OMEROS CORPORATION (NASDAQ:OMER) Files An 8-K Submission of Matters to a Vote of Security Holders
Item 5.07Submission of Matters to a Vote of Security Holders.
The 2017 Annual Meeting of Omeros Corporation, or Omeros, was
held on June 16, 2017. Shareholders of record at the close of
business on April 12, 2017 were entitled to vote up to 43,938,655
shares of common stock at the annual meeting. A total of
36,903,630 (83.99%) shares were represented at the annual meeting
in person or by proxy. Set forth below is a brief description of
each matter voted upon at the annual meeting and the final voting
results for each matter.
(1) |
The election of the following two Class II directors, |
For |
Withheld |
Broker Non-Votes |
|
Thomas J. Cable |
18,761,762 |
1,667,750 |
16,474,118 |
Peter A. Demopulos, M.D. |
19,055,968 |
1,373,544 |
16,474,118 |
(2) |
The approval of an advisory resolution regarding the |
For |
Against |
Abstain |
Broker Non-Votes |
16,084,478 |
3,980,923 |
364,111 |
16,474,118 |
(3) |
An advisory vote on the frequency of future advisory |
One Year |
Two Years |
Three Years |
Abstain |
Broker Non-Votes |
6,548,838 |
997,810 |
12,716,699 |
166,165 |
16,474,118 |
Based on these results and consistent with its recommendation in
the proxy statement for the 2017 Annual Meeting of Shareholders,
Omeros Board of Directors has determined to hold an advisory vote
on the compensation of its named executive officers once every
three years.
(4) |
The approval of the 2017 Plan. |
For |
Against |
Abstain |
Broker Non-Votes |
15,358,229 |
4,714,127 |
357,156 |
16,474,118 |
(5) |
The ratification of the appointment of Ernst Young LLP as |
For |
Against |
Abstain |
Broker Non-Votes |
36,354,040 |
406,471 |
143,119 |
Item 8.01Other Events.
On June 21, 2017, Omeros filed a patent infringement lawsuit in
the U.S. District Court for the District of Delaware and a patent
infringement lawsuit in the U.S. District Court for the District
of New Jersey against Sandoz Inc., or Sandoz, and on June 22,
2017, Omeros filed a patent infringement lawsuit in the U.S.
District Court for the District of Delaware and a patent
infringement lawsuit in the U.S.
District Court for the District of New Jersey against Lupin Ltd.
and Lupin Pharmaceuticals, Inc., which we refer to collectively
as Lupin. The lawsuits were filed under the Hatch-Waxman Act for
Sandozs and Lupins respective infringement of six Omeros patents:
U.S. Patent Nos. 8,173,707, 8,586,633, 9,066,856, 9,278,101,
9,399,040 and 9,486,406, which relate to Omeros drug OMIDRIA
(phenylephrine and ketorolac injection) 1%/0.3% and which are
listed in the Approved Drug Products with Therapeutic Equivalence
Evaluations, known as the Orange Book, published by the U.S. Food
and Drug Administration, or FDA. The lawsuits were filed in
response to Notice Letters Omeros received from Sandoz and Lupin
that each company had filed an Abbreviated New Drug Application,
or ANDA, containing a Paragraph IV Certification under the
Hatch-Waxman Act and seeking approval from the FDA to market a
generic version of OMIDRIA prior to the expiration of the six
Orange Book-listed patents for OMIDRIA. These patents were
granted following review by the U.S. Patent and Trademark Office,
are presumed to be valid under governing law, and can only be
invalidated in federal court with clear and convincing evidence.
Under the Hatch-Waxman Act, Omeros was permitted to file suit
within 45 days from its receipt of each Notice Letter and thereby
trigger a 30-month stay of the FDAs approval of the respective
ANDAs. Each stay is expected to remain in effect until November
2019. The assertions raised in Sandozs and Lupins Paragraph IV
Notice Letters are substantially similar to those raised by Par
Pharmaceutical, Inc. and its subsidiary Par Sterile Products,
LLC, which we refer to collectively as Par, in Omeros current
patent litigation against Par. Omeros believes the assertions in
the Sandoz and Lupin Paragraph IV Notice Letters do not have
merit, and Omeros intends to vigorously prosecute its
infringement claims against Sandoz and Lupin.
Forward-Looking Statements
This Current Report on Form 8-K 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. These statements include, but are
not limited to, Omeros expectations regarding the lawsuits.
Forward-looking statements are based on managements beliefs and
assumptions and on information available to management only as of
the date of this Current Report on Form 8-K. Omeros actual
results could differ materially from those anticipated in these
forward-looking statements for many reasons, including, without
limitation, the risks, uncertainties and other factors described
under the heading Risk Factors in Omeros Quarterly Report on Form
10-Q filed with the Securities and Exchange Commission on May 15,
2017. Given these risks, uncertainties and other factors, you
should not place undue reliance on these forward-looking
statements, and Omeros assumes no obligation to update these
forward-looking statements publicly, even if new information
becomes available in the future.
About OMEROS CORPORATION (NASDAQ:OMER)
Omeros Corporation is a biopharmaceutical company engaged in discovering, developing and commercializing small-molecule and protein therapeutics for market, as well as orphan indications targeting inflammation, coagulopathies and disorders of the central nervous system. The Company’s marketed drug product, Omidria (phenylephrine and ketorolac injection), is used during cataract surgery or intraocular lens replacement. Its clinical programs include Mannan-binding lectin-associated serine protease-2 (MASP-2) (OMS721)-Lectin Pathway Disorders; PDE10 (OMS824)-CNS Disorders; peroxisome proliferator-activated receptor gamma (PPARy) (OMS405)-Addiction, and OMS201-Urology. Its preclinical programs include phosphodiesterase 7 (PDE7) (OMS527), Plasmin (OMS616), MASP-3 (OMS906)-Alternative Pathway Disorders, GPR17-CNS Disorders, GPR101-Metabolic Disorders, GPR151-CNS Disorders, GPR161-Cancer, GPR174-Immune Disorders, GPR183-Skeletal and Infectious Diseases, GPCR Platform and Antibody Platform.