Tokyo, Japan (February 1, 2010) – Daiichi Sankyo Company, Limited
(hereafter; Daiichi Sankyo), today announced that it has submitted a New Drug
Application to the Ministry of Health, Labor and Welfare for approval in Japan of
CS-8958, a proprietary anti-flu drug.
CS-8958 is a laninamivir prodrug that is a Long-Acting Neuraminidase Inhibitor.
The drug, developed entirely for the Japanese market by Daiichi Sankyo, will be
in the form of an inhalant that will directly treat the airways of influenza patients.
Clinical studies to date with adults and children suffering from type A or B influenza
viruses have proven CS-8958 to be effective with a single administration.
In non-clinical studies, CS-8958 has also demonstrated that it is efficacious with
the H1N1 and potentially lethal H5N1 (avian influenza) viruses, leading to an
expectation for wide-ranging contributions to influenza treatment in the future.
In November 2009, Daiichi Sankyo began a Phase III clinical study in Japan on
the prophylactic use of CS-8958.
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 CS-8958.
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.
Biota and Daiichi Sankyo have pooled their respective intellectual property for the
development of second generation influenza anti-virals whereby Biota will receive
royalties on sales of CS-8958 by Daiichi Sankyo in Japan. In addition, Biota and Daiichi
Sankyo are seeking a commercial partner for CS-8958 for the Rest of the World and for
which the co-owners will share the commercial returns.
