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Xarelto Media Report 11/9/16

OUS Coverage

Lawsuit against Bayer in the USA
Nov 9, 2016 | Handelsblatt
By JanKeuchel and Christina Zuhlke

The drugmaker has trouble with the blood thinner Xarelto: In the US, the number of patients complaints has risen to more than 14,000. Bayer's US partner has probably retained information for many years.
USA: 14,000 complaints against Bayer drug Xarelto
Nov 9, 2016 | Der Standard

The pharmaceutical and plant protection company Bayer sees itself in the USA with a complaint against his drug Xarelto confronted. Between January and October the number of complaints from users of the coagulation inhibitor increased according to company data from about 4.300 to 13.800. Meanwhile, even the threshold of 14,000 patient charges had been exceeded, the "Handelsblatt" reported.
Lawsuits against Bayer
Nov 9, 2016 | PNN
By Heike Jahberg

Bad news for Bayer: The pharmaceutical and crop protection group has to deal with a wave of lawsuits in the United States. This goes against the drug, with Bayer and its in Berlin is settled pharmaceutical division currently are most successful - the blood thinner Xarelto . The medicine should prevent stroke. Last year, the blockbuster generated sales of 2.2 billion euros, with the trend rising. In the past quarter, the Schering successor with Xarelto took 772 million euros, of which 139 million euros in the US.
Xarelto: Lawsuit against Bayer rolls
Nov 9, 2016 | Pharmazeutische Zeitung

The pharmaceutical and plant protection company Bayer sees itself in the USA with a complaint against his drug Xarelto confronted. Between January and October, the number of complaints from users of the coagulation inhibitor increased from about 4300 to 13,800 according to company data. Meanwhile, even the threshold of 14,000 patient charges had been exceeded, the "Handelsblatt" reported today. Xarelto has recently bestowed billion revenue Bayer.
Lawsuits against Bayer drug Xarelto in the US
Nov 9, 2016 | Arcor

The pharmaceutical and plant protection company Bayer is facing a complaint against its drug Xarelto in the USA. Between January and October, the number of complaints from users of the coagulation inhibitor increased from approximately 4300 to 13 800 according to company data. Meanwhile, even the threshold of 14,000 patient complaints had been exceeded, reported Handelsblatt (Wednesday). Xarelto has recently paid billions to Bayer.
Analysis Flash: Lamp leave Bayer on
Nov 9, 2016 | Zertifikate Anleger

The Düsseldorf bank house lamp has left the classification for Bayer after a media report about new anger with the blood thinner Xarelto on "buy" with a price target of 103 euros. The report in the "Handelsblatt" is based on already known facts, wrote analyst Volker Braun in a study of Wednesday. The number of patient complaints, which in the meantime is 14,000, is not new. / Tih / zb
Lawsuit against Bayer drug Xarelto in the USA
Nov 9, 2016 | Finanztreffe

The pharmaceutical and plant protection company Bayer faces a complaint against its drug Xarelto in the USA. Between January and October, the number of complaints from users of the coagulation inhibitor increased from about 4300 to 13,800. Meanwhile, even the threshold of 14,000 patient-cases had been exceeded, the "Handelsblatt" (Wednesday) reported. Xarelto has recently bestowed billion revenue Bayer.
BRIEF-Bayer comments on the article in
Nov 9, 2016 | Reuters

Bayer comments on the article in "Handelsblatt" on Xarelto * Believes statements published in 'Handelsblatt' on Nov. 9. about Xarelto are misleading * Says regulatory authorities in Europe and the US have confirmed the positive benefit-risk profile of Xarelto / potential malfunction of the measuring instruments has no effect on the study results Source text - bit.ly/2fS2FNl Further company coverage: (Gdynia Newsroom)
Bayer: Opinion
Nov 9, 2016 | De 4 Traders

The 'Handelsblatt' on a post from November 9, 2016 statements about the new anticoagulant Xarelto ® (rivaroxaban) made by Bayer, which are misleading. This may cause patients to discontinue their coagulation inhibitor without prior consultation with their attending physician, thus risking an increase in stroke risk. Bayer would therefore like to make the facts correct and to sensitize patients to answer their questions first. Bayer takes the following view
Good morning with Bayer, Compugroup, Epigenomics, E.ON, Freenet, Scout24, Grammer, Heidelberg Druck, Heidelcement, Lufthansa, Munich Re, Osram, VIB assets
| Boerse Social

BAYN (VB -3.6%) Bayer once again in trouble with the blood thinner Xarelto.Bayer's US partner Jansssen had apparently withheld information for several years. In the USA, the number of patient complaints has grown to more than 14,000, HB, pp. 1, 4 and 5

Full Text of Stories Below

OUS Coverage

Lawsuit against Bayer in the USA

Nov 9, 2016 | Handelsblatt

By JanKeuchel and Christina Zuhlke

The drugmaker has trouble with the blood thinner Xarelto: In the US, the number of patients complaints has risen to more than 14,000. Bayer's US partner has probably retained information for many years.
New York Xarelto is one of the favorite products of Bayer leader Werner Baumann. Last year, the blood thinner had a worldwide turnover of more than two billion euros. But obviously, Bayers' cash registers cause serious side effects. More than 14,000 patients and relatives sue in the United States against Bayer . They make Xarelto responsible for severe bleeding and death. The Leverkusen pharmacist rejected the allegations.
Rest of article is behind a paywall. View link here: http://www.handelsblatt.com/my/unternehmen/industrie/aerger-mit-blutverduenner-xarelto-klagewelle-gegen-bayer-in-den-usa/14812222.html?ticket=ST-3705568-Z5diVAgjMjG92xiNhU4x-ap3

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USA: 14,000 complaints against Bayer drug Xarelto

Nov 9, 2016 | Der Standard

The pharmaceutical and plant protection company Bayer sees itself in the USA with a complaint against his drug Xarelto confronted. Between January and October the number of complaints from users of the coagulation inhibitor increased according to company data from about 4.300 to 13.800. Meanwhile, even the threshold of 14,000 patient charges had been exceeded, the "Handelsblatt" reported. -
Xarelto has recently paid billions to Bayer. The plaintiffs now make the drug for the treatment and prevention of blood clots responsible for health damage and even deaths. Bayer rejects the accusations. A company spokesman pointed out that the American drug regulator FDA and the European regulatory authority EMA confirmed the positive benefit-risk ratio of the drug. The company had good arguments to defend itself.
Nevertheless, the risk associated with such lawsuits is not negligible. How expensive it can be, shows the legal dispute around the antibiotic Yasmin / Yaz. Bayer has now agreed to pay more than $ 2.1 billion (€ 1.90 billion) with more than 10,000 women affected. Boehringer Ingelheim, a pharmacist, paid 650 million US dollars (588.87 million euros) in 2014 to avoid a long-standing litigation against thousands of lawsuits against its coagulation inhibitor Pradaxa. (APA, 9.11.2016 )

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Lawsuits against Bayer

Nov 9, 2016 | PNN

By Heike Jahberg

Bad news for Bayer: The pharmaceutical and crop protection group has to deal with a wave of lawsuits in the United States. This goes against the drug, with Bayer and its in Berlin is settled pharmaceutical division currently are most successful - the blood thinner Xarelto . The medicine should prevent stroke.Last year, the blockbuster generated sales of 2.2 billion euros, with the trend rising. In the past quarter, the Schering successor with Xarelto took 772 million euros, of which 139 million euros in the US.
Severe side effects
From now on, there is now an imminent threat. Patients have severe side effects to the cash register. Xarelto is responsible for bleeding and death. Between January and October the number of complaints according to Bayer data rose from about 4300 to 13,800. Meanwhile, even the threshold of 14,000 complaints had been exceeded, reported the Handelsblatt. According to research by the newspaper, Bayers US sales partner Janssen should also have kept the approval authorities for many years that during the admission study numerous test devices were defective and the means in case of occurring bleeding possibly too well."The most extensively tested active ingredient"
Bayer dismissed the allegations on Wednesday and warned patients against stop the remedy without consulting their doctor. The group of new coagulation inhibitors (NOAK) reduce the risk of fatal bleeding and cerebral hemorrhage compared to the precursor preparations, according to a communication. More than 85.00 patients had already participated in clinical trials, "the Bayer preparation is already the most intensively tested active substance in the group of NOAK". The European and the US regulatory authorities have also confirmed that a potential malfunction of the encoder used in the pivotal study had no effect on the results.
For the group of trouble comes at the wrong time. Bayer is currently busy, the acquisition of seed producer Monsanto to bring across the stage. And: Pharmacies can become expensive. In the legal dispute over the antibiotic Yasmin / Yaz, Bayer has now agreed to settle more than € 1.9 billion with more than 10,000 affected women.

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Xarelto: Lawsuit against Bayer rolls

Nov 9, 2016 | Pharmazeutische Zeitung

The pharmaceutical and plant protection company Bayer sees itself in the USA with a complaint against his drug Xarelto confronted. Between January and October, the number of complaints from users of the coagulation inhibitor increased from about 4300 to 13,800 according to company data. Meanwhile, even the threshold of 14,000 patient charges had been exceeded, the "Handelsblatt" reported today. Xarelto has recently bestowed billion revenue Bayer.
The applicants medication used for treatment and prevention of blood clots for health and even deaths. Bayer rejects the accusations. A company spokesman pointed out that the American drug regulator FDA and the European regulatory authority EMA confirmed the positive benefit-risk ratio of the drug. The company have good arguments to defend itself.

However, the risk associated with such an action waves is not negligible. How expensive it can be, shows the legal dispute around the antibiotic Yasmin / Yaz. Here, Bayer has now agreed to settle more than $ 2.1 billion (1.9 billion euros) with more than 10,000 women affected. The pharmaceutical company Boehringer Ingelheim paid in 2014 to avoid a long legal dispute over thousands of lawsuits against its anticoagulant Pradaxa, 650 million US dollars.

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Lawsuits against Bayer drug Xarelto in the US

Nov 9, 2016 | Arcor

The pharmaceutical and plant protection company Bayer is facing a complaint against its drug Xarelto in the USA. Between January and October, the number of complaints from users of the coagulation inhibitor increased from approximately 4300 to 13 800 according to company data. Meanwhile, even the threshold of 14,000 patient complaints had been exceeded, reported Handelsblatt (Wednesday). Xarelto has recently paid billions to Bayer.
The plaintiffs make the drug responsible for the treatment and prevention of blood clots responsible for health damage and even death. Bayer rejects the accusations. A company spokesman pointed out that the American drug regulator FDA and the European regulatory authority EMA confirmed the positive benefit-risk ratio of the drug. The company had good arguments to defend itself.
Nevertheless, the risk associated with such lawsuits is not negligible. How expensive it can be, shows the legal dispute around the antibiotic Yasmin / Yaz. Here, Bayer has now agreed to settle more than USD 2,000 (€ 1.9 billion) with more than 10,000 affected women. The pharmacist Boehringer Ingelheim paid 650 million US dollars in 2014 to avoid a long-standing legal dispute because of thousands of complaints against his coagulation inhibitor Pradaxa.

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Analysis Flash: Lamp leave Bayer on

Nov 9, 2016 | Zertifikate Anleger

The Düsseldorf bank house lamp has left the classification for Bayer after a media report about new anger with the blood thinner Xarelto on "buy" with a price target of 103 euros. The report in the "Handelsblatt" is based on already known facts, wrote analyst Volker Braun in a study of Wednesday. The number of patient complaints, which in the meantime is 14,000, is not new. / Tih / zb

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Lawsuit against Bayer drug Xarelto in the USA

Nov 9, 2016 | Finanztreffe

The pharmaceutical and plant protection company Bayer faces a complaint against its drug Xarelto in the USA. Between January and October, the number of complaints from users of the coagulation inhibitor increased from about 4300 to 13,800. Meanwhile, even the threshold of 14,000 patient-cases had been exceeded, the "Handelsblatt" (Wednesday) reported. Xarelto has recently bestowed billion revenue Bayer.

The applicants medication used for treatment and prevention of blood clots for health and even deaths. Bayer rejects the accusations. A company spokesman pointed out that the American drug regulator FDA and the European regulatory authority EMA confirmed the positive benefit-risk ratio of the drug. The company had good arguments to defend itself.
Nevertheless, the risk associated with such lawsuits is not negligible. How expensive it can be, shows the legal dispute around the antibiotic Yasmin / Yaz. Here, Bayer has now agreed to settle more than USD 2,000 (€ 1.9 billion) with more than 10,000 affected women. The pharmaceutical company Boehringer Ingelheim paid in 2014 to avoid a long legal dispute over thousands of lawsuits against its anticoagulant Pradaxa 650 million Dollar./rea/DP/jha

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BRIEF-Bayer comments on the article in

Nov 9, 2016 | Reuters

Bayer comments on the article in "Handelsblatt" on Xarelto
* Believes statements published in 'Handelsblatt' on Nov. 9. about Xarelto are misleading
* Says regulatory authorities in Europe and the US have confirmed the positive benefit-risk profile of Xarelto / potential malfunction of the measuring instruments has no effect on the study results Source text - bit.ly/2fS2FNl Further company coverage: (Gdynia Newsroom)
View full article here: http://www.reuters.com/article/idUSFWN1DA0MC?feedType=RSS&feedName=rbssHealthcareNews&utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%3A+reuters%2FUShealthcareNews+%28News+%2F+US+%2F+Healthcare+News%29

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Bayer: Opinion

Nov 9, 2016 | De 4 Traders

The 'Handelsblatt' on a post from November 9, 2016 statements about the new anticoagulant Xarelto ® (rivaroxaban) made by Bayer, which are misleading. This may cause patients to discontinue their coagulation inhibitor without prior consultation with their attending physician, thus risking an increase in stroke risk. Bayer would therefore like to make the facts correct and to sensitize patients to answer their questions first. Bayer takes the following view:
New-generation coagulation inhibitors such as Xarelto® (rivaroxaban) from Bayer can protect humans from stroke and other life-threatening vascular occlusions. They have been developed to improve stroke prophylaxis. Decades were mainly vitamin K antagonists (VKA) available for these fields of application. However, since patients are difficult to adjust to the therapeutic effective area of VKA, regular blood clotting and dose adjustments must be performed. Because of this difficult-to-control effect of the VKA, the approval of the new coagulation inhibitors (NOAK) was a medical advance.
NOAK allow a reliable effect in fixed dosage and without constant dosage adjustment. Regular monitoring of the blood coagulation as in VKA is therefore not necessary for NOAK - as well as for many other medicines that interfere with blood clotting, eg ASA - medically. In addition, they have with equally good efficacy security benefits occur under NOAK less fatal bleeding and less cerebral hemorrhage in stroke prevention than under the Alttherapie MCA (1,3,4) . Authorization authorities all over the world granted approval based on clinical trials that demonstrate a positive benefit-risk profile for NOAK.
The bleeding management is also established for the new coagulation inhibitors such as Rivaroxaban. If the anticoagulant effect is necessary, the preparation can be immediately discontinued, so that blood clotting is normalized again. This is comparable to the time it takes for vitamin K to normalize blood clotting in patients who have received a vitamin K antagonist. In addition, and if necessary in rare cases, agents which promote blood clotting can be used. These agents are not specific for rivaroxaban and are also used in VKA.
A total of three scientific societies (2) , including the European Society of Cardiology (ESC), recommend the new anticoagulant because of their favorable risk-benefit profile preferably for stroke prevention in patients with non-heart valves induced atrial fibrillation (AF) to use. This cardiac arrhythmia is frequent in people above the age of 65 and increases the risk of stroke by a factor of five. The currently published in August 2016 recommendation of the ESC is based inter alia on the pivotal studies and a meta-analysis, in which the NOAK have their efficacy and safety compared to VKA is. (3,4)
In the period under which the approval study was carried out (2006-2010), the instruments used to determine blood coagulation at VKA were approved by the US regulatory authority and were CE certified in Europe.The European and American regulatory authorities have confirmed that a potential malfunction of the Alere meter used in the approval study had no effect on the results of the approval study. After examining all the information, the European regulatory authority concluded in its assessment report in February 2016 that Bayer and Janssen had no knowledge of the influence of the potential malfunction of the INR meter in the ROCKET AF study until 9 September 2015. ' Bayer and its development partner Janssen have always ensured that regulatory authorities receive all the information they need regarding past and ongoing clinical trials.
Bayer is continuously investigating the efficacy and safety profile of its coagulation inhibitor. Since the launch of the company, it has been consistent with the results of the clinical trials, in which more than 85,000 patients have already taken part. Studies for use in practice confirm the positive benefit-risk profile in all indications. The Bayer product is already the most extensively tested drug in the NOAK group. Over all indications, the program will include approximately 275,000 patients with completed, ongoing and planned trials.
By October 14, 2016, Bayer had been sued by approximately 13,800 Xarelto users in the US. The applicants claim that the use of Xarelto has resulted in injuries to health, such as cerebral, gastrointestinal and other bleeding and death, and requires compensation for damages and penal injuries. Bayer is convinced that it has good arguments against the claimed claims.
Rivaroxaban is marketed under the brand name Xarelto®. In the venous and arterial thromboembolism (VAT), Xarelto® is the NOAK with the widest range of application with seven approved indications.
Bayer: Science For A Better Life
Bayer is a global enterprise with core competencies in the life science fields of health care and agriculture. With its products and services, the company wants to benefit people and help improve the quality of life. At the same time, the Group wants to create value through innovation, growth and high profitability. Bayer is committed to the principles of sustainability and is socially and ethically responsible as a 'corporate citizen'. In fiscal year 2015, the Group generated sales of EUR 46.3 billion with approximately 117,000 employees. Investments amounted to EUR 2.6 billion and research and development expenses to EUR 4.3 billion. These figures include the business of high-quality polymer materials, which was launched on 6 October 2015 as an independent company under the name of Covestro. More information can be found on the Internet at www.bayer.de
Bayer Vital GmbH distributes the pharmaceuticals of the Consumer Health and Pharmaceuticals divisions as well as the animal pharmaceuticals of the Animal Health business unit in Germany. For more information on Bayer Vital GmbH, please visit:www.gesundheit.bayer.de

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Good morning with Bayer, Compugroup, Epigenomics, E.ON, Freenet, Scout24, Grammer, Heidelberg Druck, Heidelcement, Lufthansa, Munich Re, Osram, VIB assets

| Boerse Social

BAYN (VB -3.6%)
Bayer once again in trouble with the blood thinner Xarelto.Bayer's US partner Jansssen had apparently withheld information for several years. In the USA, the number of patient complaints has grown to more than 14,000, HB, pp. 1, 4 and 5
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