PHARMA: Nielsen BioSciences inks $100 million deal

PHARMA: Japan’s Maruho Licenses Wart Treatment

Rubbing a snail on a wart is among the many folklore remedies for the common skin condition – none which are effective. Thankfully for those afflicted with the unsightly skin growths, San Diego-based Nielsen BioSciences,

Inc. is taking medicinal treatment of warts out of the Dark Ages with a science-based therapeutic.

The company is currently preparing for a Phase 3 clinical trial for CANDIN – an immunotherapy to treat Verruca vulgaris, or common warts, caused by infection of the skin by human papillomavirus (HPV). Common warts are estimated to affect 10% of the global population.

“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,” said 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.”

Nielsen's Phase 2 study on CANDIN showed “virtually no skin pigmentation or scarring,” said David P. Burney, Ph.D., MBA, president and chief operating officer at Nielsen.

Burney also pointed out that common warts are not just a cosmetic issue for people who get them, they can also cause “physical discomfort, bleeding, and psychological distress” and lead to other more serious conditions if left untreated.

“There is currently no FDA-approved prescription treatment,” he said. “We are proud to continue the development of this potential new therapy and make it available to patients in need.”

Licensing Deal

On May 16, Nielsen announced it had entered into a licensing agreement with Maruho Co Ltd, to make CANDIN available to patients in need in Japan.

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.

New Indication

The potential $100 million is dependent on approval on CANDIN for treating common warts by Japan's PMDA regulatory body. Nielsen predicts approval and commercialization of CANDIN to be sometime in 2026. It will not be the first approval for CANDIN. Currently, CANDIN is approved by FDA as a skin test antigen to evaluate patients' cellular hypersensitivity to Candida albbicans. The test was developed in the 1990s, Burney said, to monitor immune response. Although the same, substance, Burney explained that the test and the treatment are “two different indications.”

“The way the drug will be administered will be different. The dose will be different,” he said. “From FDA's perspective, it will be two different drugs not the same drug with two indications.”

In addition to the CANDIN test, Nielsen also markets SPHERUSOL – a skin test for Valley Fever.

Both skin tests are manufactured in San Diego and then distributed from Nielsen's Sorrento Valley headquarters. The company has utilized revenues from the sale of the existing products to fund its R&D efforts into new products like the CANDIN treatment for warts, Burney said.

“We're unique in the sense that we have our R&D program, but we also have a successful commercial business,” he said. “We're a profitable commercial pharma business with an active R&D program.” ■