checkAd

     2109  0 Kommentare Ligand’s Partner Novan Submits New Drug Application to the U.S. FDA for Berdazimer Gel, 10.3% (SB206) for the Treatment of Molluscum Contagiosum

    Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announced that its partner Novan, Inc. (Nasdaq: NOVN) has 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 (molluscum). Assuming the filing is accepted by the FDA and given a typical 12-month review process, Novan anticipates a potential first quarter 2024 approval.

    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,” said Todd Davis, CEO of Ligand. “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,” commented Paula Brown Stafford, President and CEO of Novan.

    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<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.

    Seite 1 von 4


    Business Wire (engl.)
    0 Follower
    Autor folgen

    Ligand’s Partner Novan Submits New Drug Application to the U.S. FDA for Berdazimer Gel, 10.3% (SB206) for the Treatment of Molluscum Contagiosum Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announced that its partner Novan, Inc. (Nasdaq: NOVN) has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking marketing approval for berdazimer gel, 10.3% …

    Schreibe Deinen Kommentar

    Disclaimer