Biota Holdings Limited (ASX: BTA) today welcomed the announcement that GlaxoSmithKline (“GSK”) has granted its first sub-license to manufacture and supply zanamivir. The sub-license is to Simcere Pharmaceutical Group (“Simcere”) of China, and permits the manufacture and supply of zanamivir in China, Indonesia, Thailand, Vietnam and other developing countries. Zanamivir is the active ingredient in Relenza, the anti-influenza drug developed by GSK under licence from Biota.
Biota CEO Mr Peter Cook said “When GSK requested Biota’s approval for this agreement with Simcere, it was readily given in recognition of the critical public health need. We hope to see GSK further increase supply to ensure that the world is able to gain better access to zanamivir, one of the world’s only two effective antiviral drugs in the event of an avian flu pandemic”.
The agreement enables Simcere to manufacture and sell zanamivir in China, Indonesia, Thailand, Vietnam and all United Nations classified Least Developed Countries. GSK’s competitor, Roche, has already put in place a number of arrangements with developing countries for the manufacture and use of the rival anti-influenza drug Tamiflu, ranging from licensing such as the Simcere deal, to sub-contract manufacturing agreements with more than 16 third parties in 10 different countries. Biota will be entitled to receive royalties on sales by Simcere, under the sub-license.
About Biota Biota is a leading antiviral drug development company based in Melbourne, with key expertise in respiratory diseases, particularly influenza. Biota developed the first-in-class neuraminidase inhibitor, zanamivir, and subsequently marketed by GlaxoSmithKline (GSK) as Relenza. Relenza is currently being stockpiled by a number of national governments for defense against avian influenza. Biota receives royalties from sales of Relenza.
Recent Biota research breakthroughs have included a series of candidate drugs aimed at RSV (Respiratory Syncytial Virus, bronchiolitis), subsequently licensed to MedImmune Inc. Biota has Phase I clinical trials underway with HRV (human rhinovirus) and is also engaged in early stage research targeting hepatitis C virus infection. In addition, Biota has key partnerships with Sankyo; for the development of second generation influenza antivirals (called LANI or Long Acting Neuraminidase Inhibitors) and with Thermo Electron (Inverness Medical); Biota developed the FLU OIA® influenza diagnostics, currently marketed in the US.
™Relenza is a registered trademark of the GlaxoSmithKline group of companies.
®FLU OIA & FLU OIA A/B are registered trademarks of Thermo Electron Corporation.
*Further information available at www.biota.com.au.
Investor / Analyst Enquiries Media Enquiries Biota Holdings Limited Tim Duncan or Nerida Mossop Peter Cook Hinton & Associates T: +61 3 9915 3720 T: +61 3 9600 1979 Damian Lismore M: 0408 441 122 T: +61 3 9915 3721
