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Major Milestones

Biota has a proud history as a world-leader in antiviral drug development and a track record of bringing products to the market. The following lists some of major milestones in Biota's history.

2009

  • Biota expanded its antibacterial interests following the asset acquisitions of Prolysis Limited and MaxThera Inc.
  • Biota returns $20 million to shareholders.
  • The long acting neuraminidase inhibitor, laninamivir, shown to be effective in Phase III clinical trials in Asia.
  • Phase IIa trials of human rhinovirus (HRV) drug achieve clinical proof of concept.
  • Daiichi Sankyo exercise right to market CS-8958 ("laninamivir") in Japan.
  • Biota and GlaxoSmithKline conclude litigation through mediation.

2008

  • LANI Phase III clinical trials for treatment of influenza commenced in Japan.
  • RSV License and collaboration agreement with MedImmune assigned to AstraZeneca.
  • AstraZeneca acquired RSV Asian rights for US$3.5m
  • LANI Phase II clinical trials for treatment of influenza completed in Japan and elsewhere in Asia.
  • Phase IIa trials of its human rhinovirus (HRV) drug commenced.

2007

  • Biota completed Phase I trials of an antiviral for the prevention and treatment of human rhinovirus (HRV) in high risk COPD and asthma patients.
  • Commencement of Phase I clinical trials on respiratory syncytial virus (RSV) under the licensing agreement with MedImmune Inc.
  • Commencement of Phase II trial for treatment of influenza by LANI in Japan and elsewhere in Asia.

    2006

    • Biota entered into a licensing and collaboration agreement with Boehringer Ingelheim to develop and commercialise Biota's novel nucleoside analogues, designed to treat hepatitis C virus (HCV) infections and potentially other diseases.
    • Biota commenced Phase I trials of an antiviral for the prevention and treatment of human rhinovirus (HRV) in high risk COPD and asthma patients.
    • Biota admitted to the ASX 300.

    2005

    • Biota entered into a licensing and collaboration agreement with MedImmune Inc (USA) to develop and commercialise Biota's small molecule compounds for the prevention and treatment of respiratory syncytial virus (RSV) infection.
    • Governments began stockpiling Relenza™ for defence against avian (bird) influenza.
    • Biota entered into an agreement with Aerogen, Inc (USA) to use its Aeroneb nebuliser in clinical trials of the LANI compounds developed by Biota and Sankyo (Japan).

    2004

    • Biota awarded a US$5.6 million National Institutes of Health award for its long-acting inhaled neuraminidase inhibitors (LANI) program.
    • Biota initiated legal proceedings against GlaxoSmithKline for the company's failure to promote and support Relenza™.
    • Biota consolidated its USA and Australian operations to a purpose built facility in Melbourne.

    2003

    • Sankyo (Japan) and Biota entered into an agreement to jointly develop long-acting inhaled neuraminidase inhibitors (LANI).
    • Biota and Inverness Medical (Thermo Electron) launched new influenza rapid diagnostic tests, BioStar® OIA® FLU and BioStar® OIA® FLU A/B, in the U.S (subsequently marketed by Inverness Medical as part of their BioStar range).
    • Biota awarded a $2.7 million research and development Start grant to advance its RSV program.

    2002

    • Biota  entered into a collaboration and licensing agreement with GlaxoSmithKline for the discovery and development of novel antivirals for hepatitis C (HCV) and other viruses.
    • Biota successfully fought off a hostile takeover bid.

    2001

    • Biota acquired NuMAX Pharmaceuticals Inc (USA).
    • Biota regained rights to its long-acting inhaled neuraminidase inhibitors (LANI) from GlaxoSmithKline.

    2000

    • Biota announced an agreement with GlaxoWellcome on the discovery and development of a long acting drug.

    1999

    • FDA approved Relenza™ which was launched in most countries that year.

    1998

    • An application filed for U.S. marketing of zanamivir under the tradename Relenza™.
    • FDA approved the Biota-Biostar influenza diagnostic test, OIA® FLU, for sale in the USA.
    • Biota awarded a $3.2 million research and development Start grant to advance its human rhinovirus (HRV) program.

    1997

    • Zanamivir Phase III trials completed.
    • Biota conducted the first clinical trial of OIA® FLU prototype diagnostic test in Adelaide (South Australia).
    • Biota entered into an agreement with Biostar (Colorado, USA.  Now known as Inverness Medical) for marketing the influenza diagnostic test OIA® FLU.

    1996

    • Biota and Biostar (Colorado, USA - now known as Inverness Medical) entered into an agreement to develop a rapid diagnostic test for influenza.  Research and Development conducted under Biota's stewardship at both Biota and Biostar's laboratories.

    1994

    • Zanamivir entered Phase II clinical trials.
    • Biota's first research facility, the Biota Chemistry Laboratory at Monash University opened in December.  Biota commenced research and development on novel approaches to rapid testing in influenza diagnosis.

    1993

    • Zanamivir moved into Phase I clinical testing.

    1990

    • Biota signed a license and development agreement with the Glaxo Group (UK) for zanamivir.

    1989

    • The discovery of zanamivir, the world's first neuraminidase inhibitor, was announced (published in 1993 as: von Itzstein, et al., Nature 363:418-23, 1993).

    1985

    • Biota Holdings floated on the Australian Stock Exchange (ASX:BTA) raising $3 million, which was invested in R&D projects including work focused on the discovery of influenza neuraminidase inhibitors.
    • Biota Holdings Limited incorporated in October.

    1983

    • The three dimensional structure of influenza neuraminidase was  published by Dr Peter Colman and colleagues (Colman et al., Nature 303:41-4, 1983).