Japanese filing planned for therapeutic indication, while prophylaxis trials to start this year.
Biota and Daiichi Sankyo reported positive results from an Asia-based Phase III influenza therapy trial. It compared the firms’ long-acting neuraminidase inhibitor flu candidate, laninamivir (CS-8958), with oseltamivir (Roche’s Tamiflu).
Daiichi Sankyo has Japanese rights to the drug and says that it aims to file an NDA for laninamivir during fiscal 2009. The company is also planning to start a clinical study for prophylactic use of the drug in late 2009.
The Phase III trial involved 1,000 adult patients with confirmed, naturally acquired influenza A or B. Results showed a single inhaled dose of laninamivir was as effective as a twice-daily, five-day course of oseltamivir. A parallel Phase II/III trial comparing laninamivir with oseltamivir in paediatric patients also met its primary and secondary endpoints.
Biota, meanwhile, is progressing the clinical development program for laninamivir in North America and Europe, supported by NIH funding of some $5.6 million. The company is looking for a licensing partner for laninamivir for all non-Japanese markets including the U.S.
In 2003 Biota and Daiichi Sankyo merged their respective LANI programs. The molecule CS-8958 was discovered by Daiichi Sankyo, which retained the option to manufacture and market the drug in Japan in return for funding the Japanese trials.