YASTEST
UTRECHT, Netherlands and NANJING,
China, Jan. 08, 2018 (GLOBE NEWSWIRE) -- Merus (Nasdaq:MRUS) and
Simcere Pharmaceutical Group today announced that Merus has agreed
to grant Simcere an exclusive license to develop and commercialize
in China three bispecific antibodies utilizing Merus' proprietary
Biclonics® technology platform in the area of immuno-oncology.
Merus will retain all rights outside of China.
Under the terms of the agreement,
Merus has agreed to lead research and discovery activities while
Simcere has agreed to be responsible for the Investigational New
Drug (IND) enabling studies, clinical development, regulatory
filings and commercialization of these product candidates in
China. As a key strategic component of the collaboration,
Simcere will be responsible for IND enabling studies and
manufacturing of clinical trial materials in China, which Merus
intends to use to assist regulatory filing and early stage clinical
development in the rest of the world.
"We believe this collaboration
leverages Merus' unique platform and Biclonics® suite of
technologies with Simcere's drug development experience and strong
commercial presence in China," said Ton Logtenberg, Ph.D., Chief
Executive Officer of Merus. "For Merus, this represents an
important step towards becoming a commercial-stage company with a
strong pipeline of differentiated bispecific antibodies in
immuno-oncology. There is a clear strategic fit between the two
companies and we believe that by combining our collective expertise
and resources, we will be able to develop innovative therapeutics
in the China market and globally."
"We are very excited about the
collaboration with Merus," said Mr. Jinsheng Ren, Chairman and CEO
of Simcere. "Simcere is committed to developing innovative
therapeutics for the Chinese market. This collaboration provides
Simcere access to Merus' leading bispecific antibody platform and
has the potential to introduce multiple first-in-class
immuno-oncology therapeutics in the Chinese market. The opportunity
allows us to leverage our capability, expertise and investment in
China to support the development of innovative bispecific
antibodies in the global markets."
Merus will be eligible to receive
upfront and milestone payments contingent upon Simcere achieving
certain specified development and commercial goals. Merus
will be eligible to receive tiered royalty payments on sales of any
products resulting from the collaboration in China from
Simcere. Simcere will be eligible to receive tiered royalty
payments on sales outside of China from Merus. Additional
financial details were not disclosed.
About
Simcere Pharmaceutical Group
Simcere is a research and
development-driven Chinese pharmaceutical company committed to
bringing high quality and more effective therapies to patients by
combining in house R&D with partnerships. Simcere focuses its
efforts on therapeutic areas of oncology, neurology,
inflammation/immunology, cardiovascular and infectious
diseases.
Simcere is dedicated to research
& development of innovative pharmaceuticals and branded generic
drugs in China, with a State Key Lab of Translational Medicine and
Innovative Drug Development. By leverage of its commercial
capability, all top products of the company have leading market
share in China.
By leveraging partnering
experience with multinational pharmaceutical companies and
innovative biotech companies, Simcere continues to advance
international medical scientific achievements transformation and
create value for partners in China.
For more information,
visit www.simcere.com, or contact yan.ma@simcere.com
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®, which are based on the full-length IgG format, are
manufactured using industry standard processes and have been
observed in preclinical studies to have similar features as
conventional monoclonal antibodies, such as long half-life and low
immunogenicity. Merus' most advanced bispecific antibody candidate,
MCLA-128, is expected to soon be evaluated in a Phase 2 combination
trial 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 most advanced 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, which is designed to bind to PD-L1 and a non-disclosed
second immunomodulatory target and is being developed in
collaboration with Incyte Corporation. For additional
information, please visit Merus' website, www.merus.nl.
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 Merus' use of Simcere's IND
enabling studies and manufacturing of clinical trial materials in
China to assist regulatory filing and early stage clinical
development of Merus' product candidates in the rest of the world,
the collaboration leveraging Merus' unique platform and Biclonics®
suite of technologies and Simcere's drug development experience and
strong commercial presence in China, Simcere's drug development
experience and commercial presence in China and its ability to
leverage its capability, expertise and investment in China to
support the development of innovative bispecific antibodies in the
global markets, the potential of the collaboration to introduce
multiple first-in-class immuno-oncology therapeutics in the Chinese
market, the importance of the agreement towards Merus becoming a
commercial-stage company, the strength of Merus' pipeline of
differentiated bispecific antibodies in immuno-oncology, the
strategic fit between the two companies, the ability of the
companies to combine their collective expertise and resources to
develop innovative therapeutics in the Chinese market and globally,
Merus' eligibility to receive payments contingent upon Simcere
achieving certain specified development and commercial goals, and
to receive tiered royalty payments based on sales in China from
Simcere, the timing of commencing a Phase 2 combination trial for
MCLA-128, and the treatment potential of Merus' product
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: 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; protection of
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:
Investors:
Kimberly Minarovich
+1 646 368 8014
kimberly@argotpartners.com
Media:
David Rosen
+1 212 600 1902
david.rosen@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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