Daiichi Sankyo receives marketing approval for Inavir in Japan

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.