ObsEva R&D Day Showcases Multiple Women’s Health Programs and Outlines Plans for Transition to Commercial Operations
07 Diciembre 2018 - 11:12AM
ObsEva R&D Day Showcases Multiple Women’s Health Programs and
Outlines Plans for Transition to Commercial Operations
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:
- ObsEva outlined significant R&D program plans for 2019 and
2020 for its three potential best-in-class/first-in-class new
chemical entities, including six Phase 3 trials and one Phase 2b
trial. Cash on hand is now expected to be sufficient to fund
operations to mid-2020, as opposed to into the first half of 2020
previously.
- The Phase 3 IMPLANT 4 trial with Nolasiban for improving IVF
outcomes has been initiated and patients are being screened.
The placebo-controlled, double-blind trial is being conducted at 51
clinical sites in 10 countries, primarily in Europe (n=43), Russia
(n=4) and Canada (n=4), and will enroll approximately 800 patients
who are undergoing single embryo (blastocyst) transfer (SET) on Day
5 post IVF. A successful IMPLANT 4 primary endpoint readout
is expected to support the filing of a Marketing Authorization
Application (MAA) in Europe in late 2019.
- The Nolasiban commercial strategy addresses two key areas of
need in IVF, namely increasing success rates of embryo transfer
and, in turn, reducing procedure and healthcare costs.
Commercial planning is underway with the initial target
geography of Europe having nearly 800,000 ART cycles performed
annually, with growth of approximately 8% per year. The
potential value of nolasiban is to deliver approximately one-third
more babies to couples undergoing IVF, while at the same time
providing cost benefits to both patients and payors via higher
success rates and lower rates of double embryo transfer (DET) and
subsequent multiple births. Given the high concentration of
IVF clinics in both Europe (in EU5 ~900 clinics) and the U.S. (~500
clinics), ObsEva believes a small infrastructure will be sufficient
to commercialize nolasiban in target markets.
- Patient enrollment has recently accelerated in the Phase 3
PRIMROSE 1 and PRIMROSE 2 trials of linzagolix for the treatment of
heavy menstrual bleeding due to uterine fibroids. Six-month
primary endpoint results are expected from these trials in the
second half of 2019. ObsEva believes it is the only company with a
Phase 3 development program for uterine fibroids that includes a
non-hormonal add back therapy (ABT) dosing regimen.
- Following an end-of-Phase 2 meeting scheduled with the FDA
prior to the end of 2018, in the first quarter of 2019 ObsEva plans
to initiate Phase 3 trials with linzagolix for treating
endometriosis-associated pelvic pain. This program will
target two linzagolix doses, one without ABT (first line therapy)
and one with low dose ABT, addressing clinician feedback that the
majority of patients ultimately will prefer no ABT. The ABT
option (second line) will be reserved to patients requiring full
estrogen suppression hence having the need for ABT to protect bone.
- With the recent completion of Part A of the Phase 2a PROLONG
trial of the oral and selective prostaglandin F2 alpha antagonist
OBE022 for treating acute pre-term labor, the randomized
placebo-controlled Part B of the trial is now underway. Preliminary
efficacy data is expected in the first quarter of 2019 in
approximately 30 patients and may support a go/no-go Phase 2b
decision.
A live and archived webcast of the event
including slides is available here.
About ObsEvaObsEva 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.
For further information, please
contact:
Media Contact Switzerland and
Europe:Christophe LampsDynamics Groupcla@dynamicsgroup.ch
+41 22 308 6220 Office+41 79 476 26 87 Mobile
Media Contact U.S.:Marion
JanicRooneyPartners LLCmjanic@rooneyco.com+1 212
223 4047 Office+1 646 537 5649 Mobile
CEO Office Contact:Shauna
DillonShauna.dillon@obseva.ch+41 22 552 1550
Investor Contact:Mario
CorsoSenior Director, Investor Relationsmario.corso@obseva.com+1
857 972 9347 Office+1 781 366 5726 Mobile