Keywords: influenza treatment, Biota Holdings, CS-8958

Biota’s LANI Phase III clinical trials in Asia prove successful

Article | 10 August 2009

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Australia’s Biota Holdings has announced successful results from the Asian Phase III clinical trials of CS-8958, its second generation influenza treatment. CS-8958 now has been assigned the new name of laninamivir’by the World Health Organization under its International Non-proprietary Names (INN) drug identification system. Laninamivir is a long-acting neuraminidase inhibitor (LANI) and is co-owned with Japan’s Daiichi Sankyo.

In the Phase III trial in adults, a single inhaled dose of laninamivir was shown to be as effective as oseltamivir (Tamiflu) administered orally twice daily for five days (total of 10 doses). A parallel Phase II/III trial of CS-8958 in pediatric patients also met the primary and secondary endpoints compared to oseltamivir.

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“The success of the multifaceted Phase III trials in Asia is significant. Laninamivir offers a new therapeutic agent in the treatment of influenza with particular advantages for stockpiling applications” said Peter Cook, Biota's managing director.

Trial Results

The Phase III study was conducted by Daiichi Sankyo in Japan, Taiwan, Hong Kong and Korea and enrolled around 1,000 adult patients who had confirmed, naturally acquired influenza A or B. Patients in the trial received either 20mg or 40mg of laninamivir as a single inhaled dose or 75mg of oseltamivir twice daily for five days. Participants in the trial were distributed equally across three treatment groups. The primary end point of the trial was time to symptom resolution, while the secondary end point was time for body temperature to return to normal.  Both doses of laninamivir were as effective as oseltamivir and were well tolerated.

Future plans

Daiichi Sankyo has secured the rights to manufacture and market laninamivir in Japan and funded the Japanese trials. Daiichi Sankyo is seeking approval from the Japanese regulatory authority to market laninamivir in Japan, with submission anticipated by March 2010. A clinical study for prophylaxis of influenza is expected to commence in Japan in late 2009. Biota will receive an undisclosed royalty on sales and a number of fixed sum payments on the achievement of certain sales milestones.

Biota will continue to advance the clinical development program required to support registration in North America and Europe. The US National Institutes of Health has to date committed a total of $5.6 million to support the western clinical development program.

A licensing partner is now being sought for all markets outside Japan, including the US. Under the Commercialisation and Licence Agreement between Biota and Daiichi Sankyo, the parties will share commercial returns from licensing outside Japan.