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. This trend is increasing due to advancements in ART and IVF technologies such as the Eeva Test.