Kaken Pharmaceutical Co., Ltd. (“Kaken”, head office Bunkyo-ku, Tokyo, Japan; President and Representative Director, Tetsuo Onuma) and Arbor Pharmaceuticals, LLC. (“Arbor”, head office Atlanta, GA, U.S.A.; CEO, Ed Schutter) concluded a licensing agreement on February 27, 2019 for the development and commercialization of ivermectin lotion, 0.5% (US brand name: Sklice® Lotion, 0.5%) for the treatment of head lice, a parasitic infectious disease, in Japan.
Under the terms of the agreement, Kaken will receive an exclusive license to develop, commercialize and market the ivermectin lotion, 0.5% in Japan for head lice. In return, Kaken will make an upfront payment to Arbor. Arbor will also be eligible to potentially receive regulatory and sales milestones, as well as tiered royalties on sales.
Ivermectin is an anthelminthic agent.
In Japan, oral ivermectin tablet “Stromectol® Tablets 3mg” has already been approved and marketed by MSD K.K. and has been distributed by Maruho Co., Ltd. for intestinal strongyloidiasis and scabies.
Two identical multi-center, randomized, double-blind, vehicle-controlled studies were conducted in the US to verify the efficacy and safety of the ivermectin lotion, 0.5%. It was approved and has been marketed in the U.S.
At Review Conference on Unapproved or Off-label Use Drugs of High Therapeutic Needs of Ministry of Health, Labor and Welfare, the ivermectin lotion, 0.5% was designated as one of such drugs. Kaken notified its official intention to develop the product, and then concluded the licensing agreement to develop and commercialize it in Japan.
Headquartered in Atlanta, Georgia, Arbor Pharmaceuticals is a specialty pharmaceutical company which currently markets prescription products for the cardiovascular, neurology, hospital and pediatric markets. Arbor also has several branded products in late-stage development. In addition, through its Wilshire Division, the company markets multiple generic prescription products and has a number of ANDAs on file with the FDA and in various stages of development. Further to its extensive pipeline, the company continues to actively pursue growth through acquisition or licensing of marketed or late-stage development products. For more information regarding Arbor Pharmaceuticals or any of its products, visit www.arborpharma.com.