Verrica Pharma's viral skin condition drug gets rejected—again, with its CMO flagged for deficiencies

The FDA rejected Verrica Pharmaceuticals' molluscum contagiosum drug, VP-102, which would have been the first approved treatment for the viral skin condition. The rejection came after the company's contract manufacturing organization, Sterling Pharmaceuticals Services was placed on Official Action Indicated (OAI) status by the FDA, the most serious category of violation.

An OAI suggests that objectionable conditions were found, and regulatory action is recommended. Verrica stated that the deficiency was due to issues were flagged at a general inspection of Sterling, which manufactures Verrica’s bulk solution drug product for its leading drug.

The FDA's complete response letter, which Verrica announced May 24, is the second for VP-102. The first CRL came last September and also noted problems at Sterling.

Verrica contends that “none of the issues identified by the FDA during the reinspection were specific to the manufacturing of VP-102,” and there were no open questions for the company's approval request package or product label.

“Based on the successful PAI (preapproval inspection) of VP-102 at Sterling and our understanding that the division was ready to communicate our label, we believe our NDA meets the statutory standards for approval and that any issues at Sterling do not impact the manufacturing, quality, efficacy or safety of VP-102,” said Verrica President and CEO Ted White in a recent company statement. He noted that while VP-102 is a solvent-based topical product, the observations at Sterling which led to its OAI classification were “predominantly related to its distinct sterile operations where higher-risk, sterile ophthalmic products are manufactured by Sterling” for the U.S. government, among other distributors.

Verrica echoed the same sentiment last September when the FDA issued a complete response letter detailing problems at Sterling. At the time, Sterling told Verrica it had taken corrective measures to address the FDA’s concerns and expected a resolution of the issues in the next 30 days, adding to White’s stated confidence in a September statement that the drug has a path forward.

Based on the outcome of the September classification as VAI (Voluntary Action Indicated) and the following Established Inspection Report (EIR) that stated the FDA would not take or recommended action against Sterling, Verrica says it was led to believe that issues at Sterling had been resolved to the FDA’s satisfaction.

Then in November, Sterling was reclassified with a Voluntary Action Indicated status. That led to a week-long reinspection this February.

“Verrica is extremely disappointed in the agency’s issuance of the CRL (complete response letter) under the totality of these circumstances,” White stated. “However, as Verrica weighs all its options to bring the first FDA-approved treatment for molluscum, one of the largest unmet needs in dermatology, to the market as soon as possible, it will continue to work collaboratively with the agency.

The company intends to file a Type A meeting request by the end of the week. While Verrica is working with Sterling to help it satisfy the deficiency, it is also engaging an additional contract manufacturer to supply the drug.

Last September, Jefferies analysts wrote that the drug could generate $300 million in peak sales. Verrica listed aggregate cash and equivalents as $70.4 million at the end of 2021.