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The partnership aims to develop and commercialize a skin-care drug candidate being developed to treat actinic keratosis, which, left untreated, can progress to cancer.
On Dec. 11, 2017, Almirall, a skin-health focused pharmaceutical company based in Barcelona, Spain, announced an agreement with Athenex, a US-based biopharmaceutical company, to further develop and commercialize a drug candidate, KX2-391, for treating actinic keratosis and other skin conditions.
Under the agreement, Athenex will receive an up-front fee and near-term payments of up to $55 million and will also be eligible to receive launch and additional indications-milestones for $65 million. There will additionally be sales-performance milestones related to KX2-391 estimated to be $155 million. Athenex will receive additional sales milestones, should the sales exceed currently projected amounts, and there will be tiered royalties starting at 15% based on annual net sales. Incremental increases in royalty rates will be included with increased sales. The transaction is subject to antitrust clearance by antitrust authorities.
Athenex will grant to Almirall an exclusive license under the Athenex IP to research, develop, and commercialize the drug candidate in the United States and in European countries, including Russia. Athenex will be responsible for conducting all preclinical and clinical studies up to approval by FDA in the US. Almirall, in return, will use its expertise to support development of the drug in Europe and also to commercialize the product in the licensed territories.
KX2-391 is a first-in-class dual Src kinase and tubulin polymerization inhibitor. It is in Phase III development as a topical medicinal product for treating actinic keratosis, a common skin condition that is induced through ultra-violet light damage. Left untreated, the lesions carry the risk of progressing to squamous cell carcinoma.