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
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