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Almirall Announces Late-Breaking Oral Presentation of KX2-391 Ointment in Two Phase III Studies at the American Academy of Dermatology Annual Meeting

EXTON, Pa., Feb. 5, 2019 /PRNewswire/ -- Almirall, S.A. (ALM), today announced that an abstract reporting the results from two Phase III studies of KX2-391 Ointment in the treatment of actinic keratosis has been accepted for presentation at the Late-Breaking Research Program at the 2019 American Academy of Dermatology Annual Meeting, to take place March 1–5, 2019 in Washington, DC.

The presentation (Abstract 11216), with the title "KX2-391 Ointment 1%, a Novel Dual Src/Tubulin Inhibitor, is Efficacious and Safe in the Treatment of Adults with Actinic Keratosis in Two Phase III Studies", will be delivered in Session S034 (Late-breaking Research: Clinical Trials) on Saturday, March 2, 2019, between 1:00pm and 4:00pm Eastern Time in Ballroom A at the Walter E. Washington Convention Center.

The two Phase III studies (KX01-AK-003 and KX01-AK-004) are double-blind, vehicle-controlled, randomized, parallel group, multicenter, efficacy and safety studies of KX2-391 Ointment 1% in adults with actinic keratosis on the face or scalp. Each study enrolled 351 subjects in 31 US sites, totaling 702 subjects in 62 US sites. The results of the previous Phase II study of KX2-391 Ointment 1% were reported in the 2018 American Academy of Dermatology Annual Meeting in San Diego in February 2018.

Dr. Ted Lain, board-certified dermatologist, Chief Medical Director for Sanova Dermatology and an investigator in the Phase III studies, stated, "Despite the continuing efforts of the dermatology community to counsel the public on the implications of sun exposure, there are an increasing number of patients presenting each year with actinic keratoses. This investigational topical therapy has the potential to offer patients a safe and effective treatment with an application period of only 5 days, and I look forward to this becoming available as an option for patients."

Almirall and Athenex entered into a strategic partnership in December 2017 to further develop and commercialize KX2-391 for the treatment of actinic keratosis and other skin conditions in the United States and Europe, including Russia. Athenex is responsible for conducting all preclinical and clinical studies up to US FDA approval. Almirall will employ its expertise to support the development in Europe and also to commercialize the product in the licensed territories. Projected peak sales for KX2-391 are expected to be in excess of €250 million.

About Almirall

Almirall is a leading skin-health focused global pharmaceutical company that partners with healthcare professionals, applying Science to provide medical solutions to patients & future generations. Our efforts are focused on fighting against skin health diseases and helping people feel and look their best. We support healthcare professionals in its continuous improvement, bringing our innovative solutions where they are needed. The company, founded 75 years ago and with headquarters in Barcelona, is listed on the Spanish Stock Exchange (ticker: ALM). Almirall has become a key element of value creation to society according to its commitment to major shareholders and its decision to help others, to understand their challenges and to use Science to provide them with solutions for real life. Total revenues in 2017 were 755.8 million euros. More than 1,830 employees are devoted to Science.

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Corporate Communications Contact:
Almirall U.S.
Sam Widdicombe 
Tel.: 949-331-0269

This document includes only summary information and does not intend to be comprehensive. Facts, figures and opinions contained herein, other than historical, are "forward-looking statements". These statements are based on currently available information and on best estimates and assumptions believed to be reasonable by the Company. These statements involve risks and uncertainties beyond the Company's control. Therefore, actual results may differ materially from those stated by such forward-looking statements. The Company expressly disclaims any obligation to review or update any forward-looking statements, targets or estimates contained in this document to reflect any change in the assumptions, events or circumstances on which such forward-looking statements are based unless so required by applicable law.

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Last Updated: 06-Feb-2019