FDA Grants "Fast Track" to Omeros' Complement Inhibitor OMS721 for aHUS

-- Phase 2 Trial and Compassionate Use Program Advance --

Jul 23, 2015, 07:00 ET from Omeros Corporation

SEATTLE, July 23, 2015 /PRNewswire/ -- Omeros Corporation (NASDAQ: OMER) today announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation to OMS721 for the treatment of patients with atypical hemolytic uremic syndrome (aHUS). OMS721 is the company's lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2), the key regulator of the lectin pathway of the immune system. Omeros is currently evaluating the drug in a Phase 2 clinical trial for the treatment of aHUS and other thrombotic microangiopathies (TMAs). TMAs are a family of rare, debilitating and life-threatening disorders characterized by excessive thrombi (clots) in the microcirculation of the body's organs, most commonly the kidney and brain. Earlier this year, Omeros announced positive data from the Phase 2 trial and commencement of an investigator-requested compassionate use program for OMS721 to allow extended treatment of patients who completed the trial's four-week dosing. Recent efficacy and safety data from the ongoing Phase 2 clinical trial were submitted to the FDA in the company's request for Fast Track status for OMS721.

FDA's Fast Track program facilitates the development of drugs intended to treat serious or life-threatening conditions and that have the potential to address unmet medical needs. A drug program with Fast Track status is afforded greater access to the FDA for the purpose of expediting the drug's development, review and potential approval. Many drugs that receive Fast Track designation are also considered appropriate to receive Priority Review, and their respective New Drug Applications (NDAs) may be accepted by the FDA as a "rolling submission" in which portions of an NDA are reviewed before the complete application is submitted. Priority Review and rolling submission can each provide further acceleration of FDA's approval process.

"FDA's Fast Track designation of OMS721 for aHUS reflects the unmet need associated with this disease and recognizes the drug's potential as an important option for the treatment of aHUS," stated Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. "We look forward to working with the FDA to streamline the development of this promising drug, and we currently remain on track to discuss with the Agency later this year both the data from our Phase 2 trial in TMAs as well as our plans for our Phase 3 program."

The Phase 2 clinical trial evaluating OMS721 in the treatment of TMAs, including aHUS, thrombotic thrombocytopenic purpura and human stem cell transplant-related TMAs, is ongoing in multiple sites in both the United States and Europe. The majority of the patients enrolled to date are those suffering from aHUS.

About Omeros' MASP-2 Program Omeros controls the worldwide rights to MASP-2 and all therapeutics targeting MASP-2, a novel pro-inflammatory protein target involved in activation of the complement system, which is an important component of the immune system. The complement system plays a role in the inflammatory response and becomes activated as a result of tissue damage or microbial infection. MASP-2 appears to be unique to, and required for the function of, one of the principal complement activation pathways, known as the lectin pathway. Importantly, inhibition of MASP-2 does not appear to interfere with the antibody-dependent classical complement activation pathway, which is a critical component of the acquired immune response to infection, and its abnormal function is associated with a wide range of autoimmune disorders. MASP-2 is generated by the liver and is then released into the circulation. Adult humans who are genetically deficient in one of the proteins that activate MASP-2 do not appear to be detrimentally affected by the deficiency. Omeros has received both Orphan Drug status and Fast Track designation from the U.S. FDA for its lead human MASP-2 antibody OMS721. An ongoing Phase 2 clinical program is evaluating OMS721 in the treatment of thrombotic microangiopathies (TMAs), including atypical hemolytic uremic syndrome, thrombotic thrombocytopenic purpura and stem cell transplant-related TMAs. An investigator-requested compassionate use program for OMS721 is also underway. Chronic toxicity studies with systemically delivered OMS721 demonstrated no drug-related adverse events, and Omeros plans to commercialize OMS721 for one or more therapeutic indications as a subcutaneous injection.

Omeros also believes that it has identified the proteins that activate the complement system's alternative pathway in humans, which is linked to a wide range of immune-related disorders. In addition to its lectin pathway inhibitors, the Company is advancing the development of antibodies that block activation of the alternative pathway.

About Omeros Corporation Omeros is a biopharmaceutical company committed to discovering, developing and commercializing both small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, coagulopathies and disorders of the central nervous system. Derived from its proprietary PharmacoSurgery® platform, the company's first drug product, Omidria® (phenylephrine and ketorolac injection) 1%/0.3%, has been approved by the FDA for use during cataract surgery or intraocular lens (IOL) replacement to maintain pupil size by preventing intraoperative miosis (pupil constriction) and to reduce postoperative ocular pain. Omidria received a positive opinion from the European Medicines Agency in May and is currently under review for final marketing approval by the European Commission. Omeros also recently partnered its arthroscopic product, OMS103, for commercialization with Fagron Sterile Services and affiliated JCB Laboratories, and sales are expected to begin this year. Including the program for OMS721, Omeros has five clinical-stage development programs focused on: complement-related thrombotic microangiopathies; Huntington's disease, schizophrenia, and cognitive impairment; and addictive and compulsive disorders. In addition, Omeros has a proprietary GPCR platform, which is making available an unprecedented number of new GPCR drug targets and corresponding compounds to the pharmaceutical industry for drug development.

Forward-Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, which are subject to the "safe harbor" created by those sections for such statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as "anticipate," "believe," "could," "estimate," "expect," "goal," "intend," "look forward to," "may," "plan," "potential," "predict," "project," "should," "will," "would" and similar expressions. 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, risks associated with Omeros' ability to obtain regulatory approval for its Marketing Authorization Application in the EU for the commercialization of Omidria®, sales of OMS103, Omeros' unproven preclinical and clinical development activities, regulatory oversight, product commercialization, intellectual property claims, competitive developments, litigation, and 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 11, 2015. 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, even if new information becomes available in the future.

 

SOURCE Omeros Corporation