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."
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. 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.
