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Archive Information meeting material

Briefing on FY2006 Financial Results FAQ For investors, securities analysts

Date and time:16:00 - 17:00, Wednesday, May 16, 2007
Location:DAIICHI SANKYO COMPANY, LIMITED Headquarters, 10th floor meeting room

Q1. Please tell us what you can about the schedule and protocol on Phase 3 trials for diabetes drug CS-011

Q2. We understand that CS-011 will now undergo trials for a period of over two years. Is the company able to differentiate CS-011 sufficiently, even if generic brands of a existing products are launched?

Q3. Penem antibiotic SUN A0026 has backtracked from “In Application” to “Phase 3”. What has happened?

Q4. It appears TIMI44 tests will be conducted for anti-platelet agent Prasugrel (CS-747). What kind of tests are these? Furthermore, will the results of the Phase 3 trials (TRITON tests) be announced at the AHA (American Heart Association) in November?

Q5. Are Phase 2b trials on oral factor Xa inhibitor DU-176b for AF (Atrial Fibrillation) first conducted domestically?

Q6. Around when is the mid-term evaluation for Phase2b trials on oral factor Xa inhibitor DU-176b scheduled?

Q7. There was an explanation that the effect of a synergy with domestic sales was showing since April. What is the source of this synergy effect?

Q8. How does the company view the target for treatment for dysuria Urief in the current term? Would it be safe to say that sales will exceed 8 billion yen?

Q9. Are sales of Olmesartan / Amlodipine combination CS-8663, for which a launch is planned in the third quarter of FY2007, included in the plan for the current term?

Q10. Are sales of VIT45, which is a succesor to Venofer, a treatment for iron deficiency anemia currently sold in the US, taken under consideration in the plan for the current term? How do you see the profitability of Luitpold?

Q11. The figures in the current plan appear somewhat different from the figures in the mid-term business management plan. What changed?

Q1. Please tell us what you can about the schedule and protocol on Phase 3 trials for diabetes drug CS-011.

A1. Carcinogenicity trials were conducted on this PPARγ agonist for two years, and the results are currently under review by the FDA. The objective of Phase 3 trials currently underway is to demonstrate the superiority over the existing glitazone drugs. Phase 3 has become a large-scale trial as it includes several tests, and the FDA has instructed us to perform trials for more than two years to prove its safety.

Q2. We understand that CS-011 will now undergo trials for a period of over two years. Is the company able to differentiate CS-011 sufficiently, even if generic brands of a existing products are launched?

A2. The company believes it can compete well even if generics of existing products come onto the market.

Q3. Penem antibiotic SUN A0026 has backtracked from “In Application” to “Phase 3”. What has happened?

A3. This drug Faropenem was licensed-out to Replidyne, and Replidyne made the application in the US. A decision however was made to conduct additional trials, following the instruction of the FDA.

Q4. It appears TIMI44 tests will be conducted for anti-platelet agent Prasugrel (CS-747). What kind of tests are these? Furthermore, will the results of the Phase 3 trials (TRITON tests) be announced at the AHA (American Heart Association) in November?

A4. As shown in our R&D meetings, TIMI44 is a controlled study against high dosage of Plavix (600 mg). Furthermore, with regard to announcement on TRITON results, the company would be happy to make a presentation at the AHA conference. However, since the trial will last around summer, the company believes that the schedule is quite challenging.

Q5. Are Phase 2b trials on oral factor Xa inhibitor DU-176b for AF (Atrial Fibrillation) first conducted domestically?

A5. Trials overseas are proceeding on almost a similar schedule. In principle, trials are conducted concurrently.

Q6. Around when is the mid-term evaluation for Phase2b trials on oral factor Xa inhibitor DU-176b scheduled?

A6. The company wishes to conduct a mid-term evaluation this year or early next year and decide whether to proceed to Phase 3 trials upon a review of the results.

Q7. There was an explanation that the effect of a synergy with domestic sales was showing since April. What is the source of this synergy effect?

A7. The collaboration experience on Cravit and Olmetec during the year and a half integration preparation period is useful. Furthermore, the company established a new promoting system after sufficient training on the products. With regards to wholesalers, the company is working to prevent declines in account transactions. In addition, cross-wise structure is beginning to prove effective.

Q8. How does the company view the target for treatment for dysuria Urief in the current term? Would it be safe to say that sales will exceed 8 billion yen?

A8. The deregulation of long-term prescription regulation has a large impact. Although the target of 8 billion yen is a stretch, it is a suitable figure for the company.

Q9. Are sales of Olmesartan / Amlodipine combination CS-8663, for which a launch is planned in the third quarter of FY2007, included in the plan for the current term?

A9. The sales are included in the plan for DSI, our US subsidiary. However, the sales are not so large as this will be the first year.

Q10. Are sales of VIT45, which is a succesor to Venofer, a treatment for iron deficiency anemia currently sold in the US, taken under consideration in the plan for the current term? How do you see the profitability of Luitpold?

A10. New iron preparation VIT45 is not only a successor to Venofer, but it also targets gynecological anemia. Since Venofer was primarily for dialysis treatment, preceding investment is required in FY07 to expand the business area. As a result, Luitpold expects some decline in profit. The sales of VIT45 are considered in the plan, however, it is not large since it will be the first year.

Q11. The figures in the current plan appear somewhat different from the figures in the mid-term business management plan. What changed?

A11. The company re-evaluated the figures at the budgeting stage. There was some impact from temporarily keeping some businesses within the group, that were to be spun-off at the time of the mid-term business management plan. In addition, research and development expenses have increased, but there is no major change to the conditions.