Berlin, April 19, 2014 - In its printed edition of April 19, 2014 the German news magazine "Der Spiegel" has published an article under the headline "Control is better" that references a number of anticoagulants, including Xarelto from Bayer. In the article, the hypothesis is put forward that the benefits of Xarelto not requiring routine coagulation monitoring might lead to an increased risk to patients. Bayer Vital GmbH responds to this article as follows:

We strongly dispute the allegation that the advantage of Xarelto not requiring regular monitoring of coagulation parameters would lead to an increased risk to patients.

Patient safety is Bayer's highest priority. In the very early phases of clinical development, long before Xarelto was launched in the market, we conducted numerous studies that included the question whether patients taking Xarelto may need regular checking of coagulation parameters to monitor its effects. These studies were conducted in collaboration with independent experts. These studies (more than 50 Phase-I studies and about 20 Phase-II studies) provided evidence and confidence to conduct the Phase-III trials in various indications without routine monitoring of coagulation parameters. The pivotal Phase-III trials provided evidence on the safety and efficacy of Xarelto with fixed doses without routine coagulation monitoring. The positive benefit-risk profile was also confirmed in different patient groups where either higher or lower serum levels were to be expected. The finding that routine coagulation monitoring is unnecessary is borne out of the data from broad clinical use.

Importantly, in Phase-III studies, Xarelto has been shown to be associated with a significantly reduced rate of the most severe bleeds, such as intracranial haemorrhage and fatal bleeding events in comparison to vitamin K antagonists (VKAs) in patients with non-valvular atrial fibrillation, and to significantly reduce the risk of major bleeding in patients with pulmonary embolism in comparison to the dual drug approach of low molecular weight heparins and VKAs.

Xarelto is an important additional treatment option for anticoagulation. Compounds from the drug class of the VKAs have been available for decades. These drugs are very effective, but they do have a number of disadvantages. These include the fact that VKAs have a narrow therapeutic window as well as numerous interactions with food and other drugs. Due to this and the fact there is no regular dosing regimen, VKAs require routine monitoring of coagulation parameters as well as frequent dose adjustments Regular monitoring of the coagulation parameters is necessary - not only to find the optimum dose for the patient when treatment is initiated, but also later to keep the VKA dose within the therapeutic window. This means that the VKA dose has to be adjusted frequently. The reason for this is, as already mentioned, the narrow therapeutic window of the VKA. Even small variations in the activity of the drug may result in either an increased risk of bleeding or a thrombosis.

Xarelto has been available since 2008, initially licensed to protect people undergoing elective hip or knee replacement surgery from the risk of blood clots. Since 2011, Xarelto has been available in Germany as an alternative medication for stroke prevention in patients with non-valvular atrial fibrillation. Xarelto offers reliable anti-coagulation at fixed doses without the need for routine monitoring of coagulation parameters. There are no relevant interactions with food and only few interactions with other commonly used drugs. Therefore, the effect of Xarelto is more predictable than that of the VKAs.

Apart from that, the following applies:

In special situations, e.g. emergency surgery or overdose, it may be helpful to check coagulation parameters to determine the blood levels of Xarelto. This is possible with special tests Bayer developed in collaboration with manufacturers of diagnostic tests. These tests have been available since 2011 and can be used in clinical practice.

Impaired renal function can influence the dosage of anticoagulants in patients with non-valvular atrial fibrillation. Bayer investigated this in the course of the clinical development of Xarelto and developed a lower dosage for patients with impaired renal function who suffer from non-valvular atrial fibrillation. Studies have also demonstrated that this group of patients does not need regular coagulation monitoring.

To support the responsible use of Xarelto, Bayer has developed a special programme which helps doctors to assess the benefit-risk balance for the individual patient. In addition to the support for physicians, Bayer provides information cards for patients. These cards provide additional information and warnings regarding bleeding risk to patients that help them identify signs of bleedings and advise them to contact their doctor in such cases.

About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of health care, agriculture and high-tech materials. Bayer HealthCare, a subgroup of Bayer AG with annual sales of EUR 18.9 billion (2013), 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, Medical Care and Pharmaceuticals divisions. Bayer HealthCare's aim is to discover, develop, manufacture and market products that will improve human and animal health worldwide. Bayer HealthCare has a global workforce of 56,000 employees (Dec 31, 2013) and is represented in more than 100 countries. More information is available at www.healthcare.bayer.com.

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