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Takeda announces possible Actos successor

Takeda says it has a second potential successor to its diabetes blockbuster treatment, Actos, which currently brings in almost a third of the Japan-based firm's revenue

Japan's largest pharmaceutical company Takeda has said that it has a second potential successor to its diabetes blockbuster treatment, Actos (pioglitazone), which currently brings in almost a third of the firm's revenue.

Takeda is under pressure because US regulators have been examining Actos to see if it carried similar cardiac damage risks attached to the world's best-selling diabetes drug from GlaxoSmithKline (GSK), Avandia (roseglitazone). Takeda needs to find a successor product before the drug loses patent protection in 2011.

In Q2 FY07, Actos sales rose 27 per cent as doctors around the world saw it as a safer option to Avandia, which has been linked to a 43 per cent increase in heart-attack risk in a high-profile study. GSK has fought off the findings by presenting longitudinal safety data to the FDA, who has since decided to keep the drug on the US market, with some changes to the product label. Takeda also presented safety data, keeping Actos on the market with no label change.

Actos' successor, SYR-472, is in the second of three stages of patient studies needed for regulatory review, according to Kiyoshi Kitazawa, head of Takeda's product-planning unit. The drug's development status was revealed in a conference call with analysts and reporters on 1 August. Takeda also said that it was developing SYR-322 as another possible Actos replacement.

Takeda is a medium-sized company, despite its position in the Japanese market and a large US presence. Its R&D spend is dwarfed by those of Pfizer and GSK, so its pipeline is fairly weak in comparison. As a result, Actos sales far outstrip those of Takeda's other medicines, making the drug an increasingly important source of revenue and growth.

Takeda posted a 5.1 per cent jump Q1 FY07 profits, due to Actos sales rising JPY 106.6bn (USD 900m). In Q2 FY07, US sales of the drug increased 19 per cent to reach USD 728m.

Deutsche Securities analysts based in Tokyo have warned that the more Takeda relies on Actos for profit growth, the greater the risk to its share price. They added that it was crucial for Takeda to develop a DPP4 inhibitor before Actos's patent expires and it loses market share to generic drugs and newer therapies, adding that they still did not know how well the investigational drugs were doing.

2nd August 2007

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