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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.
The license is for all indications treated by the B244 platform.
Key Points:
- The license is for all indications treated by the B244 platform.
- Under the license agreement, Maruho will commercialize the product exclusively in Japan.
- Maruho also has the rights to AOB's B244 for all additional indications including later stage programs related to inflammation.
- "B244 offers an opportunity to extend our portfolio for the treatment of Atopic Dermatitis as well as other inflammatory indications.
Retrieved on:
Wednesday, September 27, 2023
IRAK4,
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Regulation of food and dietary supplements by the U.S. Food and Drug Administration,
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Pharmaceutical industry PALO ALTO, Calif., Sept. 27, 2023 /PRNewswire/ -- Evommune, Inc., a biotechnology company discovering and developing new ways to treat immune-mediated inflammatory diseases, today announced that it has entered into a strategic collaboration with Maruho Co., Ltd., to exclusively develop and commercialize EVO756 in Japan. Under the terms of the agreement, Evommune is eligible to receive up to $60 million in upfront and customary milestone payments. In addition, Evommune is eligible to receive meaningful royalties on future sales of EVO756 in Japan.
Key Points:
- Under the terms of the agreement, Evommune is eligible to receive up to $60 million in upfront and customary milestone payments.
- In addition, Evommune is eligible to receive meaningful royalties on future sales of EVO756 in Japan.
- "We are thrilled to enter into this collaboration with Maruho, a globally respected organization that has developed and commercialized pharmaceuticals in Japan for over 100 years.
- We believe that this is the start of a long term, multifaceted relationship between Evommune and Maruho, with the potential to accelerate development and access to EVO756 for patients in Japan and around the world."
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Incyte,
Dermatology Incyte (NASDAQ:INCY) and Maruho Co., Ltd. today announced that the companies have entered into a Strategic Alliance Agreement for the development, manufacturing and exclusive commercialization of ruxolitinib cream, a novel cream formulation of Incytes selective JAK2 inhibitor ruxolitinib, for treatment of autoimmune and inflammatory dermatology indications in Japan.
Key Points:
- Incyte (NASDAQ:INCY) and Maruho Co., Ltd. today announced that the companies have entered into a Strategic Alliance Agreement for the development, manufacturing and exclusive commercialization of ruxolitinib cream, a novel cream formulation of Incytes selective JAK2 inhibitor ruxolitinib, for treatment of autoimmune and inflammatory dermatology indications in Japan.
- Maruho will receive the rights to develop, manufacture and exclusively commercialize ruxolitinib cream, and other potential future topical formulations of ruxolitinib, in autoimmune and inflammatory dermatologic diseases, including vitiligo and atopic dermatitis, in Japan.
- Maruho President and CEO, Atsushi Sugita said, "Incyte has successfully launched ruxolitinib cream in the U.S. and provided a new treatment for patients suffering from atopic dermatitis.
- As a specialty pharmaceutical company in dermatology aimed at improving the lives of patients, supporting the development of ruxolitinib cream has great significance for Maruho.
