SEATTLE, May 24, 2011 /PRNewswire/ — Omeros Corporation (NASDAQ: OMER) today reported the allowance by the US Patent and Trademark Office (USPTO) of an additional patent claiming the composition of OMS103HP, the Company’s arthroscopic PharmacoSurgery™ product in Phase 3 clinical development. The patent will have a term extending into January 2020.
“This patent extends coverage for OMS103HP and adds to our established intellectual property portfolio for our PharmacoSurgery platform,” stated Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. “The clinically meaningful and statistically significant improvement in postoperative knee function seen in our Phase 2 meniscectomy trial played a role in the USPTO’s decision. The drug is now in a Phase 3 meniscectomy program and we expect data in the first half of 2012.”
Omeros is preparing additional patent applications directed to OMS103HP that would further extend its patent protection until at least 2032.
Omeros’ OMS103HP Program
OMS103HP is Omeros’ PharmacoSurgery™ product candidate being developed for use during arthroscopic procedures, including partial meniscectomy surgery, and was designed to provide a multimodal approach to preemptively block the inflammatory cascade induced by arthroscopy. OMS103HP is a proprietary combination of anti-inflammatory/analgesic active pharmaceutical ingredients (APIs), each with well-known safety and pharmacologic profiles. Each of the APIs are components of generic, FDA-approved drugs that have been marketed in the United States as over-the-counter or prescription drug products for over 15 years and have established and well-characterized safety profiles.
In a Phase 2 clinical trial that evaluated OMS103HP in patients undergoing partial meniscectomy surgery, OMS103HP provided clinically meaningful and significantly greater efficacy than vehicle as measured by patient-reported functional scores using the Knee Injury and Osteoarthritis Outcome Score (KOOS), passive knee flexion and visual analog scale pain scores. The patient-reported outcomes measuring symptoms, pain, activities of daily living, sport and recreational activities and quality of life associated with the operated knee showed a sustained benefit through postoperative Day 90.
In the first quarter of 2011, Omeros announced that OMS103HP failed to meet pre-specified efficacy endpoints in a Phase 3 clinical program in patients undergoing arthroscopic anterior cruciate ligament (ACL) reconstruction surgery. Omeros is unable to draw any conclusions about OMS103HP’s effect in the Phase 3 ACL program due to confounding factors, and the Company has no plans to conduct additional ACL reconstruction trials at this time. The primary endpoint for Omeros’ meniscectomy Phase 3 trials is different than that used in its ACL program. Accordingly, Omeros believes that the results of its ACL program do not affect the viability of its meniscectomy program.
About Omeros Corporation
Omeros is a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing products focused on 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, 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. These statements include, but are not limited to, statements regarding the Company’s expectation that it will have data from its Phase 3 meniscectomy program in the first half of 2012, its plans to file additional patents for OMS103HP that would extend its patent protection until at least 2032, and that Omeros may 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. 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 May 10, 2011. 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 Corporation