Geneva, Switzerland and Boston, MA – 2 November, 2020 – ObsEva SA (NASDAQ: OBSV / SIX: OBSN), a clinical-stage biopharmaceutical company developing and commercializing novel therapies to improve women’s reproductive health, today announced an oral communication and a live symposium at SEUD Online Week 2020 to take place November 3 – 6.
On November 5, lead author Professor Jacques Donnez, Société de Recherche pour l'Infertilité, Brussels, and Catholic University of Louvain, Belgium, will present the positive results from PRIMROSE 2, a Phase 3 clinical trial comparing linzagolix at different dose regimens versus placebo in the treatment of heavy menstrual bleeding due to uterine fibroids. The efficacy and safety data for both a full suppression regimen with concomitant hormonal add-back therapy (ABT), as well as a partial suppression regimen without hormonal ABT support the potential best-in-class profile of linzagolix in the treatment of uterine fibroids.
The same day, ObsEva will be hosting a live symposium entitled “The power of the GnRH antagonist MoA to personalize fibroid management: One Size Does Not Fit All” chaired by Professors Petraglia & Donnez. The focus of the symposium is to highlight the importance of the potential of an oral GnRH antagonist to alleviate symptoms of heavy menstrual bleeding due to uterine fibroids through both full as well as partial suppression with and without ABT, respectively. This optionality potentially allows for more women suffering from this condition to be treated effectively.
-Oral communication of abstract presented by Professor Jacques Donnez (BE) on Thursday 05 November in session of “Free communications 7: uterine fibroids” beginning at 3:40pm CET.
“The Effect of Linzagolix on Heavy Menstrual Bleeding (HMB) due to Uterine Fibroids (UF): Results from a Placebo-Controlled, Randomized, Phase 3 Trial”
-Live Symposium co-chaired by Professors Felice Petraglia (IT) & Jacques Donnez (BE) on Thursday 05 November, 2:00pm – 2:40pm CET
“The power of the GnRH antagonist MoA to personalize fibroid management: One Size Does Not Fit All”
The link to the live symposium will be available under “Events Calendar” in the investors section of ObsEva’s website at www.ObsEva.com
The SEUD Online Week 2020 is accessible at https://sow2020.seud.org.
Virtual exhibition and ObsEva’s booth are already open.
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 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.
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.
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. 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.
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