
Date and time:16:00 - 17:00, Wednesday, May 16, 2007
Location:DAIICHI SANKYO COMPANY, LIMITED Headquarters, 10th floor meeting room
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.
A2. The company believes it can compete well even if generics of existing products come onto the market.
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.
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.
A5. Trials overseas are proceeding on almost a similar schedule. In principle, trials are conducted concurrently.
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.
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.
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.
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.
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.
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.