Briefing on FY2007 Financial Results FAQ for investors, securities analysts

Date and time:

16:00 -, Wednesday, November 07, 2007

Location:

NIPPON KEIDANREN KAIKAN, Golden room

Q1:

In the TRITON trial (phase 3 trial), Prasugrel is compared against 300 mg of Clopidogrel (approved dosage). We however hear that 600 mg of Clopidogrel is often used as a loading dose in medical practice. Is there no problem in the trial with this dosage?

Q2:

Clopidogrel became this big from a 20% reduction in ischemic events* compared to existing products. Can we think that Prasugrel will also become a drug to replace Clopidogrel?

Q3:

Is it not difficult to exclude three patient subpopulations with a higher risk of major bleeding (patients who were 75 years of age or older, weighed less than 60 kg, or had a prior history of stroke) in clinical practice?

Q4:

Approximately what percent of Clopidogrel indicationsdoes TRITON cover?

Q5:

What are the pharmacodynamic clinical trials reported in the media 2 weeks ago? Are these required for the NDA filing?

Q6:

By a delay in the launch of Prasugrel, will the number of MR staff in the US that you have planned possibly change?

Q7:

You have been performing marketing activities for anti-hypertensive Benicar jointly with Forest Laboratories. Would the share of voice (SOV) decline by sole promotion of Daiichi Sankyo from early fiscal 2008?

Q8:

How can Azor reduce the side effect of edema that is caused by sole administration of Amlodipine?

Q1:

In the TRITON trial (phase 3 trial), Prasugrel is compared against 300 mg of Clopidogrel (approved dosage). We however hear that 600 mg of Clopidogrel is often used as a loading dose in medical practice. Is there no problem in the trial with this dosage?

A1:

Generally, in the US, comparisons are made against the approved dosage. We had discussions with the FDA, and believe there will be no problem. The trial called TIMI44 has proven that Prasugrel 60mg is significantly superior to Clopidogrel 600 mg in efficacy. Furthermore, there are patients who do not respond or have weak responses to Clopidogrel, but there are no such patients in Prasugrel. Prasugrel is very effective with poor responders of Clopidogrel. Prasugrel provides a high overall inhibition of platelet aggregation, rapid onset of action, and consistent patient response.

Q2:

Clopidogrel became this big from a 20% reduction in ischemic events* compared to existing products. Can we think that Prasugrel will also become a drug to replace Clopidogrel?

A2:

When we look at the history of anti-platelet treatments, the advent of aspirin reduced events by 22%. When Clopidogrel arrived, there was a further reduction of 20% in risk. This time, Prasugrel further reduced this by 19% over Clopidogrel. Meanwhile, risk for bleeding has increased. Based on the data recently announced, we believe that Prasugrel contributes greatly to treatments, when we exclude three patient subpopulations with a higher risk of major bleeding (patients who were 75 years of age or older, weighed less than 60 kg, or had a prior history of stroke)
*Cardiovascular death, heart attack, and stroke.

Q3:

Is it not difficult to exclude three patient subpopulations with a higher risk of major bleeding (patients who were 75 years of age or older, weighed less than 60 kg, or had a prior history of stroke) in clinical practice?

A3:

The analysis of TRITON is not completely finished. We will continue with the analysis so we can prepare a guideline on dosing for these patient subpopulations.

Q4:

Approximately what percent of Clopidogrel indicationsdoes TRITON cover?

A4:

It is true that Clopidogrel has a wide indication. TRITON covers 60% of the patients with Acute Coronary Syndrome (ACS), who are receiving Percutaneous Coronary Intervention (PCI). We will confirm the effect of Prasugrel in the other 40% by TRILOGYstarting in the 2nd quarter of 2008.

Q5:

What are the pharmacodynamic clinical trials reported in the media 2 weeks ago? Are these required for the NDA filing?

A5:

These trials are not required for NDA filing to the FDA. These are trials to observe, among others, the inhibition of platelet aggregation when Clopidogrel is switched to Prasugrel, and these rather are trials used for marketing. Please note that the trials were not stopped, but were suspended temporarily to amend the protocol.

Q6:

By a delay in the launch of Prasugrel, will the number of MR staff in the US that you have planned possibly change?

A6:

The data from TRITON are fantastic. Therefore, we believe there will be no delay.

Q7:

You have been performing marketing activities for anti-hypertensive Benicar jointly with Forest Laboratories. Would the share of voice (SOV) decline by sole promotion of Daiichi Sankyo from early fiscal 2008?

A7:

We do not think that the SOV will decline. We will put further effort to increase the SOV even promoted by Daiichi Sankyo alone.

Q8:

How can Azor reduce the side effect of edema that is caused by sole administration of Amlodipine?

A8:

We are not sure why, but it is a fact that the incidence of edema has been decreased.