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Auxogyn, Inc., Merck Serono Strike Eeva Test Pact



4/3/2014 7:10:56 AM

Auxogyn Signs Exclusive License Agreement With Merck Serono For Eeva Test

* Merck Serono, the biopharmaceutical division of Merck KGaA, Darmstadt, Germany, 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

MENLO PARK, Calif.--Auxogyn, Inc., a company dedicated to advancing women’s reproductive health, today announced an exclusive license agreement with Merck Serono, the biopharmaceutical division of Merck KGaA, Darmstadt, Germany which operates as EMD Serono in the United States and Canada, 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. “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’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 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 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 and Auxogyn announced a strategic partnership on the Eeva Test.

Dr. Susan Herbert, Executive Vice President, Global Business Development and Strategy for Merck Serono 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

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. 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 EMD Serono, Inc.

EMD Serono, Inc., a subsidiary of Merck KGaA, Darmstadt, Germany, is a specialized biopharmaceutical company dedicated to developing therapies with groundbreaking potential. The company has strong market positions in neurology, endocrinology and in reproductive health. In addition, EMD Serono has an enduring commitment to solve the unsolvable, with state-of-the-art science dedicated to developing new therapies in our core focus areas of neurology, oncology, immuno-oncology and immunology. With a long-standing history of industry expertise and a dedication to shape the future of healthcare, the company’s US footprint continues to grow, with approximately 1,100 employees around the country and fully integrated commercial, clinical and research operations in the company’s home state of Massachusetts.

For more information, please visit www.emdserono.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.

About Merck KGaA, Darmstadt, Germany

Merck KGaA, Darmstadt, Germany, is a global pharmaceutical, chemical and life science company with total revenues of € 11.1 billion in 2013, a history that began in 1668, and a future shaped by approx. 38,000 employees in 66 countries. Its success is characterized by innovations from entrepreneurial employees. Merck KGaA's operating activities come under the umbrella of Merck KGaA, Darmstadt, Germany, in which the Merck family holds an approximately 70% interest and shareholders own the remaining approximately 30%. In 1917 the U.S. subsidiary Merck & Co. was expropriated and has been an independent company ever since.

Worldwide there are two separate companies that bear the name “Merck”, the original Merck KGaA from Darmstadt, Germany, the oldest pharmaceutical and chemical company in the world, and the pharmaceutical company Merck & Co. in the United States. The rights to the name and trademark MERCK in North America (USA and Canada) lie with Merck & Co., the former U.S. subsidiary of Merck, whereas Merck KGaA operates in North America under the umbrella brand EMD. In the rest of the world, Merck KGaA owns the rights to the Merck name and trademark.'

Contacts

Auxogyn
Sherree Lucas, 650-681-0932
or
Auxogyn
Lily Eng, 415-262-5966

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