INFORMATION
For Trade Press Release Only
May 19, 2009
Contact: 513.271.3700
Richard L. Eberly
Meridian Life Science Achieves production specification for THE AUSTRALIAN NEONATAL Rotavirus vaccine
Meridian Life Science, Inc., of Memphis, Tennessee, today announced a milestone in the production of a live oral neonatal rotavirus vaccine for Australia’s Murdoch Childrens Research Institute (MCRI) and global health nonprofit organization PATH. MCRI contracted Meridian Life Science to manufacture the RV3 vaccine candidate strain of rotavirus for use as a live oral pediatric vaccine.
Researchers in Melbourne, Australia, identified the RV3 rotavirus strain in newborn babies and found that babies who were naturally infected with the RV3 strain had no symptoms and were protected from contracting rotavirus disease in the first three years of life.
MCRI selected Meridian Life Science to develop the RV3 vaccine according to appropriate current Good Manufacturing Practices (cGMP) parts 21 CFR Parts 210 and 211 for use in Phase 1 and 2 human clinical trials.
“Meridian is pleased to have been selected by MCRI and PATH for the cGMP manufacture of this rotavirus vaccine as this project is such a good fit for Meridian’s core virology and virus based product manufacturing capabilities. The collaboration with MCRI and PATH has been a very close partnership with scientists from MCRI working alongside Meridian scientists to ensure successful technology transfer, scale up, and production of the RV3 vaccine. Meridian and our scientists are proud to be a part of this RV3 vaccine development effort that could save the lives of many infants and young children,” said Victor Van Cleave, vice president of Research and Development (R&D) at Meridian Life Science.
Rotavirus, a global health care issue, infects nearly every child by the age of three and is the leading cause of severe dehydrating diarrheal illness and deaths in infants and young children worldwide.
Professor Julie Bines, head of the RV3 Rotavirus Vaccine Program at MCRI and professor of Paediatrics at the University of Melbourne said up to 500,000 infants and young children die each year as a result of rotavirus infection, with children in developing countries accounting for nearly 90 percent of all deaths because of poor healthcare options.
“The RV3 rotavirus vaccine is a highly promising candidate, in that it is naturally adapted to grow in the intestine of newborn babies, making it an ideal candidate for vaccination in the newborn period. Delivering a rotavirus vaccine at birth has many advantages. It provides the earliest opportunity to protect babies from rotavirus gastroenteritis as well as benefits to implementation programs, particularly in developing countries,” said Professor Bines.
Meridian manufactured a working Vero cell bank, an RV3 master viral bank and the final RV3 vaccine product for MCRI and PATH. Through a highly collaborative effort between Meridian and MCRI scientists, the team achieved a virus titer 80 percent greater than the required specification. Release testing of this vaccine product will be complete within the next two months, after which MCRI intends to commence a Phase 1 trial.
“We are truly pleased that Meridian Life Science has reached this critical milestone with the RV3 vaccine candidate,” said Dr. Georges Thiry, director of PATH’s rotavirus vaccine development project. “PATH is supporting a portfolio of rotavirus vaccine candidates, which includes RV3, and we look forward to the forthcoming clinical evaluation of this vaccine.”
ABOUT MERIDIAN LIFE SCIENCE:
Meridian Life Science,® Inc. provides contract R&D, process development, and clinical cGMP biomanufacturing of vaccines, viral challenge materials, gene therapies, virus-like particles, and recombinant proteins at its contract biopharmaceutical manufacturing facility in Memphis, Tennessee. This business focuses on materials that will be used in Phase 1 and 2 clinical trials that are intended for use as “injectables”. As such, they are produced under cGMP Regulations for Biologics and Human Drugs under the auspices of the US Food and Drug Administration. With 25 years of cell culture experience, virus production, purification, assay development and quality, Meridian has become a leader and trusted partner for Phase 1-2 cGMP biomanufacturing solutions. Meridian also supplies critical assay reagents, antigens, antibodies, and contract biological R&D and manufacturing services to the research, diagnostic, and biopharmaceutical markets. Meridian Life Science services its customers from three primary manufacturing operations in Memphis, Tennessee; Saco, Maine; and Boca Raton, Florida. The Company’s shares are traded through NASDAQ’s Global Select Market, symbol VIVO. Meridian’s website address is www.meridianlifescience.com.
ABOUT MURDOCH CHILDRENS RESEARCH INSTITUTE:
Murdoch Childrens Research Institute is Australia’s largest and most prestigious child health institute. Its staff work side by side with the doctors and nurses at Melbourne’s Royal Children’s Hospital and the Department of Paediatrics, University of Melbourne and have a unique opportunity to make discoveries and translate them into real benefits for children. The team of 1,100 passionate researchers conducts innovative, world class research into a wide range of conditions affecting children, including asthma, premature birth, cancer, depression, genetic conditions, obesity, and infectious diseases. For more information, please visit Murdoch Childrens Research Institute’s website.
ABOUT PATH:
PATH is an international nonprofit organization that creates sustainable, culturally relevant solutions, enabling communities worldwide to break longstanding cycles of poor health. By collaborating with diverse public- and private-sector partners, PATH helps provide appropriate health technologies and vital strategies that change the way people think and act. PATH’s work improves global health and well-being. For more information, please visit www.path.org.
FOR ADDITIONAL INFORMATION CONTACT:
Daniel A. Shelly, PhD, MBA, Director of Marketing and Business Development, 513.271.5266
Murdoch Contact: Alyssa Jones, Acting PR & Development Manager, +613.8341.6220
PATH Contact: Allison Clifford, Communications Officer, +1.202.822.0033
FORWARD LOOKING STATEMENTS:
The Private Securities Litigation Reform Act of 1995 provides a safe harbor from civil litigation for forward-looking statements accompanied by meaningful cautionary statements. Except for historical information, this report contains forward-looking statements which may be identified by words such as "estimates", "anticipates", "projects", "plans", "seeks", "may", "will", "expects", "intends", "believes", "should" and similar expressions or the negative versions thereof and which also may be identified by their context. Such statements, whether expressed or implied, are based upon current expectations of the Company and speak only as of the date made. The Company assumes no obligation to publicly update any forward-looking statements. These statements are subject to various risks, uncertainties and other factors that could cause actual results to differ materially, including, without limitation, the following: Meridian’s continued growth depends, in part, on its ability to introduce into the marketplace enhancements of existing products or new products that incorporate technological advances, meet customer requirements and respond to products developed by competition. While Meridian has introduced a number of internally developed products, there can be no assurance that it will be successful in the future in introducing such products on a timely basis. Ongoing consolidations of reference laboratories and formation of multi-hospital alliances may cause adverse changes to pricing and distribution. Costs and difficulties in complying with laws and regulations administered by the United States Food and Drug Administration can result in unanticipated expenses and delays and interruptions to the sale of new and existing products. Changes in the relative strength or weakness of the U.S. dollar can change expected results. One of Meridian’s main growth strategies is the acquisition of companies and product lines. There can be no assurance that additional acquisitions will be consummated or that, if consummated, will be successful and the acquired businesses successfully integrated into Meridian’s operations. In addition to the factors described in this paragraph, Part I, Item 1A Risk Factors of our Form 10-K contains a list of uncertainties and risks that may affect the financial performance of the Company.
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