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ViaCell Announces ViaCyte Collaboration with EMD Serono, Inc.

Companies Committed to Advancing Reproductive Medicine

ViaCell, Inc. (Nasdaq:VIAC) announced today it has entered into an agreement under which EMD Serono, Inc., an affiliate of Merck KGaA, Darmstadt, Germany, will provide support related to the clinical development of ViaCyteSM, ViaCell’s investigational product for the cryopreservation and thawing of human oocytes for use during assisted reproductive technology. In addition, EMD Serono has agreed to provide certain quantities of two of its products, Gonal-f® RFF Pen (follitropin alfa injection) and Ovidrel® Prefilled Syringe (choriogonadotropin alfa injection), for the treatment of patients participating in the ViaCyte study. Financial terms were not disclosed.

“We are delighted to have EMD Serono, a leader in fertility health, supporting the clinical development of ViaCyte,” said Marc D. Beer, President and Chief Executive Officer of ViaCell. “This collaboration provides us with important support and gives us access to a wealth of knowledge and experience as we advance ViaCyte through our pivotal trial and toward commercialization.”

“We believe oocyte cryopreservation has the potential to continue to drive the evolution of reproductive medicine and research from a historical focus of infertility to fertility preservation,” stated Fereydoun Firouz, President of EMD Serono, Inc. “EMD Serono looks forward to collaborating with companies such as ViaCell, to support advancements in reproductive medicine including the investigation of different technologies that may lead to new discoveries for patients.”

ViaCell commenced a pivotal clinical trial evaluating ViaCyte in March 2007. The primary objective of the pivotal study is to determine the efficacy of the ViaCyte media for the cryopreserving and thawing of human oocytes. The open-label study will also evaluate safety. Women seeking IVF, diagnosed with male factor infertility, are eligible to enroll. The primary efficacy endpoint is live birth rate and 50 live births must be achieved. Approximately 300 healthy women, age twenty-one to thirty-five, who are currently seeking fertility treatment, are expected to enroll in the study. Participants in the ViaCyte clinical trial will undergo traditional in vitro fertilization (IVF). Women enrolled in the study will receive FSH to stimulate the development of egg-containing follicles in the ovaries and r-hCG to induce the release of mature eggs from the ovaries. The oocytes recovered will be cryopreserved using ViaCyte. The oocytes will be thawed following storage in liquid nitrogen and subsequently inseminated. Embryos will be transferred to the subject’s uterus using a non-surgical procedure. Additional information about the trial is available online at http://www.clinicaltrials.gov.

About ViaCyte

ViaCyte is an investigational product intended to broaden reproductive options for women through the cryopreservation and thawing of human oocytes. The oocyte is a large cell with a high content of water, historically making it difficult to freeze. ViaCell’s proprietary technology to cryopreserve and thaw human oocytes uses a choline chloride-based media designed to protect the cells from damage during the freezing process with the goal of making it possible to successfully store and thaw oocytes for future use. There is currently no FDA-cleared product for oocyte cryopreservation.

About ViaCell

ViaCell, Inc. is a biotechnology company dedicated to enabling the widespread application of human cells as medicine. The Company markets ViaCord®, a product offering through which families can preserve their baby’s umbilical cord blood at the time of birth for possible future medical use in treating over 40 diseases including certain blood cancers and genetic diseases. ViaCell also conducts research and development primarily to investigate other potential therapeutic uses of umbilical cord blood-derived stem cells and on technology for expanding populations of these cells. ViaCell’s pipeline is focused in the areas of cancer, cardiac disease, diabetes and fertility. For more information about ViaCell, visit our website at http://www.viacellinc.com.

This press release contains forward-looking statements regarding the clinical development and potential of ViaCyte. Such statements are based on management's current expectations. Successful completion of the ViaCyte clinical trial and the potential for ViaCyte are subject to a number of risks and uncertainties which could cause actual results to differ materially from the Company's current expectations. For example, there is no assurance that the results of the clinical trial will show that ViaCyte is safe and effective in the preservation and storage of oocytes. ViaCell may not be able to enroll a sufficient number of patients in the clinical trial or to enroll patients as rapidly as we expect. ViaCell may not be able to generate a sufficient number of live births. ViaCell may encounter safety issues. Manufacturing the ViaCyte media is a complex process. We may be unable to have the ViaCyte media consistently manufactured to specifications. Even if the data from the clinical trial is positive, there is no assurance that the FDA will agree that ViaCell has met the standards for 510(k) clearance, ViaCell’s specified regulatory pathway for ViaCyte. The FDA could at any time determine that ViaCyte will require pre-marketing authorization, which would involve additional trials, time and expense. There is no assurance that the FDA will ever approve the product. Even if approved, there is no assurance that ViaCyte will achieve commercial success or be able to successfully compete with other oocyte cryopreservation and IVF products. Drug and device development involves a high degree of risk. For more information on the risks and uncertainties associated with the Company and its products and programs, see the factors set forth under the heading “Risk Factors” in the Company's report on Form 10-Q for the quarter ended June 30, 2007, which is on file with the Securities and Exchange Commission and which factors are incorporated herein by reference. ViaCell does not undertake any obligation to update forward-looking statements.

ViaCell® and ViaCord® are registered trademarks and ViaCyteSM is a service mark of ViaCell, Inc. Gonal-f® and Ovidrel® are registered trademarks of EMD Serono or its affiliates.

ViaCell, Inc.
Justine E. Koenigsberg, 617-914-3494
Senior Director, Corporate Communications


Source: Business Wire (September 4, 2007 - 6:34 AM EST)

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