Merck Serono, a division of Merck KGaA, Darmstadt, Germany (operates as EMD Serono in Canada) Announces Exclusive License Agreement with Auxogyn for Eeva Test

• Merck Serono, a division of Merck KGaA, Darmstadt, Germany (operates as EMD Serono in Canada) will receive commercialization rights from Auxogyn for the Eeva Test, which is designed to provide objective embryo viability data to IVF clinicians
• Agreement reflects Merck Serono's and Auxogyn's commitment to bringing innovative technologies to the IVF community designed to help improve patient outcomes

MISSISSAUGA, ON, April 3, 2014 /CNW/ - Merck Serono, the biopharmaceutical division of Merck,  a division of Merck KGaA, Darmstadt, Germany (operates as EMD Serono in Canada)   today announced an exclusive license agreement with Auxogyn, Inc., Menlo Park, California, USA, a company dedicated to advancing women's reproductive health, for Auxogyn's proprietary Early Embryo Viability Assessment (Eeva^®) Test.

The Eeva Test is a non-invasive diagnostic test used adjunctively to traditional morphology. It utilizes time-lapse imaging and computer software to analyze embryo development, creating lab-based measurements that provide reproductive endocrinologists and embryologists with objective information which can help to assess embryo development and viability. The Eeva Test results deliver objective information that may assist clinicians in improving IVF (in vitro fertilization) patient outcomes.

"This new agreement further underscores our commitment as a leader in fertility treatment to develop innovative science, medicines and technologies that have the power to improve outcomes for patients throughout the in vitro fertilization process," said Dorothea Wenzel, head of the Global Business Franchise Fertility at Merck Serono, a division of Merck KGaA, Darmstadt, Germany. "The Eeva Test can make the difference for the patient, as it can help to objectively identify the embryos with the highest implantation potential."

"We are excited to further expand our relationship with Merck Serono," said Lissa Goldenstein, President and Chief Executive Officer of Auxogyn. "With this licensing agreement, Merck KGaA, Darmstadt, Germany's  established commercial expertise will accelerate the availability of the Eeva Test in key international markets and Auxogyn's innovative test will continue to provide in vitro fertilization clinicians with valuable information that may improve patient outcomes. Most importantly, working together increases our collective ability to enhance outcomes and the chances of having a baby."

This agreement is a strong reflection of both companies' commitment to providing clinicians with innovative new technologies that have the potential to benefit patients dealing with fertility issues. Financial details of the agreement are not being disclosed.

Under the terms of the agreement, Merck Serono, a division of Merck KGaA, Darmstadt, Germany, will obtain exclusive rights to commercialize the Eeva Test in Europe and Canada, with the option to extend to selected countries and regions.

The license agreement builds on a successful relationship between the companies that was started in 2010 when Merck Serono, a division of Merck KGaA, Darmstadt, Germany initially invested in Auxogyn through a Series A Preferred Stock financing made by Merck Serono's corporate venture capital fund, MS Ventures. In 2012, Merck Serono, a division of Merck KGaA, Darmstadt, Germany, and Auxogyn announced a strategic partnership on the Eeva Test.

Dr. Susan Herbert, Executive Vice President, Global Business Development and Strategy for Merck Serono, a division of Merck KGaA, Darmstadt, Germany, commented: "This agreement is strong validation for our strategy with MS Ventures to invest at an early stage in companies that develop next generation technologies and products that may improve patient outcomes in therapeutic fields that are relevant to Merck Serono."

Auxogyn received the CE mark for the Eeva System in 2012, and it is currently available for use in certain countries in the European Union and Canada. In the United States, where Auxogyn retains commercialization rights, Auxogyn has filed a submission with the U.S. Food and Drug Administration (FDA) for the clearance of the Eeva System, and this application is currently under review by the FDA.

According to the European Society of Human Reproduction and Embryology (ESHRE), approximately five million additional babies have been born worldwide as a result of assisted reproduction technologies (ART) like IVF since 1978.1 This trend is increasing 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 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 the select countries in the EU. In the United States, a 510(k) application for the Eeva System is currently under review by the FDA. For more information regarding Eeva, please visit www.eevaivf.com/

About MS Ventures
MS Ventures is the strategic corporate venture capital fund of Merck Serono, the biopharmaceutical division of Merck KGaA, Darmstadt, Germany.. The fund was established in March 2009 and focuses primarily on early stage investments. MS Ventures has a strategic mandate and invests in companies that develop products and/ or technologies that could benefit patients in therapeutic areas relevant to Merck Serono, a division of Merck KGaA, Darmstadt, Germany. MS Ventures has a total of € 140 million under management for strategic investments, investments through its Israel BioIncubator and for spin-offs from the Merck Serono organization. For more information, please visit www.ms-ventures.com.

About Merck Serono
Merck Serono is the biopharmaceutical division of Merck KGaA, Darmstadt, Germany.. 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 affiliate subsidiary of Merck Serono, a division of Merck KGaA, Darmstadt, Germany.

Merck Serono, a division of Merck KGaA, Darmstadt, Germany 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 www.merckserono.com.

Merck KGaA, Darmstadt, Germany. 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 KGaA, Darmstadt, Germany,  generated total revenues of € 11.1 billion in 2013. Around 38,000 Merck KGaA, Darmstadt, Germany.  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 KGaA, Darmstadt, Germany 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 KGaA, 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.

About EMD Serono, Canada
EMD Serono is a Division of EMD Inc., Canada, an affiliate of Merck KGaA, Darmstadt, Germany. In Canada, EMD Serono provides innovative drug therapies that address unmet medical needs in the areas of neurodegenerative diseases, fertility and endocrinology. EMD Serono employs approximately 150 people across Canada and is headquartered in Mississauga, Ontario. For more information, please visit to http://www.emdserono.ca.

SOURCE: Merck Serono

Shikha Virdi, 905-919-0200 ext. 5504