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): May 22, 2015
OMEROS CORPORATION
(Exact name of registrant as specified in its charter)
|
|
|
|
|
Washington |
|
001-34475 |
|
91-1663741 |
(State or other jurisdiction
of incorporation) |
|
(Commission
File Number) |
|
(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):
¨ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
¨ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
¨ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
¨ |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 5.07 |
Submission of Matters to a Vote of Security Holders. |
The 2015 Annual Meeting of
Shareholders of Omeros Corporation, or Omeros, was held on May 22, 2015. Shareholders of record at the close of business on April 2, 2015 were entitled to vote up to 37,825,261 shares of common stock at the annual meeting. A total of
32,389,677 (85.63%) shares were represented at the annual meeting in person or by proxy. The following is a brief description of each matter voted upon at the annual meeting and the number of votes cast for, against or withheld, as well as the
number of abstentions and broker non-votes, as to each such matter:
(1) The election of the following two Class III directors, each to serve until the
2018 Annual Meeting of Shareholders or until his successor is duly elected and qualified or until his earlier death, resignation or removal:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For |
|
|
Withheld |
|
|
Broker Non-Votes |
|
Gregory A. Demopulos, M.D. |
|
|
15,561,611 |
|
|
|
1,353,658 |
|
|
|
15,474,408 |
|
Leroy E. Hood, M.D., Ph.D. |
|
|
14,996,847 |
|
|
|
1,918,422 |
|
|
|
15,474,408 |
|
(2) The ratification of the appointment of Ernst & Young LLP as Omeros independent registered public accounting
firm for the fiscal year ending December 31, 2015.
|
|
|
|
|
|
|
For |
|
Against |
|
Abstain |
|
Broker Non-Votes |
32,223,954 |
|
147,562 |
|
18,161 |
|
0 |
On May 22, 2015, Omeros issued a press release announcing that the
European Medicines Agencys Committee for Medicinal Products for Human Use had adopted a positive opinion for Omeros drug product Omidria® (phenylephrine and ketorolac injection)
1%/0.3%. 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. |
|
|
|
Exhibit Number |
|
Description |
|
|
99.1 |
|
Press release dated May 22, 2015 |
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.
|
|
|
OMEROS CORPORATION |
|
|
By: |
|
/s/ Gregory A. Demopulos |
|
|
Gregory A. Demopulos, M.D. |
|
|
President, Chief Executive Officer and |
|
|
Chairman of the Board of Directors |
Date: May 28, 2015
EXHIBIT INDEX
|
|
|
Exhibit Number |
|
Description |
|
|
99.1 |
|
Press release dated May 22, 2015 |
Exhibit 99.1
Omidria® Receives Positive Opinion from European
Medicines Agencys Committee for Medicinal Products for Human Use
Unanimous Recommendation to Grant European
Marketing Authorization for Omidria Based on Benefit/Risk Profile
SEATTLE, WA May 22, 2015 Omeros Corporation
(NASDAQ: OMER), a biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for both large-market as well as orphan indications targeting inflammation, coagulopathies and disorders of
the central nervous system, today announced that the European Medicines Agencys (EMAs) 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 CHMPs 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.
We are pleased that CHMP unanimously endorsed the benefits of Omidria for both ophthalmic surgeons and
their patients in Europe, stated Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. Omeros controls the worldwide rights to Omidria, and our independent product launch in the U.S. is progressing nicely. For
Omidria in Europe, we plan to partner for marketing and distribution, and we look forward to the European Commissions decision in July.
About Omidria®
Omeros PharmacoSurgery® product
Omidria® contains the mydriatic (pupil-dilating) agent phenylephrine and the anti-inflammatory agent ketorolac and was developed for use during cataract or other IOL replacement surgery. The
FDA has approved Omidria for use during cataract surgery or IOL replacement to maintain pupil size by preventing intraoperative miosis (pupil constriction) and to reduce postoperative ocular pain.
Important Risk Information for Omidria®
Systemic exposure of phenylephrine may cause elevations in blood pressure. In clinical trials, the most common reported ocular adverse reactions at
two to 24 percent are eye irritation, posterior capsule opacification, increased intraocular pressure, and anterior chamber inflammation; incidence of adverse events was similar between placebo-treated and Omidria-treated patients. Omidria® must be added to irrigation solution prior to intraocular use. Omidria is not approved for use in children.
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 companys 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 is currently
under review for marketing approval by the European Medicines Agency. Omeros has six clinical-stage development programs focused on: complement-related thrombotic microangiopathies; Huntingtons disease, schizophrenia, and cognitive impairment;
addictive and compulsive disorders; and preventing problems associated with surgical procedures. 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 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 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 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.
Contact:
Omeros Corporation
Investor Relations
206.676.5000
ir@omeros.com
Omeros (NASDAQ:OMER)
Historical Stock Chart
From Mar 2024 to Apr 2024
Omeros (NASDAQ:OMER)
Historical Stock Chart
From Apr 2023 to Apr 2024