Armetheon reaches agreement with FDA on SPA for final pivotal trial of tecarfarin

Armetheon, Inc., today announced that 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 (OAC) 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 many issues with warfarin which tecarfarin was designed not to have, and the introduction of non-monitored OACs several years ago, warfarin continues to be the major OAC 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.

n 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, PhD, Co-Founder, President & COO. "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 US alone."

We believe tecarfarin, if approved, could become the best-in-class vitamin K antagonist (VKA) where today warfarin is the main choice. Currently, existing OACs, such as warfarin, are 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 MD, FACC Co-Founder and Chairman of Armetheon. Milner previously co-founded two publicly-traded pharmaceutical companies, and is currently CEO of Heart Metabolics Ltd (Ireland). "We are also particularly grateful for the timelines, clarity and consistency of the FDA's guidance throughout the process."

"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 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, MD, 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).