Associated tags: Wart, Nielsen, Patent, Candida albicans, United, Food and Drug Administration, HPV, Food, Biotechnology, MBA, Pharmaceutical industry, Patient, Pharmaceutical, Viral, Finger, Common, Cryotherapy, Infection, FDA, Doctor of Philosophy, Clinical Trials, Skin, Health, Bleeding, Nature
Locations: UNITED STATES, JAPAN
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Pharmaceutical industry Nielsen BioSciences, Inc. (“Nielsen”), a privately-held, San Diego-based biopharmaceutical company, today announced the first patient enrolled in CFW-3A – a Phase 3, randomized, double-blind, placebo-controlled study of the safety and efficacy of CANDIN® for the treatment of Verruca vulgaris (common warts) in adolescents and adults.
Key Points:
- Nielsen BioSciences, Inc. (“Nielsen”), a privately-held, San Diego-based biopharmaceutical company, today announced the first patient enrolled in CFW-3A – a Phase 3, randomized, double-blind, placebo-controlled study of the safety and efficacy of CANDIN® for the treatment of Verruca vulgaris (common warts) in adolescents and adults.
- Nielsen is partnering with Maruho Co. Ltd. (“Maruho”) in the clinical development program for CANDIN.
- “The first patient treated with CANDIN represents a major milestone for the company, and for patients affected by common warts around the world,” said David P. Burney, PhD, MBA, President and Chief Operating Officer at Nielsen BioSciences.
- Common warts are estimated to affect approximately 10 percent of the global population.1 There are currently no FDA-approved prescription treatments.
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Nielsen CANDIN is an approved diagnostic skin test and currently not approved by the FDA or Japan’s PMDA for the treatment of common warts.
Key Points:
- CANDIN is an approved diagnostic skin test and currently not approved by the FDA or Japan’s PMDA for the treatment of common warts.
- 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.
- With the upfront payment and milestones, Nielsen has the potential to earn greater than $100 million from the license agreement with Maruho.
