Geneva, Switzerland and Boston, MA –
July 1, 2020 - ObsEva SA (NASDAQ:
OBSV / SIX: OBSN - a clinical-stage biopharmaceutical company
focused on the development and commercialization of novel
therapeutics for serious conditions that compromise a woman’s
reproductive health and pregnancy), and Yuyuan BioScience
Technology (“Yuyuan”) today announced that Yuyuan has submitted a
pre-IND meeting request for nolasiban to the Center for Drug
Evaluation at the Chinese National Medical Products Administration
(NMPA). Nolasiban, a novel, oral oxytocin receptor antagonist, is
being developed for improving clinical pregnancy and live birth
rates in women undergoing in vitro fertilization (IVF). Two Phase 3
studies have been completed in Europe.
As per the partnership agreement, Yuyuan has the
exclusive rights to develop and commercialize nolasiban in the
People’s Republic of China (PRC). Yuyuan will fund all development
and registration activities in the PRC. This submission represents
the first milestone in the process to enable a Phase 1 and Phase 2
proof-of-concept study in China.
“We are excited with today’s submission of our
pre-IND meeting request for nolasiban which demonstrates the
diligence and commitment of our Chinese partner, Yuyuan,” said
Ernest Loumaye, CEO and Co-Founder of ObsEva. “A full analysis of
all the available clinical data has strengthened our belief that
nolasiban has the potential to play a role in improving clinical
pregnancy and live birth rate following IVF. This submission is the
first, important step towards establishing the optimal dosing
regimen for nolasiban in IVF.”
“The submission of our pre-IND dossier is a
critical step in assessing nolasiban’s potential in improving live
birth rates in women undergoing IVF,” said Steven Chen, Chairman
and CEO of Yuyuan. “With more than 950,000 ART cycles in 2017,
China has the largest number of IVF-related procedures in the
world. We are delighted to collaborate with ObsEva and potentially
establish nolasiban as a cornerstone of IVF treatment.”
About ObsEva
ObsEva is a biopharmaceutical company developing
and commercializing novel therapies to improve women’s reproductive
health and pregnancy. Through strategic in-licensing and
disciplined drug development, ObsEva has established a late-stage
clinical pipeline with development programs focused on treating
endometriosis, uterine fibroids, preterm labor, and improving
embryo transfer (ET) outcomes following IVF. ObsEva is listed on
the Nasdaq Global Select Market and is trading under the ticker
symbol "OBSV" and on the SIX Swiss Exchange where it is trading
under the ticker symbol “OBSN”. For more information, please visit
www.ObsEva.com.
About Yuyuan Bioscience
Technology
Yuyuan Bioscience Technology is a leading
biopharmaceutical company based in China focused on discovering,
developing and commercializing innovative medicines for unmet
medical needs in the assisted reproductive area. The company
continues to introduce a competitive portfolio of therapeutic
programs aimed at helping to bring more solutions to this field.
Yuyuan Bioscience has a top class leadership team with deep
experience at assisted reproductive therapeutics and within biotech
organizations. The team has a strong track record of success –
successfully having taken drug candidates into clinical trials in
China, secured regulatory approvals and achieved great market
success. Yuyuan Bioscience has always adhered to the development
concept of “doing moral business, craving long-lasting career”,
providing comprehensive, accurate and professional services for
China's assisted reproductive medical field.
About Assisted Reproductive
Technology
Infertility affects about 10% of
reproductive-aged couples, with more than two million assisted
reproductive technology (ART) treatments (including IVF and
intracytoplasmic sperm injection (ICSI)) performed worldwide each
year. In China, more than 950,000 ART cycles (IVF, ICSI, fetal ET)
were performed in 2017 (National Health Commission of the PRC,
presented at the 23rd International Federation of Fertility
Societies conference in Shanghai, 2019)
While the success of ART depends on multiple
factors including ovarian response, fertilization, embryo quality
and ET procedure, a successful pregnancy ultimately hinges on the
receptivity of the uterus to accept embryo implantation. Uterine
contractions at the time of ET, as well as suboptimal thickness of
the uterine wall and insufficient blood flow to the uterus, may
impair the implantation of the embryo.
About Nolasiban
Nolasiban (previously known as OBE001), is an
oral oxytocin receptor antagonist which was licensed from Merck
KGaA, Darmstadt, Germany, in 2013. ObsEva retains worldwide,
exclusive, commercial rights (ex China).
Cautionary Note Regarding Forward
Looking Statements
Any statements contained in this press release
that do not describe historical facts may constitute
forward-looking statements as that term is defined in the Private
Securities Litigation Reform Act of 1995. These statements may be
identified by words such as "believe", "expect", "may", "plan,"
"potential," "will," and similar expressions, and are based on
ObsEva’s current beliefs and expectations. These forward-looking
statements include statements regarding the potential of nolasiban
to contribute to improving clinical pregnancy and live birth rates
following IVF, and Yuyuan’s ability to successfully develop and
commercialize nolasiban in China, including establishing the
optimal dosing regimen. These statements involve risks and
uncertainties that could cause actual results to differ materially
from those reflected in such statements. Risks and uncertainties
that may cause actual results to differ materially include the risk
that the benefits from the transaction may not be fully realized or
may take longer to realize than expected, uncertainties inherent in
the conduct of clinical trials and clinical development and related
regulatory reviews and approvals, including the risk that the
results of earlier clinical trials may not be predictive of the
results of later-stage clinical trials, related interactions with
regulators, including YuYuan’s interactions with the NMPA, ObsEva’s
reliance on third parties over which it may not always have full
control, and other risks and uncertainties that are described in
the Risk Factors section of ObsEva’s Annual Report on Form 20-F for
the year ended December 31, 2019, the Risk Factors disclosed in
ObsEva’s Report on Form 6-K filed with the Securities and Exchange
Commission (SEC) on May 5, 2020, and other filings ObsEva makes
with the SEC. These documents are available on the Investors page
of ObsEva’s website at http://www.obseva.com. Any forward-looking
statements speak only as of the date of this press release and are
based on information available to ObsEva as of the date of this
release, and ObsEva assumes no obligation to, and does not intend
to, update any forward-looking statements, whether as a result of
new information, future events or otherwise.
For further information, please contact:
CEO Office contactShauna
DillonShauna.dillon@obseva.ch+41 22 552 1550
Investor ContactMario CorsoVice President,
Investor Relationsmario.corso@obseva.com
+1 857 972 9347 Office+1 781 366 5726 Mobile
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