April 29, 2014 — Armetheon Inc. announced it has reached agreement with the U.S. Food and Drug Administration (FDA) on a special protocol assessment (SPA) for the final pivotal trial of tecarfarin. Tecarfarin is positioned to be the only oral anticoagulant therapy for patients with prosthetic heart valves (PHV) specifically identified in the label.
In addition, the pivotal trial will enroll predominantly patients with all indications for anticoagulation, not just those with PHV, thereby supporting a broad label if the product is approved. Despite the introduction of non-monitored oral anticoagulants several years ago, warfarin continues to be the major oral anticoagulant in the market for all indications. Tecarfarin is designed to compete favorably with warfarin in this market, since in previous clinical trials tecarfarin appeared superior to warfarin both in the overall population and in the significant percentage of patients with compromised warfarin clearance.
In March 2014, the American Heart Association (AHA) and the American College of Cardiology (ACC) updated their practice guidelines for managing patients with valvular heart disease. The guidelines now state that patients with PHV requiring anticoagulation should not use the recently approved direct thrombin inhibitors or Factor Xa inhibitors. This leaves warfarin, and potentially tecarfarin, as the only options for patients with PHV.
"Currently, there is a tremendous unmet need to provide adequate anticoagulation for patients with prosthetic heart valves," said M. (Ken) Kengatharan, Ph.D., co-founder, president and COO of Armetheon. "Our tecarfarin product candidate, with a projected patent term exclusivity period close to 2029, represents a robust commercial opportunity in this patient population estimated to be more than $500M annually in the United States alone."
Currently, existing oral anticoagulants such as warfarin are seen as suboptimal due to their propensity to interact negatively with commonly prescribed drugs, and due to widespread genetic variability in clearance. Tecarfarin was specifically designed to avoid these problems, in particular because it is metabolized differently to avoid interactions with other medications. Thus, tecarfarin may present fewer complications and allow for a more uniform and predictable response to therapy.
"The key element here is allowing all patients, and in particular the difficult-to-manage patients with prosthetic heart valves, to have a better anticoagulant than any available today. It will be a significant advance in patient care, not to have to worry about other drugs or genetics causing problems such as accidental overdoses and to remove the uncertainty that exists when prescribing the currently available oral anticoagulants," said Peter Milner, M.D., FACC, co-founder and chairman of Armetheon.
"Over the last two years it has become apparent that there is a large unmet medical need for a better chronic oral anticoagulant for patients who need a VKA [Vitamin K antagonist], in particular those with mechanical heart valves; one that can be monitored using widely available technologies and, if necessary, reversed. Tecarfarin has the potential to address this need," said Jeffrey Weitz, M.D., professor of medicine and biochemistry, Heart and Stroke Foundation/J.F. Mustard chair in cardiovascular research, McMaster University, and executive director of the Thrombosis & Atherosclerosis Research Institute (TaARI).
For more information: www.armetheon.com