Sol-Gel acquires Gorlin syndrome drug candidate Patidegib from PellePharm

Sol-Gel Technologies, an Israel-based dermatology company, has acquired patidegib, a Gorlin syndrome drug candidate in phase 3 development, from US-based biotechnology company PellePharm, in a deal worth up to $75 million.

Patidegib has breakthrough therapy and orphan drug designations from the US Food and Drug Administration (FDA).

With potential market of more than $300 million, the topically-applied patidegib is a hedgehog signalling pathway blocker intended for the treatment of Gorlin syndrome and is designated as investigational compound SGT-610.

Sol-Gel Technologies anticipates to expand its pipeline with the potential to be the first- ever therapy for preventing new basal cell carcinomas in Gorlin syndrome, if approved by the FDA.

Alon Seri-Levy — Sol-Gel Technologies CEO said: “Rare diseases represent a high margin therapeutic category, and we estimate that SGT-610, if approved by the FDA, has the potential to generate, at peak, annual net sales in excess of $300 million.

“We conducted extensive due diligence on patidegib’s earlier development programs and consulted with expert clinicians to design a rigorous new Phase 3 trial that we believe can overcome the deficiencies of the earlier Phase 3 study to generate the safety and efficacy data necessary to support an FDA approval.

“We have a strong track record of conducting clinical studies of topical dermatologic drugs and we expect to leverage our experience to advance SGT-610 toward FDA approval, with the objective of providing Gorlin syndrome patients with the first drug that could prevent new basal cell carcinomas (BCCs).”

Sol-Gel Technologies said it will pay PellePharm an upfront payment of $4.7 million and total development and new drug application (NDA) acceptance milestones of up to $6 million, and up to $64 million in commercial milestones as well as single digit royalties under the terms of the acquisition.

Patidegib has also been granted orphan drug designation by the European Medical Agency (EMA). Its approval in both the US and the European Union could be based on a single pivotal phase 3 study.

Sol-Gel Technologies anticipates to begin the phase 3 clinical trial of patidegib in the second half of this year and expects the results by the end of 2025.