- European Medicines Agency Validates Yselty MAA for Uterine Fibroids; 
US NDA Planned for 1H 2021 
 
   - Phase 3 EDELWEISS 3 (Conducted in Europe and US) Study of Yselty for 
Treatment of Endometriosis is Progressing as Planned; Primary Endpoint 
Readout Expected 4Q 2021 
 
   - Phase 3 EDELWEISS 2 (Conducted in the United States) Yselty 
Endometriosis Study Discontinued Due to Enrollment Challenges; No Safety 
Concerns Identified 
 
 
 
 
 
   GENEVA, Switzerland and BOSTON, MA (Jan 11, 2021) -- ObsEva SA (NASDAQ: 
OBSV; SIX: OBSN), a biopharmaceutical company developing and 
commercializing novel therapies to improve women's reproductive health, 
today announced several important updates on its Yselty program. 
 
   Validation of Marketing Authorization Application for the Treatment of 
Uterine Fibroids 
 
   The Marketing Authorization Application (MAA) is an application for 
approval submitted to the European Medicines Agency (EMA) and is a 
critical step in marketing a product in the EU. Validation marks the 
beginning of the review period. The Yselty MAA for the uterine fibroids' 
indication is based on data from the Phase 3 PRIMROSE 1 study (conducted 
in the US, which enrolled 574 women with uterine fibroids) and PRIMROSE 
2 (conducted in Europe and the US, which enrolled 535 women with uterine 
fibroids). In both studies, patients with heavy menstrual bleeding (HMB) 
associated with uterine fibroids were administered Yselty doses of 100 
mg or 200 mg, with and without hormonal add-back-therapy (ABT; 1 mg 
estradiol/0.5 mg norethisterone acetate), or placebo. 
 
   "We are very pleased that the EMA has validated our application for 
Yselty, a potential best-in-class treatment for women suffering from 
heavy menstrual bleeding associated with uterine fibroids," said 
Elizabeth Garner, M.D., M.P.H., Chief Medical Officer of ObsEva. "Yselty 
is the only GnRH antagonist to provide flexible dosing options that will 
allow us to better address the individual needs of the diverse 
population of women with uterine fibroids. This marks a major milestone 
in making Yselty available in the E.U., and we look forward to working 
closely with the EMA as we advance Yselty towards commercialization. We 
also remain on track to submit the US NDA during the first half of 2021, 
a key objective for the company this year." 
 
   PRIMROSE 1 and 2 successfully met their primary endpoint, with all doses 
showing statistically significant and clinically relevant reductions in 
HMB compared to placebo. There was a clear efficacy dose response, with 
the highest responder rates for the primary endpoint observed in women 
who received the 200 mg with ABT dose. Highly significant efficacy was 
also achieved for the low-dose 100 mg non-ABT regimen. Substantial 
improvements were also observed with all doses for the secondary 
endpoints of amenorrhea, time to reduced menstrual blood loss, 
hemoglobin levels in anemic subjects, pain, and quality of life. 
 
   ObsEva anticipates follow-up data and 6-month post treatment assessment 
data in Q1 2021. Additional information about this study can be found 
https://www.globenewswire.com/Tracker?data=9WDP9idgUjI--AzZkB_5ry-OJ6akfdEuMv6uikmMw4Ww9yCIiN7SIMjVETasFC8mGEzpNrS3X5FqErp3zJBq0yLgqBhCyYIuBUxhhTPVnvkdzgNWxSVfXpehq3IgfEWJc4A-qeahu6PdYDxWActMEw== 
here. 
 
   Clinical Development Program for the Treatment of 
Endometriosis-Associated Pain 
 
   The clinical development program for the endometriosis indication is a 
key priority for ObsEva. The EDELWEISS 3 trial in the EU is progressing 
as planned, with primary endpoint data expected in 4Q 2021. Screening 
and enrollment for EDELWEISS 2 in the US has been increasingly 
challenging, particularly in the context of the persisting difficult 
environment of the ongoing pandemic and has led to ObsEva's decision to 
discontinue the study.  No new or significant safety issues have been 
observed. 
 
   "After careful consideration, we strongly believe halting the EDELWEISS 
2 study is the right decision for ObsEva, given the ongoing enrollment 
challenges. This decision also gives us the ability to conserve over $30 
million," said Brian O'Callaghan, CEO of ObsEva. We remain fully 
committed to developing and commercializing Yselty in both uterine 
fibroids and endometriosis and are continuing to explore partnership and 
other financing opportunities to support the program. We also plan to 
conduct, as soon as is feasible, a new Phase 3 endometriosis study with 
a number of design and operational changes to facilitate faster 
enrollment, with a goal to maintain the original MAA and NDA filing 
timelines for this important indication. In addition, this 
cost-efficient approach will also help ObsEva progress our other 
pipeline programs, including ebopiprant, which recently yielded positive 
Phase 2 results in the treatment of preterm labor. We are also 
considering and planning for the potential development of linzagolix in 
prostate cancer, possibly in combination with estrogen add-back, a known 
approach to lowering side effects of androgen deprivation therapy. 
Overall, our strategy to more efficiently complete the development of 
the endometriosis indication development while improving utilization of 
capital will support our clinical development strategy and bring us 
another step closer to addressing unmet needs in women's reproductive 
health." 
 
   The ongoing Phase 3 EDELWEISS 3 study will enroll approximately 450 
patients with endometriosis associated pain, with a co-primary endpoint 
of response on both dysmenorrhea (menstrual pain) and non-menstrual 
pelvic pain. The study includes a 75 mg once daily dose without hormonal 
ABT, and a 200 mg once daily dose in combination with hormonal ABT (1mg 
E2 / 0.5mg NETA). Subjects who have completed the initial six-month 
treatment period will have the option to enter a 6-month treatment 
extension. Data from the primary endpoint readout are expected in 4Q 
2021. Additional information about this study can be found 
https://www.globenewswire.com/Tracker?data=9WDP9idgUjI--AzZkB_5rw_gBZN57uoNbLnzJJJnFmi60cQ_TkR5vp-i0x5Ee-MYH21Dl96RHe6vEHL29i9E0Tbo1QPXwM8VjGuL5FSPa0Y= 
here. 
 
   About Yselty(R) 
 
   Yselty(R) (linzagolix, previously known as OBE2109) is a novel, oral, 
once daily, GnRH receptor antagonist with a potentially best-in-class 
profile. Yselty 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 Yselty from 
Kissei in late 2015 and retains worldwide commercial rights, excluding 
Asia, for the product. 
 
   Yselty(R) is a registered trademark owned by Kissei for use by ObsEva. 
Yselty(R) is not yet approved for use anywhere in the world. 
 
   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 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 
visit 
https://www.globenewswire.com/Tracker?data=OAijS86bw6N8sz6ROdMDv9xfTSk9aHD31QWkOpSd6JS0HcNQAXN4U_ppGZQCe1pKcVxCoEUnSAFziLNb5dno_A== 
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, including the timing, 
advancement and potential therapeutic benefits of linzagolix, the 
potential for linzagolix to be a commercially competitive product, the 
timing of data from clinical trials, expectations regarding regulatory 
and development milestones, including the potential timing of regulatory 
submissions to the EMA and FDA, 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 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 ongoing novel coronavirus 
pandemic, 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 
November 5, 2020 and other filings ObsEva makes with the SEC. These 
documents are available on the Investors page of ObsEva's website at 
https://www.globenewswire.com/Tracker?data=Zu1mIEngcpdMHRoAwECr8oiOCHGw-jizQIi0TGg9C7LI9PdKKclhQn6T7fDoZ3wY9ERqy9XOfycByU3U-UvWrYnFcVcQdO2DLs9uhT3g1ck= 
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:

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January 11, 2021 01:00 ET (06:00 GMT)