56.0 1.5 75.0 5.7 6,811.0 46.5 4,732.0 (8.0) 1.7 (494.0) 0.0 Bristol-Myers Squibb Co. 5,384.0 3.5 7.4 4,665.0 86.7 4.3 7.9 1,393.0 25.9 0.4 (2.9) 2,992.0 55.6 4.7 1.8 1,706.0 31.7 829.0 15.4 136.0 2.5 (34.6) (42.4) 5,759.0 27.9 (272.0) 4,396.0 1.1 (1,761.0) (2,462.0) Eli Lilly & Co 5,292.8 2.8 4.9 5,017.4 94.8 2.5 4.9 1,203.2 22.7 (2.9) 7.1 3,174.0 60.0 1.3 5.5 1,556.4 29.4 1,040.4 19.7 7,789.0 37.5 2,581.5 (6,057.3) 1.0 4,232.5 (2,111.3) Johnson & Johnson 15,239.0 (7.4) 1.4 5,498.0 36.1 (13.3) (4.9) 1,102.0 7.2 24.4 7.2 2,706.0 17.8 (17.5) (8.2) 622.0 4.1 1,638.0 10.8 239.0 1.6 12.2 19,581.0 31.9 7,001.0 (1,709.0) 0.7 (1,102.0) (5,181.0) Merck & Co., Inc. 5,899.9 (2.5) 9.6 5,899.9 100.0 (2.5) 9.6 1,257.4 21.3 16.3 18.9 3,170.7 53.7 2.5 12.0 1,065.6 18.1 1,395.3 23.7 1,103.5 18.7 4.5 (5.2) 7,638.1 32.8 (545.5) (130.0) 1.4 (6,249.4) (3,337.9) Pfizer Inc. 10,984.0 (9.4) 1.1 10,063.0 91.6 (9.0) (0.4) 2,685.0 24.4 (9.8) (1.3) 4,803.0 43.7 (8.8) (2.1) 3,236.0 29.5 1,663.0 15.1 192.0 1.8 (54.1) (51.6) 21,714.0 47.0 8,763.0 (210.0) 1.8 (10,138.0) (7,464.0)
Three Months Ended June 30, 2009

Total Revenues YOY Quarterly Revenue Growth (%) Sequential Quarterly Revenue Growth (%) Total Pharmaceutical Sales % of Sales YOY Quarterly Revenue Growth (%) Sequential Quarterly Revenue Growth (%) Top-selling Product % of Sales YOY Quarterly Revenue Growth (%) Sequential Quarterly Revenue Growth (%) Top Five Products % of Sales YOY Quarterly Revenue Growth (%) Sequential Quarterly Revenue Growth (%) Sales "At-risk" % of Sales R&D Expense % of Sales New Drug Product Sales % of Sales YOY Quarterly Revenue Growth (%) Sequential Quarterly Revenue Growth (%) Operating LTM EBITDA Operating EBITDA Margin (%) Free Cash Flow Margin (%) Net Acquisitions and Divestitures Total Debt with Equity Credit/ Operating LTM EBITDA (x) Net Debt LTM Dividends Source: Company reports. 7,494.9 2.5 11.6 3,946.0 52.7 (4.3) 8.5 1,331.0 17.8 22.2 (30.0) 2,395.0 32.0 1.5 23.5 336.0 4.5 670.2 8.9 8,166.3 27.5 3,302.5 (1,759.4) 1.9 8,815.4 (2,291.4)
June 21, 2010
23
Corporates
Pharmaceutical Comparisons U.S. Yearly Statistics
($ Mil.) Abbott Laboratories Amgen 14,642.0 (2.4) 14,642.0 100.0 (2.4) 3,493.0 23.9 (2.9) 13,357.0 91.2 (3.6) 4,894.0 33.4 2,864.0 19.6 233.0 1.6 52.3 6,873.0 46.9 39.7 0.0 1.5 (2,841.0) 0.0 BristolMyers Squibb Co. 20,597.0 6.5 17,715.0 86.0 13.4 5,603.0 27.2 17.8 11,487.0 55.8 18.4 6,893.0 33.5 3,531.0 17.1 960.0 4.7 (4.1) 5,271.0 25.6 1.5 4,648.0 1.3 (1,526.0) (2,461.0) Bristol-Myers Squibb Co. 18,808.0 (8.7) 18,808.0 100.0 6.2 6,146.0 32.7 9.7 12,699.0 67.5 10.6 7,429.0 39.5 3,647.0 19.4 559.0 3.0 (41.8) 5,829.0 31.0 4.5 (1,675.0) 1.1 (2,153.0) (2,483.0) Eli Lilly & Co 20,378.0 109.4 19,284.7 94.6 9.3 4,696.1 23.0 (1.4) 12,293.3 60.3 10.3 6,415.9 31.5 3,840.9 18.9 6,905.8 33.9 21.1 (6,179.3) 1.5 4,535.9 (2,056.7) Eli Lilly & Co 21,836.0 7.2 20,628.8 94.5 7.0 4,915.7 22.5 4.7 13,214.5 60.5 7.5 7,309.3 33.5 4,326.5 19.8 26.4 0.1 8,036.3 36.8 6.5 (72.3) 0.8 2,164.5 (2,152.1) Johnson & Johnson 63,747.0 4.3 24,567.0 38.5 (1.2) 3,748.0 5.9 (20.2) 12,773.0 20.0 (14.8) 5,480.0 8.6 7,577.0 11.9 19,628.0 30.8 10.8 (429.0) 0.6 (957.0) (5,024.0) Johnson & Johnson 61,897.0 (2.9) 22,520.0 36.4 (8.3) 4,304.0 7.0 14.8 10,850.0 17.5 (15.1) 1,550.0 2.5 6,986.0 11.3 985.0 1.6 20,065.0 32.4 14.3 (2,316.0) 0.7 (4,884.0) (5,327.0) Merck & Co., Inc. 23,850.3 (1.4) 23,850.3 100.0 (1.4) 4,336.9 18.2 1.7 12,247.2 51.4 (6.3) 4,318.1 18.1 4,805.3 20.2 4,505.0 18.9 5.0 8,064.7 33.8 7.8 0.0 0.8 754.0 (3,278.5) Merck & Co., Inc. 27,428.3 15.0 25,236.0 92.0 5.8 4,659.7 17.0 7.4 12,360.7 45.1 0.9 8,220.4 30.0 5,845.0 21.3 4,118.5 15.0 (8.6) 7,012.7 25.6 (5.6) (8,972.6) 2.5 7,849.6 (3,479.1) ScheringPlough Corporation 18,502.0 45.8 14,253.0 77.0 40.1 2,119.0 11.5 28.6 5,980.0 32.3 12.6 1,165.0 6.3 3,529.0 19.1 5,107.0 27.6 11.1 285.0 1.6 4,798.0 (422.0) Pfizer Inc. 50,009.0 3.6 45,558.0 91.1 3.1 11,434.0 22.9 (7.8) 20,522.0 41.0 (5.2) 20,418.0 40.8 7,754.0 15.5 920.0 1.8 (61.3) 21,115.0 42.2 19.7 (43,123.0) 2.3 22,693.0 (5,548.0)
2009
Total Revenues Year-Over-Year Revenue Growth (%) Total Pharmaceutical Sales % of Sales Year-Over-Year Revenue Growth (%) Top-selling Product % of Sales Year-Over-Year Revenue Growth (%) Top Five Products % of Sales Year-Over-Year Revenue Growth (%) Sales "At Risk" % of Sales R&D Expense % of Sales New Drug Product Sales % of Sales Year-Over-Year Revenue Growth (%) Operating EBITDA Operating EBITDA Margin (%) Free Cash Flow Margin (%) Net Acquisitions and Divestitures Total Debt with Equity Credit/ Operating EBITDA (x) Net Debt Dividends 30,764.7 4.2 16,486.0 53.6 (1.3) 5,488.0 17.8 21.4 9,846.0 32.0 3.0 1,337.0 4.4 2,743.7 8.9 8,861.7 28.8 12.3 (2,370.6) 1.9 6,523.9 (2,414.5) Abbott Laboratories
Amgen 15,003.0 1.6 15,003.0 100.0 1.6 3,598.0 24.0 (0.4) 13,850.0 92.3 1.8 2,299.0 15.3 3,030.0 20.2 153.0 1.0 (60.1) 6,929.0 46.2 35.4 (56.0) 1.5 624.0 0.0
Pfizer Inc. 48,296.0 (0.3) 44,174.0 91.5 (0.6) 12,401.0 25.7 (2.2) 21,641.0 44.8 9.3 12,990.0 26.9 7,512.0 15.6 2,379.0 4.9 (38.2) 22,099.0 45.8 16.5 (1,172.0) 0.8 (6,448.0) (8,541.0)
Wyeth 22,833.9 1.9 19,025.4 83.3 2.2 3,927.9 17.2 3.5 11,570.7 50.7 2.2 5,930.1 26.0 3,244.7 14.2 344.7 1.5 (3.3) 8,268.2 36.2 10.3 (97.6) 1.4 (2,806.1) (1,520.3)
2008
Total Revenues Year-Over-Year Revenue Growth (%) Total Pharmaceutical Sales % of Sales Year-Over-Year Revenue Growth (%) Top-selling Product % of Sales Year-Over-Year Revenue Growth (%) Top Five Products % of Sales Year-Over-Year Revenue Growth (%) Sales "At Risk" % of Sales R&D Expense % of Sales New Drug Product Sales % of Sales Year-Over-Year Revenue Growth (%) Operating EBITDA Operating EBITDA Margin (%) Free Cash Flow Margin (%) Net Acquisitions and Divestitures Total Debt with Equity Credit/ Operating EBITDA (x) Net Debt Dividends 29,527.6 13.9 16,708.0 56.6 14.2 4,522.0 15.3 47.6 9,558.0 32.4 20.4 1,341.0 4.5 2,688.8 9.1 7,977.0 27.0 13.2 (250.0) 1.4 6,365.7 (2,174.3)
Source: Company reports. Continued on next page.
24
June 21, 2010
Corporates
Pharmaceutical Comparisons U.S. Yearly Statistics (Continued)
($ Mil.) Abbott Laboratories BristolMyers Squibb Co. 19,348.0 8.0 15,622.0 80.7 12.7 4,755.0 24.6 46.0 9,699.0 50.1 18.5 89.0 0.5 3,472.0 18.0 1,001.0 5.2 (23.6) 4,323.0 22.3 0.5 317.0 1.5 4,047.0 (2,213.0) Eli Lilly & Co 18,633.5 18.8 17,637.7 94.7 19.1 4,761.0 25.6 9.1 11,145.3 59.8 18.2 425.5 2.3 3,486.7 18.7 2,024.2 10.9 (8.9) 6,132.8 32.9 11.9 (2,751.9) 0.8 176.0 (1,853.6) Johnson & Johnson 61,095.0 14.6 24,866.0 40.7 6.9 4,697.0 7.7 12.3 14,992.0 24.5 7.6 8,507.0 13.9 7,680.0 12.6 18,688.0 30.6 12.5 (1,158.0) 0.5 222.0 (4,670.0) Merck & Co., Inc. 24,197.7 6.9 24,197.7 100.0 6.9 4,266.3 17.6 19.2 13,066.1 54.0 (2.7) 7,949.4 32.9 4,557.7 18.8 4,292.6 17.7 155.3 8,810.0 36.4 11.1 (1,135.9) 0.7 (2,491.4) (3,307.3) ScheringPlough Corporation 12,690.0 19.8 10,173.0 80.2 18.8 1,648.0 13.0 32.9 5,311.0 41.9 19.5 1,182.0 9.3 2,926.0 23.1 991.5 7.8 2.6 3,012.0 23.7 11.9 (15,787.0) 4.0 7,169.0 (382.0)
Amgen 14,771.0 3.5 14,771.0 100.0 3.5 3,614.0 24.5 (12.3) 13,610.0 92.1 1.3 2,525.0 17.1 3,266.0 22.1 383.0 2.6 6.4 6,763.0 45.8 28.0 (697.0) 1.7 4,026.0 0.0
Pfizer Inc. 48,418.0 0.1 44,424.0 91.8 (1.5) 12,675.0 26.2 (1.6) 19,809.0 40.9 (16.6) 952.0 2.0 7,573.0 15.6 3,852.0 8.0 77.8 20,211.0 41.7 7.2 (410.0) 0.7 (12,336.0) (7,975.0)
Wyeth 22,399.8 10.1 18,622.0 83.1 10.3 3,793.9 16.9 1.9 11,326.2 50.6 12.9 4,492.1 20.1 3,149.3 14.1 356.6 1.6 (6.0) 7,635.3 34.1 13.7 (100.0) 1.5 (1,643.2) (1,423.5)
2007
Total Revenues Year-Over-Year Revenue Growth (%) Total Pharmaceutical Sales % of Sales Year-Over-Year Revenue Growth (%) Top-selling Product % of Sales Year-Over-Year Revenue Growth (%) Top Five Products % of Sales Year-Over-Year Revenue Growth (%) Sales "At Risk" % of Sales R&D Expense % of Sales New Drug Product Sales % of Sales Year-Over-Year Revenue Growth (%) Operating EBITDA Operating EBITDA Margin (%) Free Cash Flow Margin (%) Net Acquisitions and Divestitures Total Debt with Equity Credit/ Operating EBITDA (x) Net Debt Dividends Source: Company reports. 25,914.2 15.3 14,632.0 56.5 18.0 3,063.0 11.8 49.9 7,939.0 30.6 25.0 2,791.0 10.8 2,505.6 9.7 6,863.1 26.5 6.1 0.0 1.8 9,393.0 (1,959.1)
June 21, 2010
25
Corporates
Pharmaceutical Comparisons European Yearly Statistics
($ Mil.) Company Name GlaxoSmithKline 44,254.10 16.50 36,993.80 83.60 16.40 7,764.10 17.50 20.30 13,572.00 30.70 12.30 5,534.00 12.50 4,807.9 10.90 3,432.00 7.80 37.30 15,749.80 35.60 7.40 (4,123.10) 1.60 15,204.80 1.00 (4,823.50) Sanofi-Aventis 40,859.30 6.30 36,003.20 88.10 4.50 4,294.20 10.50 12.50 16,952.40 41.50 8.70 4,002.80 9.80 6,389.80 15.60
513.10 1.30 NM
AstraZeneca 32,804.00 3.80 32,804.00 100.00 3.80 4,959.00 15.10 (4.60) 18,542.00 56.50 8.40 3,641.00 11.10 4,409.00 13.40

Roche 45,274.10 7.50 35,993.30 79.50 8.40 5, 742.90 12.70 5.0 20,702.90 45.70 11.60 976.50 2.20 8,211.00 18.10 1,503.60 3.30 (21.00) 16,341.70 36.10 18.00 (73.80) 2.40 22,993.50 1.40 (4,056.60)
Novartis 44,267.00 6.80 28,538.00 64.50 8.40 6,013.00 13.60 4.80 13,847.00 31.30 6.20 3,631.00 8.20 5,840.00 13.20 3,882.00 8.80 32.40 12,248.00 27.70 14.10 (1,801.00) 1.10 (3,461.00) (0.20) (3,993.00)
Bayer 43,455.40 (5.30) 14,593.40 33.60 4.40 1,781.80 4.10 4.60 6,437.20 14.80 7.30 147.8 0.30 2,575.10 5.90

2009
Total Revenues Year-Over-Year Revenue Growth (%) Total Pharmaceutical Sales % of Sales Year-Over-Year Revenue Growth (%) Top-Selling Product % of Sales Year-Over-Year Revenue Growth (%) Top Five Products % of Sales Year-Over-Year Revenue Growth (%) Sales "At Risk" % of Sales R&D Expense % of Sales New Drug Product Sales % of Sales Growth % Year-over-year Operating EBITDA Operating EBITDA Margin (%) Free Cash Flow Margin (%) Net Acquisitions and Divestitures Total Debt/EBITDA (x) Net Debt Net Debt with Equity Credit/Operating EBITDA (x) Dividends
17,440.40 42.70 13.10 (7,763.10) 0.70 6,542.60 0.40 (4,012.60)
12,770.00 38.90 17.90
0.90 (290.00) 0.00 (2,988.00)
8,716.70 20.10 7.20 (259.30) 2.00 13,759.20 1.80 (1,356.60)
2008
Total Revenues Year-Over-Year Revenue Growth (%) Total Pharmaceutical Sales % of Sales Year-Over-Year Revenue Growth (%) Top-Selling Product % of Sales Year-Over-Year Revenue Growth (%) Top Five Products % of Sales Year-Over-Year Revenue Growth (%) Sales "At Risk" % of Sales R&D Expense % of Sales New Drug Product Sales % of Sales Growth % Year-over-year Source: Company reports. Continued on next page. 45,177.30 7.00 37,810.40 83.70 6.40 7,674.90 17.00 18.30 14,337.60 31.80 4.30 8177.00 18.10 6,486.00 14.40 2,498.00 5.50 (33.40) 40,672.20 (1.70) 40,672.20 100.00 (1.70) 4,039.50 9.90 4.80 16,501.70 40.60 6.90 1,341.10 3.30 6,731.40 16.60

31,601.00 6.90 31,601.00 100.00 6.90 5,200.00 16.50 (0.30) 17,110.00 54.10 11.50 1,099.00 3.50 5,179.00 16.40

42,261.40 (1.10) 33,315.70 78.80 (4.00) 5,487.30 13.00 16.00 18,616.80 44.10 7.70 1,322.00 3.10 7,322.60 17.30 1,903.00 4.50 19.20
41,459.00 8.90 26,331.00 63.50 9.60 5,740.00 13.80 15.00 13,044.00 31.50 15.20 483.00 1.20 5,716.00 13.80 2,931.00 7.10 104.0
48,565.20 1.60 15,792.00 32.50 4.30 1,802.90 3.70 17.30 6,346.90 13.10 9.00 169.70 0.30 2,265.90 4.70

26
June 21, 2010
Corporates
Pharmaceutical Comparisons European Yearly Statistics (Continued)
($ Mil.) Company Name GlaxoSmithKline 17,566.70 38.90 7.90 (825.60) 1.70 14,729.50 1.20 (5,580.40) Sanofi-Aventis 16,172.70 39.80 15.30 (984.10) 0.50 3,114.00 0.40 (3,987.80) AstraZeneca 10,903.00 34.50 6.40 32.00 1.10 7,452.00 1.20 (2,776.00) Roche 15,324.20 36.30 10.90 (2,746.00) 0.30 15,802.90 (1.00) (3,748.40) Novartis 11,724.00 28.30 10.30 (11,601.00) 0.60 1,247.00 0.10 (3,395.00) Bayer 10,058.90 20.70 (1.30) (2,385.60) 2.30 19,733.00 1.80 (1,661.20)
2008 (Cont.)
Operating EBITDA Operating EBITDA Margin (%) Free Cash Flow Margin (%) Net Acquisitions and Divestitures Total Debt/EBITDA (x) Net Debt Net Debt with Equity Credit/Operating EBITDA (x) Dividends
2007
Total Revenues Year-Over-Year Revenue Growth (%) Total Pharmaceutical Sales % of Sales Year-Over-Year Revenue Growth (%) Top-Selling Product % of Sales Year-Over-Year Revenue Growth (%) Top Five Products % of Sales Year-Over-Year Revenue Growth (%) Sales "At Risk" % of Sales R&D Expense % of Sales New Drug Product Sales % of Sales Growth % Year-Over-Year Operating EBITDA Operating EBITDA Margin (%) Free Cash Flow Margin (%) Net Acquisitions and Divestitures Total Debt/EBITDA (x) Net Debt Net Debt with Equity Credit/Operating EBITDA (x) Dividends Source: Company reports. 45,204.80 (2.20) 38,273.70 84.70 (4.20) 6,963.00 18.20 5.60 14,113.00 36.90 (4.90) 9,862.40 25.80 6,391.70 16.70 3,748.00 3.40 378.70 17,167.70 38.00 7.40 2,041.70 1.20 12,017.60 0.70 (5,711.30) 37,028.60 (1.10) 37,028.60 100.00 (1.10) 34,478.20 9.30 7.30 13,809.80 37.30 7.00 912.10 2.50 5,988.80 16.20

29,559.00 11.60 29,559.00 100.00 11.60 5,216.00 17.60 0.70 15,344.00 51.90 10.20 992.00 3.40 5,162.00 17.50

38,444.10 9.70 30,652.50 80.00 10.40 4,596.70 15.00 14.00 15,353.30 50.10 11.10 1,472.60 7.20 6,331.70 19.50 1,597.00 2.00 318.10 14,170.00 36.90 10.90 0.00 0.40 15,187.50 (1.00) (2,522.50)
38,072.00 10.70 24,025.00 63.10 6.40 5,012.00 13.20 18.70 11,330.00 47.20 9.00 0.00 0.00 5,088.00 21.20 1,437.00 2.20 486.50 9,717.00 25.50 10.60 (488.00) 0.60 (7,407.00) (0.80) (2,638.00
42,748.20 11.80 13,552.40 31.70 37.30 1,375.40 10.10 30.60 5,210.00 38.40 34.10 148.90 1.00 2,003.80 14.80

14,220.40 38.40 11.10 140.00 0.60 5,583.60 0.40 (3,132.40)
9,724.00 32.90 11.90 (14,470.00) 1.60 9,369.00 1.00 (2,650.00)
9,187.20 21.50 (0.70) (648.00) 2.00 16,086.80 1.30 (1,020.40)
June 21, 2010
27
Corporates
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Global Pharmaceutical R&D Pipeline

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