Melbourne, Australia — 19 April 2007- Biota Holdings
Limited (ASX:BTA) today announced that its long acting
neuraminidase inhibitor (LANI), CS8958, an anti-influenza
1. demonstrated effectiveness against the avian flu virus H5N1;
2. completed Phase I studies in Japan; and
3. received ethics approval to commence comparable studies in the UK.
Biota’s partner for LANI, Daiichi-Sankyo, overnight announced that laboratory
studies had confirmed CS8958’s effectiveness against the avian flu virus H5N1 in
addition to its effectiveness against influenza A and B type non-avian viruses.
Daiichi-Sankyo also announced that it has completed a Phase I clinical trial in Japan
on CS8958 and expects to start Phase II studies in October.
The UK studies will extend the safety and pharmacokinetics studies of CS8958 in
man. The double-blinded study will involve up to 40 healthy volunteers using a
single dose, and will trial up to four separate, single dose levels. The study is being
funded as part of a US$5.6 million grant provided by the US National Institutes of
Health. The studies will utilise a newly licensed inhaler designed by Hovione and
complement the studies completed by Daiichi-Sankyo in Japan. The UK studies will
generate data in western subjects and lay the basis for further clinical development
CS8958 is a long acting neuraminidase inhibitor and offers higher potency, lower
dose and the potential for once only treatment and once weekly prophylactic
protection from influenza. These properties are known consumer advantages over
existing inhaled and oral therapies.
CS8958 and a range of other LANI type compounds are co-owned by Biota and
Biota CEO, Peter Cook said “These are important milestones in the development of
second generation anti-influenza products. We have every confidence in the
product’s profile as it offers the potential for a very real improvement in therapy for
both the prescriber and ultimate user of the product”.
Daiichi-Sankyo Co. Ltd (TSE 4568) is one of Japan’s largest pharmaceutical
companies, with annualised worldwide sales of US$8.2 billion (A$10 billion).
Daiichi-Sankyo has a long history of discovering new classes of drugs, including the
first-in-class statin drug for treatment of high cholesterol. In 2003, Daiichi-Sankyo
and Biota combined their LANI research programs.
Biota is a leading antiviral 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
respiratory syncytial virus (RSV) or bronchiolitis, licensed to MedImmune Inc. 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 key partnerships with
Daiichi-Sankyo for the development of second generation influenza antivirals and
with Inverness Medical to market Biota developed FLU OIA influenza diagnostics.
Relenza™ is a registered trademark of the GlaxoSmithKline group of companies.
BioStar ® OIA® FLU and BioStar ® OIA® FLU A/B are registered trademarks of Inverness Medical.
*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: +61 408 441 122
T: +61 3 9915 3721
Company name: DAIICHI SANKYO COMPANY, LIMITED
Representative: Takashi Shoda, President and Representative Director
(Code no.: 4568, First Section, Tokyo, Osaka and Nagoya Stock Exchanges)
Please address inquiries to Toshio Takahashi, Corporate Officer in Charge,
Corporate Communications Department
Completion of Phase I Trial on the Anti-influenza Drug CS-8958
Tokyo, April 18, 2007 – DAIICHI SANKYO COMPANY, LIMITED announced today that it
has completed a Phase I clinical trial in Japan on the DAIICHI SANKYO-originated antiinfluenza
drug CS-8958 and expects to start Phase II trials this fall.
CS-8958 is a long-acting neuraminidase inhibitor that is expected to show a therapeutic effect
only by one administration and a protective effect by one administration a week. The
compound is under development as an inhalant that will act directly on the pulmonary and
tracheal sites of infection. Non-clinical studies have confirmed its effectiveness against the
H5N1 avian flu virus in addition to its effectiveness against both A and B type non-avian flu
CS-8958 was designated as a priority item for face-to-face consultation and advice by the
Pharmaceuticals and Medical Devices Agency (PMDA) in August 2006, which will give it
priority for consultations on clinical trial planning and other issues. DAIICHI SANKYO aims
to file an NDA at end-2009 and is pursuing development in full consultation with the
regul atory authorities and specialists. As measures are stepped up to deal with new strains of
influenza virus, CS-8958 may make an important contribution by increasing the range of
options available for treating and preventing flu infections.
In Europe and the US, Australia-based Biota Holdings Ltd., a joint development company, is
conducting Phase I trials for CS-8958.