-Long-term follow-up study to evaluate bone mineral density in women 
completing at least 20 weeks of treatment in Phase 3 PRIMROSE 1 or 
PRIMROSE 2 - 
 
 
 
   GENEVA, Switzerland and BOSTON, MA -- April 27, 2021 -- ObsEva SA 
(NASDAQ: OBSV) (SIX: OBSN), a biopharmaceutical company developing and 
commercializing novel therapies to improve women's reproductive health, 
today announced the initiation of the observational PRIMROSE 3 study. 
PRIMROSE 3 will evaluate long-term bone mineral density (BMD) in 
subjects who completed at least 20 weeks of treatment in the Phase 3 
PRIMROSE 1 (US only) and PRIMROSE 2 (Europe and EU) studies. 
 
   "GnRH antagonists are an exciting new therapeutic approach for the 
treatment of uterine fibroids. In the setting of dose-dependent 
reductions in estradiol, it is important to understand changes in bone 
mineral density following treatment, especially amongst potentially 
perimenopausal women," said Felicia Cosman, M.D., a leading expert in 
bone health and professor of medicine at Columbia University. "I look 
forward to seeing informative data from the PRIMROSE 3 study which will 
provide insights for women and practitioners on the long-term effects on 
bone health of high and low doses of linzagolix with and without 
hormonal add-back therapy." 
 
   PRIMROSE 3 is a long-term follow-up study of PRIMROSE 1 and 2 patients 
across all dosing regimens of Yselty--100 mg or 200 mg daily, alone or 
with add-back therapy (ABT), as well as placebo recipients--and will 
evaluate BMD in patients for up to 24 months following completion of 
treatment. To be eligible for enrollment, subjects must have: completed 
at least 20 weeks of treatment in PRIMROSE 1 or 2, had an 
end-of-treatment DXA scan within 35 days from the last treatment 
administration, completed treatment within 24 months of enrollment, been 
enrolled by PRIMROSE clinical sites who agreed to participate in 
PRIMROSE 3. Of the 405 women who met these criteria, it is expected that 
over 300 will enroll. Patients will be evaluated via DXA scan of the 
femoral neck, hip, and spine at 12, 18 and 24 months. In addition, 
information will be collected on patients' menopausal status, physical 
activity, intercurrent medical conditions, and other factors that may 
affect bone mineral density. Study participants will be recommended to 
use calcium and Vitamin D supplementation. 
 
   "We look forward to advancing our comprehensive uterine fibroids program 
and will continue to build on the momentum of our positive Phase 3 
PRIMROSE 1 and PRIMROSE 2 data," said Brian O'Callaghan, CEO of ObsEva. 
"We recently reported week 52 data and post-treatment follow-up data up 
to 76 weeks, demonstrating that continued treatment with Yselty provided 
sustained reductions in heavy menstrual bleeding, continued pain 
reduction and evidence of bone mineral density recovery. The strong 
results on the full suppression dose (200 mg) with ABT showed that 
Yselty could potentially offer best-in-class efficacy while the 100 mg 
without ABT regimen is the only GnRH antagonist option in development 
for women that are contraindicated for ABT or want to avoid exogenous 
hormones. We are encouraged by the data generated to date, which 
demonstrate Yselty is optimally designed to balance efficacy, a 
favorable tolerability profile and flexible dosing options to address 
the needs of more women. We believe our observational study will give us 
valuable data to inform patients and providers considering treatment 
with Yselty, if approved." 
 
 
 
   About Yselty(R) (Linzagolix) 
 
   Yselty(R) (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. 
 
 
 
   About Uterine Fibroids 
 
   Uterine fibroids are common benign tumors of the muscular tissue of the 
uterus. Uterine fibroids affect women of childbearing age and can vary 
in size from undetectable to large bulky masses.  Few long-term medical 
treatments are available, and as a result, approximately 300,000 
hysterectomies are performed for uterine fibroids every year in the US. 
 
   The symptoms of uterine fibroids are wide-ranging and include heavy 
menstrual bleeding, anemia, pelvic pressure and bloating, urinary 
frequency and pain that can be extremely debilitating with a significant 
impact on quality of life. These symptoms can also have an impact on 
mental health, creating the additional burden of anxiety and distress. 
 
 
 
   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 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 other similar expressions, and 
are based on ObsEva's current beliefs and expectations. These 
forward-looking statements include expectations regarding the potential 
therapeutic benefits and the clinical development of ObsEva's product 
candidates, the potential for new indications for  any of ObsEva's 
product candidates, the timing of enrollment in and data from clinical 
trials, expectations regarding regulatory and development milestones, 
including the potential timing of regulatory submissions to the EMA and 
FDA, the timing of and ObsEva's ability to obtain and maintain 
regulatory approvals for its product candidates, the results of 
interactions with regulatory authorities and the potential to raise 
additional funds or enter into strategic partnerships in the future. 
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, 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 
 
   Shauna.dillon@obseva.ch 
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   +41 22 552 1550 
 
   Investor Contact: 
 
   Joyce Allaire 
 
   jallaire@lifesciadvisors.com 
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   +1 (617)-435-6602 
 
 
 
 
 
 
 
   Attachment 
 
 
   -- Press Release in Pdf 
      https://ml-eu.globenewswire.com/Resource/Download/51e79236-46d3-4bfc-8695-6b23b3195bd2

(END) Dow Jones Newswires

April 27, 2021 01:00 ET (05:00 GMT)