Daiichi Sankyo: New Influenza Drug May Boost Flagging Japanese Market

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Daiichi Sankyo: new influenza drug may boost flagging Japanese market

Tokyo-based Daiichi Sankyo has filed a New Drug Application in Japan for its inhaled influenza antiviral, laninamivir. This neuraminidase inhibitor, administered in just a single inhaled dose, retains activity to strains resistant to the market leader, Roche's Tamiflu. As such, its approval may provide a much-needed boost to the declining Japanese antiviral market. ( http://www.bharatbook.com/detail.asp?id=70257&rt=Daiichi-Sankyo-Co-Ltd-PharmaVitae-Profile.html )

The actual submission is for CS-8958, a prodrug of laninamivir which is converted to the active form in the body. Encouraged by the rapid turnaround for Shionogi's Rapiacta (peramivir), which was launched in January 2010, Daiichi Sankyo expects the drug to be on sale in Japan within the next 14 months.

Laninamivir is a neuraminidase inhibitor with a long period of action, which is administered in a single inhaled dose. Daiichi Sankyo, which co-owns the drug with Australian biotech Biota, will be marketing the compound in Japan. Results from an Asian Phase III trial showed ...
... CS-8958/laninamivir to be non-inferior to Tamiflu (oseltamivir; Roche) in terms of time to resolution of symptoms. A Japanese Phase III trial investigating laninamivir for the prevention of influenza infection is currently ongoing.

Tamiflu and GlaxoSmithKline's Relenza (zanamivir), the only efficacious influenza drugs available until the recent launch of Rapiacta (peramivir; Shionogi), will soon have to face a fourth competitor in Japan. Tamiflu's widely reported neuropsychiatric side effects in children and adolescents have contributed to considerable sales declines in the country, from $323m in 2005 to $73m in 2008 according to IMS Health. That said, the drug still dominates the Japanese market, which is now worth just $92m.

Despite the Tamiflu-led decline of the market, historical sales indicate the considerable potential in Japan. The once-only administration of laninamivir (a key advantage over the repeated dosing of Tamiflu and Relenza) and its activity against Tamiflu-resistant strains position the drug favorably. While the inhaled mode of administration will provide a significant obstacle to uptake in Japan, Datamonitor believes that Daiichi Sankyo can overcome this challenge by communicating the convenience of a once-only inhalation with prolonged activity, altering negative perceptions among physicians and patients. Thus, a potentially lucrative opportunity awaits both in terms of pandemic stockpiling and seasonal use in a country with history of widespread adoption of influenza antivirals.

Related research

Daiichi Sankyo Co., Ltd: PharmaVitae Profile
http://www.bharatbook.com/detail.asp?id=70257&rt=Daiichi-Sankyo-Co-Ltd-PharmaVitae-Profile.html

Commercial Insight: Influenza Vaccines and Antivirals - The pandemic's long-term impact
http://www.bharatbook.com/detail.asp?id=103782&rt=Commercial-Insight-Influenza-Vaccines-and-Antivirals-The-pandemics-long-term-impact.html

The Japanese Pharmaceutical Market Outlook to 2014: Policy environment, market structure, competitive landscape, growth opportunities
http://www.bharatbook.com/detail.asp?id=130208&rt=The-Japanese-Pharmaceutical-Market-Outlook-to-2014-Policy-environment-market-structure-competitive-landscape-growth-opportunities.html

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