Almirall and Kaken Pharmaceutical enter into a license and distribution agreement for European rights to the topical formulation of efinaconazole

-  Efinaconazole is a triazole antifungal compound indicated for the treatment of fungal infection of the nail, known as onychomycosis

-  Almirall acquires exclusive rights for the development and commercialization of  this topical antifungal in Europe

BARCELONA, Spain, July 1, 2021 /PRNewswire/ -- Almirall S.A. (BME: ALM), a global biopharmaceutical company focused on skin health, and Kaken Pharmaceutical (KKPCF) announced today that the companies have entered into a license and distribution agreement in which Kaken Pharmaceutical grants Almirall the exclusive right for the development and commercialization of the topical formulation of efinaconazole in Europe.

This active principle, a triazole antifungal compound discovered by Kaken Pharmaceutical, is indicated for the treatment of onychomycosis, a fungal infection of the nail. Since it has low binding affinity with keratin, the main component of nails, it has superior nail-penetrating properties. Global prevalence of onychomycosis is estimated to be around 5.5%^[1] and the condition is responsible for 50% of all consultations for nail disorders^[2].

The product has been marketed in Japan since 2014 under the trade name of Clenafin^®. It has also been launched in the United States, Canada, Korea, Taiwan, Hong Kong and Macau by Kaken Pharmaceutical's partner companies under the trade name of Jublia^®.

Under the agreement, Kaken Pharmaceutical receives an upfront cash payment and has the potential to receive milestone payments and royalties on the net sales of the product. Almirall plans to have a pre-submission meeting with regulatory authorities within the next year to prepare the approval of the product in Europe.

With the addition of this new product, Almirall strengthens its European medical dermatology portfolio and reinforces its commitment to patients and dermatologists by offering them novel therapeutic options that really make a difference in their lives.

^[1]  Gupta AK, Mays RR, Versteeg SG, et al. Global perspectives for the management of onychomycosis. Int J Dermatol. 2018.

^[2]  Piraccini, B.M, Alessandrini, A. Onychomycosis: A Review. J Fungi [Internet]. 2015 Jun;1(1): 30-43. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5770011/. doi: 10.3390/jof1010030.

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