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Subsequent Events
Bayer, the U.S. Food and Drug Administration (FDA) and the Canadian regulatory authority Health Canada were notified during the second half of October that an independent, randomized, controlled clinical trial being conducted in high-risk cardiac surgery patients in Canada (BART study), in which Trasylol® (aprotinin injection) was one of the substances being used, had been halted. In the context of a planned periodic data analysis carried out by the BART Data Safety Monitoring Board (DSMB), it was reported that there was a reduction in bleeding but also an increase in all-cause mortality – that almost reached conventional statistical significance for 30-day mortality – for patients in the Trasylol® treatment arm compared to patients who received either aminocaproic acid or tranexamic acid. As a result, the trial was halted. Detailed data have not, as yet, been shared with Bayer. The BART investigators will now collect data from all centers throughout Canada and undertake data analysis. This is expected to take up to eight weeks, or perhaps longer.
On November 5, following consultation with the German Federal Institute for Drugs and Medical Devices (BfArM), the FDA, Health Canada, and other health authorities, Bayer announced that it has elected to temporarily suspend worldwide marketing of Trasylol®. The company took this global action following direction from the German BfArM and requests from the FDA and other regulators that Bayer temporarily suspend Trasylol® marketing in their respective countries until final BART data were available. Once the complete BART dataset is available, Bayer will work with health authorities to evaluate whether these data have any impact on the positive benefit-risk assessment for Trasylol®. At that time, the temporary marketing suspension will be reevaluated.
The FDA, Health Canada and other health authorities have indicated their interest in working with Bayer to create a program for use during the temporary suspension under which physicians in these markets might request and receive Trasylol® for treatment of certain surgical patients with an established medical need. Bayer will work with the FDA, Health Canada, and any other authorities who wish to institute similar programs, to outline appropriate patient profiles and the specific details.
Bayer believes that the totality of the available data continues to support a favorable riskbenefit profile for Trasylol® when used according to labeling.
First through third quarter global 2007 sales for Trasylol® were €93 million, including approximately €63 million from the U.S. and €5 million in Germany.
At the beginning of October 2007, Bayer HealthCare’s Consumer Care Division acquired the global Citracal® line of over-the-counter calcium supplements from the U.S. company Mission Pharmacal. Citracal® is primarily sold in North America and saw net sales of US$ 47.0 million (approx. €36 million) for fiscal year 2006/2007.
Bayer Vital GmbH is the subject of an investigation by the German Federal Cartel Office concerning certain agreements with pharmacies on drug pricing. Bayer is cooperating with the Federal Cartel Office in clarifying the allegations.
Bayer MaterialScience has initiated extensive cost-structure measures to support its value-creation and efficiency-improvement targets. The goal is to achieve savings of €300 million annually by the end of 2009. The measures focus primarily on further process and cost optimization at production facilities, rigorous management of marketing and distribution expenses, and a significant reduction in administrative costs. Total special charges of €150 million to €200 million are expected to be taken through 2009 in order to realize these savings. We anticipate that the headcount reduction necessitated by the measures can be achieved in a socially compatible way and through normal attrition.
At the end of October 2007 Bayer agreed to sell the Hennecke group, part of the MaterialScience subgroup, to the Adcuram group, Vienna/Munich. The sale is scheduled to be completed by the end of the year, subject to the approval of the antitrust authorities. The Hennecke group is headquartered in Sankt Augustin, near Bonn, Germany, and has further sites in Pittsburgh, United States; Singapore; and Shanghai, China. It employs approximately 500 people and had sales of about €80 million in 2006.
On November 5, following consultation with the German Federal Institute for Drugs and Medical Devices (BfArM), the FDA, Health Canada, and other health authorities, Bayer announced that it has elected to temporarily suspend worldwide marketing of Trasylol®. The company took this global action following direction from the German BfArM and requests from the FDA and other regulators that Bayer temporarily suspend Trasylol® marketing in their respective countries until final BART data were available. Once the complete BART dataset is available, Bayer will work with health authorities to evaluate whether these data have any impact on the positive benefit-risk assessment for Trasylol®. At that time, the temporary marketing suspension will be reevaluated.
The FDA, Health Canada and other health authorities have indicated their interest in working with Bayer to create a program for use during the temporary suspension under which physicians in these markets might request and receive Trasylol® for treatment of certain surgical patients with an established medical need. Bayer will work with the FDA, Health Canada, and any other authorities who wish to institute similar programs, to outline appropriate patient profiles and the specific details.
Bayer believes that the totality of the available data continues to support a favorable riskbenefit profile for Trasylol® when used according to labeling.
First through third quarter global 2007 sales for Trasylol® were €93 million, including approximately €63 million from the U.S. and €5 million in Germany.
At the beginning of October 2007, Bayer HealthCare’s Consumer Care Division acquired the global Citracal® line of over-the-counter calcium supplements from the U.S. company Mission Pharmacal. Citracal® is primarily sold in North America and saw net sales of US$ 47.0 million (approx. €36 million) for fiscal year 2006/2007.
Bayer Vital GmbH is the subject of an investigation by the German Federal Cartel Office concerning certain agreements with pharmacies on drug pricing. Bayer is cooperating with the Federal Cartel Office in clarifying the allegations.
Bayer MaterialScience has initiated extensive cost-structure measures to support its value-creation and efficiency-improvement targets. The goal is to achieve savings of €300 million annually by the end of 2009. The measures focus primarily on further process and cost optimization at production facilities, rigorous management of marketing and distribution expenses, and a significant reduction in administrative costs. Total special charges of €150 million to €200 million are expected to be taken through 2009 in order to realize these savings. We anticipate that the headcount reduction necessitated by the measures can be achieved in a socially compatible way and through normal attrition.
At the end of October 2007 Bayer agreed to sell the Hennecke group, part of the MaterialScience subgroup, to the Adcuram group, Vienna/Munich. The sale is scheduled to be completed by the end of the year, subject to the approval of the antitrust authorities. The Hennecke group is headquartered in Sankt Augustin, near Bonn, Germany, and has further sites in Pittsburgh, United States; Singapore; and Shanghai, China. It employs approximately 500 people and had sales of about €80 million in 2006.
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