MENLO PARK, Calif., June 3, 2015 /PRNewswire/ -- Armetheon, Inc., a specialty pharmaceutical company developing novel small molecule drugs for cardiovascular diseases, today announced that Sanjay Kakkar, MD, MSc, MPH, has been appointed Chief Executive Officer, effective immediately. Dr. Kakkar brings more than 20 years of experience in global, high-growth enterprises, with a successful track record in advancing novel technologies for the improvement of human health. With expertise that includes the development of novel drugs and biologics targeting thrombosis and atherosclerosis as well as building entrepreneurial companies, Dr. Kakkar's background is uniquely suited to the advancement of Armetheon's lead product candidate, the oral anticoagulant, tecarfarin, which is poised to enter into a final registration study (Tecarfarin for AntiCoagulation Trial, TACT) under a Special Protocol Assessment (SPA) agreed upon with the FDA.
"Sanjay's appointment as CEO takes place at a pivotal time for Armetheon, as we prepare for tecarfarin's remaining pivotal trial," said Peter Milner, MD, FACC, Co-Founder and Chairman of Armetheon. "Based on our market research, tecarfarin can address compelling clinical needs in the U.S. anticoagulant market, particularly for patients with valve disease. Since last year, Armetheon has made substantial progress to support our lead program, receiving a SPA from the FDA for TACT and completing a $24 million Series B financing earlier this year. We look forward to Sanjay's leadership in building on this strong momentum and advancing toward NDA filing and potential commercialization of tecarfarin."
Dr. Kakkar stated, "I am delighted to join Armetheon and work with a high-caliber team that shares the vision of building a leading U.S. specialty cardiovascular company. Tecarfarin has great potential in the market, pending progress of the final trial and regulatory review. The goal is to rapidly advance this program, explore additional markets, and further expand the pipeline with new therapies addressing significant unmet needs."
Prior to joining Armetheon, Dr. Kakkar was the founding Chairman of Jai Medica Pvt. Ltd. (Jai Health), a personalized healthcare company focused on the prevention and management of heart disease and other non-communicable diseases. At Jai Health, he designed and developed Jai Heart, a genomicsbased risk estimation test for heart disease. Dr. Kakkar also has served as National Coordinating Investigator for the Global Anticoagulant Registry in the FIELD-Atrial Fibrillation (GARFIELD-AF Registry), a research initiative led by the Thrombosis Research Institute, London, to enhance understanding of stroke prevention and future treatment strategies in patients with non-valvular AF. Previously, he co-founded and served as CEO of Trigen, a privately owned biotechnology company discovering and developing novel therapeutics for the treatment of cardiovascular diseases, in particular thrombosis and atherosclerosis. Dr. Kakkar began his career in the pharmaceutical industry at Sandoz (now Novartis) in Italy before moving to Pharmacia (now Pfizer) in the US, where he ran medical affairs for the thrombosis therapy area. Dr. Kakkar is a medical graduate from King's College, University of London, holds a Master's degree in healthcare management from Harvard University, and a Master's degree in preventive cardiology from Imperial College.
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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