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EMD Serono Launches Landmark Patient Registry for Egg Freezing

November 7, 2008

ROCKLAND, Mass., Nov. 7 /PRNewswire/ — EMD Serono, Inc., an affiliate of Merck KGaA of Darmstadt, Germany, announced the launch of the Human Oocyte Preservation Experience (HOPE) Registry surrounding next week’s 64th Annual Meeting of the American Society for Reproductive Medicine (ASRM). The HOPE Registry is the only comprehensive national patient registry in the United States designed to study the safety and efficacy of oocyte cryopreservation procedures, commonly known as egg freezing.

The objective of the HOPE Registry is to track the outcome of oocyte cryopreservation cycles and to validate the efficacy of the different techniques used to freeze and thaw eggs. The HOPE Registry will evaluate the two techniques commonly used in egg freezing, “slow-cooling” and “vitrification,” and assess the safety of these procedures by systematically capturing information to determine if the babies born from different egg freezing techniques are healthy. The data collected will be thorough in scope and will include patient demographics as well as specifics on the different laboratory procedures used to freeze, thaw and fertilize each oocyte and produce the transferable embryos. Additionally, pregnancy outcomes will be tracked and evaluated, as well as the health and development of the children following birth and at one year of age.

Although egg freezing remains an experimental procedure, in recent years the number of pregnancies resulting from the fertilization of thawed oocytes has increased. Estimates show that almost 500 children have been born worldwide from these techniques and only four of these children (0.8%) had a genetic abnormality. This success is due, in large part, to a better understanding of the physiology of eggs as well as advancements leading to improved freezing technologies. The HOPE Registry will help support the goals of the ASRM’s Practice Committee, which called for more studies on the health outcomes of children born from various egg freezing techniques in 2006.

“We need to validate the safety and efficacy of egg freezing for it to become a more widely available option for women who for a variety of reasons would like to preserve their fertility. The HOPE Registry is an exciting vehicle that will assist us in the evidence-gathering process and will facilitate the furthering of the science and the acceptance of oocyte cryopreservation as an effective clinical practice,” said Dr. Alan Copperman, Director of the Division of Reproductive Endocrinology and Vice-Chairman of the Department of Obstetrics, Gynecology, and Reproductive Science at Mount Sinai Medical Center in New York, and co-director of Reproductive Medicine Associates of New York.

One patient group that has benefited significantly from egg freezing is women who have been diagnosed with certain types of cancer during their reproductive years and wish to preserve their fertility before cancer treatments. This is one of the few viable options for these women, who require chemotherapy and/or radiotherapy treatments that may cause infertility and premature ovarian failure depending on their cancer diagnosis.

Lindsay Nohr Beck is a cancer survivor who used oocyte cryopreservation before starting chemotherapy. She is the Founder and Executive Director of Fertile Hope, a nonprofit organization dedicated to providing reproductive information and support to cancer patients and survivors.

“Each year, more than 140,000 people are diagnosed with cancer during their childbearing years,” said Ms. Nohr Beck. “The HOPE Registry is expected to substantiate egg freezing as an option, so that fertility is one less obstacle these patients may need to overcome in fulfilling their dreams of becoming a parent and living the lives they imagined prior to their cancer diagnosis.”

The HOPE Registry aims to enroll approximately 400 women of reproductive age over a three year period. Women participating in the Registry will have their oocytes frozen, thawed and the resulting fertilized embryos transferred. It is open to all qualified investigators across the country who are freezing and later thawing oocytes for embryo production. Local ethics committee or Institutional Review Board approval will be required for each participating center. The HOPE Registry will be conducted according to the principles of good clinical practice and the Declaration of Helsinki, and will be listed on clinicaltrials.gov.

“As a leader in fertility health, EMD Serono is proud to support the HOPE Registry to validate oocyte cryopreservation techniques that may prove to be a viable option to assist women in preserving their fertility,” said Fereydoun Firouz, President and CEO of EMD Serono. “We are thrilled to play a major role in accumulating data on this new fertility treatment.”

Data will be collected according to the protocol in a uniform manner for every enrolled patient. Systematic tracking will continue for an additional two years to obtain birth outcomes from patients who achieved pregnancy within the third year of enrollment. Cumulative results from the HOPE Registry will be presented and discussed during an annual investigators’ meeting. These results will subsequently be published to provide a widely accessible resource for patients and their caregivers regarding the safety and efficacy of the different egg freezing techniques, as well as the postnatal outcomes of the babies born from embryos generated from frozen/thawed oocytes.

Cancer patients should consult with an oncologist before considering oocyte preservation. Fertility treatment is not recommended for patients with sex hormone dependent tumors of the reproductive tract and accessory organs.

About EMD Serono, Inc.

EMD Serono, Inc., an affiliate of Merck KGaA, Darmstadt, Germany, is a leader in the US biopharmaceutical arena, integrating cutting-edge science with unparalleled patient support systems to improve people’s lives. The company has strong market positions in neurodegenerative diseases, with Rebif(R) (interferon beta-1a), as well as in endocrinology, with Saizen(R) (somatropin (rDNA origin) for injection), Serostim(R) (somatropin (rDNA origin) for injection) and Zorbtive(TM) (somatropin (rDNA origin) for injection). EMD Serono is a leader in fertility treatments, with Gonal-f(R) (follitropin alpha for injection), Luveris(R) (lutropin alfa for injection) and Ovidrel(R) Prefilled Syringe (choriogonadotropin alpha injection). With a clear focus on the patient and a leadership presence in the biopharmaceutical industry, EMD Serono’s US footprint continues to grow, with more than 950 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 http://www.emdserono.com/.    About Merck KGaA  

Merck is a global pharmaceutical and chemical company with total revenues of Euro 7.1 billion in 2007, a history that began in 1668, and a future shaped by 32,458 employees in 59 countries. Its success is characterized by innovations from entrepreneurial employees. Merck’s operating activities come under the umbrella of Merck KGaA, in which the Merck family holds an approximately 70% interest and free shareholders own the remaining approximately 30%. In 1917 the U.S. subsidiary Merck & Co. was expropriated and has been an independent company ever since.

For more information, please visit http://www.merck.de/.

EMD Serono, Inc.

CONTACT: Colleen Minden, +1-781-681-2192

Web site: http://www.emdserono.com/http://www.merck.de/http://clinicaltrials.gov/




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