Healthcare Industry News: thrombosis
News Release - May 8, 2015
Armetheon, Inc. Announces Appointment of Andrew C. Lam as Vice President of Product DevelopmentMENLO PARK, Calif., May 8, 2015 -- (Healthcare Sales & Marketing Network) -- Armetheon, Inc., a specialty pharmaceutical company developing novel small molecule drugs for cardiovascular diseases, today announced the appointment of Andrew C. Lam as Vice President of Product Development. Mr. Lam has over 27 years of experience in pharmaceutical product development and has contributed to regulatory approvals in the US, EU, Japan and China. At Armetheon, he will lead CMC development and pharmaceutical operations and be a key member of the Company's core team responsible for seeking approval in the US for tecarfarin, a novel oral anticoagulant that is in late-clinical stage development. Mr. Lam's appointment is effective immediately.
"Andrew has an impressive track record in delivering results throughout the development chain in large pharmaceutical companies, as well as early stage biotech companies, from drug design and formulation through scale-up manufacturing and commercialization. We believe his skills and insights will be critical as we progress our advanced-stage proprietary pipeline, including our lead candidate tecarfarin, currently in Phase 3 development to treat thrombosis," said Dr. M. (Ken) Kengatharan, Co-founder and President of Armetheon.
Mr. Lam stated, "Armetheon is dedicated to identifying and developing cardiovascular therapies that can significantly improve treatment options for patients, including potentially reducing adverse events. I am thrilled to be part of the leadership team at Armetheon, and I look forward to continued progress of the Company's programs."
Prior to assuming his full-time position as Vice President of Product Development, Mr. Lam served as a consultant to Armetheon. Prior to this, he was Vice President of Product Development at Altheos, Inc., where he managed pharmaceutical development of novel Rho Kinase Inhibitor compounds. Previously, he was Executive Director of Formulation and CMC for Exelixis, Inc., where he directed pre-formulation and formulation development of small molecule therapeutics in oncology. Mr. Lam began his career at ALZA Corporation, a Johnson & Johnson company, where he attained positions of increasing responsibility including Senior Director, Head of Liquid OROS® Technology Development. During his tenure, he contributed to the development and approval of three oral controlled release products, including CONCERTA® which has achieved total sales in excess of $1.5 billion annually since its release in 2002. In 2002, Mr. Lam was the recipient of the Johnson Medal for Research and Development, the highest scientific honor that Johnson & Johnson awards employees, for development of the OROS Multi-layer Technology for CONCERTA. Mr. Lam earned his B.S. degree in Chemical Engineering with honors from the University of California, Davis.
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 and cardiac arrhythmias. 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.
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