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Bayer to start late-stage trials on stroke drug

German drugs and chemicals group Bayer will start final-stage trials on venous thromboembolism drug BAY 59-7939 following promising Phase II or mid-stage results, it said on Monday.
/ Source: Reuters

German drugs and chemicals group Bayer will start final-stage trials on venous thromboembolism drug BAY 59-7939 following promising Phase II or mid-stage results, it said on Monday.

“Based on these positive data, Bayer HealthCare will begin preparation of Phase III clinical program in the fourth quarter of this year,” Bayer said in a statement.

Venous thromboembolism is characterized by clots that interfere with blood circulation.

BAY 59-7939 is one of two drugs in an otherwise sparse Bayer research pipeline that analysts say has major potential. It is expected to fetch sales of more than 1 billion euros ($1.26 billion) annually.

The results of the trial were released at a congress of the International Society on Thrombosis and Haemostasis in Sydney.

The trials included more than 1,300 patients and demonstrated safety and efficacy for BAY 59-7939 similar to enoxaparin, the drug in Sanofi-Aventis’ Lovenox.

In both studies BAY 59-7939 was given twice daily in tablet form, in contrast to Lovenox, which must be given as an injection. Additionally, trials are investigating the efficacy and safety of giving BAY 59-7939 to patients once a day.

Safety and efficacy of BAY 59-7939 was shown across a wide range of 2.5-10 mg given twice daily in the studies, Bayer said.