ObsEva SA Announces Phase 3 IMPLANT 2 Clinical Trial Results of Nolasiban in IVF to be Presented at Annual ASRM Meeting Tuesday October 9, 2018

  • Recipient of Prize Paper Award from the Society for Assisted Reproductive Technology (SART)

Geneva, Switzerland and Boston, MA – October 5, 2018– ObsEva SA (NASDAQ: OBSV / SIX: OBSN), a Swiss  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, today announced that the Phase 3 IMPLANT 2 clinical trial results will be presented at the 74th annual meeting of the American Society of Reproductive Medicine (ASRM) taking place in Denver, Colorado, October 6-10, 2018.

ObsEva is pleased to acknowledge that the presentation has been awarded the Prize Paper of the Society for Assisted Reproductive Technology (SART).

Prize Paper Session:       Tuesday, October 9         10:45 am-12:00 pm Mountain Daylight Time (MDT)

11:45 am MDT: “A Placebo-controlled, Randomized, Double Blind, Phase 3 Study Assessing Ongoing Pregnancy Rates After Single Oral Administration of a Novel Oxytocin Receptor Antagonist, Nolasiban, Prior to Single Embryo Transfer”

About the IMPLANT 2 Clinical Trial

IMPLANT 2 is a Phase 3, randomized, double blind, clinical trial designed to confirm the efficacy of nolasiban to increase the chance of pregnancy and live birth in patients undergoing IVF or ICSI. Following ovarian stimulation, egg retrieval and fertilization, eligible women were randomized to receive either a single, oral dose of 900 mg nolasiban or placebo, 4 hours before Day 3 or Day 5 fresh, single embryo transfer (SET). The primary endpoint was ongoing pregnancy at 10 weeks after SET. Women with confirmed pregnancies were monitored until delivery, with a key secondary endpoint being live birth, and the infants are being followed-up for 6 months.

About Assisted Reproductive Technology (ART)

Infertility affects about 10 % of reproductive-aged couples, with more than 2 million ART treatments (mostly IVF) performed worldwide each year. Currently 59% of fresh embryo transfers are performed on Day 5 and 31% on Day 3 in the United States (CDC report, 2015 data).

While the success of ART depends on multiple factors such as embryo 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 reduced 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 with the potential to decrease uterine contractions, improve uterine blood flow and enhance the receptivity of the endometrium to embryo implantation, all of which may increase the chance of successful pregnancy and live-birth among patients undergoing ART. ObsEva licensed nolasiban from Merck KGaA, Darmstadt, Germany, in 2013 and retains worldwide, exclusive, commercial rights.

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. 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 IVF outcomes. 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.

For further information, please contact:

Media Contact Switzerland and Europe:
Christophe Lamps
Dynamics Group
cla@dynamicsgroup.ch
+41 22 308 6220 Office
+41 79 476 26 87 Mobile

Media Contact U.S.:
Marion Janic
RooneyPartners LLC
mjanic@rooneyco.com
+1 212 223 4017 Office
+1 646 537 5649 Mobile

CEO Office Contact:
Shauna Dillon
Shauna.dillon@obseva.ch
+41 22 552 1550

Investor Contact:
Mario Corso
Senior Director, Investor Relations
mario.corso@obseva.com
+1 857 972 9347 Office
+1 781 366 5726 Mobile

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Note that the following information contains information on investigational medicinal products. These products have not yet been approved for marketing by the European Medicines Agency or the U.S. Food and Drug Administration and are still under development. Further additional investigations may be needed in order for the marketing authorization to be granted, which grant may depend on a variety of factors and is not guaranteed. Click on “return” if you do not wish to receive such information. By clicking on “continue” you acknowledge that you wish to receive scientific information on our investigational products.

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Disclaimer

Note that the following information contains information on investigational medicinal products. These products have not yet been approved for marketing by the European Medicines Agency or the U.S. Food and Drug Administration and are still under development. Further additional investigations may be needed in order for the marketing authorization to be granted, which grant may depend on a variety of factors and is not guaranteed. Click on “return” if you do not wish to receive such information. By clicking on “continue” you acknowledge that you wish to receive scientific information on our investigational products.

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