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A Novel Oral Anticoagulant is Planned to be Developed for Patients with Prosthetic Heart Valves or Chronic Renal Dysfunction
Date:3/8/2013

California San Francisco (UCSF), a world-renowned expert in pharmacokinetics, CYP-dependent drug metabolism and P-gp dependent drug transport.

Unlike many of the novel non-monitored OACs and warfarin, tecarfarin is not metabolized by CYP enzymes or transported by P-gp in addition to not being excreted via the kidney.

"For oral anticoagulation, we believe tecarfarin if approved will be an important clinical tool in addition to warfarin and the novel non-monitored OACs. We are preparing to meet with the FDA and the EMA to propose a clinical trial design and final registration package for tecarfarin in these two regions," said Dr M. (Ken) Kengatharan ,  President & COO of Armetheon and a General Partner at Atheneos Capital. He added, "we expect to submit for marketing authorization in the US and the EU in less than 4 years. With an increasing use of CYP variant genetic testing and the recent uptick in patient self-monitoring perhaps due to reimbursement  by healthcare providers, we strongly believe the time to develop and commercialize tecarfarin is now."

About anti-coagulation therapy in special populations

Oral anticoagulants, are used to slow down or stop the formation of blood clots in the out-patient environment. Currently available anticoagulants include warfarin (Coumadin®) that inhibits vitamin K epoxide (VKOR) and the novel non-monitored OACs that directly either inhibit thrombin or Factor Xa. In patients with prosthetic heart valves, OACs are given to prevent clot formation within these valves. Patients with mechanical heart valves generally remain on warfarin sometimes in combination with aspirin while most patients with bioprosthetic valves are eventually switched to aspirin. However, experts now recommend that the novel non-monitored OACs should not to be used in these patients.

In patients, who have a genetic variant of metabolizing enzymes such as CYP2C9, anticoagul
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SOURCE Armetheon, Inc.
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