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 - Seite 2

“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.

About Berdazimer

Berdazimer sodium, the active ingredient in berdazimer gel, 10.3% (SB206), is a new chemical entity. Berdazimer gel, 10.3% for the treatment of molluscum contagiosum is a potential first-in-class topical nitric oxide-releasing agent with positive Phase 3 data submitted to the FDA. Berdazimer gel, 3.4% (SB204), a topical monotherapy in Phase 3 clinical development for the treatment of acne, utilizes the same active ingredient as berdazimer gel, 10.3% and is formulated specifically to address acne.

About Molluscum

Molluscum contagiosum is a common, contagious skin viral infection caused by the molluscipoxvirus, affecting approximately six million people in the U.S., with the greatest incidence in children aged one to 14 years. Infected children typically present with 10 to 30 unsightly lesions, and in severe cases, they can have around 100 lesions, mostly clustering on the face, trunk, limbs and axillary areas. Over 70% of molluscum patients go untreated. There are no FDA-approved therapies for molluscum, with current treatments limited to potentially painful in-office, healthcare provider-administered physical procedures or cantharidin, or off-label prescriptions and over-the-counter products. Molluscum may take a long time to resolve, with lesions persisting 13 months to 5 years, and transmission of this highly-contagious virus is common, spreading to other children through direct skin contact or sharing contaminated objects like towels. In-household transmission to other children is reported around 41%. Despite the prevalence and high transmissibility, there is a significant unmet need in the molluscum treatment landscape.