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☆ Bayer stops blood thinner drug trial due to lack of effect, in major setback
▼ + stars: | 2023-11-20 | by ( Ludwig Burger | ) www.reuters.com time to read: +3 min

Logo and flags of Bayer AG are pictured outside a plant of the German pharmaceutical and chemical maker in Wuppertal, Germany August 9, 2019. REUTERS/Wolfgang Rattay/File Photo Acquire Licensing RightsNov 19 (Reuters) - Germany's Bayer (BAYGn.DE) has aborted a large late-stage trial testing a new anti-clotting drug due to lack of efficacy, dealing a fresh blow to the embattled drugmaker and throwing its most promising medium-term development project in doubt. The trial halt, which followed recommendation of independent trial supervisors, marks another setback for a company burdened by a weak herbicide business, high debt and by U.S. lawsuits over the alleged carcinogenic effect of its commonly used Roundup weedkiller. Bayer said it will further analyse the data of the discontinued trial, known as OCEANIC-AF, which was initiated in August 2022. It said the independent trial supervisors recommended the continuation of a separate phase III trial, OCEANIC-STROKE, testing asundexian to prevent repeated strokes in participants who have already suffered one.

Persons: Wolfgang Rattay, Germany's Bayer, Bill Anderson, Bayer, Stefan Oelrich, Johnson, Ludwig Burger, Jose Joseph, Miranda Murray, Christopher Cushing Organizations: Bayer AG, REUTERS, Bristol, Myers Squibb, Johnson, Thomson Locations: Wuppertal, Germany, United States, asundexian, U.S, Frankfurt, Bengaluru

☆ The EU outlined its plan to equalize drug access and lower prices. Pharma firms are not happy
▼ + stars: | 2023-04-27 | by ( Jenni Reid | ) www.cnbc.com time to read: +2 min

A molecular biologist examines wastewater samples for pathogens in the safety laboratory at the Max Delbrück Center for Molecular Medicine in Mitte. One of the EU's key aims is to deliver more timely and equitable patient access to medicines across the 27-nation bloc. The group also found 92% of "innovative medicines" were available in Germany, compared with 30% in smaller and Eastern European EU member states. Companies can extend it up to 10 years if they launch the drug in all 27 EU member states within two years. However, pharmaceutical firms and lobby groups say the move could hamper innovation and the overall availability of drugs.

A version that was leaked earlier this year showed that Brussels was preparing to shorten an additional period of intellectual property protection, known as data exclusivity, which comes on top of drug patent protection. "The duration of data exclusivity, which may be reduced, could actually have a catastrophic impact for Europe," he said. He said the intentions of Brussels lawmakers - improving patient access to innovative drugs while making the European pharma sector more competitive - were noble but any shortening of intellectual property protection would have the opposite effect. Bayer shares lag'HIGHLY ATTRACTIVE'In the United States, a different set of drug market rule changes are underway, with some of the highest-selling products set to see negotiated price discounts under the Inflation Reduction Act (IRA). Among the biggest drivers was the company's decision to prepare a U.S. launch of its next-generation stroke prevention drug asundexian on its own.

FRANKFURT, March 24 (Reuters) - Bayer (BAYGn.DE) said the focus of its drug research would shift away from women's health, a traditional pillar of Germany's largest drugmaker, to hone in on neurology, rare diseases and immunology. "When it comes to research and the subsequent clinical phases, we will no longer have an explicit focus on women's health," the head of Bayer's pharmaceuticals unit, Stefan Oelrich, told Reuters on Friday. The shifted focus comes as Bayer is due to have a change at the top in June. Bayer, which acquired a large women's health business under the 2006 takeover of Schering Pharma, will focus drugs research on oncology, cardiovascular disease, neurology, rare diseases and immunology, the company said in a statement. Research efforts in immunology could still yield products in women's health but Bayer's dedicated work on the therapeutic area overall had fallen short of expectations, he said.

Both are legacy issues from Monsanto, which Bayer acquired for more than $60 billion in 2018. Another activist, Elliott, took a 1.1 billion euro stake in Bayer in 2019 but has kept a low profile. The next-generation blood thinner is one of four new drug hopefuls that Bayer said on Tuesday had combined peak sales potential of more than 12 billion euros. That included an improved outlook for kidney drug Kerendia, with potential annual sales now seen at more than 3 billion euros. ($1 = 0.9313 euros)Reporting by Ludwig Burger and Patricia Weiss Editing by Mark PotterOur Standards: The Thomson Reuters Trust Principles.

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