Under a development funding and royalties agreement with Novan for berdazimer gel, Ligand is entitled to receive up to
'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,' said
'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,' commented
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.
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
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