Almirall and Kaken Pharmaceutical enter into a license and distribution agreement for European rights to the topical formulation of efinaconazole 01 July 2021
  • 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 - 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%[i] and the condition is responsible for 50% of all consultations for nail disorders[ii].

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.


About Almirall

Almirall is a global biopharmaceutical company focused on skin health. We collaborate with scientists and healthcare professionals to address patient's needs through science to improve their lives. Our Noble Purpose is at the core of our work: 'Transform the patients' world by helping them realize their hopes and dreams for a healthy life'. We invest in differentiated and ground-breaking medical dermatology products to bring our innovative solutions to patients in need.

The company, founded in 1943 and headquartered in Barcelona, is publicly traded on the Spanish Stock Exchange and is a member of the IBEX35 (ticker: ALM). Throughout its 77-year history, Almirall has retained a strong focus on the needs of patients. Currently, Almirall has a direct presence in 21 countries and strategic agreements in over 70, through 13 subsidiaries, with about 1,800 employees. Total revenues in 2020 were 814.5 million euros.

For more information, please visit almirall.com

About Kaken Pharmaceutical

Kaken Pharmaceutical Co., Ltd. (KAKEN) is a specialty pharmaceutical company in Japan with strong experience in developing and commercializing novel pharmaceuticals and medical devices in the fields of orthopedics and dermatology. KAKEN concentrates its R&D resources in areas such as the immune system, the nervous system, and infectious diseases. KAKEN's ongoing quest is to Bringing Smiles to Everyone. For this purpose, KAKEN strives to improve the quality of life of patients through the development and distribution of superior pharmaceuticals.

For further information, visit http://www.kaken.co.jp.

  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.

Attachments

  • Original document
  • Permalink

Disclaimer

Almirall SA published this content on 01 July 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 01 July 2021 07:08:18 UTC.