UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM 8-K
CURRENT REPORT
Pursuant
to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): June 2, 2014
OMEROS CORPORATION
(Exact name of registrant as specified in its charter)
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Washington |
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001-34475 |
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91-1663741 |
(State or other jurisdiction
of incorporation) |
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(Commission
File Number) |
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(IRS Employer
Identification No.) |
201 Elliott Avenue West
Seattle, Washington 98119
(Address of principal executive offices, including zip code)
(206) 676-5000
(Registrants telephone number, including area code)
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the
following provisions (see General Instruction A.2. below):
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 8.01 Other Events
On June 2, 2014, Omeros Corporation issued a press release announcing that the U.S. Food and Drug Administration (FDA) has approved
Omidria (phenylephrine and ketorolac injection) 1%/0.3% for use during cataract surgery or intraocular lens replacement (ILR) to maintain pupil size by preventing intraoperative miosis (pupil constriction) and to reduce postoperative pain.
Omidria is the first Omeros product to receive FDA approval.
A copy of the press release is attached hereto as Exhibit 99.1 and is
incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
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Exhibit
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Description |
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99.1 |
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Press release dated June 2, 2014 relating to FDA approval of Omidria. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned hereunto duly authorized.
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OMEROS CORPORATION |
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By: |
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/s/ Gregory A. Demopulos |
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Gregory A. Demopulos, M.D. |
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President, Chief Executive Officer and
Chairman of the Board of Directors |
Date: June 2, 2014
EXHIBIT INDEX
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Exhibit
Number |
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Description |
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99.1 |
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Press release dated June 2, 2014 relating to FDA approval of Omidria. |
Exhibit 99.1
Omeros Receives FDA Approval of Omidria for Use in Cataract and Other Intraocular Lens
Replacement Procedures
Omeros to Host Conference Call Today at 4:30 p.m. ET
SEATTLE June 2, 2014 Omeros Corporation (NASDAQ: OMER) today announced that the U.S. Food and Drug Administration (FDA) has approved
Omidria (phenylephrine and ketorolac injection) 1%/0.3% for use during cataract surgery or intraocular lens replacement (ILR) to maintain pupil size by preventing intraoperative miosis (pupil constriction) 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.
Omidria, the first commercial product from Omeros PharmacoSurgery® platform, is a
proprietary combination of a mydriatic (pupil-dilating) agent and an anti-inflammatory agent that is added to irrigation solution standardly used during cataract surgery and other ILR procedures (e.g., refractive lens exchange), collectively the
most common surgical procedures performed in the U.S. at nearly four million annually. Omidria is the only FDA-approved product for intraocular use that prevents intraoperative miosis and reduces postoperative pain, providing consistent and
predictable management of both of these ILR-related problems for ophthalmic surgeons and their patients.
Omidria is an important advance in
cataract and lens replacement surgery, stated Richard L. Lindstrom, M.D., adjunct clinical professor emeritus at the University of Minnesotas Department of Ophthalmology and past president of both the American Society of Cataract and
Refractive Surgeons and the International Society of Refractive Surgery. Miosis and postoperative pain are frequent and largely unpredictable, and their occurrence can make the procedure more difficult for the surgeon and unpleasant
postoperatively for the patient. While not changing their surgical routine, the use of Omidria will better allow ophthalmic surgeons to control the operative experience and, I expect, will improve surgical outcomes.
In pivotal trials in which all patients received standard pupil-dilating and anesthetic agents prior to surgery, Omidria demonstrated statistically
significant and clinically meaningful improvement in the prevention of miosis and reduction of postoperative pain relative to placebo. Ocular adverse reactions in the trials were similar between the Omidria and placebo groups and included eye
irritation, posterior capsule opacification, increased intraocular pressure and anterior chamber inflammation.
The approval and near-term market
launch of Omidria could not come at a better time, stated Eric B. Donnenfeld, M.D., clinical professor of ophthalmology at New York University and immediate-past president of the American Society of Cataract and Refractive Surgery. With
increasingly restrictive regulations around compounding, surgeons are looking for a safe and effective FDA-approved product to improve surgical outcomes by maintaining pupil dilation during lens
replacement surgery and that quickly resolves postoperatively, potentially allowing faster recovery of vision. In addition, the anti-inflammatory ketorolac in Omidria could reduce the need for preoperative NSAIDs.
With FDA approval of Omidria, Omeros is completing preparations for a late summer/early fall 2014 U.S. product launch.
The FDA approval of Omidria is the first of what we expect will be a long line of product approvals for Omeros given our deep pipeline of products, many
of which are currently in clinical trials, stated Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. We have continued to round out our commercialization team and are focused on obtaining European approval for
Omidria, securing Medicare pass-through reimbursement and successfully launching the product in the U.S. later this year. In parallel, our premier clinical and non-clinical programs are advancing, and we look forward to sales of Omidria
significantly defraying future development costs of our rich pipeline.
Important Risk Information for Omidria
Systemic exposure of phenylephrine may cause elevations in blood pressure. In clinical trials, the most common reported adverse reactions at two to 24 percent
are eye irritation, posterior capsule opacification, increased intraocular pressure, and anterior chamber inflammation. Omidria must be diluted prior to use. Omidria is not approved for use in children.
About Omidria
Omeros PharmacoSurgery® product Omidria (pronounced oh-MID-ree-uh) is a proprietary combination of the mydriatic (pupil-dilating) agent phenylephrine and the anti-inflammatory agent ketorolac, which was developed
for use during cataract or other intraocular lens replacement (ILR) surgery. The FDA has approved Omidria (phenylephrine and ketorolac injection) 1%/0.3% for use during cataract surgery or ILR to maintain pupil size by preventing intraoperative
miosis (pupil constriction) and to reduce postoperative pain. The European Medicines Agency (EMA) is currently reviewing the Marketing Authorization Application (MAA) for Omidria.
About Cataract Surgery and Intraocular Lens Replacement (ILR)
Cataract surgery and other intraocular lens replacement (ILR) procedures involve replacement of the original or artificial intraocular lens of the eye with a
new artificial lens. These procedures are typically performed to replace a lens opacified by a cataract or to correct a refractive error of the lens (i.e., refractive lens exchange).
Conference Call and Webcast Today at 4:30 p.m. Eastern Time
The Omeros management team will host a conference call today at 4:30 p.m. Eastern Time to discuss the approval of Omidria. Interested parties may
participate in the conference call by dialing (866) 515-2910 (United States and Canada) or (617) 399-5124 (International). In addition, the live conference call is being webcast and can be accessed on the Events page of the
Companys website at www.omeros.com.
A replay of the webcast will be available on the Companys website for one week. A telephone replay will
also be available for one week, which can be accessed by dialing (888) 286-8010 (United States and Canada) or (617) 801-6888 (International) and entering conference ID number 68733741.
About Omeros Corporation
Omeros is a biopharmaceutical
company committed to discovering, developing and commercializing 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 Companys lead drug product, Omidria (phenylephrine and ketorolac injection) 1%/0.3%, has been approved by the FDA for use during
cataract surgery or intraocular lens replacement (ILR) to maintain pupil size by preventing intraoperative miosis (pupil constriction) and to reduce postoperative pain. Omeros is completing preparations for a late summer/early fall 2014 U.S. product
launch. Omidria is currently under review for marketing approval by the European Medicines Agency. Omeros six other clinical programs are focused on schizophrenia, Huntingtons 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, look forward to, may, plan, potential,
predict, project, should, will, would and similar expressions. Forward-looking statements are based on managements 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 effectiveness of
Omidria sales and marketing efforts, Omidria market acceptance, product pricing and reimbursement, Omeros ability to obtain regulatory approval for its Marketing Authorization Application in the EU for the commercialization of Omidria,
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 Companys Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 12, 2014. 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.
Contact:
Jennifer Cook Williams
Cook Williams Communications, Inc.
Investor and Media Relations
360.668.3701
jennifer@cwcomm.org
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