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2016-10-24

ObsEva SA: ObsEva Announces Results of the IMPLANT Phase 2 Trial of OBE001 (nolasiban) for the Improvement of Pregnancy and Live Birth Rates Following IVF/ICSI

ObsEva SA / ObsEva Announces Results of the IMPLANT Phase 2 Trial of OBE001
(nolasiban) forthe Improvement of Pregnancy and Live Birth Rates Following
IVF/ICSI . Processed and transmitted by Nasdaq Corporate Solutions.The issuer
is solely responsible for the content of this announcement.
Trial shows meaningful increase in pregnancy and live birth rates in patients
treated with OBE001

ObsEva to proceed with a Phase 3 clinical trial in Europe

Geneva, Switzerland, 24 October 2016 - ObsEva SA, a Swiss biopharmaceutical
company focused on the development and commercialization of novel
therapeutics for serious conditions that impact a woman's reproductive health
and pregnancy, announced today the results of its IMPLANT clinical trial, a
Phase 2 clinical trial of OBE001 (nolasiban) for the improvement of clinical
pregnancy and live birth rates in women undergoing embryo transfer (ET)
following in vitro fertilization (IVF)/intracytoplasmic sperm injection
(ICSI). The trial was designed to assess the safety and efficacy of a range
of doses of OBE001, an oral oxytocin receptor antagonist, compared to
placebo.

In the trial population of 247 patients, both the percentage of women with a
clinical pregnancy (defined as an intra-uterine pregnancy with positive
embryo heart beat at six weeks after ET) by over an absolute 9 percent and
live birth rates were increased by 10.4 percent (actual live birth rates were
39.6 percent and 29.2 percent for patients treated with OBE001 and patients
who received placebo, respectively). While the trial did not achieve its
pre-defined primary endpoint of a statistically significant dose-response
trend on the percentage of women with clinical pregnancy (powered at 80
percent to detect an absolute difference of 20 percent between placebo and
ascending doses of OBE001), ObsEva believes the results were clinically
meaningful and equivalent to a 26 percent increase relative to placebo.

The lack of a statistically significant dose-response appears to be primarily
due to an imbalance in the 300 mg dose group, in the number of the patients
who had a high progesterone level at baseline relative to the other arms.
ObsEva believes that high progesterone levels can be a possible negative
predictive factor for live birth. In a post-hoc analysis that excluded
patients with a progesterone level in the top quartile of the patient pool, a
statistically significant relationship between the dose of OBE001 and the
ongoing clinical pregnancy at week 10 (trend test p-value = 0.035) and live
birth rates was identified (trend test p-value = 0.025). In addition, a live
birth rate of 51.0 percent was recorded in patients who received a 900 mg
dose of OBE001 compared to 30.6 percent in the placebo group. This was the
highest observed live birth rate in the trial and equivalent to a 67 percent
increase relative to placebo. OBE001 was well tolerated in all dose groups.

"We are encouraged by the meaningful increase in pregnancy and live birth
rates observed in patients treated with OBE001, particularly in women with
normal progesterone levels at the time of embryo transfer," said Ernest
Loumaye, MD, PhD and CEO and co-Founder of ObsEva. "We believe that if
confirmed in larger trials, this would represent a major breakthrough for
improving the success rate of IVF, a procedure more and more frequently used
to address the need of the growing number of couples seeking treatment for
infertility."

The IMPLANT trial was a prospective, dose ranging, randomized, double-blind,
placebo-controlled trial, which enrolled 247 patients across 26 specialist
IVF centers in five European countries including Belgium, Czech Republic,
Denmark, Poland and Spain. Patients received a single oral dose of OBE001
(100 mg, 300 mg or 900 mg) approximately four hours before a Day 3 fresh
embryo transfer and were evaluated for up to 10 weeks. Pregnancies, births
and infant health were monitored up to six months after birth.

Based on the results of the IMPLANT trial, ObsEva intends to initiate in
Europe a Phase 3 clinical trial in women undergoing IVF. The European Phase 3
trial, which ObsEva will refer to as IMPLANT-2, is planned to start in the
first half of 2017.

About IVF and OBE001 (nolasiban)

Infertility affects about 11 percent of reproductive-aged women in the United
States. Every year, approximately 1.6 million IVF/ICSI treatments are
performed globally. In the United States, approximately 210,000 IVF/ICSI
treatments were performed in 2014, in the EU, 620,000 approximately IVF/ICSI
treatments were performed in 2012 and in Japan, approximately 325,000
IVF/ICSI treatments were performed in 2012. The success rate, or live birth
rate, of such treatments is highly dependent on the quality of the embryo,
the transfer procedure and ultimately the receptivity of the uterus. The
cost of one IVF/ICSI cycle varies between $8,000 to$15,000 in the United
States, €2,000 to €10,000 in the EU and $2,000 to $6,000 in Japan. OBE001
(nolasiban) is an oral oxytocin receptor antagonist with the potential to
decrease uterine contractions, improve uterine blood flow and enhance the
receptivity of the endometrium to embryo implantation, thereby enhancing
clinical pregnancy and live birth rates following IVF/ICSI.

About ObsEva

ObsEva is a clinical-stage biopharmaceutical company focused on the clinical
development and commercialization of novel therapeutics for serious
conditions that compromise a woman's reproductive health and pregnancy.
ObsEva is focused on providing therapeutic solutions for women between the
ages of 15 and 49 who suffer from reproductive health conditions that affect
their quality of life and ability to conceive or that may lead to
complications during pregnancy. ObsEva's goal is to build a leading women's
reproductive health and pregnancy company focused on conditions where current
treatment options are limited and significant unmet need exists. Through
strategic in-licensing and disciplined drug development, ObsEva has
established a clinical-stage pipeline with development programs focused on
treating the symptoms associated with endometriosis and uterine fibroids,
improving clinical pregnancy and live birth rates in women undergoing in
vitro fertilization, and treating preterm labor. ObsEva is supported by
leading healthcare investors and a globally recognized board and is
well-positioned to establish a leadership position in women's reproductive
therapeutics. For more information, please visitwww.ObsEva.com.

###

MEDIA CONTACT

Liz Bryan
Spectrum
+1 (202) 955 6222
lbryan@spectrumscience.com

COMPANY CONTACT

Delphine Renaud
ObsEva, CEO Office
+41 22 552 1550
delphine.renaud@obseva.ch

Press Release
http://hugin.info/157613/R/2050733/767166.pdf

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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: ObsEva SA via Globenewswire

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