Daiichi-Sankyo expands US pharmaceutical business

According to a Nikkei report, Japanese-based pharmaceutical company Daiichi-Sankyo (D-S) is expanding its US pharmaceutical business in a bid to generate sales of at least JPY 200bn (USD 1.8bn) in FY09.

The revised sales figure is approximately double that for FY06, according to Nikkei.

The US subsidiary of D-S has already increased its sales staff by 50 per cent to reach 1,350 and will hire around 200 more sales representatives by FY09 to promote its cholesterol-lowering drug WelChol (colesevelam).

WelChol has been on the US market as a cholesterol-busting treatment since September 2000, but in December 2006 D-S requested FDA approval to market the drug as a type-2 diabetes treatment.

According to Nikkei, D-S should gain FDA approval for the alternate use in November and will begin marketing WelChol as a diabetes drug in January 2008.

Prasugrel's future uncertain
Nikkei also identified D-S' pipeline anti-thrombotic prasugrel as another potential earner. In January 2007, AG Edwards analysts predicted that annual prasugrel sales could exceed USD 800m by 2011.

However, a clinical trial comparing prasugrel with Bristol-Myers Squibb (BMS) and sanofi-aventis' Plavix (clopidogrel), showed that the drug had its downsides. Although the TRITON trial demonstrated that prasugrel was 19 per cent more effective than Plavix, the results revealed that the risk of bleeding was greater with prasugrel.

Cardiologists at the American Heart Association Convention in Orlando, where the TRITON data was presented, said that prasugrel was indeed ready for an NDA, but BMS loses its Plavix patent in 2011. The cardiologists speculated that prasugrel would not be able to compete with generic Plavix.

D-S' head of US operations comments on expansion
In an interview with The Pink Sheet in August 2007, D-S's head of US operations, Joe Pieroni, revealed his thoughts on the contribution of the US arm to total D-S sales: "Right now we represent about 10 per cent of all of D-S worldwide sales here in the US. That includes all businesses, even though 90 per cent of the company is pharmaceuticals."

"I think in a three-year horizon we would represent about 25 per cent, 26 per cent of the profit of D-S, and if you express it in terms of growth over these three year periods of sales and profit, we represent about 60 per cent of the growth of sales and profit for the parent company, so there's no doubt that it is definitely an engine for future growth both in terms of sales and profit," concluded Pieroni.