Ligand Pharmaceuticals' Partner Pelthos Therapeutics Launches ZELSUVMI Topical Gel for Molluscum Contagiosum Treatment.

Ligand Pharmaceuticals announced that its partner Pelthos Therapeutics has commercially launched ZELSUVMI, the first at-home treatment for molluscum contagiosum. Ligand earned a $5 million milestone payment from Pelthos and owns 56% of the company following a merger. Ligand is entitled to a 13% royalty on worldwide sales and up to an additional $5 million in commercial sales milestones.

Pelthos Therapeutics (NYSE American: PTHS) has commercially launched ZELSUVMI™ (berdazimer) topical gel 10.3%, marking a significant milestone as the first and only FDA-approved at-home treatment for molluscum contagiosum. The novel nitric oxide-releasing gel, which received FDA Novel Drug designation in January 2024, is now commercially available through prescription. In Phase 3 clinical trials involving 891 patients, ZELSUVMI demonstrated complete clearance in 33% of patients compared to 19.7% in the control group at week 12, with some patients showing results within two weeks. The treatment targets an estimated 16.7 million affected people in the United States, with up to 6 million new cases annually.

To support the launch, Pelthos has deployed 50 sales territory managers nationwide and implemented the ZelsuvmiGo patient support program to facilitate patient access and education. Pelthos launches first at-home treatment for molluscum contagiosum, addressing a 16.7M patient market with significant commercial potential. Pelthos Therapeutics has successfully launched ZELSUVMI™ (berdazimer) topical gel 10.3%, representing a significant commercial milestone as the first and only FDA-approved at-home treatment for molluscum contagiosum. This launch targets an estimated 16.7 million affected patients with up to 6 million new cases annually in the U.S., predominantly children. The product's Novel Drug designation from the FDA in January 2024 highlights its innovative approach. Clinical efficacy data shows complete clearance in nearly 33% of patients versus 19.7% in the control group at week 12, with some patients seeing results within two weeks. The convenience factor is substantial – this once-daily topical medication can be applied at home by patients or caregivers, eliminating the need for frequent office visits and uncomfortable in-office procedures. From a commercial execution standpoint, Pelthos has deployed 50 sales territory managers nationwide focusing on high-volume prescribers and implemented the ZelsuvmiGo patient support program to facilitate patient onboarding. The company has secured distribution through retail pharmacies, ASPN pharmacy services, and mail-order options, creating multiple access points for patients. The addressable market is substantial given the condition's prevalence, contagious nature, and previous lack of at-home treatment options. With the product now commercially available, investors should monitor prescription uptake rates, payor coverage developments, and initial revenue generation in coming quarters to gauge commercial traction in this previously underserved market.

Ligand Pharmaceuticals announced that its partner Pelthos Therapeutics has commercially launched ZELSUVMI, the first at-home treatment for molluscum contagiosum. Ligand earned a $5 million milestone payment from Pelthos and owns 56% of the company following a merger. Ligand is entitled to a 13% royalty on worldwide sales and up to an additional $5 million in commercial sales milestones.

References:
[1] https://www.stocktitan.net/news/PTHS/pelthos-therapeutics-launches-zelsuvmitm-berdazimer-topical-gel-10-3-dw6d0qmessoe.html