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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.
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.
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 the world.
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/linzagolix is a new chemical entity discovered by Kissei R&D and currently in development in Japan by Kissei.
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 expectations regarding the potential best-in-class efficacy and therapeutic benefits of linzagolix, including addressing the unique needs of black women. 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 uncertainties inherent in the conduct of clinical trials and clinical development, 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, ObsEva’s reliance on third parties over which it may not always have full control, the impact of the novel coronavirus outbreak, 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 August 6, 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:
+41 22 552 1550