Meridian Bioscience Completes Production of Clinical Respiratory Syncytial Virus (RSV) for Human Clinical Trials
CINCINNATI--(BUSINESS WIRE)--Jan. 4, 2007--Meridian Bioscience, Inc., Cincinnati, Ohio (NASDAQ:VIVO) today announced that its wholly owned subsidiary, Meridian Life Science, Inc. (MLS), formerly Viral Antigens, Inc., completed manufacturing of a clinical infectious inoculum of respiratory syncytial virus (RSV) in its biopharmaceutical facility located in Memphis, TN. The RSV clinical material will be used by a contract biopharmaceutical client to conduct human challenge studies in order to establish optimal infectious levels in healthy adult volunteers. The client, Alnylam Pharmaceuticals, has commenced a clinical program to evaluate the anti-viral activity of its therapeutic product for treatment of RSV infection.
Respiratory synytial virus (RSV) is the most important cause of pneumonia and bronchiolitis in infants and small children. RSV infections appear in large outbreaks every winter. RSV is very contagious, and most children have experienced infection by two years of age. Immunity to RSV does not prevent re-infections. Re-infections tend to be less severe than primary infections and occur throughout life. RSV also can be an unusual cause of significant respiratory illness in normal and elderly adults.
"Meridian Life Science played an important role in Alnylam's ability to undertake an experimental infection study for the development of ALN-RSV01, an RNAi therapeutic for the treatment of RSV," said Barry Greene, Chief Operating Officer of Alnylam. "This study represents a significant step forward for Alnylam as it advances this program toward generation of human proof-of-concept anti-viral data."
Richard L. Eberly, President, Meridian Life Science, Inc., commented, "We are pleased to have successfully produced the RSV clinical material that will be utilized for important studies advancing the clinical program for Alnylam's therapeutic treatment for RSV. The combination of Alnylam's clinical expertise with our scientific and technical capabilities led to the development and production of important clinical viral materials needed for the initiation of human clinical trials."
Dr. Preston Dorsett, Vice President of Science and Technology, Meridian Life Science, Inc., commented, "The manufacturing process utilized clinical viral isolates and cell culture to generate infectious respiratory syncytial virus for use in the human challenge study."
MLS's contract biopharmaceutical manufacturing facility produces proteins and other biologicals for biopharmaceutical and biotechnology companies engaged in research for new drugs and vaccines. This business focuses on materials that will be used in Phase I and II clinical trials. This past year, MLS completed manufacturing of a recombinant protein for the National Institutes of Health for use in a Phase I/II clinical trial of a vaccine for parvovirus. The proteins that are produced in this facility are intended for use as "injectibles". As such, they are produced under cGMP Regulations for Biologics and Human Drugs under the auspices of the FDA.
Meridian is a fully integrated life science company that manufactures, markets and distributes a broad range of innovative diagnostic test kits, purified reagents and related products and offers biopharmaceutical enabling technologies. Utilizing a variety of methods, these products and diagnostic tests provide accuracy, simplicity and speed in the early diagnosis and treatment of common medical conditions, such as gastrointestinal, viral and respiratory infections. Meridian's diagnostic products are used outside of the human body and require little or no special equipment. The Company's products are designed to enhance patient well-being while reducing the total outcome costs of healthcare. Meridian has strong market positions in the areas of gastrointestinal and upper respiratory infections, serology, parasitology and fungal disease diagnosis. In addition, Meridian is a supplier of rare reagents, specialty biologicals and related technologies used by biopharmaceutical companies engaged in research for new drugs and vaccines. The Company markets its products and technologies to hospitals, reference laboratories, research centers, veterinary testing centers, physician offices, diagnostics manufacturers and biotech companies in more than 60 countries around the world. The Company's shares are traded through NASDAQ's Global Select Market, symbol VIVO. Meridian's website address is www.meridianbioscience.com.
CONTACT: Meridian Bioscience, Inc.
John A. Kraeutler, President & COO, 513-271-3700
SOURCE: Meridian Bioscience, Inc.