Anti-flu drug laninamivir by Daiichi Sankyo to be launched by 2011

Laninamivir, an inhaled drug to treat H1N1 swine flu, is also found effective against H5N1 avian influenza

Laninamivir, an inhaled anti-viral to treat H1N1 swine flu by Daiichi Sankyo, is currently in final phases of human studies.

Laninamivir’s late-stage trial is begun in Japan to validate the potential of the drug in preventing H1N1 swine flu as well as bird flu infections, Japan’s third-largest drugmaker, Daiichi Sankyo said in release.

Daiichi Sankyo plans to apply for approval of laninamivir, which is also known as CS-8958, by March 2010. It aims to bring it to market by March 2011.

Laninamivir (CS-8958) is an anti-influenza virus agent, expected to be effective after a single dose due to its long action as a neuraminidase inhibitor.

After inhalation, laninamivir is retained for a long time in the target organ.

Non-clinical studies conducted so far have shown that laninamivir was effective not only against seasonal influenza, but also against new type influenza (swine A/H1N1) in-vitro and in-vivo.

Laninamivir has also shown efficacy against H5N1 avian influenza virus in non-clinical tests.

Daiichi Sankyo announced results from a Phase III study of the anti-influenza virus agent  laninamivir in August.

Laninamivir study, named MARVEL (Multinational Asian Clinical Research for Influenza Virus Extermination on Long-Acting Neuraminidase-Inhibitor study), was performed as a randomized, double-blind, and active-controlled study in order to confirm the efficacy and safety of  the drug.

Laninamivir was administered as a single inhaled dose of 20 or 40 mg compared to oseltamivir phosphate 75 mg (Tamiflu capsule) orally administered twice daily for 5 days (total of 10 times) in adult patients with influenza A or B virus infection.

According to the results, non-inferiority to oseltamivir phosphate was confirmed in both the 20 mg group and 40 mg group of laninamivir in terms of the primary endpoint, which was the time to alleviation of influenza illness.

Laninamivir 40 mg group was superior to 20 mg group in efficacy in the comparison between the dose groups. Both 20 mg and 40 mg of CS-8958 were well tolerated.

In addition, Daiichi Sankyo conducted a randomized, double-blind, active-controlled Phase II/III study for pediatric use in parallel with MARVEL study, and the efficacy and safety of laninamivir administered as a single inhaled dose of 20 or 40 mg was compared to oseltamivir phosphate (Tamiflu???? for oral suspension) as well.

Both the 20 mg group and 40 mg group of CS-8958 were better than oseltamivir phosphate group in efficacy.Both 20 mg and 40 mg of laninamivir were well tolerated in pediatric patients.

Australian drugmaker Biota  owns the U.S. and UK rights to develop and market laninamivir.

Shionogi,another Japanese drug maker has applied for approval of the experimental influenza treatment peramivir, an intravenous drug, in Japan, recently.

Peramivir recently gained emergency use authorization from US FDA to treat severely ill H1N1 swine flu infection.

Shionogi bought the Japan and Taiwan rights to peramivir from US firm BioCryst.

For the six months ended September 30, 2009, consolidated net sales of Daiichi Sankyo amounted to ¥470.5 billion (up 15.8% year on year).

Despite the appreciated Japanese yen compared with the same period last year, the Group’s revenue increased by a contribution of ¥66.1 billion from the net sales of Ranbaxy Laboratories Limited, which was consolidated as a subsidiary in October 2008.

In terms of profitability, operating income of Daiichi was ¥50.8 billion (down 17.5% year on year) as the company proactively invested in research and development. Ordinary income was ¥52.2 billion (down 12.4% year on year).

Daiichi’s net income was ¥18.6 billion (down 45.0% year on year) which reflected cases including non-application for R&D tax credit and income tax amendments related to the previous year.

Key highlights of the period under review include the launch of a high dosage preparation in Japan for the synthetic antibacterial agent Cravit in July, and the U.S. launch of Effient, a novel antiplatelet agent, in August.

Effient’s launch follows those from other countries such as the U.K. and Germany, and its sales are performing steadily.