Omeros Responds to Statnews.com Story
August 23 2017 - 11:00AM
Business Wire
Omeros 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 made public.
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
trials.
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.
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 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.
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version on businesswire.com: http://www.businesswire.com/news/home/20170823005708/en/
Cook Williams Communications, Inc.Jennifer Cook Williams,
360-668-3701Investor and Media Relationsjennifer@cwcomm.org
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