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Bayer Healthcare
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Names Figures Facts 2012Bayer HealthCare
ForwArd-Looking StAteMentS
This brochure may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup manage-ment. 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 Bayers 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.
impressumimprint
Foreword 3
Bayer HealthCare executive Committee 4
key figures 2011 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
Contacts 32
2
Contents
names Figures Facts 2012
CoVer: Bayer HealthCare combines the global activities of its four divisions: Animal Health, Consumer Care, Medical Care and Pharmaceuticals.
Published by: Bayer HealthCare AG, Communications & Public AffairsOliver Renner51368 Leverkusen, Germany
English version: Language Service, Currenta GmbH & Co. OHG, Germany
Edited by:Christina Sehnert, christina.sehnert@bayer.com
Brbel Doormann, baerbel.doormann@bayer.com
Dear Readers,
Our mission as a company is to develop innovative products and solutions that improve the lives of humans and animals. To this end, Bayer HealthCare researches and develops prescription medicines, primarily in areas where there is a high level of medical need, such as cancer therapy or the treatment of cardiovascular disease. Our Consumer Health segment includes non-prescription medicines, derma-tology products, blood glucose meters, medical devices, contrast agents, and pharmaceuticals and grooming products for companion animals and lifestock.
Bayer HealthCare is already one of the world's leading companies in the health care industry today, and we plan to further extend this position in the coming years. At present, we believe that the greatest opportunities for development can be found in the new growth markets in Asia and Latin America, but also in Eastern Europe. In these regions in particular, the demand for innovative health care products is continuing to rise strongly. In the United States and Western Europe, however, the situation is different. In these markets that are equally important to us, public health care systems are facing the challenge of increasing the efficiency of their medical care. To be economically successful in the future, we at Bayer HealthCare must find ways to offer the right products and solutions that meet the specific needs of our customers and create clear added value in both market environments.
The key to this is innovation. We at Bayer HealthCare have at our disposal excellent capabilities in medical research and new product development. Thanks to the scientific know-how and personal dedication of our employees in these areas, we currently have one of the strongest pipelines of innovative products in the industry.
However, we must continue to work on developing new solutions that meet the needs of our customers and will be successful on the market. Here, we benefit firstly from our broad positioning in the health care sector and secondly from the great regard and trust that the Bayer brand enjoys around the globe.
This brochure will give you an insight into the diversity and strength of our company. I hope that this edition of Names Figures Facts will spur your fascination for Bayer HealthCare and our mission - "Science For A Better Life".
Dr. Jrg ReinhardtChief Executive Officer Bayer HealthCare
Science for A Better Life
Foreword
3
Manfred VehreschildCFo and Head of Central Administra-tion & organization
nigel SheailHead of global Business develop-ment & Licensing
oliver renner Head of Corporate Communications & Public Affairs
4
Bayer HealthCare
Bayer HealthCare executive Committee
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 & Public Affairs, global Business development & Licensing, Human resources, Law and Patents and Product Supply. the executive Committee sets the course for the companys future. its task is to make strategic decisions that lead to a sustained increase in the companys value.
dr. Jrg reinhardtChief executive officer Bayer HealthCare
dr. kemal MalikHead of development and Chief Medical officer of the Pharma- ceuticals division
Alan MainHead of the Medical Care division
dr. dirk ehle Head of the Animal Health division
Prof. Andreas BuschHead of global drug discovery
dr. Hartmut klusikHead of Product Supply
Andreas FibigHead of the Pharma- ceuticals division
dr. Alexander BeyHead of Law and Patents and Compliance officer
Andreas gntherHead of Human resources
erica L. MannHead of the Consumer Care division
5key figures 2011
Bayer HealthCare 2010 2011 Change
million % Fx (& p) adj. %
Sales 16,913 17,169 1.5 2.4
eBitdA 4,116 4,502 9.4
eBit 1,861 3,191 71.5
Special items (1,169) (176)
gross cash flow 2,948 3,254 10.4
net cash flow 3,320 3,357 1.1
Sales by division 2010 2011 Change
million % Fx (& p) adj. %
Animal Health division 1,120 1,186 5.9 5.1
Consumer Care division 3,371 3,534 4.8 7.1
Medical Care division 2,468 2,500 1.3 2.4
Pharmaceuticals division 9,954 9,949 -0.1 0.6
Sales by region 2010 2011 Change
million % Fx adj. %
europe 6,375 6,376 0.0 -0.1
north America 4,666 4,360 -6.6 -2.4
Asia/Pacific 3,269 3,656 11.8 9.4
Latin America/Africa/Middle east 2,603 2,777 6.7 10.1
Sites of Bayer HealthCare and its divisions
Sites: 5
employees: 55,700
Sales: 17,169 million
Berlin (Pharmaceuticals)Monheim (Animal Health) Leverkusen (Bayer HealthCare)
tarrytown (Medical Care)Morristown (Consumer Care)
Fx (& p) adj. = currency- (and portfolio-) adjusted
Fx (& p) adj. = currency- (and portfolio-) adjusted
Fx adj. = currency-adjusted
Bayer HealthCareBayer HealthCare
6
Best-Selling Consumer Health Products 2010 2011 Change
million % Fx adj. %
Contour (Medical Care) 602 640 6.3 7.7
Aspirin* (Consumer Care) 418 440 5.3 8.6
Advantage product line (Animal Health) 408 420 2.9 6.2
Ultravist (Medical Care) 313 316 1.0 2.0
Aleve/naproxen (Consumer Care) 273 285 4.4 9.1
Bepanthen/Bepanthol (Consumer Care) 212 235 10.8 10.6
Canesten (Consumer Care) 210 224 6.7 6.9
Magnevist (Medical Care) 215 187 -13.0 -11.8
Iopamiron (Medical Care) 185 185 0.0 -4.7
One A Day (Consumer Care) 178 174 -2.2 2.3
total 3,014 3,106 3.1 4.8
Proportion of Consumer Health sales 43 % 43 %
Fx adj. = currency-adjusted
* Sales of Aspirin including Aspirin Cardio, which is reflected in the sales of the Pharmaceuticals segment increased by 8.8 % (Fx adj. + 10.4 %) in 2011 to 844 million (2010: 776 million).
key figures 2011
Best-Selling Pharmaceutical Products 2010 2011 Change
million % Fx adj. %
Betaferon/Betaseron (Specialty Medicine) 1,206 1,117 -7.4 -5.4
Kogenate (Specialty Medicine) 1,004 1,075 7.1 8.3
Yaz/Yasmin/Yasminelle (General Medicine) 1,111 1,070 -3.7 -2.9
Nexavar (Specialty Medicine) 705 725 2.8 3.5
Adalat (General Medicine) 664 640 -3.6 -4.8
Mirena (General Medicine) 539 581 7.8 10.7
Avalox/Avelox (General Medicine) 497 486 -2.2 -1.8
Aspirin Cardio (General Medicine) 358 404 12.8 12.6
Glucobay (General Medicine) 347 362 4.3 4.2
Levitra (General Medicine) 429 332 -22.6 -22.2
Cipro/Ciprobay (General Medicine) 262 232 -11.5 -11.4
Diane (General Medicine) 171 182 6.4 7.0
Zetia (General Medicine) 138 179 29.7 23.5
Kinzal/Pritor (General Medicine) 178 172 -3.4 -3.4
Fosrenol (General Medicine) 99 147 48.5 42.0
total 7,708 7,704 -0.1 0.5
Proportion of Pharmaceuticals sales 77 % 77 % Products are ranked by full year 2011 sales. Fx adj. = currency-adjusted
Xarelto production team in Leverkusen
india
7
Status: december 31, 2011
3,0002,0000 200 400 600 800 1,000 14,0008,000
employees by Segment:
PharmaceuticalsConsumer Health*
37,10018,600
Stat
us: d
ecem
ber
31, 2
011
*the Consumer Health segment comprises Bayer HealthCare's Animal Health, Consumer Care and Medical Care divisions.
Headcount according to country
500
526
621republic of korea
477
481
582Finland
483
640
651Canada
660Argentina
667indonesia
996russian Federation
1,056turkey
1,087Spain
1,474France
1,704Brazil
1,553italy
6,126China
2,208Mexico
2,516Japan
601United kingdom
564
USA 8,205
390
394
253 republic of South Africa
324 Morocco
286 Philippines
12,952germany
270 guatemala
Venezuela
Switzerland
el Salvador
Poland
United Arab emirates
Colombia
Australia
Pakistan
8Active worldwide
Bayer HealthCare and its divisions are represented in nearly all markets of the world.
9Active 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 headquar- ters 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 located in Germany (Monheim and Berlin, respectively). Local companies belonging to Bayer HealthCare 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 differenti- ated portfolio, Bayer HealthCare is reliant on a diversely composed workforce. After all, one of the cornerstones of Bayer HealthCares success is the creativity of its employees. This is why Bayer HealthCare is keen to attract the most talented candidates from all over the world to the company.
Diversity pays off in particular in the health care industry. The development of innovative products in this field requires cooperation between many partners. The more diverse the composition of those involved, the greater the creative potential that can be generated by collaboration. Their diverse knowledge, experiences and values can then be put to profitable use to produce innovative customer solutions and meet global challenges.
10
Animal Health
Sick pets can also impair the health of humans, for example by transmitting 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 physical closeness 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 HealthCares best-selling consumer health products in 2011, generating annual sales of roughly 420 million. The Baytril antibiotic for the treatment of serious infectious diseases in livestock and companion animals has been setting standards for many years. Veraflox, the first next-generation veterinary fluoroquinolone for the treatment of infections in dogs and cats, was launched in 2011. Thanks to its special mechanism of action, it exerts a stronger bacterial action than existing fluoroquinolones. The product has been granted regulatory approval in Europe and - according to the terms of the regulatory approval - can be used to treat different infections caused by specific bacterial pathogens.
The 2010 acquisition and integration of the New Zealand-based Bomac Group into Animal Health was followed in 2011 by the construction of a new Center for Innovation and Development in Auckland where products with a special focus on the needs of the Asia/Pacific region will be developed. The first products have already been re-registered and launched in the region. More than 200 other registration dossiers are currently being reviewed by the authorities.
With sales of approximately 1.2 billion in 2011, the Animal Health Division contributed 6.9 percent to Bayer HealthCares total sales.
net sales 2011: approx. 1.2 billionSite: 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
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 2011: approx. 3.5 billionSite: Morristown, new Jersey, 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 non-prescription 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 categories, including analgesics, cardiovascular risk prevention, cough and cold, dermatol-ogy, gastrointestinals and nutritionals.
In fact, some of the worlds 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. In addition to focusing its growth in emerging markets, Consumer Care continues to seek Merger & Acquisition (M&A) opportunities to deepen its pipeline and diversity of product offerings.
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
14
Medical Care
in a laboratory in Minneapolis (USA) Bayer researchers diana dutcher and Mark Hilse demonstrate on a model of blood vessels how thrombi and deposits can be removed by a minimally invasive procedure using a catheter.
15
the Medical Care division
net sales 2011: approx. 2.5 billionSite: tarrytown, new York, USA
Bayer HealthCares Medical Care Division is comprised of two business units -- Radiology and Interventional (R&I) and Diabetes Care. The R&I unit, established on January 1, 2012, merged Bayer HealthCare's contrast agent and medical devices businesses. Radiology & Interventional is a world leader in developing and manufacturing contrast agents used in X-ray, computed tomography (CT) and magnetic resonance imaging (MRI), as well as injection systems for diagnostic and therapeutic medical procedures in CT, MRI and cardiovascular and peripheral vascular disease.
The unit also provides service support for the systems as well as medical data management products. Product examples from the business unit include contrast agents Ultravist, Magnevist and Gadovist/Gadavist; injection systems Stellant D and Spectris Solaris EP; thrombectomy system AngioJet Ultra, and the Certegra
Informatics Platform. The products are marketed to cardiolo-gists, radiologists and vascular surgeons in hospitals and out-patient clinical sites through a global direct sales organiza-tion, supplemented in some locations by local distributors. The Diabetes Care unit is one of the leading providers of blood glucose monitoring systems, monitors to test glycated hemo- globin (HbA1c), lancing devices, diabetes management software and patient education and lifestyle support services.
The portfolio of blood glucose meters includes Contour, Contour XT, Contour Link (with Medtronic), Contour USB, Contour TS and Breeze 2. Monitors for measurement of glycated hemoglobin include the A1CNow+ monitor for health-care providers, and A1CNow SELFCHECK for home use.
Outside Europe, these products are generally sold to consumers through pharmacies, drugstores, mass merchants, hospitals or wholesalers. In Europe, they are sold mainly through pharmacies.
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 2011: approx. 9.9 billionSite: Berlin, Germany
Bayer HealthCares success story in the pharmaceuticals business goes back almost 125 years. The first product marketed by the Pharmaceutical Depart-ment of Bayer was the antipyretic Phenacetin in 1888. Bayer also 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 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 prosper- ing in the increasingly competitive pharmaceuticals market. The division com- bines 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 drug products to treat bacterial infections, such as respiratory tract and urinary tract infections. In the field of Mens Health, the division offers a wide range of therapeutic options, including treatments for erectile dysfunction and testosterone deficiency.
Bayer HealthCare has launched a novel Factor Xa inhibitor for the treatment of life-threatening blood clots that is taken once daily in tablet form. This product is now registered in more than 110 countries for the prevention of thrombosis after elective hip or knee replacement surgery.
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).
It was recently also granted regulatory approval in Europe, the United States and Japan for the prevention of stroke in patients with atrial fibrillation. In Europe, it also re- ceived approval in the treatment of deep vein thrombosis and the prevention of recurrent deep vein thrombosis and pulmonary embolism in late 2011.
The Womens Healthcare segment of the General Medi- cine Business Unit is a pioneer in its field, concentrating on three areas: contraception, menopause management and the development of gynecological treatments.
Bayer is the world leader in the field of female hormonal contraception, in particular in the area of oral contra-ception. The pill has been enabling women to engage in conscious family planning for more than 50 years.
Bayer HealthCare offers a wide range of different contra- ceptives to meet individual needs, including a low-dosage contraceptive which is the first product from a new class of oral contraceptives whose estrogen component has the
same action as estradiol, an estrogen that is produced by the female body.
The range also includes products to relieve the symptoms associated with menopause. In the gynecological therapy segment, the company is working to develop new thera- peutic 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, Bayer HealthCare has already launched a drug product for the treatment of endometriosis in Europe.
The Specialty Medicine Business Unit offers innovative therapeutic options to markedly improve the quality of life for people suffering from severe, chronic and life-threat-ening diseases.
Some 2.5 million people worldwide suffer from multiple sclerosis (MS), a chronic inflammatory disease of the central nervous system usually occurring in episodes.
19
Bayer scientist Dr. Xin Ma prepares a drug development study at the Global Drug Discovery innovation Center in Beijing (China).
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
Bayer HealthCare was one of the first companies to offer a causal treatment for this autoimmune disease that reduces 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 worlds 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 hepatocel-lular 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, thyroid cancer and lung cancer.
The pharmaceutical products are primarily distributed through wholesalers, pharmacies and hospitals. In addi- tion, products are also co-developed and co-marketed in partnerships with other companies.
Gisela Niepraschk conducts a visual inspection of blisters containing Nexavar tablets.
research and development
Samples for future medical research such as tissue specimens are stored in biobanks. They are cross-referenced to various disease stages and examination findings in a central database.
20
research and development at Bayer HealthCare
1,948 million of the Bayer Groups total research and development (R&D) spending went to Bayer HealthCare in 2011, corresponding to 66.4 percent of the groups entire research expenditure, or 11.3 percent of Bayer Health- Care's sales. 7,700 employees research and develop innovative active in- gredients for the treatment of diseases where there is a high level of medical need.
Active ingredient discovery research at Bayer HealthCare Pharmaceuticals is concentrated on the areas of Cardiology & Hematology, Oncology and Womens Healthcare, while the inflammation mechanisms and therapeutic options in ophthalmology are also of interest. The division aims to identify and optimize low-molecular-weight substances and develop new biologics. In many of these projects, Bayer's scientists work together in close collabora-tion with external cooperation partners. One example of an innovative active ingredient is the anticoagulant rivaroxaban (trade name: Xarelto), which was invented in Bayer's laboratories in Wuppertal. The extensive clinical trial program supporting rivaroxaban makes it the most studied oral, direct Factor Xa inhibitor in the world today, with the most scientific publications. More than 75,000 patients in total are taking part in the clinical development program to investigate the preparations potential in the prevention and treatment of a broad spectrum of acute and chronic thromboembolic disorders, including stroke prevention in patients with atrial fibrillation, treatment of deep vein thrombosis, prevention of recurrent deep vein thrombosis or pulmonary embolism, and finally secondary prevention of acute coronary syndrome.
One of the many other innovative substances in the pipeline is riociguat, an active ingredient for the treatment of pulmonary hypertension which is the first drug from a new class of vasodilatative substances. Other priorities in cardiology research are heart failure and kidney disorders, as heart disease and chronic kidney disease often share a common disease mechanism. The division also evolves products that have already been granted regulatory approval, for example by developing novel formulations.
Despite major advances in the fight against cancer, there is still a high level of medical need for therapies to prolong survival and improve the quality of life. The development pipeline in Oncology comprises various targeted antibodies and low-molecular-weight substances. In addition to the active ingredient sorafenib (trade name: Nexavar), these include regorafenib, a
research and development
21
contraceptive patch and a new, low-dose intrauterine system through to the further development of oral contraceptives.
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 radiology and interven-tional, the division is focused on investments in informatics, contrast media, fluid delivery and other accessories to deliver innovative integrated solutions to customers. Investment areas include high field MR, low radiation CT, radiology workflow, equipment service in addition to vascular intervention systems for treating constricted or blocked blood vessels (such as Cotavance, a drug-coated balloon catheter). The divisions expanded global network of leading clinical researchers will contribute to research that supports innovative clinical studies. The acquisition of the Bomac Group with its headquarters in Auckland, New Zealand, has strengthened the Animal Health Divisions research activities in the livestock sector. Auckland joins Monheim (Germany) and Shawnee (United States) as a new, regional development center. The grow- ing demand for animal protein necessitates innovative solutions for food-producing animals. Another important segment is the treatment of age-related diseases in com- panion animals. Further efforts are devoted to developing new formulations and user-friendly applications for familiar active ingredients.
One recent innovation within the Consumer Care busi- ness includes the launch of Bayer Advanced Aspirin in the United States. A combination of Bayers commitment to technological advances in medicine along with its rich analgesic heritage resulted in the introduction of the pro- duct that offers consumers faster, tough pain relief. Bayer Advanced Aspirin was first introduced in the United States in 2011 and plans are under way for launches in other countries.
research and developmentresearch and development
22
development substance that inhibits various enzymes stimulating tumor growth and angiogenesis, and Alpha-radin, a novel alpha-pharmaceutical agent that has pro-duced positive results in a Phase III study for the treatment of prostate cancer and which is scheduled to be filed for regulatory approval in mid 2012. Another innovative field in oncology research at Bayer HealthCare is cancer stem cell research. Cancer stem cells are believed to play a significant role in the development, metastasis and re- currence of cancer. The objective is to develop new therapeutic options for cancer stem cells.
Aflibercept (VEGF Trap-Eye) could make an important con- tribution in the treatment of serious eye diseases. The active ingredient has exhibited promising results in two clinical Phase III trials in the treatment of wet age-related macular degeneration. The product was granted regulatory approval in the United States in November 2011 and is expected to receive authorization in Europe in the second half of 2012.
Bayer HealthCare's Pharmaceuticals Division is also active in the field of womens healthcare, conducting research into innovative approaches to treat gynecological disorders such as endometriosis and uterine fibroids. Visanne, a new treatment option for endometriosis, was launched in Europe in 2010. Bayer HealthCare is also working on further developing the broad spectrum of contraception options, ranging from the development of an innovative
Dr. Christoph Schatz checks a slide with tissue samples.
23
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-16 (uLD LNG contraceptive system)
Nexavar
Nexavar
Nexavar
Nexavar
Nexavar
regorafenib (DaST inhibitor)
regorafenib (DaST inhibitor)
riociguat (sGC stimulator)
riociguat (sGC stimulator)
Tedizolid
Vaginorm
aflibercept (veGf Trap-eye)
aflibercept (veGf Trap-eye)
aflibercept (veGf Trap-eye)
Xarelto
Multiple sclerosis
Treatment of bone metastases in hormone-refractory/castration-resistant prostate cancer
Reduction of submental fat
Contraception
PET imaging in diagnosis of Alzheimers disease
Magnetic resonance imaging
Contraception, duration of use: 5 years
Breast cancer
Adjuvant therapy of liver cancer
Non-small-cell lung cancer
Adjuvant therapy of kidney cancer
Thyroid cancer
Colorectal cancer
Treatment of metastatic or inoperable gastrointestinal stromal tumors
Pulmonary hypertension (CTEPH)
Pulmonary hypertension (PAH)
Complicated skin infections and pneumonia
Vulvovaginal atrophy
Diabetic macular edema
Abnormal retinal angiogenesis following pathological myopia
Central retinal vein occlusion
Treatment and secondary prevention of venous thromboembolism
* as of February 14, 2012**co-promotion
PET = positron emission tomography; CTEPH = chronic thromboembolic pulmonary hypertension; PAH = pulmonary arterial hypertensionThe 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 appro-vals will not be granted for these compounds.
w Product Supply
24
andreas Werner (left) and francesco Lo Grande clean and inspect the stirring rods of an ointment mixer used to manufacture Bepanthen antiseptic cream at the Grenzach-Wyhlen production site.
from sourcing to the finished product
Product Supply
25
Bayer HealthCare manufactures products at almost 60 sites around the world. The active ingredients for prescription medicines are manufactured primarily at the production sites in Wuppertal and Bergkamen (Germany) and Berkeley and Emeryville (United States). They are processed and packaged as finished pharma-ceuticals 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- or film-coated tablets but also, for example, as intrauterine systems. These formulation and packaging activities are based in Berlin, Leverkusen and Weimar (Germany), Garbagnate (Italy), Turku (Finland), So Paulo (Brazil), Beijing (China), as well as various other sites in Europe, Asia and Latin America. Kogenate, a drug product for the treatment of hemophilia, is manufactured in Berkeley (United States) using a biotechnology process, while Betaferon for the treatment of multiple sclerosis is produced in Emeryville (United States).
The main production sites for non-prescription (over-the-counter) drug products are located in Bitterfeld-Wolfen and Grenzach-Wyhlen (Germany), Cimanggis (Indone-sia), Myerstown (USA) and Madrid (Spain). 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 Health- Care supplies a total of more than 20,000 articles. The reason for this large number is the different presentations of individual products and packaging for example, different formulations, dosages, pack sizes and language versions.
Bayer HealthCare Product Supply steers the subgroups 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 pharmaceutical products is subject to extraordinarily stringent quality standards. These standards are known collective-ly as Good Manufacturing Practice (GMP). Compliance with these requirements is regularly inspected by internal experts, regulatory authorities and external consultants.
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Business development
Bayer HealthCare has expanded its life science partnership activities in the Bay area of California. The company makes laboratory space available to start-up companies for their research work under the project name CoLaborator.
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Partnerships for innovative products
Bayer HealthCare is an innovation- and growth-oriented enterprise investing across its divisions not only in own R&D activities, but also in external collaborations. In order to secure access to innovative research and technologies, expand the product portfolio and strengthen its regional market presence, the company is constantly searching for opportunities to collaborate. Partnerships cover a broad range of models from R&D collaborations, licensing agreements, co-marketing agreements and regional alliances to acquisitions. The philosophy is that successful transactions must meet the needs of both partners.
With the innovative anticancer drug Nexavar, the Pharmaceuticals Division and Onyx Pharmaceuticals, Inc., USA have gone all the way from drug discovery to market. The co-development and co-promotion agreement with Janssen Pharmaceuticals for the anticoagulant Xarelto has led to multiple joint launches. In collaboration with Regeneron Pharmaceuticals, Inc. Aflibercept (VEGF Trap-Eye) has successfully com- pleted Phase III trials in wet age-related macular degeneration and central retinal vein occlusion. In Oncology, a Phase III trial for the cancer drug Alpharadin was successfully completed together with Algeta ASA from Norway. Collaborations at earlier stages include very innovative approaches, such as the one with OncoMed Pharmaceuticals investigating new approaches to block cancer stem cells. Strategic alliances with international innovation partners from academia are another pillar of the companys R&D strategy, such as the joint research center for innovative thera- peutic approaches at Tsinghua University (China) and a cooperation with the Ger- man Cancer Research Center. Bayer HealthCare is also striving to build its regional portfolio in the core growth markets where partners can leverage Bayers marketing presence and local knowledge, as demonstrated through the in-licensing of tedizolid, an antibiotic from Trius Therapeutics for China, Japan and other emerging markets.
The Animal Health Division will focus on Mergers & Acquisitions and licensing activi- ty in developing markets to complement recent transactions in the United States (Piedmont Pharmaceuticals, KMG Chemicals) and Asia/Pacific (Bomac). The Consumer Care Division continues to focus its business development resources in the growth markets. The recent acquisitions of Sagmel (Russia) and Topsun (China) are examples of the successful implementation of this strategy. In addition, the division will expand its portfolio into adjacent business categories, as well as Rx to OTC switch opportunities. In the Medical Care Division, recent investments including the acquisitions of Possis Medical and Pathway Medical are excellent examples of Bayers long-term commitment to growing its cardiovascular therapy franchise. Bayer Diabetes Care has recently extended existing alliances with both the Med- tronic and Becton Dickinson corporations to better serve the needs of people treating their diabetes with insulin.
Business development
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Social commitment
Dr. Concepcin Ziga valeriano, head of the national Chagas program in Honduras, explains to visitors to the hospital how to protect against 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 responsibility in society. 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.
As the market leader in hormonal contraception, Bayer HealthCare has sup- ported family planning around the world for 50 years. In 2010, for example, the company marketed an oral contraceptive at a reduced price in Ethiopia in collaboration with the USAID (United States Agency for International Develop-ment) so that low-income women can also afford this product. Further launches followed in Uganda and Tanzania in 2011, with other eight states in sub-Saharan Africa scheduled to follow by 2014. In addition, Bayer HealthCare is working together with partners to improve knowledge of sexuality, health and contra-ception in developing countries.
More than 3.3 billion people are affected by so-called neglected diseases. In cooperation with the World Health Organization (WHO), Bayer HealthCare pro- vides medicines free of charge to treat African sleeping sickness and Chagas disease in Latin America. Bayer HealthCare reaffirmed this commitment in early 2012: it plans to work together with partners from the public and private sectors, such as the WHO and the Bill & Melinda Gates Foundation, to speed up the progress being made in fighting tropical diseases by 2020. The company 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.
Medical Care continues to support patient and other non-governmental organizations (NGOs), including the International Diabetes Federation (IDF), Foundation of European Nurses in Diabetes (FEND) and the Juvenile Diabetes Research Foundation (JDRF). The Division also supports the International Diabetes Federations Young Leaders in Diabetes Programme to foster the development of leadership skills and connections to achieve tangible improve-ments in the lives of young people with diabetes in their countries and regions.
Social commitment
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research milestones
History1888 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
More than 100 years ago, Aspirin was already known beyond the borders of Germany as an effective pain reliever.
in 1961, Anovlar became the first hormonal contracep-tive on the market in europe.
Professor Gerhard Domagk, discoverer of the sulfon- amides and Nobel Prize winner in 1939, in his laboratory.
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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 whose estrogen com-Qlaira ponent has the same action as estradiol, an estrogen that 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 Sheep infectious disease, in lambs
2009 Deworming agent for dogsProfender Dog
2011 First next-generation veterinary fluorquinolone for the Veraflox treatment of bacterial infections in cats and dogs
2011 Combination treatment against roundwormsProcox and coccidia in dogs
2011 Flea and tick collar for cats and dogs with anSeresto innovative polymer matrix that releases the needed amount of active ingredient for up to eight months
2011 A tablet with breakthrough Pro-ReleaseBayer technology is launched in the United StatesAdvanced Aspirin
2011 Innovative blood glucose sensors for highly accurateContour Next blood glucose measurement
2011 Approval in Europe, the United States and Japan for theXarelto prevention of stroke in patients with atrial fibrillation
2011 Approval in Europe for the treatment of deep veinXarelto thrombosis and the prevention of recurrent deep vein thrombosis and pulmonary embolism
Seresto provides sustained protection against ticks and fleas for dogs and cats.
Oemuer Capar conducts a visual inspection of Nexavar tablets at Bayer HealthCare's Leverkusen site.
Xarelto is a drug product to prevent and treat life-threatening blood clots. Bayer scientists Dr. alexander Straub and Dr. Susanne rhrig were involved in its research and development.
BaYer HeaLTHCare Oliver Renner oliver.renner@bayer.com
aNiMaL HeaLTH DiviSiONAstrid Khlerastrid.koehler@bayer.com
CONSuMer Care DiviSiONTricia McKernantricia.mckernan@bayer.com
MeDiCaL Care DiviSiONMeredith Fischermeredith.fischer@bayer.com
PHarMaCeuTiCaLS DiviSiONOliver Renneroliver.renner@bayer.com
A comprehensive overview of Bayer HealthCare is available on the Internet at www.bayerhealthcare.com
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