Inavir® Approved for Sale in Japan
September 13 2010 - 7:30AM
Business Wire
Biota Holdings Limited (ASX:BTA) today announced that Daiichi
Sankyo has received approval to manufacture and market Inavir®
(pronounced in-a-veer) in Japan. Inavir® is Daiichi Sankyo’s brand
of laninamivir octanoate and also previously known as CS-8958. The
approved indication is for the treatment of influenza in adults and
children.
Inavir® (laninamivir octanoate), is the first drug of a new
class of long acting neuraminidase inhibitors (LANIs) to address
the limitation of the current products, which require daily or more
frequent dosing. Neuraminidase inhibitors (NIs) are antiviral
agents effective against influenza, providing both for the
treatment of an established influenza infection or for the
prevention of influenza prior to exposure. NIs are antiviral
medicines and are not vaccines.
The new class of long acting neuraminidase inhibitors provide
the opportunity to medicate patients on a “one and done” basis and
offer a number of potential benefits. These include that the
patient is more likely to use the product properly and as intended
and also offers a reduced cost of storage and transport per course,
where the product is intended to be stockpiled.
In 2003, Biota and Daiichi Sankyo merged their respective LANI
programs. Under the co-ownership agreement, Daiichi Sankyo held an
option to manufacture and sell laninamivir in Japan, in return for
funding an extensive range of Japanese clinical trials. Under the
agreement, Biota will receive a royalty on all sales in Japan and
may also qualify for certain sale’s milestone payments.
Daiichi Sankyo and Biota have been in discussion with a number
of suitable companies for the licensing of laninamivir in the rest
of world. Those discussions are continuing. The Companies are
confident that laninamivir will prove to be a valuable therapeutic
product with many patient and community advantages.
About Daiichi Sankyo
The Daiichi Sankyo Group is dedicated to the creation and supply
of innovative pharmaceutical products to address the diversified,
unmet medical needs of patients
in both mature and emerging markets. While maintaining its
portfolio of marketed pharmaceuticals for hypertension,
hyperlipidemia, and bacterial infections, the Group
is engaged in the development of treatments for thrombotic
disorders and focused on the discovery of novel oncology and
cardiovascular-metabolic therapies. Furthermore, the Daiichi Sankyo
Group has created a "Hybrid Business Model," which will respond to
market and customer diversity and optimize growth opportunities
across the value chain.
For more information, please visit www.daiichisankyo.com
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 include a
series of candidate drugs aimed at treatment of respiratory
syncytial virus (RSV) disease and Hepatitis C (HCV) virus
infections. 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 and Daiichi Sankyo co-own a range of second
generation influenza anti-virals, of which the lead product lnavir,
is approved for marketing in Japan.
Relenza™ is a registered trademark of the GlaxoSmithKline group
of companies.
*Further information available at www.biota.com.au
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