CINCINNATI– Meridian Life Science, Inc., (MLS) of Memphis, Tennessee, a wholly-owned subsidiary of Meridian Bioscience, Inc., recently completed the manufacture of a human rhinovirus Type 16 challenge stock. MLS manufactured the rhinovirus challenge stock under contract and according to the appropriate current Good Manufacturing Procedures (cGMPs) for use in early-phase human clinical trials while simultaneously meeting the desired titer specifications under aggressive timelines.

Challenge stocks are wild type, native viruses that are fully capable of causing disease in the target population. These virus preparations are designed to be used in conjunction with clinical trials testing the efficacy of a given therapeutic. A challenge stock of infectious virus permits infection of a group of healthy volunteers where the precise viral dose, timing and progression of disease can be monitored. In turn, administration of the anti-viral therapeutic or vaccine may be tested at varying times and doses to better understand the efficacy of the drug in a controlled environment. Beyond the advantages of providing a carefully monitored test environment, the use of a challenge stock in designing an efficacy study is the increased efficiency in patient enrollment, and time to completion of the study. In clinical efficacy trials that depend on the identification of randomly infected individuals for inclusion in the study, it is common to encounter long delays and difficulties with identification of appropriate test subjects. Studies utilizing challenge stocks such as the human rhinovirus permit rapid enrollment and testing of the therapeutic resulting in significant cost savings along the road to commercialization.

Victor Van Cleave, Ph.D., Vice President of Research and Development (R&D) at Meridian Life Science, stated, “MLS is pleased to have been selected for the cGMP manufacture of a human rhinovirus Type 16 challenge stock. This project, similar to other challenge stocks and vaccines we’ve produced, was an excellent fit for MLS’ core virology and virus-based product manufacturing capabilities. The contract manufacturing process required successful technology transfer and development of a scalable production process to make this challenge stock. MLS and our scientists are proud to be a part of this drug development effort that could significantly reduce the incidence and/or severity of rhinovirus infections.”

ABOUT RHINOVIRUSES

Rhinoviruses, one of a group of viruses responsible for the “common cold” are the most common viral infectious agents found in humans. Adults average 2 to 3 infections per year while school children may experience as many as 6 to 10 infections per year with each event lasting from 7 to 10 days. The common cold is the most frequent cause of missed work and school days and annually results in approximately 100 million physician visits in the U.S. alone. The estimated economic impact in the U.S. for common cold-related infections is over $20 billion.

ABOUT MERIDIAN BIOSCIENCE, INC.

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, 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.