US Food and Drug Administration Approves RECOTHROM

Bayer HealthCare announced today that its partner, ZymoGenetics Inc., received US Food and Drug Administration (FDA) approval of RECOTHROM™ Thrombin, topical (recombinant) for use as a topical hemostatic product. Bayer acquired the product rights for all markets outside the US in 2007 and will provide US sales support for a three-year period as part of a co-promotion agreement.
“The first regulatory approval of RECOTHROM is a significant signal of the product’s strong clinical data,” said Hans Bishop, Head of Bayer’s global Hematology/Cardiology Business Unit. “RECOTHROM is an attractive addition to our specialty pharmaceutical portfolio. Our partnership with ZymoGenetics demonstrates Bayer’s continued focus on working collaboratively with innovative biotechnology companies to develop and commercialize novel protein therapeutics.”

RECOTHROM, previously referred to as rThrombin, is the first and only recombinant, plasma-free thrombin approved for use as a topical hemostatic product. The FDA has approved RECOTHROM as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques is ineffective or impractical.

The FDA approval of RECOTHROM triggers a US-Dollar 40 million milestone payment from Bayer to ZymoGenetics. ZymoGenetics will compensate Bayer HealthCare for its US sales efforts by paying a tiered commission of up to 20% on US sales and up to US-Dollar 20 million in sales bonus payments upon achievement of certain US sales levels during a three-year co-promotion period.

About RECOTHROM™
RECOTHROM is a recombinant form of human thrombin that is structurally and functionally similar to human thrombin. It is not derived from animal or human blood. With thrombin being used in more than 1 million surgeries each year in the United States, RECOTHROM gives surgeons the opportunity to provide their patients with a plasma-free thrombin alternative for surgical hemostasis. The production of recombinant proteins is not dependent on the availability of blood from animals or human donors and can be scaled-up to meet market demand.

About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of healthcare, nutrition and high-tech materials. Bayer HealthCare, a subsidiary of Bayer AG, is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Diabetes Care and Pharmaceuticals divisions. The pharmaceuticals business operates under the name Bayer Schering Pharma AG. Bayer HealthCare’s aim is to discover and manufacture products that will improve human and animal health worldwide. Find more information at www.bayerhealthcare.com.

Bayer Schering Pharma is a worldwide leading specialty pharmaceutical company. Its research and business activities are focused on the following areas: Diagnostic Imaging, Hematology/Cardiology, Oncology, Primary Care, Specialized Therapeutics and Women's Healthcare. With innovative products, Bayer Schering Pharma aims for leading positions in specialized markets worldwide. Using new ideas, Bayer Schering Pharma aims to make a contribution to medical progress and strives to improve the quality of life. Find more information at www.bayerscheringpharma.de.

Three Phase III Trials Show Rivaroxaban Outperformed Enoxaparin in Preventing Venous Thromboembolism After Major Orthopedic Surgery

Phase III clinical trial results released today underscore that rivaroxaban, the oral, once-daily, investigational anticoagulant, was significantly more effective than enoxaparin, the standard of care, in preventing venous thromboembolism (VTE) in patients undergoing total hip or knee replacement surgery. Rivaroxaban-treated patients consistently experienced lower rates of VTE events compared to enoxaparin-treated patients across three large studies as well as demonstrating a similar rate of major bleeding events. Rivaroxaban is being jointly developed by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. and Bayer HealthCare AG.

Data from the RECORD1 and RECORD2 studies, evaluating rivaroxaban in total hip replacement surgery, were presented at the 49th Annual Meeting of the American Society of Hematology. Additional data from the head-to-head RECORD3 study, which showed similar statistically significant results for rivaroxaban compared with enoxaparin in total knee replacement surgery, also were presented.

Studies presented include:

• RECORD1 (n=4,541), which demonstrated a 70 percent relative risk reduction
  (RRR) (p<0.001) in total VTE when compared with enoxaparin and an 88
  percent RRR (p<0.001) in major VTE


• RECORD2 (n=2,509), which demonstrated a 79 percent RRR (p<0.001) in
  total VTE when compared with enoxaparin, again with an 88 percent RRR
  (p<0.001) in major VTE


• RECORD3 (n=2,531), which demonstrated a 49 percent RRR (p<0.001) in
  total VTE when compared with enoxaparin, and a 62 percent RRR (p=0.016) in
  major VTE


• Major bleeding rates were similar for both drugs (less than or equal to 0.6
  percent) and differences were not statistically significant


• No routine blood monitoring was required in the Phase III RECORD program at
  the 10mg dose, based on the Phase II data and pharmacokinetic profile

"In RECORD1, 2 and 3 we have three Phase III trials showing unprecedented results in major orthopedic surgery for the prevention of VTE, and this is genuinely exciting," said Dr. A.G.G. Turpie, Principal Investigator in the RECORD program, Professor of Medicine, McMaster University, Canada. "In three different trials across large patient populations, we have seen rivaroxaban outperform the current standard of care, enoxaparin, without compromising on safety. This is strong clinical evidence that we are making a major leap forward in oral anticoagulation in orthopedic surgery."

A key secondary endpoint of the study measuring the reduction of symptomatic VTE, also showed clinically meaningful results in favor of rivaroxaban. For this endpoint, the trials showed an RRR of 45 percent (p=0.222) in RECORD1, an 80 percent RRR (p=0.004) in RECORD2 and a 66 percent RRR (p=0.005) in RECORD3, compared to the standard regimen.

"The symptomatic VTE findings in the RECORD trials are extraordinary," added Dr. Turpie. "Previous trials were successful in identifying trends towards reducing symptomatic VTE, but with RECORD2 and 3 we are seeing clinically relevant reductions in symptomatic VTE for the first time in orthopedic surgery. These results are a major milestone in the evolution of anticoagulation therapy."

Rivaroxaban is a novel, oral, once-daily direct Factor Xa inhibitor in advanced clinical development for a range of patients who could benefit from prevention and/or treatment of blood clots. Rivaroxaban works at a pivotal stage in the coagulation process to directly inhibit the enzyme Factor Xa.

Detailed Study Results

Data presented at the ASH meeting are from RECORD (Regulation of Coagulation in major Orthopedic surgery reducing the Risk of DVT and PE), a global program of four pivotal trials involving more than 12,000 patients comparing oral, once-daily rivaroxaban, with subcutaneous enoxaparin in the prevention of VTE after elective, major orthopedic surgery. Following are summary results from RECORD1, RECORD2 and RECORD3:

RECORD1 (Abstract #6)

The RECORD1 trial compared the safety and efficacy of rivaroxaban with enoxaparin in patients undergoing total hip replacement surgery. The duration of thromboprophylaxis in both treatments was five weeks. The study met its primary endpoint, and demonstrated a 70 percent RRR (p<0.001) in total VTE (composite of deep vein thrombosis, non-fatal pulmonary embolism and all-cause mortality), for patients treated with rivaroxaban compared with those treated with enoxaparin (1.1 percent and 3.7 percent, respectively). In addition, against the secondary endpoint, an 88 percent RRR (p<0.001) in major VTE (composite of proximal deep vein thrombosis, non-fatal pulmonary embolism and VTE-related death) was observed in patients treated with rivaroxaban (0.2 percent and 2.0 percent, respectively). Rivaroxaban also demonstrated a similar rate of major bleeding to enoxaparin (0.3 percent and 0.1 percent, respectively, p=0.178).

RECORD2 (Abstract #307)

The RECORD2 study evaluated the safety and efficacy of rivaroxaban compared with enoxaparin and placebo. The duration of thromboprophylaxis in patients undergoing total hip replacement was 35+/- 4 days (extended prophylaxis) for rivaroxaban or 10-14 days for those receiving enoxaparin, followed by placebo. The primary and secondary endpoints were the same as for RECORD1 with a 79 percent RRR (p<0.001) in total VTE and an 88 percent RRR (p<0.001) in major VTE for patients treated with rivaroxaban compared with those treated with enoxaparin. Rivaroxaban demonstrated a similar rate of major bleeding compared to enoxaparin (0.1 percent and 0.1 percent, respectively, p=0.980), despite the greater treatment duration with rivaroxaban in this study.

RECORD3 (Abstract #308)

The RECORD3 trial compared the safety and efficacy of rivaroxaban with enoxaparin in patients undergoing total knee replacement surgery. Enoxaparin was initiated 12 hours before surgery, and rivaroxaban was initiated 6-8 hours after surgery; both treatments were continued for 10-14 days. Primary and secondary endpoints were the same as for RECORD1 and there was a 49 percent RRR (p<0.001) in total VTE and a 62 percent RRR (p=0.016) in major VTE for patients treated with rivaroxaban compared with those treated with enoxaparin. Rivaroxaban demonstrated similar rates of major bleeding to enoxaparin (0.6 percent and 0.5 percent, respectively, p=0.774).

Copies of the abstracts may be viewed online at the ASH website: www.hematology.org/meetings/abstracts.cfm

Unmet Needs in Venous Thromboembolism (VTE)

VTE, a disease process that begins with a blood clot in a vein, includes both deep vein thrombosis (DVT) and pulmonary embolism (PE). Patients undergoing major orthopedic surgery are at risk for VTE because, during the surgery the large veins of the leg that carry blood back to the heart can be damaged, significantly increasing the risk of coagulation and thrombosis.

Each year approximately 700,000 people elect to have hip and knee replacement surgeries in the U.S. and a blood clot is the most common cause of re-hospitalization for this patient group. In fact, VTE is considered the most frequent preventable serious and potentially fatal complication following major orthopedic surgery. But the threat stretches beyond orthopedic surgeries. Blood clots are one of the leading causes of global mortality and a concern for many patient populations, including those with atrial fibrillation at risk for stroke; those at risk for acute myocardial infarction (heart attack); those undergoing major orthopedic surgery; and acutely medically ill patients.

About Rivaroxaban

To date, rivaroxaban is the most studied oral, direct Factor Xa inhibitor in clinical development. More than 20,000 patients have been evaluated in the completed Phase II programs and enrolled thus far in the Phase III programs. Almost 50,000 patients are expected to be evaluated in the total clinical development program.

Bayer HealthCare submitted a regulatory filing to the European Agency for the Evaluation of Medicinal Products (EMEA) at the end of October 2007 for approval to market rivaroxaban in the EU for the prevention of VTE in patients undergoing major orthopedic surgery of the lower limbs. Upon regulatory approval, rivaroxaban will be commercialized in Europe by Bayer Schering Pharma. A filing for rivaroxaban for a similar indication in the U.S. is planned in 2008, where upon approval, it will be will commercialized by Scios Inc. and Ortho-McNeil, Inc., both of which are wholly-owned subsidiaries of Johnson & Johnson.

Johnson & Johnson Pharmaceutical Research and Development

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD), is part of Johnson & Johnson, the world's most broadly based producer of health care products. J&JPRD is headquartered in Raritan, NJ, and has facilities throughout Europe and the United States. J&JPRD is leveraging drug discovery and drug development in a variety of therapeutic areas to address unmet medical needs worldwide.

Nexavar Becomes First and Only Approved Treatment of Hepatocellular Carcinoma in Europe

Bayer HealthCare AG and Onyx Pharmaceuticals, Inc. today announced that the European Commission has granted marketing authorization to Nexavar® (sorafenib) tablets for the treatment of patients with hepatocellular carcinoma (HCC), or liver cancer. Nexavar, an oral anti-cancer drug, is the first and only approved systemic drug therapy for liver cancer and the only drug therapy shown to significantly improve overall survival in patients with the disease. Additional regulatory filings in HCC are under review in countries around the world including the U.S. and, most recently, in Japan. Nexavar is currently approved in more than 60 countries for the treatment of patients with advanced kidney cancer.
“The approval of Nexavar, a novel multi-kinase inhibitor, represents an unprecedented advance for patients with HCC who, until now, had no approved systemic treatment options,” said Arthur J. Higgins, chairman of the Executive Committee of Bayer HealthCare. “This milestone will likely establish Nexavar as the standard of care in HCC and shows the dedication of health authorities to make Nexavar available as quickly as possible. Most importantly, it allows us to offer patients and medical professionals the potential to improve treatment outcomes for this devastating disease.”

“Liver cancer is one of the few cancers in which the number of related deaths continues to increase,” said Hollings C. Renton, chairman, president and chief executive officer of Onyx Pharmaceuticals, Inc. “This second approval for Nexavar – first in advanced kidney cancer and now, less than two years later, in HCC – demonstrates our commitment to expediting the clinical development of this innovative therapy to treat today’s unmet needs in cancer. We will move swiftly to make Nexavar rapidly available to patients.”

The European Commission’s decision to approve Nexavar is based on positive data from the international, Phase 3, placebo-controlled Sorafenib HCC Assessment Randomized Protocol (SHARP) trial which demonstrated that Nexavar extended overall survival by 44 percent in patients with HCC (HR=0.69; p=0.0006) versus placebo. The primary objective of the study was to compare overall survival in patients administered Nexavar versus those administered placebo. Median overall survival was 10.7 months in Nexavar-treated patients compared to 7.9 months in those taking placebo. There were no significant differences in serious adverse event rates between the Nexavar and placebo-treated groups with the most commonly observed adverse events in patients receiving Nexavar being diarrhea and hand-foot skin reaction. Based on these data, a supplemental New Drug Application for Nexavar was granted Priority Review status by the U.S. Food and Drug Administration (FDA) in August. Most recently, the regulatory filing in Japan has been submitted.

HCC, the most common form of liver cancer, is responsible for about 90 percent of the primary malignant liver tumors in adults. Liver cancer is the sixth most common cancer in the world and the third leading cause of cancer-related deaths globally. Over 600,000 cases of liver cancer are diagnosed worldwide each year (about 54,000 in Europe, 19,000 in the U.S. and 390,000 in China, Korea and Japan) and incidence is increasing. Currently, the 5-year survival rate for patients with liver cancer in Europe is less than 8 percent. The 5-year survival rate for liver cancer patients in the United States is 11 percent and less than 10 percent in Asia among patients with non-resectable tumors.

Nexavar’s Differentiated Mechanism
Nexavar targets both the tumor cell and tumor vasculature. In preclinical studies, Nexavar has been shown to target members of two classes of kinases known to be involved in both cell proliferation (growth) and angiogenesis (blood supply) – two important processes that enable cancer growth. These kinases included Raf kinase, VEGFR-1, VEGFR-2, VEGFR-3, PDGFR-B, KIT, FLT-3 and RET. Preclinical models have also demonstrated that Raf/MEK/ERK has a role in HCC. Therefore, blocking signaling through Raf-1 may offer therapeutic benefits in HCC.

Nexavar is currently approved in more than 50 countries, including the United States and the European Union, for the treatment of patients with advanced kidney cancer. In Europe, Nexavar is approved for the treatment of patients with advanced renal cell carcinoma (RCC) who have failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy. Nexavar is also being evaluated by the companies, international study groups, government agencies, and individual investigators as a single agent or combination treatment in a wide range of other cancers, including adjuvant therapy for kidney cancers, metastatic melanoma, breast cancer and non-small cell lung cancer (NSCLC).

About Onyx Pharmaceuticals, Inc.
Onyx Pharmaceuticals, Inc. is a biopharmaceutical company developing innovative therapies that target the molecular mechanisms that cause cancer. The company is developing Nexavar, a small molecule drug, with Bayer HealthCare. For more information about Onyx’s pipeline and activities, visit the company’s web site at: www.onyxpharm.com.

About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of healthcare, nutrition and high-tech materials. Bayer HealthCare, a subsidiary of Bayer AG, is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Diabetes Care and Pharmaceuticals divisions. The pharmaceuticals business operates under the name Bayer Schering Pharma AG. Bayer HealthCare’s aim is to discover and manufacture products that will improve human and animal health worldwide. Find more information at www.bayerhealthcare.com.

Bayer Schering Pharma is a worldwide leading specialty pharmaceutical company. Its research and business activities are focused on the following areas: Diagnostic Imaging, Hematology/Cardiology, Oncology, Primary Care, Specialized Therapeutics and Women's Healthcare. With innovative products, Bayer Schering Pharma aims for leading positions in specialized markets worldwide. Using new ideas, Bayer Schering Pharma aims to make a contribution to medical progress and strives to improve the quality of life. Find more information at www.bayerscheringpharma.de.

Bayer launches mobile website for cellphones and blackberries

Bayer AG has set up a new source of information for its latest corporate news. Users of mobile terminals – such as cellphones, blackberries, PDAs, palmtops and smartphones – can now call up the most important Bayer news items, press releases and the latest Bayer share prices as well as general information on the Leverkusen-based chemical and pharmaceutical group. The website is aimed at media representatives, analysts and anyone else who may be interested in the company, who regularly goes online via a mobile terminal and who wants to obtain the latest information about Bayer both quickly and conveniently. Within its industry, Bayer is the first company in Germany to offer a mobile-enabled website and to follow the trend towards a greater use of flat rates, so that cellphone users can surf the internet wherever they are, without restrictions and at a fixed rate.

The corporate website has been specially optimized for this application and can be called up in German and English. Users can access, among other things, corporate facts and figures, products, KPIs, stock information and charts as well as Bayer sports news. In addition, the investor relations and press pages carry the relevant contact details for queries.

Device recognition allows the identification of over 4,000 different mobile terminals. Depending on the device class, all web pages have been set up for the required display, so that graphics, text and navigation elements are specially tailored for the device that is in use.

“In our mobile information society the internet increasingly accompanies its users while traveling – a need which is clearly met by this special corporate website for mobiles, blackberries etc. It is possible to call up corporate news and share prices at any time, virtually anywhere. So Bayer is now providing perfect pocket-sized convenience,” says Heiner Springer, Head of Communications at Bayer AG.

The website is available in German at:
http://mobil.bayer.de and http://www.mobil.bayer.de

The website is available in English at:
http://mobile.bayer.com and http://www.mobile.bayer.com


For more information visit www.bayer.de

Bayer CropScience’ Nunhems acquires Korean vegetable seed company SeedEx

Bayer CropScience announced today that Nunhems, its vegetable seed business, has completed the acquisition of the assets of the South Korean vegetable seed company SeedEx which specializes in the breeding, production and marketing of Hot pepper and Brassica varieties. Both crops belong to the most important vegetable crops in Asia in terms of acreage and consumption. The Korean authorities had approved the transaction. Financial terms were not disclosed.

The acquisition strengthens Nunhems’ business in the Asia/Pacific region offering access to new Asian markets as well as growth opportunities in other regions of the world. With both crops being strategic crops for Nunhems the germplasm and breeding activities of SeedEx ideally complement Nunhems’ portfolio. Furthermore, the acquisition will bring in specifically skilled and knowledgeable staff.

Mr. Douwe Zijp, Chief Executive Officer of Nunhems comments: “The acquisition of SeedEx is an important step to strengthen our market position in Hot Pepper and Brassica in Asia. The SeedEx team with its well recognized breeding competence and market know-how will be an excellent reinforcement of our global teams.”

Mr. Sang Gil Lee, Managing Director SeedEx comments: “I am proud that my team becomes part of a global specialist company in vegetables seeds. Nunhems will supply additional resources, practical expertise and know-how on biotechnological support for the creation of new varieties.”


The Bayer Group is a global enterprise with core competencies in the fields of health care, nutrition and high-tech materials. Bayer CropScience AG, a subsidiary of Bayer AG with annual sales of about EUR 5.7 billion (2006), is one of the world’s leading innovative crop science companies in the areas of crop protection, non-agricultural pest control, seeds and plant biotechnology. The company offers an outstanding range of products and extensive service backup for modern, sustainable agriculture and for non-agricultural applications. Bayer CropScience has a global workforce of about 17,900 and is represented in more than 120 countries. This and further news is available at: www.newsroom.bayercropscience.com.

The company’s vegetable seed business operates under the name of Nunhems. Nunhems® is the global specialist in vegetable seeds and sharing smart products, concepts and expertise with the professional horticultural production industry and supply chain. Its portfolio includes leading varieties and brands in crops such as leek, onion, carrot, melon, cucumber, tomato, watermelon, lettuce, pepper and chicory witloof. With annual sales of EUR 190 million in 2006, Nunhems is among the worldZs four leading vegetable seed companies with an extensive rate of 28 species and some 2,500 varieties. With more than 1,200 people Nunhems is present in all major vegetable production areas in the world.

Find more information at www.bayercropscience.com

YAZ approved in the Netherlands as European Reference Member State

Bayer Schering Pharma AG, Germany, announced today that the Dutch regulatory authorities have granted national approval for their new low dose 24-day oral contraceptive YAZ® (3 mg drospirenone/20 mcg ethinyl estradiol) in the Netherlands. YAZ® will be registered for the indications oral contraception and the treatment of moderate acne in women seeking contraception. The Netherlands will serve as the Reference Member State for the upcoming Mutual Recognition Procedure to gain European-wide marketing approval for the product.

“We are very excited about this first European approval for YAZ®. YAZ® is the first oral contraceptive to combine the unique progestin drospirenone with 20 mcg of ethinyl estradiol in a 24-day active hormone pill regimen. Through its innovative active ingredient drospirenone, YAZ® offers additional benefits, such as the treatment of acne, to women who want reliable birth control,” said Phil Smits, M.D., Head of Women’s Healthcare at Bayer Schering Pharma AG.

YAZ®, which has been available in the U.S. since April 2006, is the fastest-growing oral contraceptive brand in the U.S. YAZ® is also the only oral contraceptive with clinically proven efficacy in the treatment of the emotional and physical symptoms associated with PMDD (Premenstrual Dysphoric Disorder), such as mood swings, irritability, anxiety, changes in appetite and eating habits, breast tenderness, bloating, and headache. YAZ® was granted this indication in the USA in October 2006. Bayer Schering Pharma AG plans to proceed with the application for the registration of the PMDD indication in Europe. With the approval for the treatment of acne in January 2007, YAZ® becomes the first and only oral contraceptive ever approved in the USA for three distinct indications.

About YAZ®
Like Yasmin®, the number one brand birth control pill worldwide, YAZ® contains the innovative progestin drospirenone. Drospirenone exhibits unique antimineralcorticoid and antiandrogenic properties, unlike any other progestin available in oral contraceptives. Due to drospirenone’s antiandrogenic action, YAZ® can be used for the treatment of acne, which is primarily caused by an increased production and/or activity of male sex hormones (androgens).

YAZ® has a new dosing regimen of 24 days of active hormone pills and four days of placebo. This innovative regimen combined with drospirenone’s benefits reduces typical monthly hormonal fluctuations compared to traditional oral contraceptives with intake regimens of 21 days of active pills and seven days of placebo.

The Bayer Group is a global enterprise with core competencies in the fields of health care, nutrition and high-tech materials. Bayer HealthCare, a subsidiary of Bayer AG, is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany.The company combines the global activities of the Animal Health, Consumer Care, Diabetes Care and Pharmaceuticals divisions. The pharmaceuticals business operates under the name Bayer Schering Pharma AG. Bayer HealthCare’s aim is to discover and manufacture products that will improve human and animal health worldwide. Find more information at www.bayerhealthcare.com

Bayer Schering Pharma is a worldwide leading specialty pharmaceutical company. Its research and business activities are focused on the following areas: Diagnostic Imaging, Hematology/Cardiology, Oncology, Primary Care, Specialized Therapeutics and Women's Healthcare. With innovative products, Bayer Schering Pharma aims for leading positions in specialized markets worldwide. Using new ideas, Bayer Schering Pharma aims to make a contribution to medical progress and strives to improve the quality of life. Find more information at www.bayerscheringpharma.de

Bayer MaterialScience completes Taiwan Ure-Tech acquisition

Bayer MaterialScience has completed its acquisition of the Taiwan Ure-Tech Group on July 1, 2007. The move has made the company the world’s largest supplier of resins and films. Bayer MaterialScience intends to move the global headquarters of its Thermoplastic Polyurethanes (TPU) Business Unit to Hong Kong by October 1, 2007.

Dr. Tim Bielfeldt, Global Head of the TPU Business Unit, explained: “By joining forces, we are combining the strengths of Ure-Tech as a TPU market leader in Asia Pacific with Bayer’s global competence. As a result, we are now the best-positioned global supplier of TPU resins and films and related solutions. Our goal is to become the number one partner for customers worldwide by delivering excellent service, fast response times and market-focused innovations.”

“The opportunities coming out of this merger are very promising,” commented Frank Huang, formerly CEO of Taiwan Ure-Tech and now a member of the TPU management team. “When you couple the global reputation Bayer MaterialScience has earned through its focus on innovation and quality with our market knowledge, product portfolio and customer focus in Greater China, the result is an exciting future for everyone concerned.”

Integrating Ure-Tech substantially boosts Bayer MaterialScience’s TPU market position in Asia Pacific, significantly expanding the company’s market share in TPU resins in this region. With Ure-Tech’s two TPU production facilities in Asia Pacific added, Bayer MaterialScience will operate eight TPU resin and film production sites around the world. Four of them are located in Asia Pacific – in Taiwan, China, Japan and India. The others are in Europe and North America.

“Moving our global headquarters to Hong Kong highlights the importance of the region,” Bielfeldt adds. “This focus puts Bayer MaterialScience in a solid leadership position, letting us tap into and capture future growth in the world’s largest and fastest expanding TPU market – Greater China.”

In 2006, the total global market for TPU resins and films was estimated to be worth about EUR 1.3 billion. In Asia Pacific, an annual growth rate of roughly 10 percent is assumed for the TPU market.

In 2006, approximately 200 employees of the Ure-Tech Group generated sales of around USD 63 million. Sales of Bayer MaterialScience’s Business Unit Thermoplastic Polyurethanes amounted to EUR 205 million last year with roughly 450 employees. Both parties have agreed not to disclose the purchase price.

About Bayer MaterialScience:
With 2006 sales of 10.2 billion euros (continuing operations), Bayer MaterialScience is among the world’s largest polymer companies. Business activities are focused on the manufacture of high-tech polymer materials and the development of innovative solutions for products used in many areas of daily life. The main segments served are the automotive, electrical and electronics, construction and the sports and leisure industries. At the end of 2006, Bayer MaterialScience had 30 production sites and employed approximately 14,900 people around the globe. Bayer MaterialScience is a Bayer Group company.

Dow Acquires Wolff Walsrode from Bayer

The Dow Chemical Company and the Bayer Group today announced the closing of Dow’s acquisition of Wolff Walsrode. The purchase price of EUR 540 million (approximately USD 725 million) includes a cash component and the assumption of financial debt and pension commitments. Following regulatory clearance from various authorities around the world, payment and share transfers have occurred, and Dow has taken full ownership of the Wolff Walsrode group of companies on June 30, 2007.
The acquisition will deliver considerable top line synergies for Dow, driven by application expertise and worldwide growth in demand for cellulosics. The acquisition is expected to be financially accretive by the end of the first year of ownership.

“The Wolff transaction marks another important milestone in our Company’s drive to expand and enhance our performance business portfolio,” said Andrew Liveris, chairman and CEO of The Dow Chemical Company. “The acquisition of Wolff Walsrode is our latest example of how Dow is delivering on a transformational growth strategy. Wolff is a strategically aligned acquisition that brings new expertise and customer focus to accelerate Dow’s growth in key specialty markets.”

For Bayer, the transaction fits with its objectives of securing a recognized buyer committed to further develop the Wolff Walsrode business. “With The Dow Chemical Company we found a buyer that offers promising perspectives for the future of Wolff,” said Bayer management board chairman Werner Wenning. The cash inflows of approximately EUR 440 million (~USD 590 million) are intended to be used to reduce Bayer’s net debt
.
Dow plans to combine Wolff with its Water Soluble Polymers business to create a new specialty business driven to become the preferred development partner and premier application expert in the cellulosics industry. Cellulosics and derivatives are widely used in formulations for food, personal care, pharmaceuticals, construction, paint and a variety of specialty industrial applications. The business will cater to formulators and brand owners whose end product label claims are underpinned by advanced cellulosics.

About Dow
Dow is a diversified chemical company that harnesses the power of innovation, science and technology to constantly improve what is essential to human progress. The Company offers a broad range of products and services to customers in more than 175 countries, helping them to provide everything from fresh water, food and pharmaceuticals to paints, packaging and personal care products. Built on a commitment to its principles of sustainability, Dow has annual sales of US$49 billion and employs 43,000 people worldwide. References to “Dow” or the “Company” mean The Dow Chemical Company and its consolidated subsidiaries unless otherwise expressly noted. More information about Dow can be found at www.dow.com.

Bayer: Science For A Better Life
Bayer is a global enterprise with core competencies in the fields of health care, nutrition and high-tech materials. The company’s products and services are designed to benefit people and improve their quality of life. At the same time Bayer creates value through innovation, growth and improved earning power. The Group is committed to the principles of sustainable development and acknowledges and accepts its role as a socially and ethically responsible “corporate citizen”. Economy, ecology and social responsibility are corporate policy objectives of equal rank. In fiscal 2006, Bayer employed 106,000 people and had sales of around €29 billion. Capital expenditures amounted to €1.7 billion, the R&D budget to €2.3 billion. More information is available on the Internet at www.bayer.com

Bayer CropScience and Monsanto enter long-term business and license agreements for key enabling technologies

Bayer CropScience AG and Monsanto Company (NYSE: MON), two of the leading agro-companies worldwide, have entered into a series of long-term business and licensing agreements related to key enabling agricultural technologies. Within the framework of these agreements Bayer CropScience will grant Monsanto a royalty bearing, non-exclusive license for its LibertyLink® herbicide tolerance technology for use in corn and soybeans, the two largest field crops in terms of acreage in the United States.

The agreements provide Monsanto with an option to market corn and soybean seeds which contain both Monsanto’s Roundup Ready® and Bayer CropScience’s LibertyLink® technologies, which could provide farmers with additional weed management solutions. Monsanto and Bayer CropScience also amended certain existing agreements in the area of herbicide tolerance to provide each other more favorable terms.

In the area of insect resistance, the two companies have also entered into a royalty-bearing agreement giving Bayer CropScience rights under certain Monsanto intellectual property. In addition, the companies amended other agreements related to insect-protection technologies, including Monsanto’s existing non-exclusive, royalty-bearing license for use of Bayer CropScience’s Dual Bt technology. This enables Monsanto to commercialize products containing multiple insect resistance genes with different modes of action.

As part of the agreements, Monsanto and Bayer CropScience cross-licensed each other under their respective patent estates for RNAi technology, an important enabling technology for the development of new agricultural products.

“I am delighted that Bayer CropScience and Monsanto have joined together to offer more choice and flexibility for farmers in the use of modern technology options,” said Prof. Dr. Friedrich Berschauer, chairman of the Board of Management of Bayer CropScience. “These agreements are an important step for Bayer CropScience as they could significantly broaden the availability of our LibertyLink® technology outside our core cotton and canola seed business. This agreement could also expand the base for our Liberty® herbicide business. At the same time, the agreements enable us to facilitate the development and commercialization of new technology solutions in the future.”

“Monsanto is pleased to have reached licensing agreements with Bayer CropScience across a range of crops and technologies,” said Hugh Grant, chairman, president and chief executive officer of Monsanto. “Farmers look to technology providers like Bayer CropScience and Monsanto Company to discover and deliver needed technologies to their farms. We believe these agreements will support and advance the work of both our companies as we independently bring innovation to the farm.”

Additional details of the agreements were not disclosed.

About Bayer CropScience
Bayer CropScience AG, a subsidiary of Bayer AG, is one of the world’s leading innovative crop science companies in the areas of crop protection, non-agricultural pest control, seeds and plant biotechnology. The company offers an outstanding range of products and extensive service backup for modern, sustainable agriculture and for non-agricultural applications. Bayer CropScience has a global workforce of about 17,900 and is represented in more than 120 countries. This and further news is available at: www.newsroom.bayercropscience.com

About Monsanto
Monsanto Company is a leading provider of technology-based solutions and agricultural products that improve farm productivity and food quality. For more information on Monsanto, see www.monsanto.com

Bayer: Phase 3 Study: Nexavar Significantly Extends Overall Survival by 44% in Liver Cancer Patients

Bayer HealthCare, a subsidiary of Bayer AG (NYSE: BAY), and Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) today announced that Nexavar® (sorafenib) tablets significantly extended overall survival in patients with hepatocellular carcinoma (HCC), or primary liver cancer versus those taking placebo by 44%. Results were presented at the 43rd annual meeting of the American Society of Clinical Oncology (ASCO). The data showed a reduced risk to die for patients treated with Nexavar versus placebo with a hazard ratio of 0.69. Results are statistical significant (p=0.0006).

The international, Phase 3, placebo-controlled Sorafenib HCC Assessment Randomized Protocol (SHARP) trial randomized and evaluated 602 liver cancer patients who had no prior systemic therapy at sites in the Americas, Europe, and Australia/New Zealand. The primary objective of the study was to compare overall survival in patients administered Nexavar versus those administered placebo. Median overall survival was 10.7 months in Nexavar-treated patients compared to 7.9 months in those taking placebo.

“Because there are no therapies that significantly improve survival for the thousands of patients with liver cancer, these findings demonstrate the compelling study results of Nexavar as the new reference standard of care for the first-line treatment of HCC,” said Dr. Josep M. Llovet, co-principal investigator and Professor of Research, Barcelona Clinic Liver Cancer (BCLC) Group, IDIBAPS, Liver Unit, Hospital Clinic Barcelona; Director of Research, HCC Program, Associate Professor of Medicine, Mount Sinai School of Medicine, New York.

Bayer and Onyx halted the SHARP trial in February 2007 when an independent data monitoring committee determined in a pre-scheduled analysis that the overall survival endpoint had been met. There were no significant differences in serious adverse events between the Nexavar and placebo-treated groups with the most commonly observed adverse events in patients receiving Nexavar being diarrhea and hand-foot-skin reaction. Based on the strength of the data, the companies are now in the process of preparing applications to the U.S. Food and Drug Administration (FDA) and European health authorities for this new indication for Nexavar in treatment of patients with liver cancer.

“Although much progress has been made in cancer research, the number of lives lost to liver cancer is increasing,” said Dr. Jordi Bruix, co-principal investigator and Head of the Barcelona Clinic Liver Cancer (BCLC); Senior Consultant, Liver Unit, Hospital Clinic of Barcelona. “For that reason, these results represent an unprecedented achievement and Nexavar could become the first widely-approved new therapy for this difficult to treat cancer.”

Hepatocellular carcinoma is the most common form of liver cancer and is responsible for about 90 percent of the primary malignant liver tumors in adults. It is the fifth most common cancer in the world and the third leading cause of cancer-related deaths globally. Over 600,000 new cases of HCC are diagnosed globally each year (19,000 in the United States and 32,000 in the European Union), and in 2002 approximately 600,000 people (about 13,000 Americans and 57,000 Europeans) died of HCC. Although overall cancer incidence and mortality are decreasing in the United States, both the incidence and mortality of liver cancer are increasing.

Nexavar’s Differentiated Mechanism
Nexavar targets both the tumor cell and tumor vasculature and is the only oral multi-kinase inhibitor that does not require patients to interrupt their treatment schedule.

In preclinical studies, Nexavar has been shown to target members of two classes of kinases known to be involved in both cell proliferation (growth) and angiogenesis (blood supply) – two important processes that enable cancer growth. These kinases included Raf kinase, VEGFR-1, VEGFR-2, VEGFR-3, PDGFR-B, KIT, FLT-3 and RET. Preclinical models have also demonstrated that the Raf/MEK/ERK-pathway has a role in HCC; therefore blocking signaling through Raf-1 may offer therapeutic benefits in HCC.

Nexavar is currently approved in more than 50 countries, including the United States and in the European Union, for the treatment of patients with advanced kidney cancer: In Europe, Nexavar is approved for the treatment of patients with advanced renal cell carcinoma (RCC) who have failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy.

In addition, Nexavar is being evaluated in clinical trials by the companies, international study groups, government agencies and/or individual investigators as a single agent or combination treatment in a wide range of other cancers, including adjuvant therapy for kidney cancer, metastatic melanoma, breast cancer and non-small cell lung cancer (NSCLC). The Phase 3 ESCAPE (Evaluation of sorafenib, carboplatin, and paclitaxel efficacy in NSCLC) trial recently completed enrollment of more than 900 previously untreated patients with NSCLC of all histologies.

“HCC is the second tumor type in which Nexavar has demonstrated a clinical benefit. We intend to move swiftly with our partner Onyx to file these data for health authority review,” said Susan Kelley, MD, Vice President, Therapeutic Area Oncology, Bayer HealthCare Pharmaceuticals. “Our strategy of leveraging the unique attributes of Nexavar, the only approved orally administered anti-angiogenic that targets the Raf pathway, has led to a robust ongoing clinical program that could bring the potent cancer fighting properties of this oral multi-kinase inhibitor to an even broader number of patients in the coming years.”

Bayer HealthCare
Bayer HealthCare, a subsidiary of Bayer AG, is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Diabetes Care and Pharmaceuticals divisions. The pharmaceuticals business operates under the name Bayer Schering Pharma and as Bayer HealthCare Pharmaceuticals in the US and Canada. Bayer HealthCare’s aim is to discover and manufacture products that will improve human and animal health worldwide.

Bayer Schering Pharma
Bayer Schering Pharma is a worldwide leading specialty pharmaceutical company. Its research and business activities are focused on the following areas: Diagnostic Imaging, Hematology/Cardiology, Oncology, Primary Care, Specialized Therapeutics and Women's Healthcare. With innovative products, Bayer Schering Pharma aims for leading positions in specialized markets worldwide. Using new ideas, Bayer Schering Pharma aims to make a contribution to medical progress and strives to improve the quality of life.

Bayer supports the WHO in its fight against Chagas disease

Bayer HealthCare AG supports the World Health Organization (WHO) in its fight against Chagas disease. A new agreement for the provision of 2.5 million tablets of Lampit® (active ingredient: nifurtimox) and additional funding has now been signed. This agreement will ensure the supply of Lampit® for the next five years.

This is the third agreement between Bayer HealthCare AG and the WHO to improve the provision of this effective drug for Chagas patients in Latin America – irrespective of the financial situation of the persons concerned.

Chagas disease is a parasitic infection that is widespread in many countries of Central and South America. The pathogen is transmitted by blood-sucking insects, blood transfusions with infected blood – or even during pregnancy if the mother is suffering from the disease. Between 16 and 18 million people are currently infected and another 120 million are at risk to suffer from this fatal disease.

"We are pleased to be a reliable partner supporting the WHO in its fight against this serious and widespread disease in the long term," said Arthur J. Higgins, Chairman of the Executive Committee of Bayer HealthCare AG and Chairman of the Board of Management of Bayer Schering Pharma AG. "As a leading specialty pharmaceuticals company, we feel obliged to address areas of unmet medical need and neglected diseases."

Dr. Jean Jannin, Coordinator of Communicable Disease Control, Prevention and Eradication at the WHO, emphasized: "The partnership with Bayer HealthCare will support the WHO in its commitment to combat Chagas disease. We are doing everything in our power to eliminate this disease, which represents a public health problem, by the year 2010."

Bayer HealthCare
Bayer HealthCare, a subsidiary of Bayer AG, is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Diabetes Care and Pharmaceuticals divisions. The pharmaceuticals business operates under the name Bayer Schering Pharma and as Bayer HealthCare Pharmaceuticals in the US and Canada. Bayer HealthCare’s aim is to discover and manufacture products that will improve human and animal health worldwide.

Bayer Schering Pharma
Bayer Schering Pharma is a worldwide leading specialty pharmaceutical company. Its research and business activities are focused on the following areas: Diagnostic Imaging, Hematology/Cardiology, Oncology, Primary Care, Specialized Therapeutics and Women's Healthcare. With innovative products, Bayer Schering Pharma aims for leading positions in specialized markets worldwide. Using new ideas, Bayer Schering Pharma aims to make a contribution to medical progress and strives to improve the quality of life.

Calcium channel blocker Adalat GITS offer additional benefits

Two recently published articles in the Journal of Clinical Epidemiology provide further evidence that the use of the long-acting calcium channel blocker (CCB) nifedipine GITS (Adalat GITS) has additional benefits beyond its blood pressure lowing effect. A first publication from Lubsen et al. (Journal of Clinical Epidemiology 2007; first published online) demonstrates that while the blood pressure lowering effect of nifedipine GITS did play a major role in the reduction of debilitating stroke and new overt heart failure, the anti-anginal and vascular protective effects of nifedipine GITS seem to be just as important in reducing cardiovascular events.

A second publication by Poole-Wilson et al. (Journal of Clinical Epidemiology 2007; first published online) also demonstrates that a nifedipine GITS therapy in patients with stable angina can help contain healthcare expenses by reducing the need for additional medication and the use of expensive diagnostic and surgical procedures. Both these papers are based on analyses of the ACTION-database. ACTION (A Coronary Disease Trial Investigating Outcome with Nifedipine GITS) collected data from 7,665 patients with stable angina pectoris.

Lowering blood pressure helps reduce stroke and heart failure
The ACTION-trial showed that adding nifedipine GITS to a best practice angina pectoris therapy significantly reduced the incidence of any stroke or TIA (28%) and the development of new overt heart failure (29%). Using an innovative statistical approach, Lubsen et al. found that nifedipine GITS’ ability to lower systolic blood pressure was largely responsible for these impressive results. The reduction in the risks of coronary angiography and surgery, attributed to nifedipine GITS on the other hand, are likely to be due to an anti-anginal and a vascular protective effect.


Efficient utilization of resources
Using the ACTION data, Poole-Wilson et al. showed that adding nifedipine GITS to the best practice therapy reduced the need for additional medication and also the use of expensive diagnostic and surgical procedures together with their associated costs. Basis for the calculation of hospital expenses was a reference hospital in the Netherlands. The estimated cost of medication was also based on drug pricing in the Netherlands. In total the incremental cost of the nifedipine GITS therapy was just about € 69 per year, or about € 3,036 per year of event free survival.


Bayer HealthCare
Bayer HealthCare, a subsidiary of Bayer AG, is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Diabetes Care and Pharmaceuticals divisions. The pharmaceuticals business operates under the name Bayer Schering Pharma AG, Germany. Bayer HealthCare’s aim is to discover and manufacture products that will improve human and animal health worldwide.

Bayer Schering Pharma
Bayer Schering Pharma AG, Germany, is a worldwide leading specialty pharmaceutical company. Its research and business activities are focused on the following areas: Diagnostic Imaging, Hematology/Cardiology, Oncology, Primary Care, Specialized Therapeutics and Women's Healthcare. With innovative products, Bayer Schering Pharma aims for leading positions in specialized markets worldwide. Using new ideas, Bayer Schering Pharma aims to make a contribution to medical progress and strives to improve the quality of life.

Positive interim Phase 2 Data reported for VEGF Trap-Eye in age-related macular degeneration

Bayer HealthCare AG and Regeneron Pharmaceuticals, Inc. today announced positive preliminary data from a pre-planned interim analysis of their Phase 2 randomized study of their VEGF Trap-Eye in patients with the neovascular form of age-related macular degeneration (wet AMD). The VEGF Trap-Eye met its primary endpoint of a statistically significant reduction in retinal thickness after 12 weeks compared with baseline (all groups combined, decrease of 135 microns, p < 0.0001). Mean change from baseline in visual acuity, a key secondary endpoint of the study, also demonstrated statistically significant improvement (all groups combined, increase of 5.9 letters, p < 0.0001). Moreover, patients in the dose groups that received only a single dose, on average, demonstrated a decrease in excess retinal thickness (p < 0.0001) and an increase in visual acuity (p = 0.012) over 12 weeks. There were no drug-related serious adverse events, and treatment with the VEGF Trap-Eye was generally well-tolerated. The most common adverse events were those typically associated with intravitreal injections. Detailed data from this interim analysis will be presented at an upcoming scientific conference.

“We are very pleased with the outcome of this interim analysis and the findings support the potential of VEGF Trap-Eye to improve the lives of patients suffering from wet AMD, which accounts for 90% of AMD related blindness”, said Kemal Malik, M.D., Member of the Bayer HealthCare Executive Committee, responsible for Global Development. “These results encourage us in our plans to foster next steps in development and to further study VEGF Trap-Eye in additional eye diseases.“

"These data support our efforts to develop the VEGF Trap-Eye as a potent blocker of VEGF in various diseases,” said George D. Yancopoulos, M.D., Ph.D., President of Regeneron Research Laboratories. “Importantly, the VEGF Trap-Eye may offer the potential to improve vision in patients with wet AMD with dosing less frequently than every four weeks. Our Phase 3 program is being designed to test this possibility and further evaluate the safety and efficacy of various doses and dosing intervals of the VEGF Trap-Eye.”

Based on these results, Bayer HealthCare AG and Regeneron plan to initiate the VEGF Trap-Eye Phase 3 program in the second half of 2007. The companies are collaborating on the global development of the VEGF Trap-Eye for the treatment of wet AMD, diabetic eye diseases, and other eye diseases and disorders. Bayer HealthCare AG and Regeneron will jointly commercialize the VEGF Trap-Eye outside the United States and Regeneron maintains exclusive rights in the United States.

The Phase 2 study is a 12-week, multi-centre trial involving 150 patients who are randomized to 5 groups and treated with the VEGF Trap-Eye in one eye. Two groups received three doses of either 0.5 or 2.0 mg of VEGF Trap-Eye administered every four weeks, and three groups received a single dose of 0.5, 2.0, or 4.0 mg of VEGF Trap-Eye. Patients are monitored for safety, retinal thickness, and visual acuity over 12 weeks. Retinal thickness is determined by optical coherence tomography (OCT) scans read at an independent reading centre. Visual acuity is defined as the total number of letters read correctly on the Early Diabetic Retinopathy Study (ETDRS) chart. Maintenance of vision is defined as losing fewer than 3 lines (equivalent to 15 letters) on the ETDRS chart.

The interim analysis was conducted on the first 78 patients who completed 12 weeks of study. As summarized above, overall, patients had a statistically significant improvement in retinal thickness and visual acuity. All but one patient maintained or improved vision at 12 weeks. Although the improvement in visual acuity was numerically larger in patients receiving injections every four weeks, there were no statistically significant differences across the five dose groups in either retinal thickness or visual acuity at 12 weeks.

About the VEGF Trap-Eye
Vascular endothelial growth factor (VEGF) is a naturally occurring protein in the body whose normal role is to trigger formation of new blood vessels (angiogenesis) to support the growth of the body’s tissues and organs. It has also been associated with the abnormal growth and fragility of new blood vessels in the eye, which lead to the development of wet AMD. The VEGF Trap-Eye is a fully human, soluble VEGF receptor fusion protein that binds all forms of VEGF-A along with the related placental growth factor (PlGF). The VEGF Trap-Eye is a specific and highly potent blocker of these growth factors. Blockade of VEGF, which can prevent abnormal blood vessel formation and vascular leak, has proven beneficial in the treatment of wet AMD.

About AMD
Age-related macular degeneration (AMD) is a leading cause of acquired blindness. Patients with condition can experience a loss of vision due to the development of abnormal, fragile blood vessels in the back of the eye. A particular type of AMD, called wet AMD, accounts for approximately 90% of AMD-related blindness. Wet AMD is the leading cause of blindness for people over the age of 65 in the U.S. and Europe.

Macular degeneration is diagnosed as either dry (nonexudative) or wet (exudative). In wet AMD, new blood vessels grow beneath the retina and leak blood and fluid. This leakage causes disruption and dysfunction of the retina creating blind spots in central vision and can account for blindness in wet AMD patients.

Bayer HealthCare
Bayer HealthCare, a subsidiary of Bayer AG, is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Diabetes Care and Pharmaceuticals divisions. The pharmaceuticals business operates under the name Bayer Schering Pharma AG. Bayer HealthCare’s aim is to discover and manufacture products that will improve human and animal health worldwide.

About Regeneron Pharmaceuticals
Regeneron is a biopharmaceutical company that discovers, develops, and intends to commercialize therapeutic medicines for the treatment of serious medical conditions. Regeneron has therapeutic candidates for the potential treatment of cancer, eye diseases, and inflammatory diseases and has preclinical programs in other diseases and disorders.

Bayer deal with Novartis improves profit outlook for Betaseron franchise

Bayer Schering Pharma AG, Germany, has purchased from Novartis a biologics manufacturing facility in Emeryville, California, which is currently used to produce Bayer Schering Pharma’s Betaseron® for patients in the United States. Bayer Schering Pharma will manufacture Betaseron® at the Emeryville site, retain full control of all manufacturing and process technology used in the production of Betaseron® and will continue to employ the facility’s employees.

Novartis will transfer manufacturing responsibility for Betaseron® (interferon beta-1b) including the Biologics License Application (BLA), by selling related equipment and property, as well as leasing certain buildings at the Emeryville site to Bayer Schering Pharma for a one-off payment of approximately USD 110 million. To assure a smooth transition and safeguard continuous product supply for patients, Novartis will assist Bayer Schering Pharma in assuming responsibility for Betaseron® manufacturing in Emeryville and will also help Bayer qualify another possible supplier of the product. In addition, Novartis will grant Bayer royalty-free licenses under all patents and know-how used by Novartis in relation to Betaseron®.

Bayer Schering Pharma will continue to pay Novartis royalties equivalent to those being paid currently on net sales of Betaseron® manufactured by Bayer at the Emeryville facilities until expiration of the original regulatory filing, development and supply agreement in October 2008. After this date, no more royalties will be due to Novartis on the sales of Betaseron®.

Bayer Schering Pharma will support Novartis in the regulatory filing process of a Novartis brand of interferon beta-1b. When approved by health authorities, Bayer Schering Pharma will supply this medicine to Novartis from 2009 forward and receive in return a double digit royalty payment from Novartis.

“Manufacturing knowledge is critical in this marketplace, and we are looking forward to having the employees at Emeryville join the Bayer Schering Pharma team” said Arthur Higgins, Chairman of the Board of Management of Bayer Schering Pharma AG. “In addition to improving the profitability of the Betaseron® franchise through this transaction we believe a second independent brand will reinforce the existing growth of the global MS market”.

Bayer Schering Pharma has pioneered the treatment of multiple sclerosis and is committed to expand the boundaries of MS treatment through lifecycle management of Betaseron® and the development of new treatment options. Betaseron® is the only high-dose, high-frequency interferon beta indicated for patients at the earliest stage of MS.

In 2006 prior to the close of the Novartis-Chiron transaction, Bayer Schering Pharma AG exercised its option to acquire all Betaseron®-related assets at the Emeryville site at fair market value. Since then, both sides have continued discussions about the transfer of the Betaseron® assets.

The agreement is subject to regulatory consent and resolves all outstanding legal actions between the parties regarding Betaseron®.

Further financial details were not disclosed.

About Betaseron® / Betaferon®
Betaseron®, which is marketed outside the U.S. and Canada under the trademark Betaferon®, was the first disease-modifying drug introduced for MS and is a well-established treatment around the world. Betaferon® is indicated for the treatment of relapsing forms of multiple sclerosis to reduce the frequency of clinical exacerbations. Betaferon® has the broadest experience of any MS medication. In the U.S., Europe and Japan, the drug has been approved for all relapsing forms of MS. It is able to reduce the number of MS episodes by one-third, and the frequency of moderate to severe episodes by as much as 50 percent. Sixteen years’ follow up of people treated with Betaferon® has shown that it is safe and well tolerated.

Bayer HealthCare
Bayer HealthCare, a subsidiary of Bayer AG, is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Diabetes Care and Pharmaceuticals divisions. The pharmaceuticals business operates under the name Bayer Schering Pharma AG. Bayer HealthCare’s aim is to discover and manufacture products that will improve human and animal health worldwide.

Bayer Schering Pharma
Bayer Schering Pharma is a worldwide leading specialty pharmaceuticals company. Its research and business activities are focused on the following areas: Diagnostic Imaging, Hematology/Cardiology, Oncology, Primary Care, Specialized Therapeutics and Women's Healthcare. With innovative products, Bayer Schering Pharma aims for leading positions in specialized markets worldwide. Using new ideas, Bayer Schering Pharma aims to make a contribution to medical progress and strives to improve the quality of life.

2006 a record year for Bayer

Sales up 17.2% to EUR 28,956 million / EBITDA before special items climbs 21.3% to EUR 5,584 million / EBIT before special items advances 14.2% to EUR 3,479 million / Sales and underlying EBITDA expected to grow more than 10% in 2007 / Bayer Group targets underlying EBITDA margin of about 22% for 2009 / Bayer HealthCare aims for an underlying EBITDA margin of some 27% in 2009

The Bayer Group achieved a record underlying operating result in 2006. “Fiscal 2006 was an extraordinarily eventful and very successful year for Bayer,” said Management Board Chairman Werner Wenning on Thursday at the company’s Spring Financial News Conference in Leverkusen. Bayer, he said, had improved major performance indicators substantially compared to the previous year. In addition, Bayer decisively strengthened its pharmaceuticals business with the acquisition of Schering AG, Berlin, Germany. Wenning forecast a further improvement in earning power for 2007.

Sales of the Bayer Group rose in 2006 by 17.2 percent to EUR 28,956 million (2005: EUR 24,701 million). The total for 2006 includes EUR 3,082 million in revenues from the Schering business in the period from June 23, 2006, while the divested Diagnostics Division and the subsidiaries H.C. Starck and Wolff Walsrode, as discontinued operations, are omitted except that their net earnings are included in Group net income. Adjusted for currency and portfolio effects, Group sales rose by 5.2 percent.

“The gratifying expansion of business also led to an improvement in operational profitability of which our employees are justly proud: in fact we set a new earnings record,” Wenning said. Earnings before interest, taxes, depreciation and amortization (EBITDA) and before special items rose by 21.3 percent to the record level of EUR 5,584 million (2005: EUR 4,602 million), yielding an underlying EBITDA margin of 19.3 percent in line with Bayer’s announced target for 2006. The operating result (EBIT) before special items climbed to a record high of EUR 3,479 million (2005: EUR 3,047 million).

Strong growth in sales and earnings of Bayer HealthCare

Business trends in 2006 varied across the subgroups. Bayer HealthCare was particularly successful, with above-market growth in all its divisions and additional momentum coming from the Schering acquisition. Sales of Bayer HealthCare rose by 46.6 percent to EUR 11,724 million, with business in the Pharmaceuticals segment expanding by 83.9 percent to EUR 7,478 million. “Including Schering’s sales prior to the acquisition date as well gave Bayer Schering Pharma total pro forma sales of more than EUR 10 billion for 2006. This is an impressive figure,” said Wenning. Pro forma sales grew by 8 percent year on year, compared to about 6 percent for the market as a whole.

Bayer achieved dynamic growth in major pharmaceutical products. Pro forma sales of the oral contraceptive Yasmin®, including YAZ® and Yasminelle®, advanced by 35.5 percent. The erectile dysfunction treatment Levitra® and the hemophilia drug Kogenate® posted sales growth of 20.8 and 18.7 percent, respectively. Pro forma sales of Betaferon®/Betaseron® for the treatment of multiple sclerosis expanded by 14.3 percent. “Our cancer drug Nexavar® turned in a particularly encouraging performance, posting sales of EUR 130 million in the year of its introduction,” Wenning stressed.

Sales of the Consumer Health segment moved ahead 8.1 percent to EUR 4,246 million, with all the divisions in this segment contributing to the gratifying increase. Business of the Consumer Care Division, which markets non-prescription medicines, expanded by 7.5 percent. Among its top ten products, the largest sales gains were posted by Aleve® with a 27.5 percent gain, Bepanthen® with 14.9 percent and Canesten® with 11.7 percent. The Diabetes Care (+12.8 percent) and Animal Health (+5.7 percent) divisions also boosted sales significantly.

The HealthCare subgroup’s operating result also improved considerably, with EBITDA before special items advancing 75.7 percent to EUR 2,613 million.

Even without Schering’s contribution of EUR 774 million, there was a notable 23.7 percent increase. The underlying EBITDA margin of Bayer HealthCare came to 22.3 percent, in line with the earnings guidance for 2006 which had been raised in light of the Schering acquisition.

Bayer CropScience held up well in a shrinking market

Sales of Bayer CropScience came in at EUR 5,700 million, down 3.3 percent from the previous year. Wenning said the subgroup held up relatively well in 2006 in a declining crop protection market. In the Crop Protection segment, representing the conventional agricultural chemicals business, sales decreased by 4.7 percent to EUR 4,644 million. Sales declines were partially offset by successful marketing of innovative active ingredients introduced over the past few years. Bayer CropScience achieved its 2006 target of EUR 1 billion in sales of these new active ingredients that have been launched in core markets since 2000. Sales of the Environmental Science, BioScience segment rose by 3.3 percent to EUR 1,056 million.

EBITDA before special items in CropScience was down by 5.4 percent from the previous year, to EUR 1,204 million, while the underlying EBITDA margin was 21.1 percent. The savings achieved through cost structure and efficiency improvement programs partly compensated for the squeeze on margins.

Business at Bayer MaterialScience continued to expand

The upward business trend at Bayer MaterialScience continued in 2006, with sales advancing 7.6 percent to EUR 10,161 million. This encouraging growth was due primarily to higher volumes in all business units, while selling prices rose slightly on average. Sales of the Materials segment, where the main product is polycarbonate, were up 3.1 percent from the prior year, to EUR 2,925 million. In the Systems segment, dominated by the polyurethanes business, sales climbed by 9.5 percent year on year to EUR 7,236 million.

EBITDA before special items for the subgroup, at EUR 1,677 million (2005: EUR 1,764 million) almost matched the previous year’s level. Substantial price hikes for energy and raw materials were offset by volume growth and price increases, but earnings were held back by start-up costs for facilities, temporary production interruptions and expenses for expanding the sales organization in the Asian growth market. The underlying EBITDA margin was 16.5 percent.

Strong growth in Europe

In regional terms, Bayer achieved its largest absolute sales increase in Europe, where sales climbed by about EUR 1.9 billion, or 17.5 percent, in 2006 to EUR 12,652 million. Sales in Germany grew 17.7 percent to EUR 4,525 million. Business expanded by 19.8 percent to EUR 7,779 million in North America and by 13.2 percent to EUR 4,610 million in Asia/Pacific. Sales in Greater China advanced by a substantial 24.1 percent from the previous year, to EUR 1.5 billion. Business in the Latin America/Africa/Middle East region grew 16.5 percent to EUR 3,915 million.

Group net income rose to nearly EUR 1.7 billion

Earnings in 2006 were diminished by net special charges of EUR 717 million (2005: EUR 533 million). Included in the 2006 figure are special charges of EUR 273 million (net) related to the acquisition and integration of Schering AG, Berlin, Germany, EUR 200 million (2005: EUR 109 million) in restructuring expenses, EUR 172 million (2005: EUR 451 million) (net) in litigation-related charges and minus EUR 72 million (2005: plus EUR 27 million) (net) in other special items. EBIT after special items improved by 9.9 percent to EUR 2,762 million (2005: EUR 2,514 million). The non-operating result of minus EUR 782 million (2005: minus EUR 602 million) included an increase in interest expense related to the Schering acquisition. After deducting income taxes, adding income from discontinued operations and adjusting for minority interest, net income of the Bayer Group improved by 5.4 percent to EUR 1,683 million (2005: EUR 1,597 million).

Gross cash flow increased to EUR 3,913 million (2005: EUR 3,114 million) due to the gratifying growth in business and the inclusion of Schering. Net cash flow advanced to EUR 3,928 million, compared with EUR 3,227 million in the prior year.

Significant reduction in net debt planned for 2007

Net debt amounted to EUR 17,473 million at December 31, 2006, compared to EUR 5,494 million at the end of 2005. “This already includes the approximately EUR 710 million required to pay compensation to the remaining minority shareholders of Schering under the squeeze-out resolution,” explained CFO Klaus Kühn. “We succeeded in limiting the net debt increase to EUR 12 billion, despite the EUR 17 billion paid to acquire Schering.” Just the proceeds of the divestments of the Diagnostics business and H.C. Starck, received at the beginning of 2007, along with the expected proceeds from the sale of Wolff Walsrode, will lead to a further substantial reduction in net debt of approximately EUR 4.5 billion during 2007, said Kühn.

Gratifying fourth-quarter business performance

Also contributing to the successful business year was a positive performance in the fourth quarter. Thanks to strong business gains in HealthCare, Group sales moved ahead 25.1 percent to EUR 7,970 million (Q4 2005: EUR 6,371 million). Underlying EBITDA climbed by 34.3 percent year on year, to EUR 1,258 million (Q4 2005: EUR 937 million), while underlying EBIT rose by 12.5 percent to EUR 622 million (Q4 2005: EUR 553 million). Bayer has thus improved year-on-year earnings before special items in 16 consecutive quarters. Including extraordinary tax income, Group net income jumped to EUR 311 million (Q4 2005: EUR 46 million).

Successful start to 2007

All signs point to further growth in 2007 as well: “Our sales and earnings performance in the first two months of this year gives us confidence,” said Wenning. Bayer expects to further improve its earning power over the full year. The company is anticipating a more than 10 percent increase in Group sales, equivalent to about 5 percent after adjusting for currency and portfolio effects. “We plan to increase underlying EBITDA by more than 10 percent and slightly improve our EBITDA margin,” Wenning explained. To safeguard future growth, Bayer is planning capital expenditures of EUR 1.7 billion during 2007, including EUR 1.6 billion for property, plant and equipment. Research and development expenditures are likely to total about EUR 2.8 billion. “Thus in 2007 alone, we plan to invest a total of about EUR 4.5 billion in the future of our company,” Wenning announced.

Bayer HealthCare aims to grow with or faster than the market in all divisions in 2007, and to improve its underlying EBITDA margin toward 24 percent. Wenning said he currently takes a positive view of the general market environment for CropScience this year, although it remains to be seen how market conditions will develop in the various regions: “We want to expand our position as an innovation leader in chemical crop protection and therefore aim to grow slightly faster than the market.” The subgroup intends to improve its underlying EBITDA margin toward 22 percent.

Bayer MaterialScience is planning further volume increases in 2007, with earnings at a good, value-creating level, and intends to considerably improve its underlying EBITDA margin in the first quarter of 2007 compared with the fourth quarter of 2006. Given the high volatility of raw material prices, a reliable longer-term forecast for this subgroup is not possible at present.

New order of magnitude for Bayer Group earnings

“Our planning for 2007 shows that the measures we have implemented in recent years are working,” Wenning continued, outlining the company’s longer-term perspectives. In 2009 the Bayer Group aims to achieve an underlying EBITDA margin in the region of 22 percent. In 2002, the margin was 12 percent. “This shows we are headed toward a new order of magnitude in terms of earnings,” he announced.

In this connection, Bayer sees a very positive future trend for its HealthCare business in particular. For 2009 this subgroup is aiming for an underlying EBITDA margin of about 27 percent. CropScience, too, plans to further increase the underlying EBITDA margin through 2009, anticipating a level of approximately 25 percent under normal market conditions. In years with favorable business conditions, the underlying EBITDA margin for Bayer MaterialScience is expected to exceed 18 percent.

Solid foundation for the future of Bayer Schering Pharma

“We can undoubtedly say that 2006 has been one of the most significant years in Bayer’s history,” Wenning said, referring particularly to the Schering acquisition. The Management Board Chairman explained that the new Bayer Schering Pharma is among the world’s leading suppliers of specialty pharmaceuticals, adding that with its attractive product portfolio and highly promising research and development projects, the company is on track to further expand this position.

Wenning reminded his audience that it was less than a year ago that Bayer published its offer to Schering AG stockholders. “We have come a long way since then,” he said. For example, Bayer now holds more than 96 percent of the outstanding shares of Schering, and the squeeze-out of the minority stockholders has been initiated. Furthermore, the timely entry of the domination and profit and loss transfer agreement into the commercial register is enabling Bayer to rapidly integrate the acquisition. Important decisions were made at an early stage on matters such as the common business model, organizational structure and site-related issues. In addition, plans have been announced to eliminate about 6,100 positions worldwide – out of the total number at Bayer HealthCare and Schering – by 2009. “We will implement these measures fairly and in a socially responsible manner,” Wenning stressed.

With these measures, the company’s management is establishing a solid foundation for the future of Bayer Schering Pharma, he explained. “We are convinced that the expansion of our HealthCare business will strengthen the entire Bayer Group for the long term.”

Bayer increases dividend to EUR 1.00

Bayer AG’s Supervisory Board today accepted the proposal of the Board of Management to recommend to the Annual Stockholders’ Meeting on April 27, 2007, a dividend for fiscal 2006 of EUR 1.00 per share. This represents an increase of 5.3 percent on the dividend of EUR 0.95 paid for 2005. “Despite the high charges related to the Schering acquisition, we would like our stockholders to participate appropriately in the success we achieved in fiscal 2006,” said Werner Wenning, Chairman of the Board of Management.

The total dividend payout grew 10.1 percent, to EUR 764 million, because the number of shares entitled to a dividend increased by 34 million to 764,341,920 as a result of the capital increase in July 2006.

The Bayer Group’s financial statements will be presented and discussed at the Spring Financial News Conference on March 15, 2007.

Bayer HealthCare strengthens presence in Eastern Europe

Bayer HealthCare has taken over the marketing and distribution network of its partner Pharmonyx Ltd. in Russia, Belarus, the Ukraine and Kazakhstan. Pharmonyx has been responsible for marketing and distributing BHC’s products in these countries since 1999. Both parties have agreed to refrain from commenting on the financial details of the takeover.

“This transaction is in line with the global strategy of Bayer HealthCare for further expansion in the health care business and will also strengthen our presence in the fast-growing Eastern Europe region,” said Arthur Higgins, Management Board Chairman of Bayer HealthCare AG. “The establishment of a competitive organization will help us to achieve our goal of sustained growth in what are extremely important markets for the future.”

This new organizational alignment will strengthen Bayer HealthCare’s presence in Eastern Europe and provide a boost to the expansion plans of its Consumer Care, Bayer Schering Pharma and Diabetes Care divisions. 219 staff will be integrated into the Bayer HealthCare organization under the terms of the transaction. The majority of the new employees will continue to provide Sales and Marketing support for medical practices and pharmacies in the future.

Bayer to Cut 6,100 Jobs Worldwide

Bayer HealthCare today published concrete plans regarding the previously announced synergy goals. The integration of the activities of the former Schering AG, Germany, with the Pharma division of Bayer HealthCare will result in annual savings of EUR 700 million from 2009. Adjustments to personnel requirements and the consolidation of processes and systems will each contribute about half to the targeted global synergy effects.

As announced in 2006, reducing the overlap between the two companies will result in approximately 6,100 job cuts worldwide. There is to be a reduction of 3,150 jobs in Europe. In addition, 1,000 jobs in the USA, 750 jobs in the Asia, Pacific and Japan region as well as 1,200 jobs in Latin America and Canada are affected.

Of the 6,100 jobs worldwide there will be a reduction of 1,400 in the global research and development functions and 1,850 in production by 2009. Approximately 2,850 positions from central administration as well as local and regional structures will be reduced.

"We want to create an internationally successful pharmaceutical company with competitive cost structures," said Werner Wenning, Chairman of the Bayer AG Group Management Board and the Supervisory Board of Bayer Schering Pharma. "We said right from the start of the integration that job cuts would be necessary in order to achieve the synergy targets. These essential streamlining measures are to be fairly implemented in a socially acceptable process - balanced across the globe. This includes the reduction of the number of locations, cutting down on structural and personnel overcapacity, the concentration of research and development activities as well as the harmonization of structures and processes in marketing and administration."

Of the 6,100 jobs worldwide a total of approximately 1,500 will be shed in Germany. Berlin will remain the largest location and the headquarters of Bayer Schering Pharma AG. Key global functions and business areas will be consistently drawn together in Berlin.

"The integration process at Bayer Schering Pharma is well on track", said Arthur Higgins, Chairman of the Bayer Schering Pharma AG Board of Management and of Bayer Healthcare AG. "We are creating the basis for future growth and building an organization that will be competitive in the international marketplace."

The measures announced today are to be realized in a fair and transparent process and take account of the local employment regulations in the respective countries. They are intended to create slimmed down and efficient structures and do away with double functions and overlaps. The goal is thus to strengthen innovation and growth in the company and as a result to increase profitability.

The cutbacks will be implemented in cooperation with the employee representatives. The company has begun discussions with employee representatives to work out detailed solutions together.