Enrollment in Nielsen’s phase III trial for common warts treatment is expected to begin in the second half of 2023.

Nielsen BioSciences, Inc. has entered into a license agreement with Maruho Co., Ltd. granting Maruho exclusive rights to market Candin in Japan for the treatment of Verruca vulgaris. 

Candin is an approved diagnostic skin test and currently not approved by the U,S. Food and Drug Administration (FDA) or Japan’s Pharmaceuticals and Medical Devices Agency for the treatment of common warts. 

Candin (Candida albicans Skin Test Antigen for Cellular Immunity) product currently marketed in the United States for its FDA -approved use as a skin test antigen for the assessment of cellular hypersensitivity to Candida albicans.  In the United States, Nielsen has completed a Phase II clinical trial investigating the compound in the treatment of human papillomavirus (HPV) conditions, including Verruca vulgaris.  Enrollment in Nielsen’s phase III trial for common warts treatment is expected to begin in the second half of 2023.

Under the terms of the license agreement, Nielsen grants Maruho an exclusive license for the post-launch sales and promotional activities of Candin in Japan after it is developed by Nielsen and approved by regulatory authorities. For the exclusive Japanese license, Maruho will pay Nielsen a substantial upfront payment, and additional development, regulatory and sales milestone payments based on outcomes. With the upfront payment and milestones, Nielsen has the potential to earn greater than $100 million from the license agreement with Maruho.

Nielsen has one United States Patent and one United States Patent Application, as well as 10 Patent Applications outside the U.S., which is associated with its development and use of Candin.

“Verruca vulgaris is not purely cosmetic in nature and can cause physical discomfort, bleeding, and psychological distress. It can also lead to other more serious conditions if left untreated. There is currently no FDA-approved prescription treatment,” says David P. Burney, PhD, MBA, President and COO at Nielsen BioSciences, in a news release.  “We are proud to continue the development of this potential new therapy and make it available to patients in need.”

“This immunotherapy biologic holds great promise for providing patients with a non-invasive form of treatment for the millions of people who develop common warts yearly,” adds H. Stewart Nielsen, Jr., Ph.D., Vice Chairman and Founder of Nielsen BioSciences. “The investigational treatment is given via an injection, which promises to be a potential improvement to standard removal of the wart via acid, surgery, cryotherapy and other methods that can damage skin.”