BARDA Contract Well on Track and Full Phase 2b Results of Human Rhinovirus Study Expected in First Half of Calendar 2012
MELBOURNE, AUSTRALIA--(Marketwire - Feb 15, 2012) - Biota Holdings Limited (
Of particular note in the first half, the Company reported that its contract with BARDA for laninaivir is progressing well with revenue of $4.3 million recognized in the first half of fiscal 2011. As previously announced, the contract, signed April 2011, included a $231 million investment by the U.S. Office of Biomedical Advanced Research and Development Authority (BARDA) toward further development of laninivir, Biota's long-acting neuroaminidase inhibitor for the treatment of influenza. The contract is fully funded over an estimated five-year period and is contingent upon the delivery of key milestones throughout the period.
Within the pipeline, the Company reported that the Phase IIb clinical study of HRV antiviral BTA798 in asthmatic subjects has completed enrolment, well ahead of schedule. Full results of the study are expected to be available early in the second calendar quarter of 2012. BTA798 has been allocated the generic name of "vapendavir" by the World Health Organisation.
"We are pleased to report encouraging progress made under our BARDA contract, as well as to see the very successful advance of our HRV antiviral program," said Biota CEO, Peter Cook. "The key business focus has been to ensure progress under the BARDA contract and manage cash and costs until the restocking of government neuraminidase inhibitor stockpiles improve Relenza royalty income. It is exciting to see the very successful advance of all our programs, although the short term focus will be on the near-term announcement of HRV Phase IIb results."
In parallel, the clinical team are planning for two Phase I studies that are expected to commence around June 2012.
*all financial figures are in Australian dollars except for the BARDA contract which represents $231 million USD.
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 and Daiichi Sankyo co-own a range of second generation influenza antivirals, of which the lead product lnavir®, is marketed in Japan. Biota holds a contract from the US Office of Biomedical Advanced Research and Development Authority (BARDA) for the advanced development of laninamivir in the USA.
Relenza™ is a registered trademark of the GlaxoSmithKline group of companies.
Inavir® is registered to Daiichi Sankyo.
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