Meridian Bioscience Awarded Contract to Manufacture Parvovirus Vaccine for National Institutes of Health - NIH
CINCINNATI--(BUSINESS WIRE)--Oct. 6, 2003--Meridian Bioscience, Inc., Cincinnati, Ohio (Nasdaq:VIVO) today announced that it has been awarded a contract to manufacture clinical grade recombinant protein Parvovirus B19 vaccine for The National Institutes of Health. Vaccine production will take place at the Company's life science manufacturing facility located at Viral Antigens, Inc. (VAI), Memphis, TN, a wholly owned subsidiary. Under the terms of this contract, National Heart, Lung, and Blood Institute (NHLBI) will pay approximately $1.4 million for VAI to manufacture a specific volume of Parvovirus B19 vaccine sufficient for Phase I human clinical trials to be conducted by the NHLBI. Upon successful completion of the Phase I clinicals, the NHLBI has an option to purchase, from VAI, additional vaccine for Phase II human clinical trials. The Phase I vaccine is due nine months from project initiation, tentatively scheduled to begin in November 2003.
The NIH/NHLBI have a long-standing interest in Parvovirus B19, an important pathogen affecting humans. Parvovirus B19 infection is common among children and adults and is often asymptomatic. Parvovirus B19 infection can result in serious and occasionally fatal hematologic diseases in susceptible patients, and is the cause of "fifth disease", a highly contagious infection of childhood. In sickle cell disease and other hereditary and acquired hemolytic anemias, acute B19 infection results in transient aplastic crisis, in which hemoglobin levels fall precipitously, anemia becomes life threatening, and congestive heart failure may ensue. Parvovirus B19 can also infect the fetus causing severe anemia, congestive heart failure, and death in utero or at birth.
Many of the clinical manifestations of Parvovirus B19 infection in humans were discovered by NHLBI scientists. As a result of this research, a method to express Parvovirus B19 structural proteins and recombinant B19 virus-like particles was developed and patented by the federal government. VAI will utilize these patented protein expression methods to supply sufficient clinical grade B19 recombinant parvovirus capsids for use as a vaccine in Phase I and Phase II clinical trials to be conducted by NIH. VAI will also be responsible for regulatory requirements including maintenance or renewal of the current Investigational New Drug Application (IND) with the U.S. Department of Health and Human Services Food and Drug Administration (FDA) for recombinant B19 parvovirus capsids.
Richard L. Eberly, General Manager, Meridian Life Science commented, "We are pleased that the NIH has awarded VAI this contract to manufacture the Parvovirus B19 vaccine for clinical trials. This project combines VAI's scientific and technical capabilities with NIH's proprietary technology for the production of a new vaccine."
The Private Securities Litigation Reform Act of 1995 provides a safe harbor from civil litigation for forward looking statements accompanied by meaningful cautionary statements. These statements identify important factors that could cause actual results to differ materially from those that might be projected. 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 Meridian's competition. While Meridian has introduced approximately 35 internally-developed products since 1991, 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. One of Meridian's main growth strategies is 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.
Meridian is a fully integrated life sciences 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 provide accuracy, simplicity and speed in the early diagnosis and treatment of common medical conditions, such as gastrointestinal, viral, urinary and respiratory infections. All Meridian 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 and specialty biologicals. The Company markets its products to hospitals, reference laboratories, research centers, veterinary testing centers and physician offices in more than 60 countries around the world. The Company's shares are traded through Nasdaq's National Market, symbol VIVO. Meridian's website address is www.meridianbioscience.com.
CONTACT: Meridian Bioscience, Inc., Cincinnati
John A. Kraeutler, 513-271-3700
SOURCE: Meridian Bioscience, Inc.