-- If approved, linzagolix will be the only GnRH antagonist with flexible 
      dose regimen options for the management of uterine fibroids: 
 
          -- 100 mg once daily for women with a contraindication to or who 
             prefer to avoid hormonal add-back therapy (ABT) 
 
          -- 200 mg once daily with concomitant ABT for long-term use (beyond 6 
             months) 
 
          -- 200 mg once daily for short-term use, in particular when rapid 
             reduction in fibroid volume is desired 
 
 
 
 
 
   -- ObsEva expects to submit a new drug application to U.S. Food and Drug 
      Administration in 1H:21 
 
 
 
 
   GENEVA, Switzerland and BOSTON, MA (November 24, 2020) -- ObsEva SA 
(NASDAQ: OBSV; SIX: OBSN), a biopharmaceutical company developing and 
commercializing novel therapies to improve women's reproductive health, 
today announced the submission of a Marketing Authorization Application 
(MAA) to the European Medicines Agency (EMA) for YSELTY(R) (linzagolix 
100mg and linzagolix 200mg) for the management of heavy menstrual 
bleeding (HMB) associated with uterine fibroids. 
 
   "The MAA submission is a major milestone for the company as it 
represents more than 5 years of drug development work by ObsEva team. I 
want to thanks all those who in the company or as subcontractors, as 
well as the more than 2,000 patients who contributed to this milestone. 
In developing multiple dose options, our long-term strategy has always 
been to meet the needs of the diverse population of women with uterine 
fibroids," said Dr. Ernest Loumaye, founder and CEO of ObsEva. 
"Successful submission of the MAA brings us a step closer toward 
commercialization of Yselty, which will provide more women a potential 
best-in-class treatment for uterine fibroids." 
 
   The Phase 3 clinical program in uterine fibroids comprises two pivotal 
trials, PRIMROSE 1 and PRIMROSE 2, that were designed to demonstrate the 
effectiveness and safety to support the claimed indication: management 
of HMB associated with uterine fibroids. The application is being 
submitted at this time as both Phase 3 studies have met their success 
criteria: both low and high doses of linzagolix with and without ABT are 
effective in the treatment of HMB associated with uterine fibroids and 
have an acceptable benefit risk profile. 
 
   The EMA is expected to notify ObsEva in December 2020 regarding the 
outcome of its validation of the MAA to ensure all essential regulatory 
elements required for a scientific assessment are included in the 
application prior to the start of the procedure. 
 
   About Linzagolix 
 
   Linzagolix (previously known as OBE2109) is a novel, oral, once daily, 
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. 
 
   About PRIMROSE 1 AND 2 
 
   PRIMROSE 1 (conducted in the United States, which enrolled 574 women 
with uterine fibroids) and the PRIMROSE 2 (conducted in Europe and in 
the United States, which enrolled 535 women with uterine fibroids) 
clinical trials are two Phase 3 clinical trials of linzagolix in 
patients with HMB associated with uterine fibroids. In both trials, 
patients were administered linzagolix doses of 100 mg or 200mg, both 
with and without hormonal ABT, or placebo. The primary endpoint of both 
trials was reduction in HMB at 24 weeks; responders were defined as 
patients with menstrual blood loss (MBL) of <= 80 mL and a >= 50 percent 
reduction from baseline in MBL, measured using the alkaline hematin 
method. Secondary endpoints included amenorrhea, time to reduced MBL, 
hemoglobin (Hb), pain, and quality of life (QoL). Safety endpoints 
included bone mineral density (BMD), and adverse events (AEs). 
Calcium/vitamin D were not provided. BMD was measured centrally via Dual 
Energy X-ray Absorptiometry (DEXA) scan at baseline and 24, 52, and 76 
weeks (6-month post treatment assessment). 
 
   Both PRIMROSE trials successfully met the 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. Substantial 
improvements were also observed in all doses for the secondary endpoints 
of amenorrhea, time to reduced MBL and amenorrhea, hemoglobin levels in 
anemic subjects, pain, and quality of life.  The 200 mg dose alone 
showed rapid and substantial reduction in uterine and fibroid volume. 
 
   In PRIMROSE 1, the responder rate was 75.5% (p < 0.001) for patients 
receiving 200 mg with ABT and 56.4% for patients receiving 100 mg 
without ABT (p =0.003), compared to 35.0% in the placebo group. The 
overall safety profile was in line with expectations. The most 
frequently observed adverse events (occurring in > 5% of patients) were 
headache and hot flushes. Mean percentage changes from baseline in BMD 
were minimal, as expected with any GnRH antagonist treatment. 
 
   In PRIMROSE 2, the responder rate was 93.9% (p < 0.001) for patients 
receiving 200 mg with ABT and 56.7% for patients receiving 100 mg 
without ABT (p < 0.001), compared to 29.4% in the placebo group. The 
overall safety profile was in line with expectations. The most 
frequently observed adverse events (occurring in > 5% of patients) were 
headache, hot flushes, and anemia. Mean percentage changes from baseline 
in BMD were minimal and consistent with previous clinical data. 52-week 
results demonstrated that continued treatment with linzagolix provided 
sustained efficacy in the reduction of HMB; responder rates of 91.6% and 
53.2% were observed in women receiving 200 mg with ABT and 100 mg 
without ABT, respectively. In addition, small incremental changes in BMD 
were observed at week 52 compared to week 24, suggesting the onset of 
plateauing BMD loss. 
 
   Additional follow-up data to be collected include PRIMROSE 1 52-week 
treatment results and 6-month post treatment assessment from both 
studies. 
 
   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, 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 
https://www.globenewswire.com/Tracker?data=t9aQK7WC87Eiri-EmY-VOpc_tVKCcfB39tm1EgY_06hKdYzya_pMv5KnrzWTub2lGsMj-_c1cB_g5aIH38SVuQ== 
www.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. 
 
   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 timing, 
advancement, best-in-class efficacy and potential therapeutic benefits 
of linzagolix, the potential for linzagolix to be a commercially 
competitive product, expectations regarding regulatory and development 
milestones, including the potential timing of regulatory submissions to 
the 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 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 November 5, 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: 
 
   CEO Office contact 
 
   Shauna Dillon 
 
   https://www.globenewswire.com/Tracker?data=UWKc4heOol7_wX5vD6jW6mzbchS6SUXRRCMI7kyhedSu3YtCapkHS5y1GaCjAcE6riuKvV-VrPe72PsTazPq7Iw6bMWtWPRG2g92a12nhKE= 
Shauna.dillon@obseva.ch

(MORE TO FOLLOW) Dow Jones Newswires

November 24, 2020 01:00 ET (06:00 GMT)