MENLO PARK, Calif., Feb. 5, 2015 -- Armetheon, Inc., a cardiovascular disease-focused, clinical stage, specialty biopharmaceutical company, today announced the successful closing of $24.3 million in Series B financing. The financing was co-led by Hercules Bioventure Partners and Capital TEN II, with participation from new and existing investors.
The funds will mainly be used to advance Armetheon's lead clinical candidate, tecarfarin, which is being investigated as a novel vitamin-K-antagonist (VKA) oral anticoagulant that avoids adverse drug reactions associated with the current standard-of-care, warfarin. Tecarfarin's final pivotal clinical study (Tecarfarin for AntiCoagulation Trial or "TACT") will compare tecarfarin with warfarin in patients with any indication that requires oral anticoagulation, including underserved populations such as patients who respond poorly to warfarin, and patients with prosthetic heart valves for whom novel oral anticoagulants such as the anti-thrombin or Factor Xa inhibitors are either contraindicated or not recommended by professional society guidelines. Armetheon's 3,000-patient, open-label, real world pivotal trial of tecarfarin will be conducted under a Special Protocol Assessment agreed upon with the FDA in April 2014.
"We are very pleased by the high degree of commitment from both institutional and angel investors in our Series B financing round. The funds will primarily be used to advance tecarfarin's new drug application filing timeline and to build an expanded organization to support Armetheon's core mission of obtaining regulatory approval for tecarfarin in the US," said M. (Ken) Kengatharan, Ph.D., President and Interim CEO of Armetheon.
In addition to co-leads Hercules Bioventure Partners and Capital TEN II, firms with significant participation in the financing included China Development Industrial Bank (CDIB) Healthcare, CDIB & Partners, iD SoftCapital Group and AmKey Ventures, as well as individual investors including Larry Hsu, Ph.D., and Mr. Stefan Roever. Dr. Hsu is the founder and former President and CEO of Impax Laboratories, and a general partner at both Capital TEN II and Hercules Bioventure Partners. Mr. Roever is a serial entrepreneur who is a founder and current CEO of Genia Technologies, Inc., which was sold to Roche in June 2014.
In connection with the financing, Dr. Hsu, who has joined the Armetheon Board of Directors, said, "I am very pleased to contribute to building Armetheon with its innovative cardiovascular drug candidates and an execution-focused team."
George Lee, Ph.D., a general partner of Hercules Bioventure Partners, said, "We are excited to be a part of Armetheon's growth and development. We see great potential in Armetheon to advance products that will offer patients and physicians expanded options for treating complex cardiovascular conditions."
Locust Walk Securities served as an advisor to Armetheon for the transaction.
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 VKAs.
Armetheon, Inc., is a privately held, San Francisco Bay area-based specialty biopharmaceutical company focused on developing novel small molecule drugs for cardiovascular diseases with high unmet need. For more information: www.armetheon.com.
Heather Lake, Director of Corporate Development
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