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Briefing on 1st Half FY2007 Financial Results FAQ for media representatives

Date and time:
14:00-, Wednesday, November 07, 2007
Location:
NIPPON KEIDANREN KAIKAN, Golden room
Q1:
I believe that Daiichi Sankyo have quite a large pipeline chiefly in cardiovascular diseases. However, I believe there is little pipeline for cancer. What is your thinking on cancer?
Q2:
We hear that the effect of Prasugrel was better than expected in the TRITON trial. Meanwhile, severe bleeding was observed. Given this finding, how will you strategize your businesses going forward?
Q3:
On October 25th, you announced a postponement of small clinical trials. Given the recent AHA announcement, how will you manage these small trials?
Q4:
What will be the effect on sales in the event the recently announced TRILOGY trial does well?
Q5:
We hear that the number of MR in the US will be 2,300 in fiscal 2009. What is the reason for the recent downward scaling to 2,200?
Q6:
Is the marketing strategy for Welchol (NDA filed for indication for treatment of diabetes) a "fixed-dose combination" of Welchol and, for example, Metformin?
Q1:
I believe that Daiichi Sankyo have quite a large pipeline chiefly in cardiovascular diseases. However, I believe there is little pipeline for cancer. What is your thinking on cancer?
A1:
From the standpoint of management, we do not believe that the pipeline is sufficient enough. Cancer is positioned as our priority therapeutic area, and we plan to increase the pipeline in terms of both quality and quantity. However, the present situation is that there are many products in the earlier phases. This year, we brought in Denosumab. However, going forward, we wish to increase our pipeline by, for example, utilizing outside resources in addition to our products.
Q2:
We hear that the effect of Prasugrel was better than expected in the TRITON trial. Meanwhile, severe bleeding was observed. Given this finding, how will you strategize your businesses going forward?
A2:
In comparison to Clopidogrel, features of Prasugrel are "more rapid onset of action," "higher overall inhibition of platelet aggregation," and "more consistent patient response." Clopidogrel was ineffective in 20~30% of the cases. However, Prasugrel was very effective in even those ineffective cases. Furthermore, bleeding was observed in certain patient subupopulations, but the incidence rate in those patient subpopulations was 20% of PCI patients. Prasugrel was very effective in the remaining 80% of the patients, and the risk of bleeding was also similar to Clopidogrel. We willperform further analysis on the 20% patient subpopulations in whom bleeding was often observed, and devise an appropriate method of dosing.
Q3:
On October 25th, you announced a postponement of small clinical trials. Given the recent AHA announcement, how will you manage these small trials?
A3:
The trials announced on October 25th are pharmacodynamic clinical trials. These studies are small pharmacodynamic trials that are performed independent of TRITON, given the situation that Clopidogrel is often used in high dosages, and other.
Q4:
What will be the effect on sales in the event the recently announced TRILOGY trial does well?
A4:
In TRITON, we only conducted the trial with patients receiving Percutaneous Coronary Intervention (PCI). In TRILOGY, we try to prove that Prasugrel is effective even in patients whose condition do not escalate to PCI, and the market for this is very big.
Q5:
We hear that the number of MR in the US will be 2,300 in fiscal 2009. What is the reason for the recent downward scaling to 2,200?
A5:
We revised the number of MR to be appropriated due to the launch of a generic drug of Floxin-Otic.
Q6:
Is the marketing strategy for Welchol (NDA filed for indication for treatment of diabetes) a "fixed-dose combination" of Welchol and, for example, Metformin?
A6:
Welchol is not a fixed-dose combination. The strategy that we will take is "combination therapy" of Welchol with, for example, Metformin.