Clinical Trial Data and Regulatory Progress on Lead Programs Targeting IVF, Endometriosis, and Uterine Fibroids to Transform Company in 2019
GENEVA, Switzerland and BOSTON, Mass. (December 7, 2018) – ObsEva SA (NASDAQ: OBSV / SIX: OBSN), a 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 held an R&D Day in New York City.
At the event, company executives and women’s health Key Opinion Leaders (KOLs) discussed recent clinical data, upcoming clinical milestones, and commercial potential of ObsEva R&D pipeline, including nolasiban, an oral oxytocin receptor antagonist for the improvement of IVF outcomes, and linzagolix, a novel, oral gonadotropin-releasing hormone (GnRH) receptor antagonist for the treatment of uterine fibroids and endometriosis. The company also outlined its recently initiated approach to commercial operations in preparation for potential European and U.S. regulatory approvals in 2021 and beyond.
"Today’s meeting presents a major opportunity to underscore the tremendous unmet needs in our disease areas of focus in Women’s Health and Fertility, and also demonstrate how ObsEva’s compounds can provide significant value by helping physicians and patients address the current therapeutic shortcomings,” said Ernest Loumaye, co-founder and Chief Executive Officer of ObsEva.
ObsEva’s Chief Commercial Officer Wim Souverijns further commented, “I recently joined ObsEva because I was attracted by its impressive late-stage R&D pipeline. Today, I am able to share some initial perspectives on how our most advanced compound, nolasiban, can potentially transform the lives of couples experiencing infertility, starting in Europe.”
Senior Executives from ObsEva’s management team were joined by KOLs Hugh Taylor, MD, Professor and Chair, Department of Obstetrics Gynecology and Reproductive Sciences at Yale School of Medicine in New Haven, Conn.; Annette Lee, MD, Medical Director of Reproductive Endocrinology & Infertility at Abington Reproductive Medicine in Abington, Penn.; and Christophe Blockeel, MD, PhD, Medical Director of the Centre for Reproductive Medicine, University Hospitals Brussels in Belgium.
Highlights of the R&D day included:
A live and archived webcast of the event including slides is available here.
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
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 clinical development of ObsEva’s product candidates, the timing of enrollment in and data from clinical trials and the results of interactions with regulatory authorities. 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, clinical development and related interactions with regulators, ObsEva’s reliance on third parties over which it may not always have full control, 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, 2017, and other filings ObsEva makes with the SEC. These documents are available on the Investors page of ObsEva’s website at 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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