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
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): March 3, 2010
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.) |
1420 Fifth Avenue, Suite 2600
Seattle, Washington 98101
(Address of principal executive offices, including zip code)
Seattle, Washington 98101
(Address of principal executive offices, including zip code)
(206) 676-5000
(Registrant’s telephone number, including area code)
(Former name or former address, if changed since last report)
(Registrant’s 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):
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 1.01 Entry into a Material Definitive Agreement.
On March 3, 2010, Omeros Corporation (“Omeros”) and Asubio Pharma Co., LTD. (“Asubio”) entered
into a License Agreement (the “Agreement”) pursuant to which Omeros received an exclusive license
to phosphodiesterase-7 (“PDE7”) inhibitors claimed in certain patents and pending patent
applications owned by Asubio for use in the treatment of movement disorders and other specified
indications. Omeros intends to use these inhibitors in its PDE7 program, which is based on Omeros’
demonstration of a previously unknown link between PDE7 and any movement disorders, such as
Parkinson’s disease and Restless Legs Syndrome.
Under the Agreement, Omeros has agreed to make development and sales milestone payments to
Asubio of up to $23.5 million upon the achievement of certain events, such as successful completion
of preclinical toxicology studies; dosing of human subjects in Phase 1, 2 and 3 clinical trials;
receipt of marketing approval of a PDE7 inhibitor product; and reaching specified sales milestones.
In addition, Asubio is entitled to receive from Omeros a low single-digit percentage royalty of
any net sales of a PDE7 inhibitor licensed under the Agreement by Omeros and/or its sublicensee(s),
provided that if the sales are made by an Omeros sublicensee, then the amount payable by Omeros to
Asubio is capped at an amount equal to a low double-digit percentage of all royalty and specified
milestone payments received by Omeros from the sublicensee.
The term of the Agreement continues so long as there is a valid, subsisting and enforceable
claim in any patents covered by the Agreement. The Agreement may be terminated sooner by Omeros,
with or without cause, upon 90 days advance written notice or by either party following a material
breach of the Agreement by the other party that has not been cured within 90 days or immediately if
the other party is insolvent or bankrupt. Asubio also has the right to terminate the Agreement if
Omeros and its sublicensee(s) cease to conduct all research, development and/or commercialization
activities for a PDE7 inhibitor covered by the Agreement for a period of six consecutive months, in
which case all rights held by Omeros under Asubio’s patents will revert to Asubio.
In connection with the pending business reorganization of Asubio, Omeros has been informed by
the parent company of Asubio, Daiichi-Sankyo, Company, Limited, that it intends to succeed to all
of Asubio’s rights and obligations under the License Agreement on April 1, 2010.
The foregoing description of the Agreement is only a summary of its material terms and does
not purport to be complete.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit | ||
| Number | Description | |
99.1
|
Press release dated March 9, 2010 announcing License Agreement between Omeros Corporation and Asubio Pharma Co., Ltd. |
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, Chief Medical Officer and Chairman of the Board of Directors | ||||
Date: March 9, 2010
EXHIBIT INDEX
| Exhibit | ||
| Number | Description | |
99.1
|
Press release dated March 9, 2010 announcing License Agreement between Omeros Corporation and Asubio Pharma Co., Ltd. |
Exhibit 99.1
Omeros Licenses PDE7 Compounds for Parkinson’s Disease Program
Seattle, Washington — March 9, 2010 — Omeros Corporation (Nasdaq: OMER) today announced that
it has obtained an exclusive license to compounds from Asubio Pharma Co., Ltd. for use in its PDE7
program, which is focused on the treatment of movement disorders. Omeros has demonstrated a
previously unknown link between phosphodiesterase-7 (PDE7) and movement disorders such as
Parkinson’s disease and Restless Legs Syndrome. The agreement with Asubio gives Omeros an expedited
path to the clinic by providing advanced preclinical product candidates that are ready for
additional toxicology studies in preparation for a Phase 1 clinical trial.
“We are pleased to have accessed these PDE7 inhibitors. Omeros has already conducted
successful preclinical studies with them, and has identified which in-licensed candidate we plan to
move forward into clinical trials,” stated Gregory Demopulos, M.D., chairman and chief executive
officer of Omeros. “We expect that our first clinical program will target Parkinson’s disease and,
assuming continued preclinical progress, that we will be able to file an investigational new drug
(IND) application to begin a Phase 1 clinical trial in 2011.”
Under the agreement, Omeros is responsible for clinical and commercial milestone payments to
Asubio. Omeros would also pay a single-digit royalty to Asubio upon potential sale of the products
named in the agreement.
About Omeros’ PDE7 Program
Omeros’ PDE7 program is based on a previously unknown link between PDE7 and any movement
disorder such as Parkinson’s disease and Restless Legs Syndrome. Based on promising preclinical
animal data in a model of Parkinson’s disease showing efficacy of PDE7 inhibitors equivalent to
that of levodopamine, the Company is advancing proprietary compounds for the treatment of movement
disorders. Levodopamine has been the standard treatment for Parkinson’s disease for nearly 40 years
but is associated with severe side effects including dyskinesias, hallucinations, sleep disorders
and cognitive impairment. Omeros’ PDE7 inhibitors may have the ability to avoid one or more of
these side effects. The Michael J. Fox Foundation has been a supporter of this program, having
provided grant funding of $464,000 to Omeros to date.
About Parkinson’s Disease
Parkinson’s disease is a progressive, degenerative disorder of the central nervous system that
can impair a person’s motor skills, speech and other functions. The disease is characterized by
tremors, muscle rigidity and the slowing of physical movement. It is chronic and progressive and
affects approximately one million people in the United States. There is currently no cure for
Parkinson’s disease.
About Asubio Pharma Co., LTD.
Asubio Pharma is a research oriented biopharmaceutical company and a wholly owned subsidiary
of Daiichi Sankyo Co., Ltd., headquartered in Japan. Asubio focuses on research and development of
innovative ethical drugs in the field of inflammation, regeneration and differentiation. Asubio has
cutting-edge technologies for innovating first-in-class small molecule medicines, peptide medicines
and stem cell-derived medicines for tissue regeneration.
About Omeros Corporation
Omeros is a clinical-stage biopharmaceutical company committed to discovering, developing and
commercializing products focused on inflammation and disorders of the central nervous system. The
Company’s most clinically advanced product candidates are derived from its proprietary
PharmacoSurgery™ platform designed to improve clinical outcomes of patients undergoing a wide range
of surgical and medical procedures. Omeros has five ongoing clinical development programs,
including four from its PharmacoSurgery™ platform and one from its Addiction program, the most
advanced of which is in Phase 3 clinical trials. Omeros may also have the near-term capability,
through
its GPCR program, to add an unprecedented number of wholly new drug targets to the market.
Behind its clinical candidates and GPCR platform, Omeros is building a diverse pipeline of antibody
and small-molecule preclinical programs targeting inflammation and central nervous system
disorders.
Forward-Looking Statements
This press release contains forward-looking statements as defined within the Private Securities
Litigation Reform Act of 1995, which are subject to the “safe harbor” created by those sections.
These statements include, but are not limited to, statements regarding the Company’s ability to
file an IND in 2011 and to begin a Phase 1 clinical trial for Parkinson’s disease. Forward-looking
statements are based on management’s 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, the risks, uncertainties and other factors described under the heading “Risk
Factors” in the Company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange
Commission on November 19, 2009. 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 publicly, even if new information becomes available in the
future.
Contact:
Jennifer Cook Williams
Cook Williams Communications, Inc.
360-668-3701
jennifer@cwcomm.org
Jennifer Cook Williams
Cook Williams Communications, Inc.
360-668-3701
jennifer@cwcomm.org
# # #