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Bayer HealthCare: The Power of Diversity
Names – Figures – Facts 2011
Med
ical
Car
e
Ani
mal
Hea
lth
Cons
umer
Car
e
Phar
mac
eutic
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Foreword 3
The Bayer HealthCare management team 4
Facts and figures 2010 5
Active worldwide 8
Animal Health 10
Consumer Care 12
Medical Care 14
Pharmaceuticals 16
Research and development 20
Product Supply 24
Business development 26
Social commitment 28
Research milestones 30
BHC in dialogue 31
2
Contents
Names – Figures – Facts 2011
COVER:Bayer researcher Dr. Johannes-Peter Stasch (left) and Professor Hossein Ardeschir Ghofrani from Giessen University Hospital (Germany) work with a model of a lung.
Foreword
3
Dear Readers,
The global healthcare market is undergoing a transformation. While cost aspects are increasingly becom-ing the main priority in many state healthcare systems, in emerging markets such as China or Brazil there is a new, growing demand for healthcare products and services. Given these changes, innovation is and will remain a crucial success factor.
For Bayer HealthCare, innovation means offering products that improve people’s lives. Excellence in research and development is essential for this. Furthermore, we must also understand people’s needs – because innovation is only innovation if our customers view it as such and it provides them with true added value. Customer orientation in all phases of product development – from research to marketing – is a key success factor in this regard.
In each of our four divisions – Animal Health, Consumer Care, Medical Care and Pharma-ceuticals – we constantly work to offer our customers real innovations:
• Animal Health is our specialist for veterinary medicine for companion animals and live-stock. Among our product innovations is Profender Dog, the first allwormer for dogs, which provides control of adult and all larval stages of the most relevant worm species in dogs.
• Our Consumer Care Division is a world leader in the over-the-counter or non-prescrip-tion drugs market. Through our Intendis business, we also place emphasis on new areas such as aesthetic dermatology, where we are working together with a partner to de-velop an injection to remove fat deposits under the chin.
• The Medical Care portfolio comprises blood glucose meters for people with diabetes and devices for diagnostic imaging and medical therapy. Cotavance, a drug-coated balloon catheter for the treatment of peripheral arterial disease, is one of the most important development projects in this division.
• At Pharmaceuticals, we research and develop new therapies primarily in areas where there is a high le- vel of medical need, such as cancer therapy, cardiovascular and hematological disorders, gynecological therapy and new molecular imaging processes. Among the promising candidates in our pipeline are the anticoagulant Xarelto and VEGF Trap-Eye for the treatment of wet age-related macular degeneration.
Bayer HealthCare is thus prepared to create value through innovation in the future as well. This brochure provides insight into the diversity and strength of our company, and I hope that this edition of “Names – Figures – Facts” will spur your fascination for Bayer HealthCare and its innovative power.
Dr. Jörg ReinhardtChairman of the Bayer HealthCare Executive Committee
Innovation that reaches its target
Dr. Jörg Reinhardt
Stat
us: A
pril
2011
4
Bayer HealthCare
The management team
Bayer HealthCare is managed by its Executive Committee. This body is composed of the four divisional heads, the heads of Research and Development as well as the heads of the cross-divisional platform functions Central Adminis-tration & Organization, Communications, Human Resourc-es, Law and Patents and Product Supply. The Executive Committee sets the course for the company’s future. Its task is to make strategic decisions that lead to a sus-tained increase in the company’s value.
Dr. Jörg ReinhardtChairman of the Bayer HealthCare Executive Committee
Manfred VehreschildHead of Central Administration and Organization
Dr. Markus Pickel Head of Corporate Communications
Andreas FibigHead of the Pharma- ceuticals Division
Dr. Kemal MalikHead of Development and Chief Medical Officer of the Pharma- ceuticals Division
Alan MainHead of the Medical Care Division
Dr. Jean-Luc Lowinski Head of the Animal Health Division
Prof. Dr. Andreas BuschHead of Pharmaceuti-cals and Animal Health Research
Dr. Hartmut KlusikHead of Product Supply
Andreas GüntherHead of Human Resources
Dr. Alexander BeyHead of Law and Patents and Compliance Officer
Erica L. MannHead of the Consumer Care Division
5
Bayer HealthCare 2009 2010 Change
€ million %
Sales 15,988 16,913 5.8
EBITDA 4,148 4,116 -0.8
EBIT 2,640 1,861 -29.5
Special items (372) (1,169)
Gross cash flow 3,153 2,948 - 6.5
Net cash flow 3,431 3,320 -3.2
5
Facts and figures 2010
Tarrytown (Medical Care)Morristown (Consumer Care)
Berlin (Pharmaceuticals)Monheim (Animal Health) Leverkusen (Bayer HealthCare)
Headquarters: 5
Employees: 55,700
Sales: €16,913 million
The BHC headquarters are located at Bayer's Leverkusen site.Headquarter sites of Bayer HealthCare and the divisions
Facts and f iguresFacts and f igures
6
Best-Selling Consumer Health Products 2009 2010 Change
€ million %
Contour (Medical Care) 601 602 0.2
Aspirin* (Consumer Care) 400 418 4.5
Advantage product line (Animal Health) 336 408 21.4
Aleve/naproxen (Consumer Care) 217 273 25.8
Bepanthen/Bepanthol (Consumer Care) 186 212 14.0
Canesten (Consumer Care) 188 210 11.7
One A Day (Consumer Care) 153 178 16.3
Baytril (Animal Health) 149 166 11.4
Supradyn (Consumer Care) 136 138 1.5
Breeze (Medical Care) 138 125 -9.4
Total 2,504 2,730 9.0
Proportion of Consumer Health sales 45 % 45 %* Total Aspirin sales = € 776 million (2010: € 715 million), including Aspirin Cardio, which is reflected in sales of the Pharmaceuticals segment.
Facts and figures 2010
Best-Selling Pharmaceutical Products 2009 2010 Change
€ million %
Betaferon/Betaseron (Specialty Medicine) 1,214 1,206 -0.7
YAZ/Yasmin/Yasminelle (General Medicine) 1,278 1,111 -13.1
Kogenate (Specialty Medicine) 888 1,004 13.1
Nexavar (Specialty Medicine) 604 705 16.7
Adalat (General Medicine) 633 664 4.9
Mirena (General Medicine) 490 539 10.0
Avalox/Avelox (General Medicine) 460 497 8.0
Levitra (General Medicine) 360 429 19.2
Aspirin Cardio (General Medicine) 315 358 13.7
Glucobay (General Medicine) 315 347 10.2
Ultravist (Specialty Medicine) 262 313 19.5
Cipro/Ciprobay (General Medicine) 331 262 -20.8
Magnevist (Specialty Medicine) 219 215 -1.8
Iopamiron (Specialty Medicine) 199 185 -7.0
Kinzal / Pritor (General Medicine) 164 178 8.5
Total 7,732 8,013 3.6
Proportion of Pharmaceuticals sales 74 % 73 % Products are ranked by full year 2010 sales.
3,000
2,000
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200
400
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Status: December 31, 2010
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7
Sales
Headcount according to country
Employees
*The Consumer Health segment comprises Bayer HealthCare's Animal Health, Consumer Care and Medical Care Divisions.
Pharmaceuticals€10,908 million
Consumer Care € 3,371 million
Animal Health € 1,120 million
Medical Care€ 1,514 million
PharmaceuticalsConsumer
Health*
38,00017,700
Stat
us: D
ecem
ber
31, 2
010
8
Active worldwide
Bayer HealthCare and its divisions are represented in nearly all markets of the world.
9
Active worldwide
The aim of Bayer HealthCare is to research, develop, manufacture and market innovative products that will improve the health of people and animals all over the world. The products are used for the diagnosis, prevention and treatment of diseases and help to enhance quality of life.
Bayer HealthCare is a globally operating company with sites on all five continents. Approximately 55,700 people work for the Bayer subgroup in more than 100 countries at all stages of the value-added chain. The company has its headquarters in Germany (Leverkusen). Two divisions (Consumer Care and Medical Care) are based in the United States (Morristown and Tarrytown). The headquarters of the Animal Health and Pharmaceuticals Divisions are also located in Germany (Monheim and Berlin, respectively). Local companies handle product distribution and are in close contact with the customer and with the authorities in the various countries.
As a global company with four divisions, sites all over the world and a differentiated portfolio, Bayer HealthCare is reliant on a diversely composed workforce. After all, one of the cornerstones of Bayer HealthCare’s success is the innovative strength of its employees. This is why Bayer HealthCare is keen to attract the most promising talent from all over the world to the company.
Overall, diversity pays off. In addition to a better understanding of customer requirements, an enhanced image and greater appeal as an employer, diversity as a business case is also gaining importance in day-to-day business: the more diverse the workforce, the greater the creative potential released through cooperation. Working together, men and women, different age groups and nationalities, and people with different ways of thinking can have a more well-rounded approach to challenges and may find solutions which would not have even occurred to a group with a more homogeneous composition.
Only in this way can the diverse knowledge, experience and values of employees be put to profitable use to produce innovative customer solutions and meet global challenges.
10
Animal Health
When pets become ill, they can also impair the health of humans - for example by spreading disease pathogens.
The goals of the Animal Health Division are to maintain the health of animals and cure veterinary diseases, with the focus primarily on treating infectious diseases and repelling parasites. In livestock – animals that play a role in food production – the safety of drug and care products is paramount for food safety. Companion animals receive special attention in clinical practice: in view of the emotional ties that people have to them but also their close relationship to the family, it is vital that they receive dependable, easy-to-use and safe medication in order to safeguard both their well-being and that of their owners.
With more than 100 different animal health and care products worldwide for livestock and companion animals, the division is one of the most successful suppliers in the field of veterinary medicine. Animal Health is well positioned in the steadily growing market for antiparasitic products for companion animals. The Advantage family of flea control products for dogs and cats was again one of Bayer HealthCare’s best-selling consumer health products in 2010, generating annual sales of roughly € 408 million. Baycox for the treatment of coccidiosis, a parasitic infectious disease in livestock, enjoyed double-digit sales growth relative to the previous year. The Baytril antibiotic for the treatment of serious infectious diseases in livestock and companion animals has been setting standards for many years.
Animal Health strengthened its business with acquisitions in 2010. The acquisition of the New Zealand-based Bomac Group added products for the treatment of mastitis and for parasite control in sheep to the farm animals product portfolio. Animal Health also acquired a technology from the U.S. company Piedmont Pharmaceuticals: a novel chewable tablet formulation that makes it possible to administer active ingredients to dogs and cats easily and reliably.
With sales of € 1.1 billion in 2010, the Animal Health Division contributed 6.6 percent to Bayer HealthCare’s total sales. The main part of the division’s sales came from the Region North America with 36.9 percent, followed by the Region Europe/Japan/MERA (Middle East, Eastern Europe, Russia and Africa) with 33.3 percent and the Region International (Asia Pacific, Latin America, South Africa) with 29.8 percent. Animal Health is active in more than 120 countries. Its animal health and care products are produced mainly in Germany and the United States, as well as at additional regional production sites.
Net sales 2010: € 1.1 billionGlobal ranking: 4Headquarters: Monheim, Germany
The Animal Health Division
11
O U R A R E A S O F F O C U S – T H E F O U R D I V I S I O N S
12
Consumer Care
neues Foto
More and more people are taking responsibility for their own health. For this reason, self-medication is becoming increasingly important.
13
The Consumer Care Division
Net sales 2010: € 3.4 billionGlobal ranking: 2Headquarters: Morristown, NJ, USA
A growing number of individuals worldwide select medicines themselves for the prevention or treatment of common ailments, as well as nutritional supple-ments to support a healthy diet. Many of them place their trust in tried-and-true nonprescription or over-the-counter (OTC) products from Bayer HealthCare's Consumer Care Division. One example is Aspirin, a more than 110-year-old brand that enjoys an unsurpassed level of global familiarity.
Consumer Care currently ranks among the top consumer healthcare companies in the world. The division operates in more than 140 countries and maintains 14 manufacturing sites and two product research and development centers. With more than 170 brands around the world and eight global brands generating annual sales of more than € 100 million each, Consumer Care is well positioned to take advantage of the sustained growth forecast for the OTC market.
The division holds a balanced portfolio of strong brands in all major OTC catego-ries, including analgesics, cardiovascular risk prevention, cough and cold, derma-tology, gastrointestinals and nutritionals. In fact, some of the world’s best-known and most trusted over-the-counter medications and nutritional supplements including Aspirin, Aleve, Alka Seltzer, Bepanthen/Bepanthol, Berocca, Canesten, Elevit, Redoxon, Rennie, Supradyn, Talcid and One A Day are part of the Consumer Care portfolio.
The division has a strong track record of growth in emerging markets and con-tinues to invest in fast-growing regions around the world to increase its global footprint and advance its international portfolio of products. Recent investments including the acquisitions of Topsun Science & Technology in China and Sagmel Inc. in Eastern and Central Europe are excellent examples of this. In 2009, Con-sumer Care also executed on its Rx-to-OTC switch strategy with the launch of the OTC proton pump inhibitor (PPI) omeprazole under the brand names Antra and Losec through an exclusive licensing agreement with Astra-Zeneca.
Consumer Care generated sales of € 3.4 billion or 19.9 percent of Bayer Health-Care’s total sales in 2010.
O U R A R E A S O F F O C U S – T H E F O U R D I V I S I O N S
neues Foto
14
Medical Care
Regular blood glucose monitoring helps people with diabetes to keep their blood sugar levels normal. This in turn can considerably reduce the risk of complications.
15
The Medical Care Division
Net sales 2010: Medical Care €1.5 billionGlobal ranking: Blood glucose monitoring systems: 3 Fluid injection systems and thrombectomy devices: 1Headquarters: Tarrytown, NY, USA
Bayer HealthCare’s Medical Care Division is one of the leading providers of blood glucose monitoring systems and medical devices. Its portfolio includes blood glucose monitoring systems, monitors to test glycated hemoglobin (HbA1c), Viterion TeleHealth and other patient education and lifestyle support services. The division also markets devices for diagnostic imaging and medical therapy.
The portfolio of blood glucose meters includes Contour, Contour TS, Contour Link, Contour USB, Didget and Breeze2. In 2010, the division continued the global rollout of the Contour USB meter which connects directly to a computer, providing users
with easy access to information and trends about their blood sugar levels. Monitors for measurement of glycated hemoglobin include the A1CNOW+ monitor for healthcare providers, and A1CNOW SELFCHECK for home use. Glycated hemoglobin is an indicator of long-term blood sugar control. Viterion TeleHealth provides remote patient monitoring technology to help manage chronic conditions such as diabetes and congestive heart failure.
Morever, Medical Care develops, markets and services medical devices that enable or enhance therapeutic medical procedures in computed tomography, magnetic resonance imaging, molecular imaging and cardiovascular applications. Its products include fluid injection systems for radiology and cardiology, vascular intervention systems for treating constricted or blocked blood vessels, magnetic-resonance-compatible accessories and equipment services. Fluid delivery systems are used to enhance computed tomography (CT), positron emission tomography (PET), magnetic resonance imaging (MRI) and angiography/cardiovascular imaging procedures. In 2010, the division’s
medical devices business was recognized for the second time with the Malcolm Baldrige National Quality Award, the highest honor a U.S. company can receive for quality and business excellence.
O U R A R E A S O F F O C U S – T H E F O U R D I V I S I O N S
16
Pharmaceuticals
More and more doctors and patients rely on innovative drugs from Bayer HealthCare's Pharmaceuticals Division.
17
The Pharmaceuticals Division
Net sales 2010: € 10.9 billionGlobal ranking: Leading positions in key therapeutic categoriesHeadquarters: Berlin, Germany
Bayer HealthCare’s success story in the pharmaceuticals business goes back more than 120 years. The first product marketed by the “Pharmaceutical Department” of Bayer was the antipyretic Phenacetin in 1888. Schering AG, the company acquired by Bayer in 2006, had already entered hormone research by the 1920s, offering the first medicine to treat menopause symptoms in 1928. For its part, Bayer quickly developed a reputation especially in the treatment of infectious diseases. Bayer researcher Gerhard Domagk, who discovered the antibacterial effect of sulfonamides, was awarded the Nobel Prize in Medicine in 1939.
Bayer HealthCare Pharmaceuticals is today the highest-selling pharmaceuticals company in Germany and holds a worldwide leading position in its main therapeutic areas. The focus on specialty pharmaceuticals and the opportunities for growth in the field of general medicine offer an outstanding basis for prospering in the increasingly competitive pharmaceuticals market. The division combines its strengths in two business units: General Medicine and Specialty Medicine.
The General Medicine Business Unit develops and markets products that are prescribed by both general practitioners and medical specialists. The extensive range of products in this segment – for the control of high blood pressure, prevention of myocardial infarction and stroke, and for diabetes management – offer doctors and patients options in both the treatment and prevention of acute disease conditions. The company also markets effective products to treat bacterial infections, such as respiratory tract and urinary tract infections. In the field of Men’s Health, the division offers a wide range of therapeutic options, including treatments for erectile dysfunction and testosterone deficiency. The latest product to be researched and developed is a drug to prevent and treat life-threatening blood clots. In clinical trials in patients undergoing elective hip or knee replacement surgery, the new active ingredient rivaroxaban, a direct, oral Factor Xa inhibitor, demonstrated increased efficacy compared to the current standard treatment, with a similar safety profile. The product has since been registered and launched in this indication in numerous countries worldwide. A
O u r a r e a s O f f O C u s – T H e f O u r D i v i s i O N s
18
Pharmaceuticals
Dr. Peter Kolkhof checks a slide before examining it under the microscope in one of the laboratories of Bayer HealthCare's Pharmaceuticals Division in Wuppertal (Germany).
large-scale clinical development program is investigating the suitability of the drug product in the prevention and treatment of various types of acute and chronic blood coagulation disorders.
The Women’s Healthcare segment of the General Medici- ne Business Unit is a pioneer in its field, concentrating on three areas: contraception, menopause management and gynecological therapies. Bayer is the world leader in the field of female hormonal contraception, in particular in the area of oral contraception. The “pill” has been enabling women to engage in conscious family planning for 50 years.
Women’s Healthcare offers a wide range of different contraceptives to meet individual needs, including low-dosage contraceptives with additional indications. One product that was first launched in the European Union in 2009 is the first product from a new class of oral contra-ceptives whose estrogen component is based on estradiol,
the same estrogen that is produced by the female body. In addition, Women’s Healthcare develops products to relieve the symptoms associated with menopause.
In the gynecological therapy segment, Bayer HealthCare is working to develop new therapeutic options for conditions with a high level of unmet medical need such as uterine fibroids (myomas) and endometriosis, a condition in which endometrial cells grow outside of the uterus. Indeed, a drug for the treatment of endometriosis was launched in Europe in the second quarter of 2010.
The Specialty Medicine Business Unit offers innovative therapeutic options to markedly improve the quality of life for people suffering from severe, chronic and life-threaten-ing diseases. Thanks to the contrast agents from Diagnostic Imaging, precise and early diagnosis can play a crucial role in the selection of optimal treatment and therefore has a positive effect on the therapeutic course.
19
Oemur Capar conducts a visual inspection of Nexavar tablets at Bayer HealthCare's Leverkusen site.
O u r a r e a s O f f O C u s – T H e f O u r D i v i s i O N s
Some 2.5 million people worldwide suffer from multiple sclerosis (MS), a chronic inflammatory disease of the central nervous system usually occurring in episodes. Bayer HealthCare was one of the first companies to offer a causal treatment for this autoimmune disease that re- duces the frequency of attacks and in this way can slow progression of the disease considerably.
Hemophilia A is a rare genetic blood coagulation disorder that can be effectively treated with blood coagulation Factor VIII. The Pharmaceuticals Division is one of the world’s most important manufacturers of drug products to treat this hereditary disease.
Crucial improvements have been achieved in selective cancer treatments – therapies that inhibit cell division and simultaneously disrupt the blood supply to the tumor. A state-of-the-art oral drug product containing the active ingredient sorafenib has been granted regulatory approval
for the treatment of renal cell carcinoma and hepatocellular carcinoma in many countries and is now undergoing studies to investigate its suitability for a large number of other forms of cancer such as breast cancer, colorectal cancer and lung cancer.
Today, medicine relies not only on conventional X-rays but also employs various diagnostic methods such as computed tomography (CT), magnetic resonance imaging (MRI) and ultrasound. Diagnostic Imaging is one of the world’s leading providers of X-ray and MRI contrast agents for in vivo diagnostics. These products are used to make tissues and organs visible in their natural position inside the body. Work is also focused on the development of markers (tracers) for positron emission tomography (PET). The PET tracer florbetaben in Bayer's pipeline makes it possible to reco- gnize beta Amyloid, one of the pathological hallmarks of Alzheimer's disease, with high accuracy very early on and while the patient is still alive.
shaping pharmaceutical products requires special skills.
research and development
fanny Knoth, stefan stargard and Dr. antje stratmann examine cell cultures under microscopes to investigate the efficacy of a substance.
20
research and development at Bayer HealthCare
Bayer HealthCare spends more on research and development (R&D) than any other Bayer subgroup: in 2010, € 2,066 million of the Bayer Group’s total research and development (R&D) spending went to Bayer HealthCare, corresponding to 67.7 percent of the group’s entire research expenditure.
Pharmaceutical drug discovery research at Bayer Health Care Pharmaceuti-cals is concentrated on four areas: Cardiology & Hematology, Oncology, Diagnostic Imaging and Women’s Healthcare. It includes identifying and optimizing low-molecular-weight substances and developing new biologics. Bayer HealthCare's Pharmaceuticals Division researches and develops innovative active ingredients for the treatment of diseases where there is a high level of medical need. It also further develops products that have already been granted regulatory approval. One example of an innovative active ingredient is the anticoagulant rivaroxaban (trade name: Xarelto), which has already been granted regulatory approval for the prevention of thrombosis after elective knee or hip replacement surgery, is marketed in 75 countries and is currently undergoing development in other indications. This thrombosis medication can be taken as a tablet once daily and is therefore a real innovation. One of the many other innovative substances in the pipeline is riociguat, an active ingredient for the treatment of pulmonary hypertension which would be the first drug from a new class of vasodilatative substances. Another focus of Bayer’s Cardiology research is heart failure.
Despite major advances in the fight against cancer, the medical need for therapies which prolong survival and improve quality of life is still great. Our development pipeline in Oncology comprises various antibodies and low-molecular-weight substances. In addition to the active ingredient sorafenib (trade name: Nexavar), these include regorafenib, a development substance with a profile for inhibiting various enzymes stimulating tumor growth and angiogenesis, and Alpharadin, a novel alpha-pharmaceutical agent currently under investigation, for example in a Phase III study for prostate cancer. VEGF Trap-Eye could make an important contribution in the treat-ment of serious eye diseases. This active ingredient has demonstrated very promising results in two Phase III clinical studies in the treatment of wet, age-related macular degeneration and, as the next step, is seeking regulatory approval in Europe. The research activities in the field of Diagnostic Imaging are focused on the development of substances (known as tracers) for molecular imaging, and for use in positron emission tomography (PET), which
research and development
21
research and developmentresearch and development
22
could support earlier and more precise diagnosis of cancer or dementia in the future. Bayer HealthCare's Pharmaceuticals Division is also carrying out research and development in the field of women’s healthcare, to offer a wide spectrum of contraceptive options. This ranges from the clinical testing of a contraceptive patch through to oral contraceptives which are intended for authorization in additional indications besides contracep-tion. A new class of oral contraceptives with an estrogen component based on estradiol – the estrogen which is also produced naturally by the female body – was granted regulatory approval in the EU in 2009. Gyneco-logical therapies are another R&D focus of Women’s Healthcare. The company launched Visanne, a new treatment option for endometriosis, in Europe in the second quarter of 2010. Endometriosis is a chronic gynecological disease in which endometrial-like tissue appears and flourishes in areas outside the uterine cavity, which leads to chronic inflammatory reactions.
The Medical Care Division conducts proprietary R&D into next-generation advances in diabetes monitoring, radiology and interventional cardiology, improving the current portfolio of marketed products as well as entering into strategic alliances with other companies to share technology and expertise. The current R&D focus in the field of blood glucose monitoring includes ease-of- use, meter accuracy, and e-health initiatives to simplify
data capture and analysis. In the field of medical devices, the division is focused on developing alternative fluid delivery mechanisms, vascular intervention systems for treating constricted or blocked blood vessels (such as Cotavance, a drug-coated balloon catheter), customer workflow efficiencies and patient-specific contrast ad- ministration, as well as molecular imaging and healthcare informatics.
The acquisition of the Bomac Group with its headquarters in Auckland, New Zealand, has strengthened the Animal Health Division’s research activities in the livestock sector. Auckland will join Monheim (Germany) and Shawnee (Kansas, USA) as a new, regional development center. The growing demand for animal protein necessi-tates innovative solutions for food-producing animals. Another important research area is the treatment of age-related diseases in companion animals. Further efforts are devoted to developing new formulations and user-friendly applications for established active ingredi-ents.
The Consumer Care Division is concentrating its research and development activities on developing existing brands through expanded indications and optimized delivery forms. In addition, Consumer Care actively seeks opportunities to switch prescription pharmaceuticals that could be marketed as over-the-counter products.
BHC's scientists' profound knowledge of human and veterinary medicine, accompanied by their expertise in inter-disciplinary technologies, forms the basis for innovative products.
Dr. Klemens Krieger and sabrina schwartzkopff from the research department of the animal Health Division apply droplets of Advocate to a cat.
23
Only one substance receives marketing authorization: On average, the develop-ment of a pharmaceutical product to market maturity takes about 10 to 12 years and costs roughly half a billion euros. Generally only one out of every 5,000 to 10,000 examined substances ultimately receives marketing authorization.
0 2 4 6 8 10 12 years
Research Preclinical Applicationsubmitted Approved
In vitro efficacy tests Efficacy and safety tests, animal testing with the final 10 to 20
substances
Tolerability testing in healthy human
subjects
Testing in a small number of patients
Testing generally in several thousand
patients
Documentation examined by regulatory authorities
Development of a pharmaceutical product: The long road
Clinical studies
Phase I Phase II Phase III
up to 10,000 substances
250 substances
1 substance
1.2 substances
1.5 substances
3.3 substances
4.7 substances
Research and Development Projects (Phase III)*
alemtuzumab
Alpharadin
aTX-101
fC Patch low
florbetaben
Gadovist
LCs (uLD LNG contraceptive system)
Nexavar
Nexavar
Nexavar
regorafenib (DasT inhibitor)
regorafenib (DasT inhibitor)
riociguat (sGC stimulator)
riociguat (sGC stimulator)
Xarelto
Xarelto
Xarelto
Vaginorm
veGf Trap-eye
veGf Trap-eye
veGf Trap-eye
Multiple sclerosis
Treatment of bone metastases in hormone-refractory prostate cancer
Reduction of submental fat
Contraception
PET imaging in diagnosis of Alzheimer’s disease
Magnetic resonance imaging
Contraception
Breast cancer
Thyroid cancer
Non-small-cell lung cancer
Treatment of metastatic or inoperable gastrointestinal stromal tumors
Colon cancer
Pulmonary hypertension (CTEPH)
Pulmonary hypertension (PAH)
Prevention of venous thromboembolism in medically ill, immobilized patients
Treatment and secondary prevention of venous thromboembolism
Secondary prevention of acute coronary syndrome / myocardial infarction
Vulvovaginal atrophy and female sexual dysfunction (FSD)
Wet age-related macular degeneration
Abnormal retinal angiogenesis following pathological myopia
Central retinal vein occlusion
* as of February 15, 2011
PAH = pulmonary arterial hypertension; CTEPH = chronic thromboembolic pulmonary hypertension
The nature of drug discovery and development is such that not all coumpounds can be expected to meet the pre-defined project goals. It is possible that any or all of the projects listed above may have to be discontinued due to scientific and/or commercial reasons and will not result in commercialized products. It is also possible that the requisite FDA, European Medicines Agency (EMA) or other regulatory approvals will not be granted for these compounds.
w Product supply
24
Product supply employee Christian Otulak fills active pharmaceutical ingredients in the supply Center in Bergkamen (Germany).
everything centrally steered: from sourcing to the finished product
Product supply
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Bayer HealthCare manufactures products at almost 60 sites around the world. The active ingredients for prescription medicines are manufactured primarily at the sites in Wuppertal and Bergkamen (Germany) and Berkeley and Emeryville (United States). They are processed and packaged as finished pharmaceuticals in plants around the world using sophisticated technology. A broad spectrum of different pharmaceutical presentations is covered: solid formulations such as tablets, sugar-coated tablets and powders, semi-solid ointments and creams, and liquid drug products for application, for example, as injections or infusions. Hormonal contraceptives are produced as sugar-coated tablets but also, for example, as intrauterine systems. These processing and packaging activities are based in Berlin, Leverkusen and Weimar (Germany), Garbagnate (Italy), Turku (Finland), São Paulo (Brazil), Beijing (China), as well as various other sites in Europe, Asia and Latin America. Kogenate, the drug product for the treatment of hemophilia, is manufac-tured in Berkeley (United States) using a biotechnology process, while Betaferon for the treatment of multiple sclerosis is produced in Emeryville (United States).
Bayer HealthCare produces its over-the-counter medicines at Bitterfeld-Wolfen and Grenzach-Wyhlen (Germany), Gaillard (France), Cimanggis (Indonesia) and Myerstown (United States), as well as at locations in Latin America and Asia. The globally marketed animal health products are mainly manufactured at the sites in Kiel (Germany) and Shawnee (United States). In addition to drug products for humans and animals, medical devices for diagnosis and therapy are produced in the United States. Bayer HealthCare supplies a total of more than 20,000 articles. The reason for this large number is the different presentation of individual products and their packaging – for example, different formulations, dosage, pack sizes and language versions.
Bayer HealthCare Product Supply steers the subgroup’s entire supply chain, from raw material sourcing through manufacturing to distribution, utilizing a global production network consisting of its own sites and those of contract manufacturers. In this way the company aims for continuous improvement of costs, flexibility and delivery reliability, maintaining high standards of quality, safety and environmental protection on a global basis. The manufacture of pharmaceuticals is subject to extraordinarily stringent quality requirements. These standards are known collec-tively as “Good Manufacturing Practice” (GMP). Compliance with these require-ments is regularly inspected by internal experts, regulatory authorities and external auditors.
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Business development
Global partnerships enable Bayer HealthCare to secure access to innovative research technologies, systematically expand its product portfolio and strengthen its regional market presence.
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Good on their own, better together
Bayer HealthCare is an innovation- and growth-oriented enterprise. That’s why its divisions invest not only in their own research and development activities and in continuous life-cycle management, but also in external collaborations. The com- pany is thus constantly on the search worldwide for opportunities to cooperate with external partners – be it in order to secure access to innovative research approaches and technologies, to systematically expand its product portfolio or to strengthen its regional market presence. Partnerships can enrich all phases of the value-added chain: whether it is research and development collaborations, licensing agreements, co-marketing agreements or regional alliances – the philosophy is that collaborations must always pay off for both partners.
The innovative anticancer drug Nexavar, for example, is the result of a develop-ment agreement with Onyx Pharmaceuticals, Inc., USA. Bayer HealthCare’s co-development and co-promotion agreement with Johnson&Johnson subsidiary Ortho-McNeil for the anticoagulant Xarelto ensures optimum development of the substance rivaroxaban. In addition to the Phase III trial in the indication age-related macular degeneration for the VEGF Trap-Eye development project being conducted jointly with Regeneron Pharmaceuticals, Inc., another Phase III trial has since started in Asia for patients suffering from revascularization of the choroid area as a result of pathological myopia, which can lead to visual impairment. Bayer HealthCare is currently collaborating in a Phase III trial with Algeta ASA to develop the cancer drug Alpharadin, a novel radiopharmaceutical active ingredient that releases alpha radiation. New approaches to block cancer stem cells are also being pursued in collaboration with OncoMed Pharmaceuti-cals. Strategic alliances with international innovation partners from academia are an essential element of our R&D strategy. In 2009, Bayer HealthCare and the Tsinghua University in Beijing, China established a joint research center for the discovery and development of innovative therapeutic approaches. Bayer Health- Care and the German Cancer Research Center are cooperating in the field of tumor diagnostics and therapy in the context of a strategic research alliance aimed at enabling more rapid exploitation of research findings for the develop-ment of new cancer drugs and improved evaluation of innovative therapeutic approaches to tumor diseases.
In the veterinary field, the Animal Health Division continued its strong focus on identifying New Chemical Entities that will be the building blocks for future products, while also adding important new commercial agreements in the Asia-Pacific region to further support its customers in important emerging markets with even better services and additional product solutions.
Business development
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social commitment
Dr. Luis alberto Benios, a doctor in the san Marcos de sierra hospital in Honduras, explains how to take Lampit tablets to Yadira and her mother Catalina Nuñez. Yadira suffers from Chagas disease.
Bayer HealthCare's Pharmaceuticals Division has many years of experience and great expertise in the field of family planning. The company is dedicated to ensuring that people in developing countries in particular can engage in conscious family planning free of charge or at reasonable prices.
Bayer HealthCare is engaged in social projects around the world, many of which are devoted to improving the supply of health care in developing countries.
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Global initiatives for better healthcare
Bayer HealthCare is committed to the principles of sustainable development and accepts a level of responsibility in society that goes well beyond the company’s own borders. At the center of all our employees’ actions are human and animal health and environmental protection. Our “Guidelines for responsible care in environmental protection and safety” ensure that all of our products for humans and animals are well tolerated and can be safely disposed of and decomposed after use. The sustainability program also makes concrete contributions to the United Nations’ Millennium Development Goals.
Self-determined family planning: as the market leader in hormonal contraception, Bayer HealthCare's Pharmaceuticals Division has supported family planning around the world, in particular for people with low incomes, for 50 years. Firstly, the company is working together with partners to improve knowledge of sexua- lity, health and contraception in developing countries. Secondly, it provides hormonal contraceptives free of charge or at reduced prices in cooperative projects, empowering women to decide for themselves about their family planning.
The war on neglected diseases: more than 3.3 billion people are affected by so-called neglected diseases. In cooperation with the World Health Organization (WHO), Bayer HealthCare provides medicines free of charge to treat African sleeping sickness and Chagas disease in Latin America. In addition, with the “Bayer Fights Chagas” project Bayer HealthCare is taking a new approach that combines corporate social responsibility and talent management. For the first time, up-and-coming managerial employees and volunteers are being brought together to develop a sustainable concept to combat Chagas disease in Argentina. Bayer HealthCare is also working together with the Global Alliance for TB Drug Development on a new treatment for tuberculosis that will shorten the duration of therapy. Should the studies prove successful, the new treatment will be made available at reduced prices, particularly in developing countries.
Training and education: Medical Care is one of three corporate sponsors of the India Diabetes Educator Project/Project Hope which provides training to healthcare workers throughout India. Another of Medical Care’s projects is a partnership with the Juvenile Diabetes Research Foundation (JDRF), including a collaboration with popstar Nick Jonas. Furthermore, the company has long been actively involved in social projects and offers its employees numerous opportuni-ties to voluntarily contribute to such projects at its corporate sites.
social commitment
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History
research milestones
The winners of the German innovation Prize: Bayer researchers Dr. elisabeth Perzborn (left), Dr. frank Misselwitz (2nd right) and Dr. Dagmar Kubitza (right) with the then German federal President Horst Köhler.
in 1961, Anovlar became the first hormonal contraceptive on the market in europe.
More than 100 years ago, Aspirin was already known beyond the borders of Germany as an effective pain reliever.
1888 Bayer enters the pharmaceuticals Phenacetin business with this antipyretic medicine
1890 Anti-aging product and later gout Piperazin medicine
1899 Pain reliever containing the active Aspirin ingredient acetylsalicylic acid
1923 Medicine to treat African sleeping Germanin sickness
1928 The first hormonal drug to treat menopause Progynon symptoms
1930 The first injectable renal contrast agent for Uroselectan X-ray images
1935 Chemotherapeutic drug to treat bacterial Prontosil infections
1950 Globally successful malaria drugResochin
1961 First European hormonal contraceptiveAnovlar
1969 First portable blood Ames Reflec- glucose metertance Meter
1975 Drug to treat coronary heart disease Adalat
1987 Antibiotic to treat bacterial infections Ciprobay
1987 Contrast agent for magnetic resonance Magnevist imaging
1987 Medicine to treat severe infectious dis- Baytril eases in livestock and companion animals
1990 New therapy principle for diabeticsGlucobay
1991 Drug for the specific treatment of chronic Fludara lymphocytic leukemia (CLL)
1992 Blood glucose meterGlucometer Elite
1993 The first recombinant Bayer drug product to Kogenate treat hemophilia
1993 The first multiple sclerosis drug to be Betaferon/ registered in the United StatesBetaseron
1994 For prevention of a second myocardial Aspirin Pro- infarction or stroketect/ Cardio
1996 Long-acting flea control product for dogs Advantage and cats
1997 Novel hormonal intrauterine contraceptive Mirena system
1999 Respiratory tract antibioticAvalox/Avelox
2000 The first oral contraceptive based on the Yasmin novel gestagen drospirenone
2003 Erectile dysfunction medicineLevitra
2003 Flea, tick and mosquito control product Advantix for dogs
2004 Animal health product to combatAdvocate/ internal and external parasitesAdvantage Multi in dogs and cats
2005 Marketing authorization granted for treat-Nexavar ment of advanced kidney cancer
2005 Deworming agent for catsProfender Cat
2007 Marketing authorization granted forNexavar treatment of liver cancer
2008 Prevention of venous thrombosis afterXarelto elective knee or hip replacement surgery
2008 First oral contraceptive based onQlaira estradiol, the same estrogen as is produced by the female body
2008 Dietary supplement to support kidney Renalzin function in cats with chronic kidney failure
2008 First automated PET (positron emission Intego tomography) infusion system in the U.S.
2009 First blood glucose meter with Contour USB integrated software
2009 Drug to control coccidiosis, a parasiticBaycox infectious disease, in lambsSheep
2009 Deworming agent for dogsProfender Dog
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BHC in dialogue
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fOrWarD-LOOKiNG sTaTeMeNTs
This brochure may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
Product names are mostly registered trademarks. All trademarks are printed in italics.
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Published by:Bayer HealthCare AGCommunicationsDr. Markus Pickel51368 LeverkusenGermany
English version:Language Service,Currenta GmbH & Co. OHG, Germany
Edited by:Christina Sehnert [email protected]
Bärbel Doormann [email protected]
Contacts:
BaYer HeaLTHCare Dr. Markus Pickel [email protected]
aNiMaL HeaLTH DivisiONAstrid Kö[email protected]
PHarMaCeuTiCaLs DivisiONOliver [email protected]
CONsuMer Care DivisiONTricia [email protected]
MeDiCaL Care DivisiONMeredith [email protected]
CONsuMer HeaLTH eurOPeHelmut Schä[email protected]
A comprehensive overview of Bayer HealthCare is available on the Internet at www.bayerhealthcare.com
BHC in dialogue
