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Biota Holdings (ASX:BTA) and Daichii Sankyo (TSE:4568) start Phase III trial
with CS-8958 to prevent influenza
Tokyo, Japan & Melbourne, Australia — 5 November 2009: Biota Holdings Limited
(ASX:BTA) and Daiichi Sankyo Co., Ltd. today announced the commencement of the
Phase III trial for the anti-influenza drug, CS-8958, in Japan. The goal is to
gain an influenza prevention indication in Japan. CS-8958 is a prodrug and
administered by inhalation. Once inhaled it is converted to the active
metabolite known as laninamivir. To date, the development of this product has
focused on treatment of influenza patients and the new study examines its use in
prevention.
This Phase III study is a multicenter, placebo-controlled, double-blind trial
that will evaluate prevention and safety of CS-8958 for families of influenza A
and B sufferers. The study measures influenza transmission among those receiving
CS-8958 or a placebo. It will be conducted in Japan and subjects will be
enrolled from household’s with influenza infected patients. The trial is a Study
of Household Influenza prophylaxis Effect of Long-acting anti-influenza Drug,
with the acronym of SHIELD.
SHIELD is also intended to establish the optimum dosage of CS-8958 for this
indication and provide a further evaluation of safety. Intra-group comparisons
will be made with regard to the incidence of adverse events and other safety
measures.
Laninamivir is a novel neuraminidase inhibitor discovered by Daiichi Sankyo for
the treatment of influenza and is co-owned with Biota Holdings Limited. Daiichi
Sankyo is pressing ahead with the development program of CS-8958 in Japan. An
application for manufacturing and marketing approval is planned to be submitted
by March 2010 for the treatment of adult and paediatric influenza utilising the
results of the Phase III therapeutic trial completed in June 2009.
Please note a copy of
Questions and Answers on the trial is attached to this announcement.
-ends-
About LANI’s (Long-Acting Neuraminidase Inhibitors)
Current neuraminidase inhibitors for influenza require daily or more frequent
dosing. The ability to dose patients on a weekly, or even less frequent, basis
offers numerous potential benefits. These include greater efficiency of storage
and distribution for a given treatment period and/or number of patients and
improved patient compliance.
About Daiichi Sankyo
A global pharmaceutical innovator, Daiichi Sankyo Co., Ltd., was established in
2005 through the merger of two leading Japanese pharmaceutical companies.
Daiichi Sankyo discovered laninamivir and has a key partnership with Biota for
the development of the product.
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 novel nucleoside analogues designed to treat
hepatitis C virus (HCV) infections, licensed to Boehringer Ingelheim, and a
series of candidate drugs aimed at treatment of respiratory syncytial virus
(RSV) disease. 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
For a copy of the Questions and Answers please contact College Hill
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
Adam Michael / Justine Lamond / Benjamyn Tan
T: +44 (0)20 7866 7857
Email: biota@collegehill.com
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