Biota Holdings of Australia and partner Daiichi Sankyo it has begun a late-stage trial in Japan for the preventative use of their investigational antiviral laninamivir for influenza.
Earlier this year the companies presented promising data Phase III Asian trials for the therapeutic use of laninamivir, which is also known as CS-8958. The drug is a novel neuraminidase inhibitor, the same class of treatment as Relenza (zanamivir), the antiviral discovered by Biota and sold by GlaxoSmithKline.
Biota said that patients infected with either the 9A H1N1 pandemic influenza strains or seasonal influenza will be eligible for enrolment in the study. They anticipate receiving approval from the Japanese Ministry of
Health and Welfare for therapeutic treatment indications by the end of the first quarter of 2011, around the same time when an application for prophylactic indications will also be filed.
Biota and Daiichi Sankyo believe that laninamivir is superior to Roche’s big-selling Tamiflu (oseltamivir). The latter is taken orally twice daily for five days, while CS-8958 is administered by inhalation of a single dose, and the aforementioned Asian trials revealed that the antiviral is as effective as Tamiflu and is well-tolerated. It has also been shown to be effective against Tamiflu-resistant viruses.
The companies added that in terms of production for Japan, they plan to supply enough treatments for 3-4 million people by 2010 and for 10 million from 2011.
