Novel, oral Factor Xa inhibitor (BAY 59-7939): Positive results of Phase II once-daily study presented
10 mg once-daily dose to be studied in Phase III clinical trials for prevention of venous thromboembolism (VTE).
Leverkusen – Bayer HealthCare (BHC) announced major results of a large, once-daily (OD) dose finding study of BHC´s novel, oral, direct Factor Xa inhibitor (BAY 59 7939) for prevention of venous thromboembolism (VTE) in patients undergoing hip replacement surgery at the 47th Annual Meeting of the American Society of Hematology (ASH). Based on these positive data, Bayer HealthCare recently announced that a 10 mg once-daily regimen is to be studied in Phase III clinical trials for prevention of VTE. Bengt Eriksson, Orthopedic Surgeon at the Sahlgrenska University Hospital/Östra, Gothenburg, Sweden and Principal Investigator of the trial presented the data at the ASH meeting in Atlanta/USA.
All doses of BAY 59 7939, across the wide 8-fold dose range studied (5–40 mg once-daily), were effective compared with the current gold standard of 40 mg subcutaneous enoxaparin once daily. The primary efficacy endpoint was determined as a composite of any DVT, objectively confirmed pulmonary embolism (PE), and all-cause mortality. The results for the primary efficacy endpoint for BAY 59 7939 reached 6.4–14.9% vs. 25.2% for enoxaparin. No dose arm had to be discontinued due to efficacy or safety concerns.
In terms of safety, a significant dose response was demonstrated for BAY 59 7939 concerning the primary safety endpoint. The primary safety endpoint was defined as the incidence of major, post-operative bleeding (p=0.039) not later than two days after the last intake of study drug. The two lowest doses of BAY 59 7939, 5 and 10 mg showed similar rates of major bleeding to enoxaparin (2.3% and 0.7% for BAY 59 7939). Based on these data the optimal dose - defined by both efficacy and safety - is 10 mg once-daily for prevention of venous thromboembolism (VTE) after major orthopedic surgery.
“Oral BAY 59 7939 once-daily holds considerable clinical promise based on the phase II data in VTE prevention after elective hip replacement surgery. The once-daily dosing decision could be made based on data from several dose finding trials with both twice daily (BID) and OD regimens including more than 2.800 patients. The comparison of all BID and OD studies indicated that safety might be further enhanced by choosing the OD treatment. Very importantly, these studies indicate that BAY 59 7939 does not require monitoring of blood coagulation or dose adjustment in VTE prevention,” said Bengt Eriksson, Principal Investigator of the trial.
The ODIXa-OD.HIP study was a randomized, double-blind, dose-finding study and was performed to compare the efficacy and safety of once-daily, oral BAY 59 7939 with subcutaneous enoxaparin for VTE prevention in patients undergoing total hip replacement. The study included 873 Patients which were randomized to receive once-daily, oral BAY 59 7939 (5, 10, 20, 30, or 40 mg) starting with the first dose given 6–8 hours after surgery, or subcutaneous enoxaparin (40 mg OD), starting the evening before surgery. Treatment continued for 5 to 9 days after surgery, mandatory bilateral venography was performed the following day. Patients were followed up 30–60 days after last dose of study drug.
Further Clinical Development of BAY 59 7939
BAY 59 7939 is being developed, in parallel, in three key indications: VTE prevention after major orthopedic surgery, VTE treatment and stroke prevention in atrial fibrillation.
The initiation of the phase III study program for BAY 59 7939 (10 mg od) for VTE prevention after major orthopedic surgery was announced on December 8, 2005 and involves several major studies – the so called RECORD studies (REgulation of Coagulation in major Orthopaedic surgery reducing the Risk of DVT and pulmonary embolism -PE) – enrolling more than 9.000 patients. The studies will compare oral BAY 59 7939 with subcutaneous enoxaparin for dosing regimens up to five weeks. At present, Bayer HealthCare is on track for filing for market authorization in late 2007.
A phase II dose-finding program with twice- and once-daily dosing for VTE treatment and stroke prevention in atrial fibrillation is ongoing. Data are planned to be presented at a major scientific congress in the second half of 2006. Based on current plans filing for market authorization in these chronic indications is anticipated for 2009.
Bayer HealthCare and Ortho-McNeil Pharmaceutical, Inc., a Johnson & Johnson company, recently announced that they have signed an agreement to jointly develop and market BAY 59-7939 for the prevention and treatment of thrombosis. In the U.S. Ortho-McNeil will receive exclusive marketing rights for the cardiology, primary care and hospital specialty markets. BHC will retain an option to co-promote Bay 59-7939 in the hospital and specialty markets through its Specialty Pharmaceutical unit in the U.S. BHC will also retain sole marketing rights for the compound in countries outside the United States.
About Bayer HealthCare AG
Bayer HealthCare AG, a subsidiary of Bayer AG, is one of the world’s leading, innovative companies in the health care and medical products industry. In 2004, the Bayer HealthCare subgroup generated sales amounting to some 8.5 billion Euro.
The company combines the global activities of the divisions Animal Health, Biological Products, Consumer Care, Diabetes Care, Diagnostics and Pharmaceuticals. Bayer HealthCare employed 35,300 people worldwide in 2004.
Bayer HealthCare’s aim is to discover and manufacture innovative products that will improve human and animal health worldwide. The products enhance well-being and quality of life by diagnosing, preventing and treating disease.
This news release contains forward-looking statements based on current assumptions and forecasts made by Bayer Group management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in our public reports filed with the Frankfurt Stock Exchange and with the U.S. Securities and Exchange Commission (including our Form 20-F). The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
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