omeros corp (OMER) Key Developments
FDA Grants Fast Track to Omeros' Complement Inhibitor OMS721 for aHUS
Jul 23 15
Omeros Corporation 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. 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.
Omeros Corporation Appoints Rajiv Shah to Board of Directors
Jun 17 15
Omeros Corporation announced that Rajiv Shah, M.D., recent Administrator of the United States Agency for International Development, has been appointed to serve on the company's board of directors. From 2010 to 2015, Dr. Shah served as Administrator of USAID. From 2009 to 2010, Dr. Shah served as the Under Secretary for Research, Education and Economics and Chief Scientist at the U.S. Department of Agriculture.
Omeros Corporation Enters into an Exclusive License Agreement with Affiliates of Fagron NV for Commercialization of OMS103
Jun 16 15
Omeros Corporation announced that it has entered into an exclusive license agreement with affiliates of Fagron NV for the commercialization of OMS103, Omeros' product for arthroscopic surgery. OMS103, added to standard irrigation solution used in arthroscopy, is Omeros' proprietary PharmacoSurgery® product designed to provide a multimodal approach to block preemptively the inflammatory cascade induced by arthroscopic surgical procedures. Nearly five million arthroscopic procedures are projected to be performed in the U.S. in 2015. Under the terms of the license agreement, Omeros granted Fagron an exclusive license to the OMS103 intellectual property, manufacturing information, and clinical data in the United States. In exchange for the U.S. license, Fagron will pay Omeros a substantial majority share of the gross revenues generated from sales of OMS103 with Omeros also receiving a minimum revenue per vial sold. In addition, Fagron will pay Omeros up to an aggregate total of $10 million in commercial milestones, some of which will be received by Omeros as revenue-share enhancement on early sales. Fagron is obligated to meet performance diligence requirements including the commencement of sales of OMS103 in 2015, to bear all sales and marketing costs, and to meet annual sales volume minimums. In addition to transferring the manufacturing and clinical information related to OMS103, Omeros is obligated to provide Fagron with introductions to arthroscopy thought leaders and assistance in understanding the therapeutic field as well as administration methods and to provide Fagron for 12 months with reasonable access to Omeros personnel to respond to any queries regarding the clinical and manufacturing data. Omeros will incur no further development costs, other than maintaining the licensed intellectual property, in connection with OMS103. The licensing agreement also contemplates potential partnerships for additional products from Omeros' PharmacoSurgery platform.
Omeros Corporation Receives Positive Opinion for Omidria from European Medicines Agency's Committee for Medicinal Products for Human Use
May 22 15
Omeros Corporation announced that the European Medicines Agency's (EMA's) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Omidria® (phenylephrine and ketorolac injection) 1%/0.3%. Omidria is used during cataract surgery and other intraocular lens (IOL) replacement procedures to maintain mydriasis (pupil dilation), prevent miosis (pupil constriction), and reduce postoperative eye pain. Cataract surgery and IOL replacement are among the most common surgical procedures worldwide, with approximately 3.9 million of them expected to be performed in Western Europe alone in 2015. The positive opinion adopted for Omidria by CHMP was supported unanimously by committee members and represents an intermediate step toward patient access to Omidria in Europe. No post-marketing follow-up studies or measures were recommended by CHMP for Omidria. Next, the CHMP opinion will be reviewed by the European Commission (EC), and the decision by the EC on approval of Omidria will be applicable to all European Union member states plus Iceland, Lichtenstein, and Norway. The EC decision is due approximately two months following CHMP's opinion. Decisions about price and reimbursement for Omidria occur on a country-by-country basis. Omidria was approved by the U.S. Food and Drug Administration in 2014 and last month was made broadly available nationwide for commercial use. The company has received strongly positive feedback from ophthalmic surgeons, the product being used in cataract and IOL replacement surgery both with and without femtosecond laser and in routine as well as complicated cases, including those with intraoperative floppy iris syndrome (IFIS) and pseudoexfoliation, a common cause of glaucoma. Reimbursement for Omidria has been confirmed across each of the U.S. Medicare Administrative Contractor regions.
Omeros Corporation Presents at UBS Global Healthcare Conference, May-19-2015 02:30 PM
May 13 15
Omeros Corporation Presents at UBS Global Healthcare Conference, May-19-2015 02:30 PM. Venue: Sheraton New York Times Square Hotel, 811 Seventh Avenue, New York, New York, United States. Speakers: Gregory A. Demopulos, Co-Founder, Chairman, Chief Executive Officer and President.