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03/11/10, General Medicine FDA Grants Orphan Drug Status to Ciprofloxacin Dry Powder Inhaler for the Treatment of Cystic Fibrosis Berlin, March 11, 2010 – Bayer Schering Pharma AG, Germany, announced today that an orphan drug designation has been granted by the U.S. Food and Drug Administration (FDA) for the ciprofloxacin dry powder inhaler (DPI) for the management of chronic pulmonary infections due to Pseudomonas aeruginosa in cystic fibrosis (CF) patients. A similar designation has already been granted by the European Medicines Agency (EMA). Ciprofloxacin DPI is an innovative drug-device combination. It combines ciprofloxacin dry powder that is formulated using Novartis’ Proprietary PulmoSphere® technology with an innovative easy-to-use delivery inhaler. Ciprofloxacin DPI is in Phase II development and is being studied for its safety and potential to improve lung function, as measured by the forced expiratory volume in 1 second (FEV1), in patients with CF. more
03/10/10, Research & Development MR contrast agents for diagnosis of breast cancer Berlin, March 10, 2010 – Bayer has started an international clinical Phase III study to develop its contrast agent Gadovist® (gadobutrol®) for use in magnetic resonance imaging (MRI) of the breast. The trial will evaluate the efficacy and safety of Gadovist in contrast-enhanced breast MRI (magnetic resonance mammography, MRM). Gadovist is already approved for the most frequently used contrast-enhanced MRI examinations including imaging of the central nervous system, the liver, the kidney and for imaging of blood vessels in adults and for the use in children aged 2 years and older. more
02/26/10, Company Bayer successful in a difficult environment Leverkusen, February 26, 2010 – 2009 was operationally one of the strongest years for the Bayer Group. “We were successful in a difficult environment, and we are optimistic for the future,” said Werner Wenning, Chairman of the Board of Management, on Friday at the Financial News Conference in Leverkusen. Earnings before interest, taxes, depreciation and amortization (EBITDA) before special items came in at EUR 6,472 million, the third-highest level in Bayer’s history. Net cash flow climbed by 49 percent to a record EUR 5,375 million, enabling net financial debt to be reduced by EUR 4.5 billion – a greater amount than planned – to EUR 9.7 billion. Group sales moved back by 5.3 percent to EUR 31,168 million (2008: EUR 32,918 million). The currency- and portfolio-adjusted (Fx & portfolio adj.) decrease was 5.7 percent. Sales of HealthCare and CropScience rose by 3.8 and 2.5 percent (Fx & portfolio adj.), respectively, to record levels. Business at MaterialScience, however, shrank by 24.7 percent (Fx & portfolio adj.) due to the economic situation. Wenning expects sales and earnings to rise in 2010. more
02/18/10, Research & Development VEGF Trap-Eye Shows Positive Results in Phase II Study in Patients with Diabetic Macular Edema Leverkusen, Germany and Tarrytown, NY, USA, February 18, 2010 – Bayer HealthCare AG and Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) today announced that VEGF Trap-Eye showed positive results in a Phase II study in patients with Diabetic Macular Edema (DME). The primary endpoint of the study, a statistically significant improvement in visual acuity over 24 weeks compared to the standard of care in DME, macular laser treatment, was met. Visual acuity improvement was measured by the mean number of letters gained over the initial 24 weeks of the study. more
01/25/10, Hemophillia Bayer to Discontinue Phase II Clinical Trial for Long-Acting Recombinant Factor VIII Following Interim Analysis Berlin, January 25, 2010 – Bayer Schering Pharma AG, Germany has announced that an independent Data Safety and Monitoring Board (DSMB) has completed an interim analysis of a phase II trial (the LIPLONG study) of the company’s long-acting recombinant factor VIII, BAY79-4980. The DSMB concluded that the study will not be able to achieve the predetermined efficacy endpoint (non-inferiority). No safety concerns were raised. As a result of the DSMB findings and recommendation, Bayer has decided to discontinue the study. more
01/12/10, Diagnostic Imaging Bayer Schering Pharma receives green light from European authorities to use Gadovist® 1.0 in children Berlin, January 12, 2010 – Bayer Schering Pharma AG successfully completed the procedure for securing approval to use the contrast medium Gadovist® 1.0 in children aged seven and above in Europe’s main markets. Germany will start to introduce Gadovist® 1.0 for this new indication in January of this year. In addition, the Swiss Regulatory Authorities have approved Gadovist® 1.0 for the use in children aged 2 years and older. more
12/10/09, Research & Development Clinical Programs with Riociguat in Pulmonary Hypertension Well on Track Berlin, Germany, December 10, 2009 – A first Phase II trial with Bayer Schering Pharma’s oral agent riociguat (BAY 63-2521) in pulmonary hypertension owing to interstitial lung disease (PH-ILD) has successfully been completed. PH-ILD is a form of pulmonary hypertension for which no approved treatment options are currently available. The primary objectives of the study – to investigate safety and tolerability of riociguat in this subgroup of PH-patients – were achieved. The study demonstrated a reduction in pulmonary vascular resistance (PVR), together with a considerable increase in cardiac output and slight improvement of exercise capacity as measured by a six-minute walk test (6-MWT). Riociguat is the first member of a novel class of therapeutics called soluble guanylate cyclase (sGC) stimulators and is being investigated as a new approach to treat different forms of pulmonary hypertension (PH). more
12/07/09, Women’s Healthcare Visanne® cleared for market launch in Europe as new treatment option for endometriosis Berlin, December 7, 2009 – Bayer Schering Pharma AG, Germany, has successfully completed the decentralized part of drug approval procedure in Europe for a new treatment of endometriosis called Visanne®. Visanne is a once-daily oral tablet containing dienogest 2 mg that has been developed specifically for the treatment of endometriosis. A dedicated clinical study programme has proven that Visanne relieves endometriosis pain with high efficacy, reduces endometriosis lesions and demonstrates a favourable safety and tolerability profile. Market launch of the product is planned from the second quarter 2010 onwards. more
12/06/09, Thrombosis Phase III EINSTEIN-Extension Study of Bayer’s Rivaroxaban Shows Significant Benefit in the Prevention of Secondary Symptomatic VTE New Orleans, Louisiana (USA), December 6, 2009 – The novel oral anticoagulant rivaroxaban 20 mg once-daily significantly reduced the risk of recurrent symptomatic venous thromboembolism (VTE) compared to placebo in patients who have been treated for a previous deep vein thrombosis (DVT) or pulmonary embolism (PE). The rate of major bleeding was low. The results of the Phase III EINSTEIN-Extension (EXT) clinical study were presented today in the official press program of the 51st Annual Meeting of the American Society of Hematology (ASH) in New Orleans, LA. more
12/02/09, Xarelto Bayer Team wins the “Deutscher Zukunftspreis” awarded by the German President Berlin / Leverkusen, December 2, 2009 – The “Deutscher Zukunftspreis 2009” of the German President has been awarded to an R & D team from Bayer: Dr. Frank Misselwitz, Dr. Elisabeth Perzborn and Dr. Dagmar Kubitza received the prize for achievements in technology and innovation from the German Federal President Horst Köhler in Berlin. The Bayer scientists from Wuppertal were honored with the prestigious award for the development of the new anticoagulant drug rivaroxaban (Xarelto®). more
12/01/09, Oncology Bayer Schering Pharma to collaborate with Micromet on novel approach to cancer therapy Berlin, December 1, 2009 – Bayer Schering Pharma AG, Germany, will develop a new BiTE antibody for the treatment of solid tumors in collaboration with the biopharmaceutical company Micromet, Inc. In January 2009, both companies had entered into an option, license and collaboration agreement. By exercising the option now, Bayer Schering Pharma has triggered a joint collaboration on the development of the BiTE antibody against an undisclosed solid tumor target through the completion of Phase I clinical trials, at which point Bayer will assume full control of the further development and commercialization of the antibody. BiTE antibodies are designed to direct the body's cell-destroying T cells against tumor cells, and represent a new therapeutic approach to cancer therapy. more
12/01/09, Multiple sclerosis Bayer’s Betaferon® approved in China for Treatment of Multiple Sclerosis Berlin, December 1, 2009 – Bayer Schering Pharma AG announced today that the Chinese State Food and Drug Administration (SFDA) has approved Betaferon® (interferon beta-1b) therapy for patients with relapsing-remitting multiple sclerosis (MS). Bayer plans to launch Betaferon in China by mid 2010. Betaferon is available in more than 100 countries around the world. more
11/30/09, Research & Development Bayer Starts Phase III Trial with Florbetaben Berlin/Chicago, November 30, 2009 – Bayer Schering Pharma AG, Germany, is progressing with the development of florbetaben to support Alzheimer diagnosis. On the occasion of the 95th Scientific Assembly and Annual Meeting of the Radiological Society of North America (RSNA), the company announced the enrollment of first patients in an international clinical Phase III trial to evaluate the efficacy and safety of florbetaben (BAY 94-9172) PET imaging in the detection of beta-Amyloid deposition in the brain. The trial will include both subjects with and without manifest dementia (e.g. Alzheimer’s disease [AD]). In the previous Phase II trial, florbetaben has successfully demonstrated its potential to detect beta-Amyloid deposition in the brain as a pathological hallmark of disease in AD patients. more
11/19/09, Xarelto Positive Results from Chronic Study with Bayer’s Rivaroxaban Will be Presented As a Late Breaker at ASH 2009 Berlin, November 19, 2009 – Findings from the Phase III EINSTEIN-Extension study will be presented in the Late Breaking Abstract Session on December 8, 2009, (7:30 am EST, Hall F, Ernest N. Morial Convention Center) at the 51st Annual Meeting of the American Society of Hematology (ASH) in New Orleans, Louisiana. more
11/11/09, Company Self-determined Family planning: worldwide initiative for maternal health and against child mortality A new Bayer HealthCare initiative with the motto “Family planning” will concentrate the company’s activities in developing countries, which have been running for 40 years now, and extend them through new projects with international partners. Thus Bayer shows its societal responsibility as the global market leader in hormonal contraception and reinforces its position as a leading pharmaceutical company in the field of women’s healthcare. more
11/11/09, Company Healthcare: Fight against Neglected Diseases As part of its societal responsibilities, Bayer HealthCare puts special emphasis on therapies for the so-called neglected diseases. More than 3.3 billion people, half of the world’s population, are threatened by these. In developing countries and emerging markets, the poorest of the poor are affected disproportionately. These diseases diminish peoples’ strength so they cannot work, and they weaken the whole community. One of the Millennium Goals (Goal 6: Combat HIV/AIDS, malaria, and other diseases) declared by the United Nations indicates the special importance of fighting these diseases. more
11/11/09, Company Data and Facts: “Family planning” Pregnancies more
10/27/09, Company Bayer back on the uptrend Leverkusen, October 27, 2009 – In the third quarter, the Bayer Group achieved a slight year-on-year increase in underlying earnings for the first time this year. “We are very pleased to have reversed the earnings trend despite the fact that many industries are still suffering from the economic crisis,” said Management Board Chairman Werner Wenning when the interim report was published on Tuesday. “We are still adhering to our ambitious full-year forecast for the Bayer Group,” he added. Wenning explained that HealthCare and MaterialScience contributed to the positive performance in the third quarter. The HealthCare subgroup again turned in a strong performance, with year-on-year increases in sales and earnings. MaterialScience nearly doubled earnings compared with the second quarter, almost reaching the prior-year level. At CropScience, on the other hand, third-quarter earnings receded markedly against the prior-year period. This subgroup’s target margin for 2009 has therefore been adjusted. more
10/23/09, Nexavar Bayer and Onyx Initiate Phase III Trial of Nexavar® in Patients with Non-Responsive Thyroid Cancer Berlin, October 23, 2009 – Bayer HealthCare AG and Onyx Pharmaceuticals, Inc. today announced that the companies have begun enrolling patients in an international Phase III trial to evaluate Nexavar® (sorafenib) tablets for the treatment of patients with radioactive iodine-refractory, locally advanced or metastatic differentiated thyroid cancer. This Phase III trial was started based on the results from Phase II clinical trials evaluating Nexavar in patients with advanced thyroid cancer. more
10/22/09, Thrombosis The risk of venous thromboembolism for drospirenone containing oral contraceptives is comparable to the risk of other oral contraceptives available on the market Berlin, October 22, 2009 – The Swiss regulatory authority Swissmedic has conducted an analysis with its expert medical committee on the latest data and studies regarding the risk of venous thromboembolism (VTE) associated with oral hormonal contraceptives. The results of this analysis were announced earlier today by Swissmedic. more
