Managing PDUFA Date Expectations
A specialty pharmaceuticals company that was already a ICR Westwicke client expected an FDA decision regarding approval of a new product that had the potential to achieve peak annual sales which could exceed anything in its current product line by at least three times.
Unexpectedly, the FDA advised the company that its decision date would be extended by 90 days to review additional information provided by the company. Management needed to be forthright about the on-going review process and the delay within the confines of a regulated industry in order to demonstrate its belief in a positive outcome for the product and to maintain investor confidence in management’s ability to interact with the regulators to achieve a positive approval decision.
ICR Westwicke’s Role
- Suggested the company be open and transparent in explaining the type of additional manufacturing data submitted to the FDA which had triggered the additional review time
- Urged the company to provide qualitative updates on the review process at investor conferences and on conference calls and to include the high level content of FDA interactions when possible
- Recommended that the company keep investors informed of its plans for commercialization for the new product under review in terms of sales force expansion, targeted physicians, managed care interactions, and planned promotional activities to demonstrate management’s steadfast faith in a positive decision
- Helped management focus investors on its existing growing product line, management’s ability to beat guidance, and other positive corporate developments, so that all attention did not focus on the one issue of the new product approval
- Highlighted to investors the on-going publication and presentation of clinical data for the new product in order to reinforce investors’ belief in the clinical efficacy and safety of the product, which would ultimately lead to an FDA approval
- Advised company to conduct a conference call regardless of the FDA’s decision in order to provide updated information regarding the launch if the product received an approval or to explain the additional steps, information and time that would be needed in the case of a negative decision from the FDA
Results
The FDA actually approved the product two days ahead of the PDUFA date with the exact indication expected by company management and investors. The shares traded up by 12% on the day of the approval announcement and conference call.