Marketing Authorization Application submission with the European Medicines Agency byyear-end 2020 and a New Drug Application submission with the U.S. Food and Drug Administration by Q1 2021.”
Dr. Hugh Taylor, Professor and Chair of Obstetrics and Gynecology at Yale University, said, “Women with uterine fibroids neednon-surgical alternatives to reduce the often unbearable effects of heavy menstrual bleeding. The prospects for a medical treatment with multiple dosing options would address a need for this diverse population of women. I am particularly impressed with the 94% responder rate and 80% amenorrhea rate that linzagolix has shown.”
Conference Call and Webcast Today
ObsEva will host a conference call and audio webcast today beginning at 8:00 a.m. Eastern Time/2:00 p.m. Central European Time to discuss Phase 3 PRIMROSE 2 trial results of linzagolix. Investors may participate by dialing (844)419-1772 for U.S. callers or +1 (213)660-0921 for international callers and referring to conference ID 1764134. A live or archived webcast of the conference call can be accessed under the “Investors” section of ObsEva’s websitewww.ObsEva.com.
About Linzagolix
Linzagolix (previously known as OBE2109) is a novel, oral, once daily, GnRH receptor antagonist with a potentiallybest-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.
About PRIMROSE 2
PRIMROSE 2 is a prospective, randomized, parallel group, double-blind, placebo-controlled phase 3 trial investigating the efficacy and safety of two dosing regimens of linzagolix, 100mg and 200mg once daily, alone and in combination with hormonal ABT for the treatment of HMB associated with uterine fibroids. Women participating in the trial did not receive Vitamin D or calcium supplementation. The trial was conducted in Europe and the US and enrolled 535 women for a treatment period of 12 months.
About ObsEva
ObsEva is a biopharmaceutical company developing and commercializing novel therapies to improve women’s reproductive health and pregnancy. Through strategicin-licensing and disciplined drug development, ObsEva has established a late-stage clinical pipeline with development programs focused on treating endometriosis, uterine fibroids and preterm labor. 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 visitwww.ObsEva.com.
About Kissei
Kissei is a Japanese pharmaceutical company with approximately 70 years of history, specialized in the field of urology, kidney-dialysis and Unmet Medical Needs. Silodosin is a Kissei product for the treatment of the signs and symptoms of benign prostatic hyperplasia which is sold worldwide through its licensees.KLH-2109/OBE2109 is a new chemical entity discovered by Kissei R&D.
