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2016-11-15

Merus Announces Favorable Decisions in Europe and Japan for Patents Covering Genetically-Modified Mice for Common Light Chain Human Monoclonal Antibodies

Merus N.V.
Press release

Merus Announces Favorable Decisions in Europe and Japan for Patents Covering
Genetically-Modified Mice for Common Light Chain Human Monoclonal Antibodies

European Patent Office Dismisses Arguments by Regeneron

Favorable Rulings Further Strengthen IP Estate in Europe and Japan through 2029

UTRECHT, The Netherlands, 2016-11-14 18:13 CET (GLOBE NEWSWIRE) -- Merus N.V.
(NASDAQ:MRUS), a clinical-stage immuno-oncology company developing innovative
bispecific antibody therapeutics, today announced that it received two
favorable rulings for its European patent EP 2147594 B1 (the “‘594 patent”) by
the Opposition Division of the European Patent Office (the “EPO”) as well by
the Trial Board of the Japanese Patent Office for its Japanese counterpart JP
5749161 (the “‘161 patent”). Both patents cover Merus’ genetically-modified
mice and their use to produce common light chain human monoclonal antibodies.

“We are very pleased by these positive rulings for Merus’ common light chain
mouse patents in Europe and Japan which we believe are a testament to the
strength of our intellectual property estate and provide us with sufficient
protection through 2029,” said Ton Logtenberg, PhD, Chief Executive Officer of
Merus. “These favorable rulings reflect the unique attributes of our
proprietary Biclonics® bispecific antibody technology platform that we believe
has broad applicability in the development of novel therapeutics for the
treatment of cancer and other serious medical conditions.”

In Europe, the Opposition Division of the EPO upheld without amendment the ‘594
patent in oral proceedings held in The Hague on October 28, 2016. The claims of
the ‘594 patent cover methods of obtaining common light chain human monoclonal
antibodies from genetically-modified mice that comprise in their genome a human
rearranged immunoglobulin light chain variable region. In Japan, the Trial
Board of the Japanese Patent Office upheld the ‘161 patent with minimal
amendments. The claims of the ‘161 patent are similar to those of the ‘594
patent.

Both the European Opposition Division and the Japanese Trial Board dismissed
arguments brought by Regeneron (NASDAQ:REGN) that the patent lacked novelty and
inventive step. In both territories, the decision is open to appeal.

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 being evaluated in a Phase 1/2 clinical trial in Europe
as a potential treatment for HER2-expressing solid tumors. Merus' second
bispecific antibody candidate, MCLA-117, is being developed in a Phase 1/ 2
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, and Biclonics® designed to bind to various combinations of
immunomodulatory molecules, including PD-1 and PD-L1.

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, including without limitation
statements regarding the strength of our intellectual property estate, the
sufficiency of our protection of our intellectual property estate, including
when such protection will terminate, the broad applicability of Biclonic®
bispecific antibodies to cancer and other medical conditions, and the treatment
potential of our bispecific antibody candidates.

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: we have incurred significant losses, are not currently profitable
and may never become profitable; our need for additional funding, which may not
be available and which may require us to restrict out operations or require us
to relinquish rights to our technologies or bispecific antibody candidates;
potential delays in regulatory approval, which would impact the ability to
commercialize our product candidates and affect our ability to generate
revenue; the unproven approach to therapeutic intervention of our Biclonics®
technology; potential difficulties in validating and developing companion
diagnostics, which could harm our development strategy; our limited operating
history; economic, political, regulatory and other risks involved with
international operations; exchange rate fluctuations or abandonment of the euro
currency; 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 adverse public reaction to
the use of cancer immunotherapies; potential delays in enrollment of patients,
which could affect the receipt of necessary regulatory approvals; our potential
exposure to costly and damaging liability claims; post-marketing restrictions
or withdrawal from the market; failure to obtain marketing approval
internationally; compliance with environmental, health, and safety laws and
regulations; anti-kickback, fraud, abuse, and other healthcare laws and
regulations exposing us to potential criminal sanctions; recently enacted or
future legislation; failure to compete successfully against other drug
companies; potential competition from other drug companies if we fail to obtain
orphan drug designation or maintain orphan drug exclusivity for our products;
the possibility that governmental authorities and health insurers may not
establish adequate reimbursement levels and pricing policies to support our
products; the potential failure of our product candidates to be accepted on the
market by the medical community; our lack of experience selling, marketing and
distributing products and our lack of internal capability to do so; potential
competition from biosimilars; our reliance on third parties to conduct our
clinical trials and the potential for those third parties to not perform
satisfactorily; our reliance on third parties to manufacture our product
candidates, which may delay, prevent or impair our development and
commercialization efforts; protection of our proprietary technology; our
patents being found invalid or unenforceable; potential lawsuits for
infringement of third-party intellectual property; adequate protection of our
trademarks; our potential failure to obtain extensions of the terms of patents
covering our products; potential difficulties protecting our intellectual
property rights in certain jurisdictions; changes in United States patent law;
protection of the confidentiality of our trade secrets; claims asserting that
we or our employees misappropriated a third-party’s intellectual property or
otherwise claiming ownership of what we regard as our intellectual property;
compliance with patent regulations; potential system failures; our ability to
attract and retain key personnel; managing our growth could result in
difficulties; the price of our common stock may fluctuate substantially;
certain of our shareholders and members of our management board own a majority
of our outstanding shares and exercise significant control over us; a
significant portion of our total outstanding shares are eligible to be sold
into the market; provisions of our Articles of Association or Dutch corporate
law might deter favorable acquisition bids for us or prevent a beneficial
change of control; we may lose our foreign private issuer status and incur
significant expenses as a result; and unfavorable or lacking analyst research
or reports might cause the price of our common shares to decline.

These and other important factors discussed under the caption “Risk Factors” in
our final prospectus filed with the Securities and Exchange Commission, or SEC,
on May 20, 2016 relating to our Registration Statement on Form F-1, 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. 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:
Merus N.V.
Shelley Margetson - s.margetson@merus.nl
+31 (0)30 253 8800

Argot Partners
Kimberly Minarovich - kimberly@argotpartners.com
1-212-600-1902

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