Inavir® 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. The new class provides the opportunity to medicate patients on a "one and done" basis and offers 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.
Inavir® is Daiichi Sankyo's registered brand for laninamivir octanoate, also previously known as CS-8958. Inavir® is delivered via a Dry Powder Inhaler. Inavir® is not a vaccine.
Neuraminidase is essential for the replication of all influenza viruses. It is an enzyme which allows new viruses to be released from the infected lung cells, further extending the infection. Neuraminidase inhibitors block this activity, preventing the release and spread of new viruses.
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. Biota will receive royalties on all sales of Inavir® in Japan and may qualify for additional milestone payments.
Biota and Daiichi Sankyo continue to explore options for development and commercialisation of laninamivir ex-Japan. Biota has been awarded a contract from the Office of Biomedical Advanced Research (BARDA) within the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (HHS) for the advanced development of laninamivir. The contract has a value of up to US$231 milllion over a five year period.
Inavir® is approved for sale in Japan for the treatment of influenza in adults and children.
Daiichi Sankyo has applied to sell Inavir® in Japan for the prevention of influenza.