Healthcare Industry News: PharmacoSurgery
News Release - February 1, 2011
Omeros Announces Eligibility of OMS103HP for EMA Centralized Marketing ApplicationSEATTLE, Feb. 1, 2011 -- (Healthcare Sales & Marketing Network) -- Omeros Corporation (Nasdaq:OMER ) today announced that the European Medicines Agency (EMA) has confirmed that OMS103HP is eligible to be submitted for marketing approval in the European Union (EU) through the EMA centralized procedure. OMS103HP is Omeros' lead product candidate currently in a Phase 3 clinical program evaluating the drug's safety and ability to improve postoperative joint function and reduce pain following anterior cruciate ligament (ACL) reconstruction surgery. Omeros continues to expect the release of Phase 3 results this quarter.
For eligible drugs, the centralized procedure permits the submission of a single marketing application to the EMA that, if approved, allows the drug to be marketed in all EU member states, as well as Iceland and Norway, rather than requiring independent national approvals. OMS103HP qualified for the centralized procedure as a significant therapeutic innovation and because it provides a new alternative to patients in preventing disease. National procedures can take more than two years to grant marketing approval, and the centralized procedure can reduce that time to commercialization in the relevant countries by as much as 12 months.
"We are pleased that EMA views OMS103HP as worthy of centralized review, potentially accelerating our drug's European market launch," stated Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. "We are working towards database lock and look forward to unblinding and analyzing the data later this quarter."
About Omeros' OMS103HP Program
OMS103HP is being developed for use during arthroscopic surgery to reduce postoperative pain and improve postoperative joint motion and function. OMS103HP is injected into standard arthroscopic irrigation solutions and perfused through the joint in low concentrations during surgery. It is currently being evaluated in a Phase 3 clinical program for anterior cruciate ligament (ACL) surgery and has also completed a Phase 2 clinical trial for meniscectomy surgery. If approved, OMS103HP would be the first commercially available drug delivered directly to the surgical site to improve function following arthroscopic surgery.
About Omeros Corporation
Omeros is a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing products focused on inflammation 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 five ongoing clinical development programs, including four from its PharmacoSurgery™ platform, the most advanced of which is in a Phase 3 clinical program, and one from its Addiction program. Omeros may also have the near-term capability, through its GPCR program, to add a large number of new drug targets 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, bleeding 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. 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 and include Omeros' ability to unblind, analyze and release the data later this quarter from its Phase 3 program evaluating OMS103HP and the ability of the centralized procedure to reduce the time to commercialization in relevant countries by as much as 12 months. 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 November 4, 2010. 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.
Source: Omeros Corp
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