Soyun Shin

Soyun Shin sought clarification on the generic entry timing, specifically if the settlement with three additional ANDA filers now means generic entry no earlier than March 2030 with pediatric exclusivity, and September 2029 without it. She also asked about the envisioned opportunities for the Prader-Willi syndrome (PWS) indication for WAKIX beyond supporting pediatric exclusivity, given a potential two-year runway from launch, and if Pitolisant HD is being considered for PWS.

Answer

Jeffrey M. Dayno, President and CEO, confirmed that without pediatric exclusivity, market entry would be September 2029, and the company is on track to obtain pediatric exclusivity, extending it to March 2030, with the Prader-Willi program being a key component. Kumar Budur, Chief Medical and Scientific Officer, stated that with approximately 15,000 PWS patients in the U.S. (half with significant EDS and no approved drugs), a successful study would address a high unmet need. He added that while Pitolisant HD is not currently being considered for PWS, the option remains open.

Soyun Shin sought clarification on the generic entry timeline, specifically if the new settlements mean generic entry would start no earlier than September 2029 without pediatric exclusivity, and March 2030 with it. She also asked about the envisioned opportunities for WAKIX in Prader-Willi syndrome (PWS), considering its role in pediatric exclusivity and the short commercial runway if approved, and if Pitolisant HD is being considered for PWS.

Answer

Dr. Jeffrey Dayno, President and CEO, confirmed that without pediatric exclusivity, generic market entry would be September 2029, and with pediatric exclusivity (which the company is on track to obtain), it would be March 2030. Dr. Kumar Budur, Chief Medical and Scientific Officer, stated that PWS represents a high unmet need with approximately 15,000 patients in the U.S., half of whom experience significant excessive daytime sleepiness with no approved drugs. He emphasized that a successful study would lead to an indication addressing this need, and while Pitolisant HD is not currently being considered for PWS, the option remains open. The larger market opportunity for the PWS program is the six-month extension of pediatric exclusivity for WAKIX.