OvaScience Provides Business Update and Outlines 2015 Corporate Progress
– Company Achieves 2015 OvaPrime and OvaTure Treatment Goals –
WALTHAM, Mass.–(BUSINESS WIRE)–OvaScienceSM (NASDAQ: OVAS), a global fertility company
focused on the discovery, development and commercialization of new
treatment options, today announced the Company has achieved its 2015
corporate goals for the OvaPrimeSM and OvaTureSM
fertility treatments.
-
OvaPrime Treatment Preceptorship Program
OvaScience
commenced a non-commercial preceptorship program with the OvaPrime
treatment at an in vitro fertilization (IVF) clinic outside of
the United States to gain insight into the clinical efficacy and
feasibility of the treatment. The Company expects that physicians
using the treatment will report patient experiences by the end of
2016, as clinically meaningful information becomes available.The
OvaPrime treatment is a potential fertility treatment that could
enable a woman to increase her egg reserve. Approximately 25 percent
of women who seek IVF treatment do not make enough or any eggs and
therefore are not candidates for IVF. The OvaPrime treatment is
designed to transfer a patient’s egg precursor (EggPCSM)
cells, immature egg cells found inside the protective ovarian lining,
to the patient’s ovaries, where they may mature into fertilizable eggs
during a standard IVF process.
-
OvaTure Treatment Clinical Development Strategy
OvaScience
has also defined the process for maturing EggPC cells that is required
for OvaTure development. Maturation of EggPC cells to eggs in vitro,
or outside the body, would eliminate the need for the hormone
hyperstimulation currently required for IVF. The Company’s progress in
developing the OvaTure treatment has provided important insights that
enabled the treatment to move into clinical translation.The
OvaTure treatment is a potential next-generation IVF treatment that
could help a woman produce healthy, young, fertilizable eggs without
hormone injections by maturing her EggPC cells into eggs outside the
body. It may be an option for women with compromised eggs, who are
unable to make eggs or who may be unwilling or unable to undergo
hormone hyperstimulation, such as women diagnosed with cancer.
-
AUGMENT Treatment
Since its introduction in select
international IVF clinics, the AUGMENT treatment has resulted in
positive patient experiences for poor prognosis patients, including
the births of 22 babies. The clinical experience with the treatment
was published in three journals, including a recent review of EggPC
cell mitochondria.i, ii, iiiThe AUGMENT
treatment is designed to improve egg health by supplementing a woman’s
mature eggs with EggPC cell mitochondria during IVF. The treatment is
not available in the U.S. -
Investor Day
The Company has rescheduled its Investor Day
to the first half of 2016 and will present at the Oppenheimer 26th
Annual Healthcare Conference in December 2015 and at the J.P. Morgan
Healthcare Conference in January 2016.
“The promising development of our OvaPrime and OvaTure fertility
treatment programs represent new options for women who would like to
have their own children but are unable to undergo IVF due to a lack of
eggs, as well as those who do not want to endure hormone treatments,”
said Michelle Dipp, M.D., Ph.D., Chief Executive Officer of OvaScience.
“In addition, based on our learnings in 2015, we continue to adapt our
commercial operations and infrastructure focused on driving the future
commercial success of our AUGMENT treatment. We look forward to
providing further details in 2016.”
About OvaScience
OvaScience (NASDAQ: OVAS) is a global
fertility company dedicated to improving treatment options for women
around the world. OvaScience is discovering, developing and
commercializing new fertility treatments because we believe women
deserve more options. Each OvaScience treatment is based on the
Company’s proprietary technology platform that leverages the
breakthrough discovery of egg precursor (EggPCSM) cells –
immature egg cells found inside the protective ovarian lining. The
AUGMENTSM treatment, a fertility option specifically designed
to improve egg health, is available in certain IVF clinics in select
international regions. OvaScience has commenced a preceptorship program
with the OvaPrimeSM treatment, which could increase a woman’s
egg reserve, and is developing the OvaTureSM treatment, a
potential next-generation IVF treatment that could help a woman produce
healthy, young, fertilizable eggs without hormone injections. OvaScience
treatments are not available in the United States. For more information,
please visit www.ovascience.com
and www.augmenttreatment.com
and connect with us on Twitter
and Facebook.
Forward-Looking Statements
This press release includes
forward-looking statements about the Company’s plans for the AUGMENT
treatment and two fertility treatments in development, including
statements relating to our expectation that physicians using the
OvaPrime treatment will report patient experiences by the end of 2016 as
clinically meaningful information becomes available. Actual results may
differ materially from those indicated by these forward-looking
statements as a result of various important factors, including risks
related to: the possibility that an insufficient number of patients will
undergo or complete treatment in the OvaPrime preceptorship program for
physicians to report clinically meaningful information about patient
experiences by the end of 2016; the possibility that international IVF
clinics that commence an OvaPrime preceptorship program may determine
not to provide or continue providing the OvaPrime treatment based on
clinical efficacy or feasibility, safety or commercial, logistic or
other reasons; the possibility that international IVF clinics that we
work with may determine not to begin or continue providing the AUGMENT
treatment for commercial or other reasons; our expectation that the
AUGMENT treatment and OvaPrime treatment meet the requirements of a
class of products exempt from premarket review and approval under
applicable regulations in those countries where we have launched or plan
to introduce the AUGMENT treatment and plan to introduce the OvaPrime
treatment; the commercial ramp up of the AUGMENT treatment; the science
underlying our treatment and treatments in development (including the
AUGMENT, OvaPrime and OvaTure treatments), which is unproven; our
ability to obtain regulatory approval where necessary for our potential
treatments; our ability to develop our potential treatments, including
the OvaPrime and OvaTure treatments, on the timelines we expect, if at
all; our ability to commercialize the AUGMENT treatment and our
potential treatments, including the OvaPrime treatment, on the timelines
we expect, if at all; as well as those risks more fully discussed in the
“Risk Factors” section of our most recently filed Quarterly Report on
Form 10-Q and/or Annual Report on Form 10-K. The forward-looking
statements contained in this press release reflect our current views
with respect to future events. We anticipate that subsequent events and
developments will cause our views to change. However, while we may elect
to update these forward-looking statements in the future, we
specifically disclaim any obligation to do so. These forward-looking
statements should not be relied upon as representing our view as of any
date subsequent to the date hereof.
###
212-453-2324
1 Fakih, M. et al. Journal of Fertilization: In Vitro,
IVF-Worldwide, Reproductive Medicine, Genetics & Stem Cell Biology, 2015.
2 Oktay, K. et al. Reproductive Sciences, 2015.
3 Woods, D. et al. Seminars in Reproductive Medicine, 2015.
Contacts
OvaScience
Cara Mayfield, 617-714-9638
Director, Corporate
Communications
cmayfield@ovascience.com
or
Michael
Devine
michael.devine@fleishman.com
