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News Breaks
June 2, 2014
07:04 EDTOMEROmeros receives FDA approval for Omidria
Omeros announced that the FDA has approved Omidria 1%/0.3% for use during cataract surgery or intraocular lens replacement to maintain pupil size by preventing intraoperative miosis and to reduce postoperative pain. The approval comes with no post-marketing commitments other than the previously agreed study of Omidria for use in pediatric patients, which, if successfully completed, makes the drug eligible for an additional six months of marketing exclusivity in the U.S. With FDA approval of Omidria, Omeros is completing preparations for a late summer/early fall 2014 U.S. product launch.
News For OMER From The Last 14 Days
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October 7, 2014
07:06 EDTOMEROmeros, Hospira enter into commercial suply agreement for Omidria
Omeros Corporation (OMER) said in a filing that on October 3, it, Hospira S.p.A. and Hospira Worldwide, Inc. (HSP) entered into a Commercial Supply Agreement, pursuant to which Hospira will act as a non-exclusive supplier of Omerosí product Omidria for commercial sale in the United States and the European Union. Pursuant to the Supply Agreement, Hospira has agreed to manufacture and supply, and Omeros has agreed to purchase, a minimum percentage of Omerosí requirements of Omidria for commercial sales and clinical supplies for the development of additional therapeutic indications in the United States. In addition, upon receipt of marketing approval in the EU, Hospira has agreed to manufacture and supply a portion of Omerosí requirements of Omidria in the EU in an amount to be mutually agreed by the parties within four months of marketing approval in Europe, with there being no minimum purchase and supply requirement in the EU if the parties do not reach agreement during such time period and the agreement is not amended thereafter. The Supply Agreement obligates Omeros to provide to Hospira a rolling, non-binding long-term forecast of Omerosí estimated required quantities of Omidria. The Supply Agreement has an initial term of five years from the date of first commercial sale of Omidria in any country in the Territory. Upon termination of the Supply Agreement, except in the case of termination for an uncured breach by Hospira, Omeros will be required to purchase all of Hospiraís inventory of Omidria and, if applicable, work in progress and reimburse Hospira for all supplies purchased or ordered based on firm purchase orders or Omerosí estimates of its requirements of Omidria.

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