MILPITAS, Calif., Aug. 18, 2015 /PRNewswire/ -- Armetheon, Inc., a specialty pharmaceutical company developing novel small molecule drugs for cardiovascular diseases, today announced the appointment of Detlef Albrecht, M.D., as Chief Medical Officer and Head of Drug Development, effective immediately. Dr. Albrecht will lead the advancement of Armetheon's pipeline of products, in particular, the oral anticoagulant drug candidate, tecarfarin, which is poised to enter into a final registration study (Tecarfarin for AntiCoagulation Trial, or TACT). Dr. Albrecht will report to Chief Executive Officer, Dr. Sanjay Kakkar.
"We are delighted to welcome Dr. Albrecht at an important time for the Company as we prepare for the remaining pivotal trial for our lead product candidate, tecarfarin," stated Dr. Kakkar. "With over 20 years of experience in preclinical and clinical research, including leading or co-leading multiple phase 3 programs through US and EU marketing approvals, Dr. Albrecht has a clear track record and expertise that will be critical for Armetheon's overall success and for the phase 3 program for tecarfarin. We value Dr. Albrecht's entrepreneurial experience in building and managing strong, dynamic teams as well as his technical and strategic insights into the pharmaceutical and biotechnology industries and we look forward to his leadership in Armetheon's efforts to expand the product pipeline."
Prior to joining Armetheon, Dr. Albrecht was President and CEO of Sorbent Therapeutics, Inc., a biopharmaceutical company developing therapies for cardiovascular and renal diseases. Previously, he built and managed R&D organizations at Ilypsa (acquired by Amgen in 2007 for $420 million) and Relypsa, where he participated in raising over $100 million in financing. Between 1992 and 2004, he led or co-led development teams at Schwarz Pharma and ALZA that achieved two US NDAs, three supplemental US NDAs, and five EU Market Authorizations for products including Edex®, Duragesic®, Ditropan XL®, Doxil®, and Concerta. Dr. Albrecht began his medical career as a practicing physician specializing in urology and he holds both medical and doctorate degrees from the Rheinisch Westfaelische Technische Hochschule (RWTH) University in Aachen, Germany.
Dr. Albrecht commented, "Armetheon has made important progress in the development of tecarfarin, which has the potential to address significant unmet needs in patients requiring anticoagulation. I am very excited to join a world-class team and lead Armetheon's product development group to bring products to patients. I also look forward to helping build the Company's R&D pipeline focused on specialty cardiovascular indications."
Tecarfarin is being investigated for use as an oral, once-daily anticoagulant that inhibits Vitamin K epoxide reductase (VKOR), an important enzyme in the coagulation system, and avoids CYP450 metabolism and renal elimination. In Phase 2 and Phase 2/3 (EMBRACE-AC) clinical testing, tecarfarin improved time in therapeutic range (TTR) in chronically anticoagulated patients. The effect of tecarfarin on TTR will be further investigated in the Company's pivotal clinical trial, TACT (Tecarfarin for AntiCoagulation Trial), which will be conducted under a Special Protocol Assessment agreed upon with the FDA. TACT is an open-label trial of 3,000 patients with any indication for anticoagulation, including prosthetic heart valve (PHV) patients. TTR was chosen as the endpoint for these trials on the basis of evidence suggesting that better anticoagulation control (as measured by higher TTR) can protect patients from severe or even fatal adverse events. Tecarfarin is monitored using INR (International Normalized Ratio) and is being investigated for use without the need for CYP2C9 genotyping since tecarfarin is not metabolized via the CYP450 system. In preclinical and early clinical studies, the anticoagulant effect of tecarfarin was reversed by existing and readily available antidotes for Vitamin K Antagonists.
Armetheon, Inc., is a privately held, specialty pharmaceutical company developing and commercializing innovative medicines addressing major unmet needs in cardiovascular disease, initially in thrombosis. Armetheon focuses on improved therapies with the goal of increased efficacy, safety, and utility, targeting specialty markets with clearly defined regulatory pathways. Armetheon's lead candidate, tecarfarin, is being investigated for use as a Vitamin K Antagonist and is currently in Phase 3 development for the prevention and management of thrombosis. For more information: www.armetheon.com.
Heather Lake, Director of Corporate Development
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SOURCE Armetheon, Inc.