Publication of OvaScience’s AUGMENT Fertility Treatment Shows Statistically Significant Improvements in Embryo Selection and Transfer Compared to Standard IVF

Guía de Regalos

Real-World Experience from International IVF Clinics Reported in
Peer-Reviewed Journal

CAMBRIDGE, Mass.–(BUSINESS WIRE)–OvaScienceSM (NASDAQ:OVAS), a global fertility company
focused on the discovery, development and commercialization of new
treatment options, announced today the first published analysis of
real-world patient experience comparing the AUGMENTSM
fertility treatment to standard in vitro fertilization (IVF). In
the same woman within the same IVF cycle, AUGMENT-treated eggs had
statistically significant higher rates of embryo selection and transfer
based on standard embryo quality measures, which resulted in
statistically significant higher rates of pregnancy, compared to
standard IVF.

The report, published today in the peer-reviewed, Journal of
Fertilization: In Vitro– IVF-Worldwide Reproductive Medicine, Genetic &
Stem Cell Biology
, includes a previously described subset of 25
patients at Fakih IVF in the United Arab Emirates (UAE) whose eggs were
prospectively allocated to two treatment groups – one that received the
AUGMENT treatment and the other that received standard IVF only. The
publication also includes the combined experience of more than 90
patients from Fakih IVF and TCART Fertility Partners in Canada that
showed substantial improvements in pregnancy rates with the AUGMENT
treatment compared to the patients’ prior IVF histories. The publication
is available at http://www.ovascience.com/technology/publications.
A presentation describing the findings is available on the Investors
page at www.ovascience.com.
The AUGMENT treatment is designed to improve egg health and is not
available in the United States.

“This first publication of AUGMENT experience from different IVF clinics
shows that AUGMENT treatment resulted in higher ongoing clinical
pregnancy rates and healthy births when compared to standard IVF,” said
Robert F. Casper, M.D., F.R.C.S.(C), Medical Director of TCART Fertility
Partners. “In addition, the new analysis by Fakih IVF demonstrated
statistically significant higher rates of embryo selection and transfer
with the AUGMENT treatment. This provides further evidence that the
AUGMENT treatment has the potential to improve egg health and embryo
quality, and may offer a new treatment option to improve IVF success.”

The eggs retrieved from a group of 25 patients at Fakih IVF were
prospectively allocated into two treatment groups: one group received
the AUGMENT treatment and the other group received standard IVF with
ICSI (intracytoplasmic sperm injection). All 25 patients met the
inclusion criteria for the retrospective analysis that required embryo
transfer be limited to only one treatment group, as including embryos
from both treatment groups would prevent an accurate assessment of
treatment benefit. Embryos that were transferred were selected from the
one treatment group that had the highest quality embryo(s) for transfer.
Accordingly, in patients where more than one embryo was transferred,
embryos were only selected from the one treatment group that included
overall highest quality embryos. Embryos were selected based on standard
morphogenetic analysis, which is composed of two measures. The first is
an objective analysis to identify genetic disorders (e.g., cystic
fibrosis) and chromosomal abnormalities (e.g., aneuploidy). This is
called preimplantation genetic diagnosis (PGD) or preimplantation
genetic screening (PGS). The second is an analysis of morphology
performed by the embryologist. There is a standard grading system used
to evaluate the embryos.

Following the PGD/PGS assessment, there were 9 patients for whom no
embryos met the criteria for transfer. The majority of embryos were
chosen based on PGD/PGS, an objective measure of embryo quality. The
remaining embryos underwent morphological assessment. The morphogenetic
analysis resulted in 14 embryo transfers from the AUGMENT group and 2
from the IVF-only group, which was statistically significant and
suggestive of improved embryo quality with the AUGMENT treatment.

Ongoing clinical pregnancy rates in these women, who previously had a 0
percent live birth rate, were higher in the AUGMENT treatment group,
with 8 women out of 14 with embryo transfers resulting in ongoing
clinical pregnancies that are expected to result in live births (and
include the births of two sets of twins). There were 0 women with
ongoing clinical pregnancies out of 2 with embryo transfers in the
IVF-only group. In the intent-to-treat (ITT) analysis of all 25
patients, there was a statistically significant improvement in pregnancy
rates with the AUGMENT treatment compared to the IVF-only group. (See
Figure 1, pg. 5 of publication)

“Evaluating the AUGMENT treatment in the same woman during the same IVF
cycle eliminates many variables and provides clinically meaningful
insight into the positive impact the treatment can have for patients,”
said Michael Fakih, M.D., Co-Founder and Medical Director of Fakih IVF.
“As IVF success typically decreases with increasing cycle number and
increasing maternal age, we were pleased to see with the AUGMENT
treatment that ongoing clinical pregnancy rates per embryo transfer were
similar to the success rates of young, donor eggs. This was particularly
encouraging given that these results were observed in patients who had
poor embryo quality and prior IVF failures.”

The publication also included a summary of patients treated at TCART
(n=34) and Fakih IVF (n=59), demonstrating improvements in pregnancy
rates above the patients’ historic IVF success rates. Prior to the
AUGMENT treatment, patients collectively underwent 328 IVF cycles, and
had a 2 and 1.4 percent live birth rate per IVF cycle initiated in
Canada and the UAE, respectively. After the AUGMENT treatment, there was
an 11- and 18-fold increase in ongoing clinical pregnancy rate per
initiated cycle in the UAE and Canada, respectively, which includes the
births of six babies. Patient experience in the publication is inclusive
of all patients up to a certain point in time.

                 
      Patient History    

Live Birth Rate per
Initiated Cycle

   

Clinical
Pregnancy Rate
per Initiated
AUGMENT
Cycle

   

Ongoing Clinical
Pregnancy
Rate/Live
Birth

Rate per Initiated
AUGMENT Cycle

Canada

(n=34)

  • Average age: 36.0
  • 1-5 prior IVF cycles
  • 71 total prior IVF cycles
1% 35%     26%
           

9 patients with 23 frozen embryos
remaining for transfer

United Arab

Emirates

(n=59)

   
  • Average age: 37.3
  • 1-16 prior IVF cycles
  • 257 total prior IVF cycles
    2%     22%     18%
Canada and UAE Have Reported Six Babies Born with the AUGMENT
Treatment
 

“As with the introduction of other new fertility technologies, we
anticipated that IVF clinics would gain experience using the AUGMENT
treatment by taking various approaches to demonstrate benefit,” said
Michelle Dipp, M.D., Ph.D., Chief Executive Officer of OvaScience. “We
are pleased that the approaches used to date have shown marked and
significant improvement with the AUGMENT treatment compared to standard
IVF. We believe that egg allocation offers a more controlled approach in
a real-world setting. We look forward to additional patient experiences
and publications that demonstrate the benefits of the AUGMENT treatment.”

IVF is the standard treatment for infertility, yet it fails the majority
of the time. Poor egg health is a major cause of IVF failure, and data
has demonstrated that the decline in egg health is largely due to a
reduction in energy production. The AUGMENT treatment is designed to
improve egg health by supplementing the energy in mature eggs during IVF.

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 outside of the United States. OvaScience is
developing the OvaPrimeSM treatment, which could increase a
woman’s egg reserve, and the OvaTureSM treatment, a potential
next-generation IVF treatment that could help a woman produce healthy,
young, fertilizable eggs without hormone injections. 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 its two fertility
treatments in development. 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 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, which we expect will depend upon
continued use of the AUGMENT treatment in our partner clinics in new and
existing regions, significant uptake in the UAE as a result of the
recent coverage, and other programs that include driving first-line use
of the AUGMENT treatment, and further results from ACE clinic experience
as they become available; 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.

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Contacts

For OvaScience:
Theresa McNeely, 617-299-7356
EVP,
Chief Communications Officer
tmcneely@ovascience.com
or
Media:
Cara
Mayfield, 617-714-9638
Director, Corporate Communications
cmayfield@ovascience.com