ASRM

health

ObsEva SA Presented Two Late-Breaking Posters at the ASRM 2020 Virtual Scientific Congress October 17-21

 

Geneva, Switzerland and Boston, MA – October 22, 2020 – ObsEva SA (NASDAQ: OBSV), a clinical-stage biopharmaceutical company developing and commercializing novel therapies to improve women’s reproductive health, today announced the presentation of two posters at the ASRM 2020 Virtual Scientific Congress and Expo during the first ever Late-Breaking Abstract Poster Session.

Late-breaking poster – P-931: Linzagolix may address the long-term treatment needs of women with uterine fibroids who have contraindications to hormonal add-back therapy: results from two Phase 3 randomized clinical trials

Dr. Linda Bradley, Professor of Ob/Gyn and Reproductive Biology and Vice Chair, Ob/Gyn and Women’s Health Institute, Cleveland Clinic OH, is lead author for a late-breaking poster, which discusses the potential for the low-dose (100 mg) of linzagolix, a once daily oral GnRH antagonist, to fill an unmet need for medical treatment of uterine fibroids in women who cannot or prefer to avoid hormonal add-back therapy (ABT). CDC data suggest that up to 50% of women with uterine fibroids may have a contraindication to ABT. Because linzagolix is the only oral GnRH antagonist being developed with a low-dose, no add-back therapy option, it has the potential to address the unique needs of black women, who are both disproportionately affected with uterine fibroids and are more likely to have contraindications to ABT.

Late-breaking poster – P-930: Efficacy and Safety of Linzagolix for the Treatment of Heavy Menstrual Bleeding Due to Uterine Fibroids:  Results from Two Phase 3 Randomized Clinical Trials

The second late-breaking poster, with lead author Dr. Elizabeth Stewart, Professor of Obstetrics and Gynecology and Chair of the Division of Reproductive Endocrinology, Mayo Clinic MN, presented results from PRIMROSE 1 and PRIMROSE 2, the two positive Phase 3 clinical trials, which support the potential best-in-class efficacy of linzagolix in the treatment of uterine fibroids.

The related abstracts are scheduled to be published online in the Fertility and Sterility Abstract Supplement in October 2020.

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 outcomes following in vitro fertilization. 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 Linzagolix

Yselty® (linzagolix) is a novel, once daily, oral GnRH receptor antagonist with a potentially best-in-class profile. Linzagolix is currently in late-stage clinical development for the treatment of heavy menstrual bleeding associated with uterine fibroids and pain associated with endometriosis. ObsEva licensed linzagolix from Kissei in late 2015 and retains worldwide commercial rights, excluding Asia, for the product. Linzagolix is not currently approved anywhere in the world.

Yselty® is a registered trademark owned by Kissei for use by ObsEva. Yselty® is not yet approved for use anywhere in

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health

ObsEva SA Presented Nolasiban Poster at the ASRM 2020 Virtual Scientific Congress October 17-21

 

Geneva, Switzerland and Boston, MA – October 20, 2020 – ObsEva SA (NASDAQ: OBSV), a clinical-stage biopharmaceutical company developing and commercializing novel therapies to improve women’s reproductive health, today announced the presentation of a poster at the ASRM 2020 Virtual Scientific Congress and Expo.

Poster number # P-482: The Effect of the Oral Oxytocin Antagonist, Nolasiban, On Pregnancy Rates in Women Undergoing Embryo Transfer Following IVF

Dr. Georg Griesinger, Professor at Luebeck University, Germany, and chair of the Department of Gynecological Endocrinology and Reproductive Medicine, University Hospital of Schleswig-Holstein, is lead author of a poster presenting results from a meta-analysis of the clinical trials and a mechanism of action study of nolasiban, an oxytocin receptor antagonist being developed for its potential to increase pregnancy rates following in vitro fertilization (IVF). Results support the further evaluation of higher doses and/or alternate regimens of nolasiban. ObsEva is partnering with YuYuan BioScience Technology, a Chinese company, for the development of nolasiban.

The related abstract is scheduled to be published online in the Fertility and Sterility Abstract Supplement in October 2020.

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 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).

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 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

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medicine

Ferring Pharmaceuticals to Share New Reproductive Medicine Data at ASRM 2020 Scientific Congress & Expo

Ferring Pharmaceuticals (US) today announced that it will present eleven company-sponsored abstracts, including six oral presentations, at the American Society for Reproductive Medicine (ASRM) 2020 Virtual Scientific Congress & Expo taking place October 17-20, 2020.

“We look forward to presenting data at this year’s ASRM congress, where leaders will gather virtually to share meaningful research that advances scientific knowledge in the field of reproductive medicine,” said Gaurang Daftary, M.D., M.B.A, Vice President, Reproductive Medicine and Maternal Health at Ferring Pharmaceuticals. “At Ferring, we are committed to addressing the medical needs of patients through the advancement of science. Our presence at ASRM this year underscores that commitment.”

Ferring’s first oral presentation highlights data from a clinical trial involving infertile women with primary hypothalamic amenorrhea, a rare patient population that is unable to ovulate and achieve pregnancy due to deficiencies in their brain’s production or secretion of a key peptide called Gonadotropin Releasing Hormone (GnRH).

Additionally, the company will present three new sub analyses of data from the recently published MEGASET-HR trial. The first abstract characterizes differences in ovarian response dependent upon the type of gonadotropin used and baseline levels of anti-Müllerian Hormone (AMH), a marker of ovarian reserve. The second presents a possible relationship between serum levels of human chorionic gonadotropin (hCG) at the end of stimulation and live birth. The third abstract from the MEGASET-HR trial describes outcomes from the transfer of fresh or frozen embryos designated as normal based on assessment of the number of chromosomes.

The details of all Ferring abstracts presented at the meeting are as follows:

Oral (O-33):
Title: Pulsatile Gonadotropin Releasing Hormone (GnRH) via Subcutaneous Pump for the Treatment of Primary Amenorrhea Associated with Hypogonadotropic Hypogonadism
Date and Time: Saturday, October 17, 2020; 2:30 PM-2:45 PM

Oral (O-169):
Title: Safety evaluation of a novel progesterone vaginal ring (PVR) in luteal phase support: SARA trial results
Date and Time: Monday, October 19, 2020; 1:50 PM-2:05 PM

Oral (O-223):
Title: Differential Ovarian Response to Gonadotropin Preparations Despite Similar Ovarian Reserve: MENOPUR in GnRH (Gonadotropin Releasing Hormone) Antagonist Single Embryo Transfer – High Responder (MEGASET-HR) Trial Analysis
Date and Time: Tuesday, October 20, 2020; 1:50 PM-2:05 PM

Oral (O-224):
Title: Serum gonadotropin association with live birth in high-responders undergoing ovarian stimulation: MENOPUR in Gonadotropin Releasing Hormone (GNRH) Antagonist Single Embryo Transfer – High Responder (MEGASET-HR) trial analysis
Date and Time: Tuesday, October 20, 2020; 2:05 PM-2:20 PM

Oral (O-225):
Title: Fresh versus frozen euploid blastocyst transfer outcomes in predicted high-responders: MENOPUR in GNRH (Gonadotropin Releasing Hormone) Antagonist Single Embryo Transfer – High Responder (MEGASET-HR) trial analysis
Date and Time: Tuesday, October 20, 2020; 2:20 PM-2:35 PM

Poster (P-443):
Title: Similar ovarian response with individualized follitropin delta dosing regimen in Japanese and non-Japanese IVF/ICSI patients
Date and Time: Monday, October 19, 2020; 4:30 PM-6:00 PM

Poster (P-591):
Title: Atosiban and Barusiban improved impaired endometrial blood flow in pregnant rabbits
Date and Time: Monday, October 19, 2020; 4:30 PM-6:00 PM

Poster (P-458):
Title: Similar dose-response profiles for

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