News Room

April 30, 2008 - Aspiring young designers give YAZ® birth control case a makeover

Nina Garcia of the Emmy-nominated series “Project Runway” and Elle magazine is calling upon designer hopefuls everywhere to submit contemporary and fashionable packaging concepts for the oral contraceptive YAZ® (drospirenone & ethinyl estradiol).



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31 March 2008 - Bayer appeals invalidity ruling on its Yasmin® Patent

Leverkusen, March 31, 2008 – Today, Bayer filed a Notice of Appeal in the United States District Court for the District of New Jersey



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11 March 2008 - Bayer HealthCare Pharmaceuticals Introduces VistaTrak™ An Innovative Contrast Media Management System

WAYNE, NJ – March 11, 2008 – Bayer HealthCare Pharmaceuticals Inc., a leader in diagnostic imaging, unveiled plans to launch VistaTrak™, an innovative contrast media management system that provides radiology departments with a new and powerful management tool to help enhance patient care and safety, optimize inventory management and improve billing accuracy.



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3 March 2008 - Court decides against Bayer's Yasmin® patent



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18 February 2008 - Bayer and Onyx Provide Update on Phase 3 Trial of Nexavar in Patients with Non-Small Cell Lung Cancer

Wayne, NJ and Emeryville, CA – (February 18, 2008) – Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) today announced that a Phase 3 trial evaluating Nexavar® (sorafenib) tablets in patients with non-small cell lung cancer (NSCLC) was stopped early following a planned interim analysis, when the independent Data Monitoring Committee (DMC) concluded that the study would not meet its primary endpoint of improved overall survival. The Phase 3 ESCAPE (Evaluation of Sorafenib, Carboplatin And Paclitaxel Efficacy in NSCLC) trial evaluated Nexavar when administered in combination with the chemotherapeutic agents carboplatin and paclitaxel in patients with non-small cell lung cancer (NSCLC). Safety events were generally consistent with those previously reported. However, higher mortality was observed in the subset of patients with squamous cell carcinoma of the lung treated with sorafenib and carboplatin and paclitaxel versus those treated with carboplatin and paclitaxel alone.



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5 February 2008 - Bayer HealthCare Awards Grant to Support Future Leaders of Bleeding Disorders Community

BERKELEY, Calif. – (February 5, 2008) – Bayer HealthCare today announced its donation of a $100,000 grant to help the National Hemophilia Foundation (NHF) fund activities for its National Youth Leadership Institute (NYLI), a program designed to develop the next generation of leaders within the bleeding disorders community. The contribution, made by the Bayer USA Foundation, marks the second year of support for this important program.



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23 January 2008 - Bayer Establishes US Special Access Program for Leukine® While Replacing Current Liquid Formulation

Wayne, NJ – Bayer HealthCare Pharmaceuticals Inc. announced today, following consultation with the United States Food and Drug Administration (FDA), that it will withdraw the current liquid formulation of Leukine® marketed in the US. This decision was made in light of an upward trend in spontaneous reports of adverse reactions, including syncope (fainting), which are temporally correlated with the liquid Leukine 500 mcg vial which currently contains EDTA (edetate disodium).



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17 January 2008 - US Food and Drug Administration Approves RECOTHROMTM



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3 January 2008 - Expanded Labeling for MabCampath® in Europe

Berlin, January 3, 2008 – The European Commission has granted marketing authorization to MabCampath® (alemtuzumab) for the treatment of patients with B-cell chronic lymphocytic leukemia (B-CLL) for whom fludarabine combination chemotherapy is not appropriate.



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20 December 2007 - Marketing of Viadur® (leuprolide acetate implant) to Phase Out By April 2008

Other therapies available for patients

Wayne, NJ. – Bayer HealthCare Pharmaceuticals Inc. announced today that after careful consideration, the company will discontinue marketing of Viadur® (leuprolide acetate implant) with Duros technology. Based on diminished market demand and growing manufacturing costs, Bayer HealthCare Pharmaceuticals has concluded that Viadur has limited long-term market viability. The decision to discontinue marketing of Viadur is not the result of safety or efficacy issues.



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05 December 2007 - Positive CHMP vote for Betaferon® label to include disability progression delay in patients with the earliest sign of MS

Betaferon® is first and only MS therapy to delay disability in patients treated after first MS attack

Berlin — The Committee for Medicinal Products for Human Use (CHMP) has recommended to include new results from the landmark BENEFIT (BEtaferon in Newly Emerging multiple sclerosis For Initial T reatment) study in the Betaferon® (interferon beta-1b) label.



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20 November 2007 - Bayer HealthCare Pharmaceuticals and MedAssets Supply Chain Systems Sign a Three-Year Agreement for Magnevist(R) Magnetic Resonance Contrast Media

WAYNE, N.J., — Bayer HealthCare Pharmaceuticals, Inc a leader in diagnostic imaging, announced today that the company has been awarded a three-year contract by MedAssets Supply Chain Systems, one of the nation's largest group purchasing organizations, to provide Magnevist(R) (gadopentetate dimeglumine) Injection contrast media to members of the MedAssets network. MedAssets serves more than 125 health systems, including 2,500 hospitals and 30,000 non-acute care healthcare providers



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19 November 2007 - Nexavar First FDA-Approved Drug Therapy for Liver Cancer

Only Systemic Therapy Proven to Significantly Improve Overall Survival in Patients with Liver Cancer

Wayne, NJ and Emeryville, CA — Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application for Nexavar® (sorafenib) tablets for the treatment of patients with unresectable hepatocellular carcinoma (HCC), or liver cancer.



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07 November 2007 - BRIGHT Results Show Less Pain and Higher Patient Satisfaction with Betaseron® than with Rebif®

Study shows injection site pain can negatively influence patient satisfaction with treatment

Wayne, NJ. — Patients with relapsing-remitting multiple sclerosis (MS) treated with 250 mcg Betaseron (interferon beta-1b) experienced less injection site pain and fewer injection site reactions than those treated with 44 mcg Rebif. Moreover, among those who experienced injection site pain, significantly more patients on Rebif versus Betaseron said that pain negatively influences their satisfaction with treatment.



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05 November 2007 - Bayer Temporarily Suspends Global Trasylol® Marketing

Leverkusen, Germany and West Haven, CT, USA — Following consultation with the German Federal Institute for Drugs and Medical Devices (BfArM), the U.S. Food and Drug Administration (FDA), Health Canada, and other health authorities, Bayer announced today that it has elected to temporarily suspend worldwide marketing of Trasylol® (aprotinin injection) until final results from the Canadian BART trial can be compiled, received and evaluated.



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30 October 2007 - Nexavar® Becomes First and Only Approved Treatment of Hepatocellular Carcinoma in Europe

Wayne, NJ and Emeryville, CA – 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.



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29 October 2007 - BEYOND study: Results do not support regulatory filing for Betaferon® 500 mcg

Berlin, Germany - Bayer Schering Pharma AG, Germany, today announced top line results from the BEYOND (Betaferon Efficacy Yielding Outcomes of a New Dose) study, a large randomized trial of patients with relapsing-remitting multiple sclerosis (MS) to investigate the efficacy, tolerability and safety of a 500 mcg dose of Betaferon® (interferon beta-1b) compared to the standard 250 mcg Betaferon® dose and Copaxone® (glatiramer acetate).



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26 - October - New Survey Finds Technology Plays a Critical Role in the Lives of People with Multiple Sclerosis Yet Many Are Not Using It to Overcome Disease-Related Challenges

-- Affordable, Easy-to-Use Accessible Technology is Within Reach for People with MS --

DALLAS, OCTOBER 26, 2007 -- According to a new survey released this week in conjunction with the National MS Society's National Conference, many people living with multiple sclerosis (MS) who experience visual, dexterity, and cognitive challenges report that technology plays a vital role in helping them live with the disease. However, relatively few are using the assistive technologies that could help them overcome many of these challenges



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25 October 2007 - Bayer Issues Additional Guidance to Physicians on Trasylol®

Leverkusen, Germany and West Haven, CT, USA - Today Bayer announced new guidance to physicians and health care providers regarding the use of Trasylol® (aprotinin injection) in patients at an increased risk of blood loss and blood transfusion undergoing coronary artery bypass graft (CABG) surgery with cardiopulmonary bypass (CPB).



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23 October 2007 - Red Hot Flashbacks: Celebrity Stylist Yang & Red Hot Mamas Giblin Share How to Keep “Cool” During “Red Hot” Menopausal Moments

WAYNE, N.J. Oct 23, 2007 – For many active, on-the-go women, menopause symbolizes uncomfortable and disruptive symptoms, such as hot flashes and night sweats.



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01 October 2007 - Bayer HealthCare Announces Positive Phase 2 Results for the VEGF Trap-Eye

Age-related Macular Degeneration (AMD) - Data presented at the Retina Society Conference in Boston Leverkusen, Germany –Bayer HealthCare and development partner Regeneron Pharmaceuticals, Inc. today announced positive results from a Phase 2 study evaluating the VEGF Trap-Eye in the neovascular form of age-related macular degeneration (wet AMD), one of the leading causes of blindness in adults.



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26 September 2007 - Genzyme and Bayer Schering Pharma AG, Germany Announce Start of Phase 3 Program with Alemtuzumab for Treatment of Multiple Sclerosis

CAMBRIDGE, Mass. and BERLIN, Germany – Genzyme Corporation (Nasdaq: GENZ) and Bayer Schering Pharma AG, Germany today announced that the first patient has been treated in the first of two planned Phase 3 trials examining the safety and efficacy of alemtuzumab for the treatment of multiple sclerosis (MS).



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24 September 2007 - Nexavar Receives Positive Opinion from European Committee for Medicinal Products for Human Use for Treatment of Liver Cancer

Wayne, NJ and Emeryville, CA – Bayer HealthCare Pharmaceuticals (NYSE: BAY) and Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) today announced that the European Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion, recommending to grant marketing authorization for Nexavar® (sorafenib) tablets for the treatment of patients with hepatocellular carcinoma (HCC), or liver cancer.



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20 September 2007 - FDA Approves Expanded Labeling for Campath® to Include First-line Treatment for Leading Form of Adult Leukemia

Study Data Demonstrated Improved Progression-free Survival with Campath Cambridge, MA and Wayne, NJ – Genzyme Corp. (Nasdaq: GENZ) and Bayer HealthCare Pharmaceuticals Inc. (NYSE: BAY) today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental biologics license application (sBLA) for Campath® (alemtuzumab) and granted regular approval for single-agent Campath for the treatment of B-cell chronic lymphocytic leukemia (B-CLL).



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14 September 2007 - Bayer completes acquisition of U.S. biologics manufacturing facility from Novartis

Berlin, Germany — Bayer Schering Pharma AG, Germany, has completed the acquisition of a biologics manufacturing facility in Emeryville, California from Novartis. Bayer will manufacture its multiple sclerosis drug Betaseron® at the Emeryville site, retain full control of all manufacturing and process technology used in the production of Betaseron® (interferon beta-1b) and has retained the employees associated with the manufacture of the product.



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12 September 2007 - FDA Advisory Committees Recommend Continued US Marketing Authorization for Trasylol

Committees also recommend further changes to US Label for Trasylol and additional safety studies Leverkusen, Germany; West Haven, CT, USA -- Today, the Cardiovascular and Renal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee to the U.S. Food and Drug Administration (FDA) held a meeting to discuss the risk /benefit profile of Trasylol® (aprotinin injection), a Bayer drug used in coronary artery bypass graft (CABG) surgery.



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27 August 2007 - Nexavar Significantly Improved Overall Survival in Phase 3 Asia-Pacific Liver Cancer Trial

Nexavar Significantly Improved Overall Survival in Phase 3 Asia-Pacific Liver Cancer Trial

Trial to be Stopped Early to Allow All Patients Access to Nexavar- Wayne, NJ and Emeryville, CA - August 27, 2007 - Bayer HealthCare Pharmaceuticals (NYSE: BAY) and Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) today announced that a planned review by an independent data monitoring committee (DMC) found that Nexavar® (sorafenib) tablets significantly improved overall survival, progression free survival, and time to progression in an Asia-Pacific regional Phase 3 trial of patients with advanced hepatocellular carcinoma (HCC), the most common form of liver cancer.



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20 August 2007 - Nexavar Granted FDA Priority Review for Treatment of Liver Cancer

Nexavar Granted FDA Priority Review for Treatment of Liver Cancer Wayne, NJ and Emeryville, CA – Bayer HealthCare Pharmaceuticals (NYSE: BAY) and Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) today announced that the supplemental New Drug Application (sNDA) for Nexavar® (sorafenib) tablets for the treatment of patients with hepatocellular carcinoma (HCC), the most common form of liver cancer, has been accepted for review and granted Priority Review status by the U.S. Food and Drug Administration (FDA).

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16 August 2007 - Bayer Reports Findings of Trasylol Independent Investigation

Investigator Report
Key Committees - Bayer Global Drug Safety



Leverkusen, Germany and West Haven, Connecticut, USA. Today, Bayer HealthCare reported findings of Mr. William Taylor's independent investigation on the i3 Drug Safety observational study on Trasylol® (aprotinin injection) to the U.S. Food and Drug Administration (FDA) and other relevant regulatory authorities and also conveyed actions the company has taken to ensure that this sort of mistake is never again repeated.



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2 August 2007 - Landmark Study in The Lancet:Patients Treated With Betaseron® After First MS Attack Experienced Significant Delay in MS Progression WAYNE, NJ – August 2, 2007 – Patients treated with Betaseron® (interferon beta-1b) shortly after their first clinical MS event or “attack” showed a 40 percent lower risk of developing confirmed disability progression compared to patients in whom treatment was delayed.



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12 July 2007 - YAZ approved in the Netherlands as European Reference Member State

YAZ is the newest oral contraceptive innovation from Bayer Schering Pharma Berlin — 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® in the Netherlands.



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09 July 2007 - Rivaroxaban shows superiority over current standard of care therapy

Rivaroxaban, a New Oral, Once-Daily Direct Factor Xa Inhibitor, Shows a Significant Reduction in Deep Vein Thrombosis and Pulmonary Embolism Compared with Enoxaparin with Similarly Low Bleeding Rates



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29 June 2007 - Bayer HealthCare Announces New 2000 IU Vial Size for Kogenate® FS Treatments

Larger vial size, new Grab & Go package help to reduce reconstitution time and provide added convenience for people living with hemophilia A Berkeley/USA — Bayer HealthCare announces today the availability of a new 2000 IU (international unit) vial size in the United States for hemophilia A patients treated with Kogenate® FS, Antihemophilic Factor (Recombinant), and Kogenate® FS Antihemophilic Factor (Recombinant), with BIO-SET®, a Needleless Reconstitution System



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27 June 2007 - Bayer and Onyx Submit Supplemental New Drug Application for Nexavar to Treat Liver Cancer

Nexavar is First Drug Therapy to Demonstrate Significant Survival Benefit in Liver Cancer Wayne, NJ/USA — Bayer HealthCare Pharmaceuticals Inc. (NYSE: BAY) and Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) today announced that a Supplemental New Drug Application (sNDA) for Nexavar® (sorafenib) tablets has been submitted to the U.S. Food and Drug Administration (FDA) for the treatment of patients with hepatocellular carcinoma (HCC), the most common form of liver cancer.



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04 June 2007 - Phase 3 Study: Nexavar® Significantly Extends Overall Survival by 44% in Liver Cancer Patients

Berlin - June 4, 2007 - Bayer HealthCare, a subsidiary of Bayer AG (NYSE:BAY), and Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) today announced thatNexavar® (sorafenib) tablets significantly extended overall survival in patients with hepatocellular carcinoma (HCC), or primary liver cancer versus those taking placebo by 44%.



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07 May 2007 - Bayer HealthCare and Intendis Announce Strategic Alliance To Co-promote YAZ® (drospirenone/ethinyl estradiol) for Treatment of Moderate Acne
Alliance Announced as Yaz Acne Clinical Trial Data Presented at 55th Annual Clinical Meeting of the American College of Obstetricians and Gynecologists (ACOG)

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03 May 2007 - Studies Presented at Neurology Conference Highlight Early Efficacy, Long-Term Tolerability, and High Patient Satisfaction with Betaseron®
Bayer HealthCare Pharmaceuticals announced today the results of three clinical studies with Betaseron (interferon beta-1b), presented this week at the American Academy of Neurology’s (AAN) 59th Annual Meeting, demonstrating early efficacy, long-term tolerability, and high patient satisfaction with treatment in patients with relapsing forms of multiple sclerosis (MS).

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02 May 2007 - Genzyme and Bayer HealthCare Announce Detailed Interim Two-Year Alemtuzumab in Multiple Sclerosis Data Presented at AAN
Interim analysis of Phase 2 comparative study showed significant results in favor of alemtuzumab versus Rebif®

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01 May 2007 - First of Its Kind Data Show: Immediate Treatment of Early MS Patients with Betaseron®
Significantly Delayed Permanent Disability Risk to confirmed EDSS progression reduced by 40 percent compared to delayed treatment

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11 April 2007 - Bayer supports the WHO in its fight against Chagas disease
Partnership with the World Health Organization (WHO) to continue

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05 April 2007 - Indy Racing Season Drives New Support for Marco Andretti and Team Hemophilia
Indy Racing Season Drives New Support for Marco Andretti and Team Hemophilia

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04 April 2007 - Genzyme Files for Expanded Label for Campath® as First-Line Treatment
Genzyme Files for Expanded Label for Campath® as First-Line Treatment For B-CLL Patients

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04 April 2007 - Bayer HealthCare Pharmaceuticals Officially Launches in the United States
Bayer HealthCare Pharmaceuticals Officially Launches in the United States

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02 April 2007 - Large Study Shows that Presence of Neutralizing Antibodies Did Not Predict Clinical Response to Betaseron Treatment
The largest dataset ever analyzed on the relevance of NAbs to interferon beta therapy.

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15 March 2007 - Werner Wenning at the Spring Financial News Conference
2006 a record year for Bayer

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20 February 2007 - Bayer HealthCare strengthens presence in Eastern Europe
More than 200 staff for Marketing and Sales integrated in Russia, Belarus, the Ukraine and Kazakhstan

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12 February 2007 - Nexavar Shown to Significantly Extend Survival for Patients with Advanced Liver Cancer
Trial To Be Stopped Early Based on Positive Outcome

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08 February 2007 - EU-Approval for Continuous Infusion of KOGENATE® Bayer
Excellent Hemostatic Control Achieved.

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