|
| |
Biota (ASX:BTA) GSK Relenza capacity to triple
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.
A link to the original GSK press release is available at:
http://www.gsk.com/media/pressreleases/2009/2009_pressrelease_10077.htm
-ends-
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.
Relenza™ is a registered trademark of the GlaxoSmithKline group of companies.
*Further information available at
www.biota.com.au
Investor / Analyst Enquiries
Biota Holdings Limited
CEO Peter Cook
T: +61 3 9915 3720
CFO Damian Lismore
T: +61 3 9915 3721
European Media Enquiries
College Hill Life Sciences
Adam Michael, Justine Lamond & Benjamyn Tan
T: +44 (0)20 7866 7857
biota@collegehill.com
| |
|
