SEATTLE--(BUSINESS WIRE)--Aug. 23, 2017--
Corporation (NASDAQ:OMER) stated today that it continues to pursue
legal action to hold responsible those behind a series of defamatory
reports about the company posted online under the pseudonym “Art Doyle,”
an entity or group that self-identifies as having a short position in
Omeros’ stock. Because of its ongoing legal action, including a number
of steps aimed at unmasking the identity of the individual(s)
responsible, Omeros elected not to respond to queries from a writer for
statnews.com who evidently had early access to and commented through
Twitter on the initial “Art Doyle” false report before it was broadly
While, for the reason stated above, Omeros will not engage in a running
dialogue with this writer, the company will respond this one time to
correct some of the inaccuracies in yesterday’s statnews.com story.
Correct information is and has been publicly available to any individual
wishing to obtain accurate background material.
The Superior Court of Washington for King County determined there was
a likelihood that Omeros would prevail on its defamation claim against
the “Art Doyle” entity(ies) and granted a motion for preliminary
injunction requiring removal of the defamatory reports and prohibiting
posting of further defamatory statements.
As of June 30, 2017, 54 patients had been enrolled in OMS721 Phase 2
clinical trials. Since then, the enrollment number has continued to
increase. Presentations of OMS721 clinical data at international
scientific meetings span February 2017 through June 2017. These
presentations are directed to respective groups of patients and are
not intended to reflect total patient counts. In addition, like most
biopharmaceutical companies, Omeros does not routinely release all
clinical data as they are generated.
As noted in the company’s press release dated August 4, 2017, more
than 150 subjects had been dosed with OMS721, and that number
continues to increase.
On March 16, 2017, Omeros publicly announced that enrollment had
opened for its Phase 3 clinical trial evaluating OMS721 in patients
with atypical hemolytic uremic syndrome, or aHUS. In connection with
this study and consistent with regulations governing
clinicaltrials.gov postings, a clinicaltrials.gov filing was made by
the company on April 17, 2017. This date, as recorded by the website
administrators at the National Institutes of Health, is found on the
clinicaltrials.gov summary for this Phase 3 trial.
The estimated completion date of the aHUS Phase 3 clinical trial for
approximately 80 patients is listed as 2020 on clinicaltrials.gov. The
posting on clinicaltrials.gov also clearly states that an interim
analysis will be conducted following treatment of approximately 40
patients for potential submission for regulatory approval. This is
consistent with Omeros’ publicly available statements that, based on
discussions with both FDA and the European Medicines Agency, the
company received guidance from those regulatory bodies that 40
patients may be sufficient for accelerated approval in the U.S. and
for full approval in Europe.
As noted in the company’s press release in February 2014, subjects in
Omeros’ Phase 1 trial were dosed subcutaneously at increasing dose
levels, with both subcutaneous and intravenous administration
resulting in sustained and high degrees of lectin pathway inhibition.
Since then, several cohorts of subjects have been administered
repeated subcutaneous doses of OMS721, yielding comprehensive
pharmacokinetic/pharmacodynamic (PK/PD) data.
Intravenous loading followed by subcutaneous maintenance dosing in the
aHUS Phase 3 clinical trial is based on those comprehensive PK/PD
data. According to the FDA medical review, Alexion similarly used
pharmacokinetic modeling to determine the dosing regimen for
eculizumab (Soliris®) in the aHUS indication.
Omeros, for competitive reasons and consistent with common practice in
the industry, has not released any PK/PD data.
Following submission of a request for breakthrough therapy designation
based on Phase 2 clinical data in patients with immunoglobulin A (IgA)
nephropathy, Omeros received notification of breakthrough designation
for OMS721 in IgA nephropathy in a letter from FDA dated June 8, 2017.
As publicly disclosed, the Phase 3 clinical trial in this program is
planned to initiate later this year.
Omeros accurately reports the status and results of its commercial,
clinical and development programs and will continue its practice of
providing updates when appropriate.
About Omeros’ MASP Programs
Omeros controls the worldwide rights to MASP-2 and all therapeutics
targeting MASP-2, a novel pro-inflammatory protein target involved in
activation of the complement system, which is an important component of
the immune system. The complement system plays a role in the
inflammatory response and becomes activated as a result of tissue damage
or microbial infection. MASP-2 is the effector enzyme of the lectin
pathway, one of the principal complement activation pathways.
Importantly, inhibition of MASP-2 does not appear to interfere with the
antibody-dependent classical complement activation pathway, which is a
critical component of the acquired immune response to infection, and its
abnormal function is associated with a wide range of autoimmune
disorders. MASP-2 is generated by the liver and is then released into
circulation. Adult humans who are genetically deficient in one of the
proteins that activate MASP-2 do not appear to be detrimentally affected
by the deficiency. OMS721 is Omeros’ lead human MASP-2 antibody.
Following discussions with both the FDA and the European Medicines
Agency, a Phase 3 clinical program for OMS721 in atypical hemolytic
uremic syndrome (aHUS) is in progress. A second Phase 3 clinical program
for OMS721 has been initiated in immunoglobulin A (IgA) nephropathy.
Also, two Phase 2 trials are ongoing. One is continuing to enroll OMS721
in IgA nephropathy following an earlier Phase 2 trial that generated
positive data in patients with IgA nephropathy and with lupus nephritis;
the other is enrolling and has reported positive data both in patients
with hematopoietic stem cell transplant-associated thrombotic
microangiopathy (TMA). A third Phase 3 program could begin later this
year in stem cell transplant-associated TMA. OMS721 can be administered
both intravenously and subcutaneously, and Omeros expects to
commercialize each formulation of OMS721 for different therapeutic
indications. In parallel, Omeros is developing small-molecule inhibitors
of MASP-2. Based on requests from treating physicians, Omeros has
established a compassionate-use program for OMS721, which is active in
both the U.S. and Europe. The FDA has granted OMS721 breakthrough
therapy designation for IgA nephropathy, orphan drug status for the
prevention (inhibition) of complement-mediated TMAs and for the
treatment of IgA nephropathy, and fast track designation for the
treatment of patients with aHUS.
Omeros also has identified MASP-3 as responsible for the conversion of
pro-factor D to factor D and as a critical activator of the human
complement system’s alternative pathway. The alternative pathway is
linked to a wide range of immune-related disorders. In addition to its
lectin pathway inhibitors, the company is advancing its development of
antibodies and small-molecule inhibitors against MASP-3 to block
activation of the alternative pathway. Omeros is preparing to initiate
manufacturing scale-up of its MASP-3 antibodies in advance of clinical
About Omeros Corporation
Omeros is a commercial-stage biopharmaceutical company committed to
discovering, developing and commercializing small-molecule and protein
therapeutics for large-market as well as orphan indications targeting
inflammation, complement-mediated diseases and disorders of the central
nervous system. The company’s drug product OMIDRIA®
(phenylephrine and ketorolac injection) 1% / 0.3% is marketed 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. In the European
Union, the European Commission has approved OMIDRIA for use in cataract
surgery and other IOL replacement procedures to maintain mydriasis
(pupil dilation), prevent miosis (pupil constriction), and to reduce
postoperative eye pain. Omeros has multiple Phase 3 and Phase 2
clinical-stage development programs focused on: complement-associated
thrombotic microangiopathies; complement-mediated
glomerulonephropathies; Huntington’s disease and cognitive impairment;
and addictive and compulsive disorders. In addition, Omeros has a
diverse group of preclinical programs and a proprietary G
protein-coupled receptor (GPCR) platform through which it controls 54
new GPCR drug targets and corresponding compounds, a number of which are
in preclinical development. The company also exclusively possesses a
novel antibody-generating platform.
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 and variations thereof. 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, risks associated with product
commercialization and commercial operations, unproven preclinical and
clinical development activities, regulatory oversight, intellectual
property claims, competitive developments, litigation, and 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 August 8, 2017. 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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20170823005708/en/
Source: Omeros Corporation
Cook Williams Communications, Inc.
Jennifer Cook Williams,
Investor and Media Relations