BARDA Awards Major Contract to Biota
02 April 2011 - 12:00AM
Business Wire
Biota Holdings Limited (ASX:BTA) advises that the Office of
Biomedical Advanced Research and Development Authority (BARDA)
within the Office of the Assistant Secretary for Preparedness and
Response (ASPR) at the U.S. Department of Health and Human Services
(HHS) has awarded up to an estimated US$231 million contract to its
wholly owned subsidiary, Biota Scientific Management Pty Ltd, for
the advanced development of laninamivir. The contract is fully
funded over an estimated five (5) year period and is contingent
upon the delivery of key milestones throughout the period.
The contract is designed to provide US based manufacturing and
clinical data to support a New Drug Application for laninamivir, to
the US Food and Drug Administration.
Biota CEO, Peter Cook, commented, “The award provides visible
recognition of the potential medical value of laninamivir to the
world’s major market. The BARDA contract will be a major
contributor to a timely introduction of the product and will create
the opportunity to significantly develop Biota’s business in the
USA.”
About Laninamivir
Laninamivir is an influenza antiviral, known as a long acting
neuraminidase inhibitor (LANI) and a unique treatment for
influenza. Unlike vaccines, neuraminidase inhibitors offer the
ability to treat an influenza infection, but may also be used
preventatively.
Current or first-generation neuraminidase inhibitors require
twice daily dosing. LANI compounds are more potent, have a longer
residence time in the lung and offer the potential of a single
administration for treatment and once a week for prevention. This
represents a significant advantage over all existing influenza
antivirals.
Laninamivir is approved for sale in Japan and was launched as
Inavir by Daiichi Sankyo in October 2010. It is not currently
approved for sale in other markets.
About Biota
Biota is a leading anti-infective drug development company based
in Melbourne Australia, with key expertise in respiratory diseases,
particularly influenza. Biota developed the first-in-class
neuraminidase inhibitor, zanamivir, subsequently marketed by
GlaxoSmithKline as Relenza. Biota research breakthroughs include a
series of candidate drugs aimed at treatment of respiratory
syncytial virus (RSV) disease and Hepatitis C (HCV) virus
infections. Biota has clinical trials underway with its lead
compound for human rhinovirus (HRV) infection in patients with
compromised respiration or immune systems.
In addition, Biota co-owns with Daiichi Sankyo a range of second
generation influenza antivirals, of which the lead product lnavir®,
is approved for marketing in Japan.
Relenza™ is a registered trademark of the GlaxoSmithKline group
of companies.
Inavir® is registered to Daiichi Sankyo.
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