Healthcare Industry News: PharmacoSurgery
News Release - October 18, 2012
Omeros Adds Vice Presidents of Regulatory and Clinical to Management TeamCathy Melfi, Ph.D. to Head Regulatory Function and Dr. Albert Yu to Serve as VP, Clinical Development
SEATTLE, Oct. 18, 2012 -- (Healthcare Sales & Marketing Network) -- Omeros Corporation (OMER), a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing products targeting inflammation, coagulopathies and disorders of the central nervous system, today announced the appointments of two new vice presidents. Cathy Melfi, Ph.D. will lead Omeros' regulatory department as vice president, regulatory affairs and quality systems. Albert Yu, M.D. will join the Company's clinical department as vice president, clinical development, where oversight of Omeros' multiple clinical-stage programs will be divided between him and Steve Whitaker, M.D., the Company's vice president, clinical development and chief medical officer.
"Cathy's more than 25 years of experience spanning regulatory affairs, health economics and outcomes research across several therapeutic areas for drugs in all stages of development will be a valuable asset to Omeros as we seek marketing approval for OMS302 for lens replacement procedures and continue the development of the rest of our pipeline," said Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. "We are equally pleased that Albert has joined the Omeros team -- his years of clinical development experience will be instrumental as we continue to build and advance our clinical pipeline. With an NDA in preparation as well as multiple clinical programs currently underway and more expected in the near-term, Cathy and Albert have already hit the ground running, and I look forward to their contributions."
"Omeros has an excellent combination of strong leadership, deep expertise across functions and an impressive pipeline," stated Catherine A. Melfi, Ph.D., vice president, regulatory affairs and quality systems of Omeros. "I am excited to help Omeros achieve its goals of commercial success and continued growth."
"Omeros' broad array of platforms and programs provides multiple opportunities to generate new and effective therapeutics," said Albert Yu, M.D., vice president, clinical development. "The drugs currently in development at the Company could significantly improve the lives of millions of patients, and I look forward to advancing these compounds aggressively through the clinic."
Dr. Melfi brings 17 years of experience in the pharmaceutical industry and 11 years of experience in academia, covering the fields of regulatory affairs and health economics and outcomes research. She has provided strategic and technical input into the development and commercialization of pharmaceutical products across all phases of development. She joins Omeros from Eli Lilly and Company, where she held technical and leadership roles of increasing scope and responsibility in Global Health Outcomes and Regulatory Affairs. Prior to joining Lilly, Dr. Melfi held various faculty and staff positions at Indiana University, including appointments in their Economics Department, in the School of Public and Environmental Affairs, and in the Indiana University School of Medicine. Dr. Melfi received her Ph.D. in Economics from the University of North Carolina – Chapel Hill and B.S. in Economics from John Carroll University.
Dr. Yu has over 20 years of clinical drug development experience, spanning small molecules to biologics and all phases of development. His background covers a wide range of therapeutic areas, including cardiovascular, central nervous system, respiratory and infectious disease. Prior to joining Omeros, Dr. Yu served as vice president of clinical affairs and chief medical officer of Calistoga Pharmaceuticals, Inc. until its acquisition by Gilead Sciences, Inc. in 2011. At Calistoga, he led the clinical development of CAL-101, a novel drug that inhibits phosphatidylinositol 3-kinase p110d isoform for the treatment of hematologic malignancies and inflammatory conditions. Before Calistoga, Dr. Yu served at ICOS Corporation as head of clinical affairs, where he led the early clinical development of Cialis®. He received his M.D. from the University of Washington and his B.S. from the Massachusetts Institute of Technology.
About Omeros Corporation
Omeros is a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing products targeting inflammation, coagulopathies and disorders of the central nervous system. The Company's most clinically advanced product candidates are derived from its proprietary PharmacoSurgery™ platform designed to improve clinical outcomes of patients undergoing a wide range of surgical and medical procedures. Omeros has four ongoing clinical development programs. Omeros may also have the near-term capability, through its GPCR program, to add a large number of new drug targets and their corresponding compounds to the market. Behind its clinical candidates and GPCR platform, Omeros is building a diverse pipeline of protein and small-molecule preclinical programs targeting inflammation, coagulopathies and central nervous system disorders.
This press release contains forward-looking statements as defined within the Private Securities Litigation Reform Act of 1995, which are subject to the "safe harbor" created by those sections. These statements include, but are not limited to, Omeros' expectations regarding the number of new clinical programs it may have in the near term; the number of patients that may benefit from Omeros' product candidates; and that Omeros may have capability, through its GPCR program, to add a large number of new drug targets and their corresponding compounds to the market. Forward-looking statements are based on management's beliefs and assumptions and on information available to management only as of the date of this press release. Omeros' actual results could differ materially from those anticipated in these forward-looking statements for many reasons, including, without limitation, the risks, uncertainties and other factors described under the heading "Risk Factors" in the Company's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 7, 2012. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and the Company assumes no obligation to update these forward-looking statements publicly, even if new information becomes available in the future.
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