Melbourne, Australia – 23rd July 2009: Biota Holdings Limited (ASX:BTA) notes that GlaxoSmithKline (GSK) has issued a Pandemic (H1N1) Influenza Update on its plans to assist governments and health authorities respond to the emergence of the new influenza A (H1N1) pandemic strain commonly referred to as swine flu.
The plans include a commitment by GSK to increase its annual production capacity of the influenza anti-viral Relenza to 190 million courses by the end of 2009. This increase represents a threefold increase to GSK’s previous capacity of 60 million courses.
Production capacity of Relenza in its standard Diskhaler format will be increased from 60 to 90 million courses. Importantly, a further 100 million courses a year of additional capacity will be available as Relenza Rotacaps/Rotahaler. This alternative Relenza treatment has been recently granted temporary approval by Swedish regulators and hence within the EU, for distribution during a pandemic.
The Rotacaps/Rotahaler is widely recognised as a simple, easy to use device. It is already manufactured by GSK for other inhaled products and offers a rapid increase in capacity for Relenza. GSK is in discussion with a number of international regulatory authorities to secure further approvals.
GSK has also indicated that it intends to donate 2 million courses of Relenza to the WHO and on which Biota has agreed to waive royalties.
Biota receives a minimum 7% royalty on global sales of Relenza by GSK and holds patent coverage in the major markets until at least December 2014.
While the positive effect of this expansion on Biota may be significant and GSK have confirmed it has contracts to supply Relenza to over 60 countries, the announcement is focussed on increased manufacturing capacity for Relenza, not orders or sales. GSK has stated that additional regulatory approvals will be required and that the capacity increases are planned for the end of calendar 2009. The expansion of Relenza capacity and any increase in resultant royalty payments, will not effect Biota’s cash position until June 2010, at the earliest.
GSK is a significant global supplier of therapeutic products for influenza, including the antiviral Relenza, vaccines, antibiotics and ancillary equipment such as anti-viral face masks, all of which have a recognised beneficial role in the management of the current global influenza pandemic by public health officials.
A copy of the GSK Press Release of 22 July 2009, London, UK, entitled Pandemic (H1N1) 2009 Influenza Update, is attached.
About Relenza
All the way from its formative basic science at CSIRO and the Victorian College of Pharmacy to its manufacture in Boronia, Victoria, zanamivir (Relenza) is an original Australian product. Zanamivir was the first of a new class of anti-viral drugs, known as neuraminidase inhibitors, capable of treating or preventing infection from the influenza virus. Neuraminidase is an essential enzyme for all influenza viruses and allows new viruses to be released from infected lung cells.
Relenza is used by inhalation and is delivered directly to the respiratory tract, the primary site of viral infection and replication. The drug works by blocking the replication and the spread of the virus.
Relenza is an anti-viral, used to treat and prevent infection from influenza. It is not a vaccine.
About Biota
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 have included a series of candidate drugs aimed at treatment of respiratory syncytial virus (RSV) disease, licensed to AstraZeneca and novel nucleoside analogues designed to treat hepatitis C virus (HCV) infections, licensed to Boehringer Ingelheim. 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 has a key partnership with Daiichi Sankyo for the development of second generation influenza anti-virals.
