Merck Serono Announces FDA Clearance for Auxogyn's Early Embryo Viability Assessment (Eeva(R)) System

PR57004

DARMSTADT, Germany, Jun. 10 /PRN=KYODO JBN/--

    - FDA clearance validates Eeva System, which enables in-vitro fertilization

(IVF) clinicians to offer the proprietary Eeva Test and further demonstrates

commitment by Merck Serono and Auxogyn to bring innovative technologies to the

IVF community

    - Eeva Test first-of-a-kind prognostic, non-invasive test that provides IVF

clinicians objective information regarding embryo development to help optimize

treatment plans for their patients

    Merck Serono, the biopharmaceutical division of Merck, today announced that

the proprietary Early Embryo Viability Assessment (Eeva(R)) System of Merck

Serono's strategic partner Auxogyn received clearance from the U.S. Food and

Drug Administration (FDA) through its de novo classification process, a

regulatory pathway for select novel, low-to-moderate risk medical devices that

are first-of-a-kind. Merck Serono is the exclusive commercial partner of

Auxogyn, Inc., for the Eeva System in Europe and Canada.

    The Eeva Test, used adjunctively to traditional morphology, is the first

and only prognostic, non-invasive embryo test to receive clearance from the

FDA. The Eeva Test utilizes proprietary software that automatically analyzes

embryo development against scientifically derived cell-division timing

parameters captured through continual video imaging. This objective information

provided to reproductive endocrinologists and embryologists helps to optimize

treatment plans for their patients.

    "The FDA clearance of the Eeva System reinforces the value of the

applicability of the Eeva Test in the IVF lab and may improve IVF outcomes. It

marks another significant and exciting milestone in our continued collaboration

with Auxogyn to further support the clinical development and commercialization

of their Eeva Test," said Meeta Gulyani, Head of Strategy and Global Franchises

at Merck Serono. "We, therefore, welcome this further validation for the

potential of the Eeva Test to objectively identify the embryos with the highest

implantation potential, which may ultimately improve patient outcomes."

    The Eeva System received the CE Mark in 2012 and has been commercially

available in the European Union ever since, and more recently in Canada since

2013. The potential of the Eeva System led to an expansion of the original

partnership agreement to include a licensing agreement between Merck and

Auxogyn, announced in April 2014 for the exclusive rights to commercialize the

Eeva Test in Europe and Canada. Auxogyn plans to commercialize the Eeva Test in

the United States later this year.

    "We're excited to receive the de novo FDA clearance for the Eeva System and

believe this marks a significant milestone in the field of IVF," said Lissa

Goldenstein, president and CEO of Auxogyn. "We have followed a rigorous,

years-long clinical validation process and regulatory pathway to bring the Eeva

Test to market. Our clearance provides a new level of confidence to IVF

clinicians who, for the first time, have quantitative information that can be

used in addition to traditional morphology to aid in deciding which embryo or

embryos to transfer."

    According to the European Society of Human Reproduction and Embryology

(ESHRE), approximately five million additional babies have been born worldwide

since 1978 as a result of assisted reproduction technologies (ART), like

IVF.[1] This trend may increase due to advancements in ART and IVF technologies

such as the Eeva Test.

    References

    1) European Society of Human Reproduction and Embryology. (2012). The

world's number of IVF and ICSI babies has now reached a calculated total of 5

million [Press release]. Retrieved from

http://www.eshre.eu/Press-Room/Press-releases/Press-releases-ESHRE-2012/5-million-babies.aspx

    About Auxogyn

    Auxogyn is revolutionizing the field of reproductive medicine by

translating scientific discoveries in early embryo development into clinical

tools. The company's flagship product, the Eeva Test, delivers consistent,

objective and quantitative information regarding embryo viability that IVF

clinicians and infertility patients can use to make important treatment

decisions. Auxogyn is privately held and funded by Kleiner Perkins Caufield &

Byers, MS Ventures, SR One and TPG Biotech.

    For more information regarding Auxogyn, please visit http://www.auxogyn.com.

    About Eeva

    Auxogyn's non-invasive early embryo viability assessment (Eeva) Test when

used adjunctively to traditional morphology may improve IVF outcomes by

providing IVF clinicians and patients with objective information on embryo

viability. The Eeva System utilizes proprietary software that automatically

analyzes embryo development against scientifically and clinically validated

cell-division timing parameters. With Eeva's quantitative data on each embryo's

potential development, IVF clinicians can optimize the treatment path for their

patients undergoing IVF procedures.

    Auxogyn received CE mark for Eeva in July 2012, and it is currently

available for use in selected countries in the EU.

    For more information regarding Eeva, please visit http://www.eevaivf.com.

    About Merck Serono

    Merck Serono is the biopharmaceutical division of Merck. With headquarters

in Darmstadt, Germany, Merck Serono offers leading brands in 150 countries to

help patients with cancer, multiple sclerosis, infertility, endocrine and

metabolic disorders as well as cardiovascular diseases. In the United States

and Canada, EMD Serono operates as a separately incorporated subsidiary of

Merck Serono.

    Merck Serono discovers, develops, manufactures and markets prescription

medicines of both chemical and biological origin in specialist indications. We

have an enduring commitment to deliver novel therapies in our core focus areas

of neurology, oncology, immuno-oncology and immunology.

    For more information, please visit http://www.merckserono.com.

    All Merck Press Releases are distributed by e-mail at the same time they

become available on the Merck Website. Please go to

http://www.merckgroup.com/subscribe to register online, change your selection

or discontinue this service.

    Merck is a leading company for innovative and top-quality high-tech

products in the pharmaceutical and chemical sectors. With its four divisions

Merck Serono, Consumer Health, Performance Materials and Merck Millipore, Merck

generated total revenues of EUR 11.1 billion in 2013. Around 38,000 Merck

employees work in 66 countries to improve the quality of life for patients, to

further the success of customers and to help meet global challenges. Merck is

the world's oldest pharmaceutical and chemical company - since 1668, the

company has stood for innovation, business success and responsible

entrepreneurship. Holding an approximately 70 percent interest, the founding

family remains the majority owner of the company to this day. Merck, Darmstadt,

Germany is holding the global rights to the Merck name and brand. The only

exceptions are Canada and the United States, where the company is known as EMD.

SOURCE: Merck Serono