Bristol-Myers Squibb: Pipeline, Products, Performance, Potential

Date: November 22, 2010
Pages: 162
Price:
US$ 1,040.00
Publisher: Espicom Business Intelligence
Report type: Strategic Report
Delivery: E-mail Delivery (PDF)
ID: B457ADE283AEN
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Bristol-Myers Squibb: Pipeline, Products, Performance, Potential
Since the merger to form the company in 1989, BMS has consistently been in the top ten research-based pharmaceutical companies in terms of pharmaceutical sales. However, in 2006, BMS reported its third consecutive year of revenue loss, which looked to threaten this position. The company is going through a transitional period, whereby many older products have seen considerable declines in sales due to generic competition whilst newer products begin to establish themselves in the market place. In fiscal 2007, BMS once again returned to revenue growth, but in fiscal 2009 revenues declined 8.7 per cent from the previous year.

This period of transition has been made more difficult due to patent issues surrounding Plavix, the company’s top selling product. BMS and its partner sanofi-aventis have been involved in litigation with Apotex since March 2002, following the filing by Apotex of an ANDA for clopidogrel with the FDA. In March 2006, the parties initially agreed a settlement, granting Apotex a royalty-bearing licence to manufacture and sell a generic clopidogrel bisulphate product in the US effective 1st June 2011, three months prior to the patent expiration. However, this agreement failed to receive antitrust clearance from the state attorneys general and consequently the suspended patent litigation was reinstated.

Problems deepened in August 2006, when Apotex decided to launch its 75 mg clopidogrel bisulphate tablets, despite the outstanding patent litigation over the drug. In response, sanofi-aventis and BMS moved for a preliminary injunction ordering Apotex to halt its sales of clopidogrel. On 31st August 2006, it was announced that the US District Court for the Southern District of New York had granted this injunction. However, the Court also ordered sanofi-aventis and BMS to post a bond in the amount of US$400 million to provide security to Apotex should the Court conclude at the end of the patent litigation that the injunction was wrongly imposed.

The patent litigation between Apotex and BMS/sanofi-aventis ended on 15th February 2007 and, in June 2007 it was announced that BMS/sanofi-aventis had been successful and Apotex’ generic product will not be released until 2011. The saga surrounding the litigation has already seen Peter Dolan, the company’s chief executive for five years, leave the company and has led to several rumours of a merger between BMS and sanofi-aventis. There could be several significant long-term implications to arise from this litigation.

BMS is looking to refresh its product portfolio, adopting a strategy of increased R&D investment despite decreased income. To this end, BMS’ research ratio has increased from 12.2 per cent in 2003, to 19.4 per cent in 2009. Higher levels of expenditure have reaped dividends for the company with three new products launched in 2009: Onglyza, Abilify and Sprycel.

There are also several established products in the portfolio which will help drive BMS’ pharmaceutical sales in the future. Avapro continues to benefit from co-development and co-marketing with sanofi-aventis and, along with Plavix, is the main focus of their collaboration. BMS is a world leader in virology, with the Sustiva franchise (which now includes Atripla) and Reyataz forecast to be leading competitors in this field for some time. The company is also heavily involved in projects to provide HIV/AIDS treatment on a worldwide scale, most notably in sub-Saharan Africa where there is the highest level of unmet medical need. Within neuroscience, Abilify continues to sell well, whilst in oncology, Erbitux has been launched and is being investigated in a variety of oncology conditions. This versatility should ensure strong sales growth.

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EXECUTIVE SUMMARY

A detailed and comprehensive overview of current financial position, company strategy, product and pipeline analysis.

THERAPEUTIC AREA FOCUS

Key product analysis and forecasting

Cardiovascular & Metabolic
  Avapro/Avalide (irbesartan)
  Plavix/Iscover (clopidrogel)
Virology
  Atripla (efavirenz+emtricitabine+ tenofovir disoproxil fumarate)
  Baraclude (entecavir)
  Reyataz (atazanavir)
  Sustiva (efavirenz)
Neuroscience
  Abilify (aripiprazole)
  Emsam (selegiline transdermal system)
Oncology
  Erbitux (cetuximab)
  Ixempra (ixabepilone)
  Sprycel (dasatinib)
Immunology
  Orencia (abatacept)

OPERATIONAL DATA

A wealth of background and detail
  A full 5-year financial performance assessment
  Key corporate events
  Key agreements
  Infrastructure
  Subsidiaries and joint ventures
Latest Results

EXECUTIVE SUMMARY

Introduction
Current Financial Position
  Company Performance
  Geographic Segment Performance
Company Strategy
  R&D Strategy
  Mergers, Acquisitions and Divestitures
  Key Agreements
    Discontinued Agreements
  Production
  Employees
Product Performance Forecasts
Pipeline Analysis
  Discontinued R&D Projects
Other Factors Affecting The Bottom Line
Conclusions/Outlook

THERAPEUTIC AREA FOCUS

R&D PIPELINE

CARDIOVASCULAR AND METABOLIC DISEASES

Marketed Products
  Avapro
  Coumadin
  Monopril
  Onglyza
  Glucophage
  Plavix
  Pravachol
R&D Projects
  Apixaban
  BMS-830216
  Dapagliflozin
  KAI-9803

VIROLOGY

Marketed Products
  Atripla
  Baraclude
  Reyataz
  Sustiva
  Videx
  Zerit
R&D Projects
  BMS-790052
  Interleukin-29

NEUROSCIENCE

Marketed Products
  Abilify
  Efferalgan
  Emsam
R&D Projects
  AGN-209323
  BMS-299897

ONCOLOGY

Marketed Products
  Erbitux
  Ixempra
  Miriplatin Hydrase
  Platinol
  Sprycel
  Taxol
R&D Projects
  Angiocept
  BMS-663513
  BMS-863233
  Brivanib
  Elotuzumab
  Ipilimumab
  Necitumumab
  Source: Espicom

IMMUNOLOGY

Marketed Products
  Orencia
R&D Projects
  Belatacept
  PS540446
  BMS-945429

APPENDIX 1 - FINANCIAL PERFORMANCE

Full Year Results 2009

APPENDIX 2 - KEY CORPORATE EVENTS

APPENDIX 3 - KEY AGREEMENTS

Alden Biopharmaceutical
Allergan
AMRI Inc
Aspen Pharmacare/Emcure Pharmaceuticals
AstraZeneca
Biocon
Celltrion Inc
Chiron Corporation
Dainippon Sumitomo Pharma
Domantis Inc
Elan Corporation Plc
Elixir Pharmaceuticals
Endocyte
Exelixis Inc
Facet Biotech
Gilead Sciences Inc
GPC Biotech Inc
ImClone Systems
Intra-Cellular Therapies Inc (ICT)
Isis Pharmaceuticals
Kai Pharmaceuticals Inc
Lexicon Genetics Inc
Lion Corporation
Medarex Inc
Merck KGaA
Merck Santé SAS
Nerviano Medical Sciences
NeurOp
Nissan Chemical Industries Ltd/Teijin Pharma Ltd
Otsuka/Taiho Pharmaceutical Co Ltd
Pfizer
Pharmacopeia Inc
sanofi-aventis
Shionogi
Sunesis Pharmaceuticals
Tranzyme Pharma
XDx Inc
ZymoGenetics Inc

APPENDIX 4 - INFRASTRUCTURE

Research And Development Facilities
Manufacturing Facilities

APPENDIX 5 - KEY PHARMACEUTICAL SUBSIDIARIES / JOINT VENTURES

Subsidiaries

APPENDIX 6 - PRODUCT INDEX

LIST OF TABLES

Principal Operating Results
Sales By Geographic Area (Origin)
Year-End Assets By Geographic Area
Erbitux Sales by Company (2008-2016)
Erbitux Sales by Indication (2008-2016)
Ixempra Sales (2008-2016)
Sprycel Sales by Indication
Efficacy Parameters in Phase III Second-line OC Trials
Efficacy Parameters in Phase III NSCLC Trials
Brivanib Sales by Indication (2012-2016)
Ipilimumab Sales by Indication (2011-2016)
Necitumumab Sales (2014-2016)
Major North American Subsidiaries
Major European Subsidiaries
Major South American Subsidiaries
Major Asia/Pacific Region Subsidiaries

LIST OF CHARTS

Sales of Top Ten Products (2008-2016)
Top Selling Products, 2009
sanofi-aventis' Sales of Aprovel (2008-2016)
DSP's Sales of Avapro (2008-2016)
BMS's Sales of Onglyza (2009-2016)
AstraZeneca's Sales of Onglyza (2009-2016)
sanofi aventis' Sales of Plavix (2008-2016)
Apixaban Total Sales (2011-2016)
Reyataz Sales (2008-2016)
BMS' Sakes of Abilify (2008-2016)
Erbitux Sales (2008-2016)
xempra Sales (2008-2016)
Sprycel Sales (2008-2016)
Brivanib Sales (2012-2016)
Ipilimumab Sales (2011-2016)
Orencia Sales (2009-2016)
Belatacept Sales (2010-2016)
Sales, Costs and Operating Income
Profitability and Research Ratios
R&D Expenditure and Capital Expenditure
Current Assets, Liabilities and Ratio
Assets, Cash and Liquidity
Employees and Productivity
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