BARDA Awards Major Contract to Biota
MELBOURNE, Australia--(BUSINESS WIRE)--Apr 1, 2011 - 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."
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.
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.
RelenzaTM is a registered trademark of the GlaxoSmithKline group of companies.
Inavir® is registered to Daiichi Sankyo.