Omeros Responds to Statnews.com Story
While, for the reason stated above,
The Superior Court of Washington for King Countydetermined there was a likelihood that Omeroswould 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.
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 2017through 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, Omerosdoes 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.
March 16, 2017, Omerospublicly 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
FDAand 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
FDAmedical 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)
Omerosreceived notification of breakthrough designation for OMS721 in IgA nephropathy in a letter from FDAdated 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
Following discussions with both the
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
Cook Williams Communications, Inc.
Jennifer Cook Williams, 360-668-3701
Investor and Media Relations