Verrica Pharmaceuticals has finally obtained approval from the Food and Drug Administration for its drug treatment of molluscum after facing two prior manufacturing-related rejections. The company’s drug Ycanth is now the first-ever approved treatment for the underdiagnosed skin condition in the U.S.
For the West Chester, Pennsylvania-based firm, this is the first FDA approval it has gained in the 10 years of its existence. The company specializes particularly in dermatology therapeutics for skin diseases.
The approval for the drug was based on two phase 3 trials, which enrolled approximately 520 people. In the trials, VP-102 demonstrated a 50% clearance of lesions compared to the placebo treatment, and this superior efficacy continued against different age groups and locations of lesions.
No price point for the drug has been announced yet, but company CFO Terry Kohler shared that details regarding this should come out sometime in the next month.
To support the expected launch of the drug in September, the company announced that it will be entering a non-binding term sheet for up to $125 million in debt financing.
The loan deal is expected to be confirmed later this week, and right after, Verrica will receive $50 million. This, in combination with the $60 million available to the firm in the form of cash and equivalents from the end of the first quarter, will push the company into the first quarter of 2025, according to representatives from Verrica.
Only hours after details for the loans were made public, share prices dipped by approximately 30% from what they were at the end of last week.
Molluscum is an underdiagnosed contagious condition that not only spreads through skin-to-skin contact but also by coming in contact with any surfaces that carry the virus. The disease is most common in children and leads to the formation of raised lesions on the skin that can cause inflammation, bacterial infections, and discomfort.
In the U.S. alone, the disease affects around 6 million people annually, and sometimes the lesions caused by the disease can last for years and even cause permanent scarring.
The tricky thing about molluscum is that it often remains undiagnosed, and according to estimates by Verrica, only 15% of molluscum cases are diagnosed. With the treatment now being approved, Ted White, the CEO of Verrica, feels that more diagnoses can be made.
Joe Bonaccorso, the company’s chief commercial officer, shared that the firm is currently set to capture around 85% of the market, which is set to be at a million patients a year.
Due to it being placed on the official action indicated (OAI) status, which is the most serious category of violation, Verrica has decided to look for new contract manufacturing organizations in addition to its current partner, Sterling Pharmaceuticals Services.