U.S. Court of Appeals for the Federal Circuit Affirms Merus' Inequitable Conduct Claim Against

U.S. Court of Appeals for the Federal Circuit Affirms Merus' Inequitable Conduct Claim Against Regeneron

ID: 554388

(Thomson Reuters ONE) -


UTRECHT, The Netherlands, July 28, 2017 (GLOBE NEWSWIRE) -- Merus N.V.
(Nasdaq:MRUS), a clinical-stage immuno-oncology company developing innovative
bispecific antibody therapeutics (Biclonics®), today announced that the U.S.
Court of Appeals for the Federal Circuit affirmed the trial court's conclusion
that Regeneron Pharmaceuticals, Inc. engaged in inequitable conduct before the
United States Patent and Trademark Office while prosecuting U.S. Patent No.
8,502,018 ('018 patent), entitled "Methods of Modifying Eukaryotic Cells."

In today's decision, the Federal Circuit ruled fully in favor of Merus,
affirming that Regeneron's '018 patent is unenforceable, having been obtained by
inequitable conduct. The Federal Circuit noted Regeneron made "false"
assertions, relied on a "misleading presentation," and withheld material
information from the United States Patent Office, and further, that Regeneron's
"litigation misconduct" "obfuscated its prosecution misconduct."

"We are pleased by today's decision, which serves as the latest vindication for
Merus in this case against Regeneron," said Ton Logtenberg, Ph.D., Chief
Executive Officer of Merus. "With this decision, and based on the continued
strength of our IP estate, Merus remains focused and believes it is well-
positioned as an innovator in the development of full-length human bispecific
antibody therapeutic candidates for serious diseases."

About Merus N.V.

Merus is a clinical-stage immuno-oncology company developing innovative full-
length human bispecific antibody therapeutics, referred to as Biclonics®.
Biclonics® are based on the full-length IgG format, are manufactured using
industry standard processes and have been observed in preclinical studies to
have several of the same features of conventional monoclonal antibodies, such as
long half-life and low immunogenicity. Merus' lead bispecific antibody




candidate, MCLA-128, is expected to begin a Phase 2 clinical trial in the second
half of 2017 in two metastatic breast cancer populations. MCLA-128 is also being
evaluated in a Phase 1/2 clinical trial in Europe in gastric, ovarian,
endometrial and non-small cell lung cancers. Merus' second bispecific antibody
candidate, MCLA-117, is being developed in a Phase 1 clinical trial in patients
with acute myeloid leukemia. The Company also has a pipeline of proprietary
bispecific antibody candidates in preclinical development, including MCLA-158,
which is designed to bind to cancer stem cells and is being developed as a
potential treatment for colorectal cancer and other solid tumors, as well as
MCLA-145 designed to bind to PD-L1 and a non-disclosed second immunomodulatory
target, which is being developed in collaboration with Incyte Corporation.

Forward Looking Statement

This press release contains forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995. All statements contained in
this press release that do not relate to matters of historical fact should be
considered forward-looking statements.

These forward-looking statements are based on management's current expectations.
These statements are neither promises nor guarantees, but involve known and
unknown risks, uncertainties and other important factors that may cause our
actual results, performance or achievements to be materially different from any
future results, performance or achievements expressed or implied by the forward-
looking statements, including, but not limited to, the following: our need for
additional funding, which may not be available and which may require us to
restrict our operations or require us to relinquish rights to our technologies
or Biclonics® and bispecific antibody candidates; potential delays in regulatory
approval, which would impact our ability to commercialize our product candidates
and affect our ability to generate revenue; the lengthy and expensive process of
clinical drug development, which has an uncertain outcome; the unpredictable
nature of our early stage development efforts for marketable drugs; potential
delays in enrollment of patients, which could affect the receipt of necessary
regulatory approvals; our reliance on third parties to conduct our clinical
trials and the potential for those third parties to not perform satisfactorily;
we may not identify suitable Biclonics® or bispecific antibody candidates under
our collaboration with Incyte or Incyte may fail to perform adequately under our
collaboration; our reliance on third parties to manufacture our product
candidates, which may delay, prevent or impair our development and
commercialization efforts; our ability to protect our proprietary technology;
our patents may be found invalid, unenforceable, circumvented by competitors and
our patent applications may be found not to comply with the rules and
regulations of patentability; we may fail to prevail in existing and potential
lawsuits for infringement of third-party intellectual property; and our
registered or unregistered trademarks or trade names may be challenged,
infringed, circumvented or declared generic or determined to be infringing on
other marks.

These and other important factors discussed under the caption "Risk Factors" in
our Annual Report on Form 20-F filed with the Securities and Exchange
Commission, or SEC, on April 28, 2017, and our other reports filed with the SEC,
could cause actual results to differ materially from those indicated by the
forward-looking statements made in this press release. Any such forward-looking
statements represent management's estimates as of the date of this press
release. While we may elect to update such forward-looking statements at some
point in the future, we disclaim any obligation to do so, even if subsequent
events cause our views to change, except as required under applicable law. These
forward-looking statements should not be relied upon as representing our views
as of any date subsequent to the date of this press release.

Contacts:
Media:
Eliza Schleifstein
+1 973 361 1546
eliza(at)argotpartners.com

Investors:
Kimberly Minarovich
+1 646 368 8014
kimberly(at)argotpartners.com




This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.

Source: Merus N.V. via GlobeNewswire




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Datum: 28.07.2017 - 13:02 Uhr
Sprache: Deutsch
News-ID 554388
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