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
- Bioa expanded its antibacterial interests following the asset acquisitions of Prolysis Limited and MaxThera Inc.
- Biota to return $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.
- 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.
- 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).
- 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.
- 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.
- 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.
- Biota acquired NuMAX Pharmaceuticals Inc (USA).
- Biota regained rights to its long-acting inhaled neuraminidase inhibitors (LANI) from GlaxoSmithKline.
- Biota announced an agreement with GlaxoWellcome on the discovery and development of a long acting drug.
- FDA approved Relenza™ which was launched in most countries that year.
- 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.
- 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.
- 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.
- 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.
- Zanamivir moved into Phase I clinical testing.
- Biota signed a license and development agreement with the Glaxo Group (UK) for zanamivir.
- 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).
- 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.
- The three dimensional structure of influenza neuraminidase was published by Dr Peter Colman and colleagues (Colman et al., Nature 303:41-4, 1983).
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