Coming Soon? The first FDA-approved Topical Prescription Product for Molluscum

January 6, 2023
Coming Soon The first FDAapproved Topical Prescription Product for Molluscum image

Ligand Pharmaceuticals Inc.’s partner Novan’s Berdazimer gel, 10.3% is a new chemical entity that releases nitric oxide and has anti-viral activity. molluscum.

Ligand Pharmaceuticals Inc.’s partner Novan submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking marketing approval for berdazimer gel, 10.3% (SB206) for the topical treatment of molluscum contagiosum.

Assuming the filing is accepted by the FDA and given a typical 12-month review process, Novan anticipates a potential first quarter 2024 approval. Berdazimer gel, 10.3% is poised to be a first-in-class topical treatment for molluscum. The active ingredient, berdazimer sodium, is a new chemical entity that releases nitric oxide and has anti-viral activity. If approved, berdazimer gel, 10.3% would be the first topical treatment indicated for molluscum with the convenience of self-application.

Under a development funding and royalties agreement with Novan for berdazimer gel, Ligand is entitled to receive up to $20 million of milestone payments and tiered royalties of 7% to 10% on future worldwide sales of berdazimer gel.

“In 2019 Ligand provided funding to Novan for the clinical development of berdazimer gel in exchange for milestones and royalties. Today’s announcement brings the Novan team one step closer to potentially marketing an important medicine and provides further validation of our strategy of expanding our royalty portfolio by providing development capital,” says Todd Davis, CEO of Ligand, in a news release. “As we look to the future, we will continue to seek similar investments in high quality assets led by highly capable teams.”

“Today marks a significant milestone for Novan and the culmination of substantial efforts of the entire Novan team – the company’s first NDA submission. I am extremely proud of our team and the progress thus far with berdazimer gel, 10.3%. Based on the robust data generated from our Phase 3 studies, we believe the product candidate is well-positioned to treat molluscum, which remains an unmet need. The NDA submission brings Novan closer to providing what could be the first FDA-approved prescription product for the treatment of this contagious viral skin infection,” added Paula Brown Stafford, President and CEO of Novan.

According to Novan, results from the pivotal Phase 3 B-SIMPLE4, clinical study evaluating berdazimer gel, 10.3% for the treatment of molluscum (NCT04535531) demonstrated highly statistically significant improvement in primary clinical endpoint (p<0.0001) in the largest cohort of molluscum patients ever studied, which results were recently published in JAMA Dermatology. Berdazimer gel, 10.3% was found to be well tolerated with mild application site pain and mild to moderate erythema reported as the most common adverse events.

“Many patients with molluscum go untreated due to a lack of FDA-approved therapeutic options. A topical gel applied by the patient or caregiver that has the potential to clear molluscum lesions and is well tolerated would likely be a significant change to clinical practice. Right now, we are limited to in-office procedures to treat this bothersome infection. I think caregivers and patients with molluscum would welcome berdazimer gel as a breakthrough in treatment. I look forward to the potential of having this option available for my patients,” said Adelaide Hebert, M.D., Chief of Pediatric Dermatology at McGovern School of Medicine and Children’s Memorial Hermann Hospital.

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