Navigation Links
FDA Grants Orphan Drug Designation to Omeros' OMS721 for Complement-Mediated Thrombotic Microangiopathies
Date:12/18/2013

SEATTLE, Dec. 18, 2013 /PRNewswire/ -- Omeros Corporation (NASDAQ: OMER) today announced that OMS721, 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, has received orphan drug designation from the U.S. Food and Drug Administration (FDA) for prevention of complement-mediated thrombotic microangiopathies (TMAs).

TMAs, including atypical hemolytic uremic syndrome and thrombotic thrombocytopenic purpura, are a family of rare, debilitating and life-threatening disorders characterized by multiple thrombi (clots) in the microcirculation of the body's organs, most commonly the kidney and brain. The lectin pathway, one of the principal complement activation pathways in the immune system, is thought to play a central role in the development of TMAs. By targeting MASP-2, OMS721 specifically blocks the lectin pathway. Omeros controls the worldwide rights to MASP-2 and all therapeutics targeting MASP-2.

Omeros is completing a Phase 1 study to assess the safety and pharmacokinetics of OMS721. As previously announced, at the highest subcutaneous dose administered to date in this study, OMS721 achieved serum concentrations that resulted in a high degree of inhibition of lectin pathway activation. The serum concentrations seen in the Phase 1 subjects are similar to those associated with efficacy in animal models of diseases, including TMA, linked to the lectin pathway. Omeros expects to report additional Phase 1 clinical data in early 2014. The Phase 2 clinical program evaluating OMS721 for the prevention of complement-mediated TMAs is expected to begin in the first quarter of 2014.

"We are pleased that the FDA has granted orphan drug designation for OMS721. The designation should accelerate the development of OMS721 and, given the limitations of current treatments for TMAs, we look forward to initiating our Phase 2 clinical program next quarter," stated Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. "The remainder of this year and the first part of 2014 promise to be exciting times across other Omeros programs as well. This month we will initiate our OMS824 Phase 2 clinical program in Huntington's disease – earlier granted orphan drug designation by the FDA – and could also report Phase 2a data for OMS824 in schizophrenia. We then look to the potential marketing approval of Omidria™, its launch completing our transition to a commercial company."

Orphan designation by the FDA is granted to promote the development of drugs that target conditions affecting 200,000 or fewer U.S. patients annually and that are expected to provide significant therapeutic advantage over existing treatments. Orphan designation qualifies a company for benefits that apply across all stages of drug development, including accelerated approval process, seven years of market exclusivity following marketing approval, tax credits on U.S. clinical trials, eligibility for orphan drug grants, and waiver of certain administrative fees.

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. Therefore, Omeros believes that it may be possible to deliver MASP-2 antibodies systemically and OMS721, its lead MASP-2 antibody, is designed to be self-administered by 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 would block activation of the alternative pathway alone or in combination with the lectin pathway.

About Omeros Corporation

Omeros is a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics targeting inflammation, coagulopathies and disorders of the central nervous system. Derived from its proprietary PharmacoSurgery® platform, the Company's lead drug product, OMS302 for lens replacement surgery, is currently under review for marketing approval by both the US Food and Drug Administration and the European Medicines Agency with commercial launch planned for 2014. Omeros' five other clinical programs are focused on schizophrenia, Huntington's disease and cognitive impairment; addictive and compulsive disorders; complement-related diseases; and preventing problems associated with surgical procedures. Omeros also 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," "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' unproven preclinical and clinical development activities, regulatory oversight, product commercialization, intellectual property claims, initiation or completion of clinical trials 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 November 7, 2013. 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
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Nektar Announces that FDA Grants Fast Track Designation to NKTR-181, a New Oral Opioid Analgesic Molecule, for the Treatment of Moderate to Severe Chronic Pain
2. Community Foundation Announces $2.6 Million In Grants From Centinela Medical Funds
3. U.S. FDA Grants Priority Review to the New Drug Application for Bayers Regorafenib to Treat Patients with Metastatic Colorectal Cancer
4. European Commission Grants Orphan Medicinal Product Designation for Emmaus Medicals Sickle Cell Treatment
5. FDA Grants Orphan Drug Designation To GeNO LLC For Use Of Inhaled Nitric Oxide In Treatment Of Persistant Pulmonary Hypertension Of The Newborn (PPHN)
6. Rep. Fattah Announces More Than $10.7 Million in Grants for Neuroscience, Scientific and Medical Research in Philadelphia
7. U.S. FDA Grants Priority Review to Bedaquiline (TMC207) for Multi-Drug Resistant Tuberculosis Treatment
8. Neuralstem Grants First Licenses For CNS Therapy Surgical Devices
9. EMA Grants Orphan Designation to Edison Pharmaceuticals for EPI-743 for Treatment of Leigh Syndrome
10. As Global Telemedicine Market Reaches $2.5 Billion, Industry Leaders Gather in San Diego to Discuss Grants, Funding, Vendor Selection, Credentialing, and More
11. Nektar Announces that FDA Grants Fast Track Designation to Etirinotecan Pegol (NKTR-102) for the Treatment of Metastatic Breast Cancer
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/12/2016)... 12. Februar 2016  Sequent Medical, Inc. gab ... Patienten für eine Studie zur Sicherheit und Wirksamkeit ... für die Behandlung von rupturierten intrakraniellen Aneurysmen begonnen ... der Neuroradiologie an der Universitätsklinik Bicètre in ... CLARYS-Studie hat den ersten Patienten aufgenommen. ...
(Date:2/12/2016)... SEOUL, South Korea , Feb. 12, ... Inc. today announced they will form a partnership ... precision medicine in cancer. The goal of the ... technology with Macrogen,s high-throughput Next Generation Sequencing capabilities ... Clinical Laboratory Improvement Amendments (CLIA) of 1988 by ...
(Date:2/12/2016)... 12 februari 2016 AAIPharma Services ... leverancier van productie en ontwikkeling op maat ... vandaag een uitbreiding aan van steriele vul- ... in Charleston, SC . ... meerdere recente investeringen. http://photos.prnewswire.com/prnh/20150806/256637LOGO ...
Breaking Medicine Technology:
(Date:2/12/2016)... , ... February 12, 2016 , ... ... Cancer Care.” , The print component of “Revolutionizing Cancer Care” is ... New York, Washington DC/Baltimore, and Seattle, with a circulation of approximately 250,000 copies ...
(Date:2/12/2016)... ... February 12, 2016 , ... US Sport Camps is pleased to announce ... located in Norwalk, serves as the host site and directing the camps is PGA ... have had successful camps in recent years around Des Moines and are fortunate to ...
(Date:2/12/2016)... , ... February 12, 2016 , ... ... explosive growth in the field of long term care. With that, says Patrick ... well-trained healthcare professionals in administrative roles in long term care environments. His company, ...
(Date:2/12/2016)... ... ... of restorative dentistry, to date there has been no other option in the U.S. to ... is a now a new protocol in stopping cavity progression; Silver Diamine Fluoride (SDF). ... The application is as simple as drying the tooth and applying the SDF to ...
(Date:2/11/2016)... CA (PRWEB) , ... February 11, 2016 , ... According ... System, a product marketed as a weight loss dietary supplement, is being recalled due ... group Beverly Hills Physicians, because there is not a single supplement on the market ...
Breaking Medicine News(10 mins):