Athenex Announces Phased European Launch of Klisyri® (tirbanibulin) for the Treatment of Actinic Keratosis

Klisyri has been approved for the treatment of actinic keratosis by the UK Medicines and Healthcare products Regulatory Agency and will initially be available for prescription in the UK and Germany

AK is one of the most common diagnoses made by dermatologists in Europe and Almirall plans to a phased roll-out for other European countries

BUFFALO, N.Y., Sept. 27, 2021 (GLOBE NEWSWIRE) -- Athenex, Inc., (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions, announced today that its partner, Almirall (Almirall, S.A., BME: ALM), has launched Klisyri® (tirbanibulin) in Germany and the UK. Klisyri received approval by the European Commission and the UK Medicines & Healthcare products Regulatory Agency (MHRA) in July and August of 2021, respectively, for the topical treatment of actinic keratosis (AK) of the face and scalp in adults.

Tirbanibulin is a novel, topical first-in-class microtubule inhibitor with a selective antiproliferative mechanism of action that we believe represents a significant step forward in the treatment of AK due to its short treatment protocol (one application daily for 5 days), proven efficacy, and safety profile.

“We are extremely pleased to see Klisyri launching in these two major European markets by our partner Almirall,” said Dr. Johnson Lau, Chief Executive Officer of Athenex. “The launch of Klisyri represents an option with acceptable tolerability and shorter duration of treatment for dermatologists to provide their patients. Athenex is also working with our commercial partners in other geographies on either clinical studies or regulatory filings and expect to launch in more geographic areas in 2022, making this important treatment available to more AK patients.”

Under the terms of the license agreement with Almirall, Athenex is eligible to receive up to $45M in milestone payments associated with launch and expansion into additional indications. The Company is also eligible to receive additional sales-related milestone payments. The terms of agreement included tiered royalties payable to Athenex starting at 15%, based on annual net sales.

Athenex also has strategic partnerships for tirbanibulin with Seqirus Pty Ltd, a subsidiary of CSL Limited in Australia and New Zealand, PharmaEssentia for Japan and Taiwan, and Xiangxue Pharmaceuticals in China.

About Klisyri® (tirbanibulin)

Klisyri® (tirbanibulin) is a microtubule inhibitor indicated for the topical treatment of actinic keratosis (AK) of the face or scalp. Two phase III studies (KX01-AK-003 and KX01-AK-004) evaluated the efficacy and safety of tirbanibulin ointment 1% (10 mg/g) in adults with AK on the face or scalp. The studies achieved their primary endpoint, which was defined as 100% clearance of the AK lesions at Day 57 within the face or scalp treatment areas, each study achieving statistical significance (p<0.0001) on this endpoint^[1].

About Actinic Keratosis

Actinic keratosis (AK) or solar keratosis is a chronic and precancerous skin disease that occurs primarily in areas that have been exposed to ultraviolet radiation for a long period of time. It is usually found on the face, ears, lips, bald scalp, forearms, the posterior part of the hands, and lower legs. It is not possible to predict which AK lesions will develop into squamous cell carcinoma. AK is the most common pre-cancerous dermatological condition^[2].

Athenex and Almirall Partnership

Athenex, Inc. (NASDAQ: ATNX) and Almirall entered into a strategic partnership in December 2017 to develop and market tirbanibulin for the treatment of actinic keratosis and other skin conditions in the United States and Europe, including Russia. Athenex has been responsible for conducting all preclinical and clinical studies in order to gain FDA approval of tirbanibulin. Almirall will leverage its expertise to support development in Europe and to market the product in all licensed territories.

About Athenex, Inc.

Founded in 2003, Athenex, Inc. is a global clinical stage biopharmaceutical company dedicated to becoming a leader in the discovery, development, and commercialization of next generation drugs for the treatment of cancer. Athenex is organized around three platforms, including an Oncology Innovation Platform, a Commercial Platform, and a Global Supply Chain Platform. The Company’s current clinical pipeline is derived from four different technologies: (1) Orascovery, based on P-glycoprotein inhibitor, (2) Src kinase inhibition, (3) Cell therapy, and (4) Arginine deprivation therapy. Athenex’s employees worldwide are dedicated to improving the lives of cancer patients by creating more active and tolerable treatments. For more information, please visit www.athenex.com.

Forward-Looking Statements

Except for historical information, all of the statements, expectations, and assumptions contained in this press release are forward-looking statements. These forward-looking statements are typically identified by terms such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “foresee,” “goal,” “guidance,” “intend,” “likely,” “may,” “plan,” “potential,” “predict,” “preliminary,” “probable,” “project,” “promising,” “seek,” “should,” “will,” “would,” and similar expressions. Actual results might differ materially from those explicit or implicit in the forward-looking statements. Important factors that could cause actual results to differ materially include: the development stage of our primary clinical candidates and related risks involved in drug development, clinical trials, regulation, uncertainties around regulatory reviews and approvals; our ability to agree with the FDA on a new clinical study for oral paclitaxel that is capital and time efficient; our ability to scale our manufacturing and commercial supply operations for current and future approved products, and ability to commercialize our products, once approved; ability to successfully demonstrate the safety and efficacy of its drug candidates and gain approval of its drug candidates on a timely basis, if at all; the preclinical and clinical results for Athenex’s drug candidates, which may not support further development of such drug candidates; risks related to our ability to successfully integrate the business of Kuur into our existing businesses, including uncertainties associated with maintaining relationships with customers, vendors and employees, as well as differences in operations, cultures, and management philosophies that may delay successful integration and our ability to support the added cost burden of Kuur’s business; risks related to counterparty performance, including our reliance on third parties for success in certain areas of Athenex’s business; our history of operating losses and our need and ability to raise additional capital; uncertainties around our ability to meet funding conditions under our financing agreements and access to capital thereunder; risks and uncertainties inherent in litigation, including purported stockholder class actions; risks and uncertainties related to the COVID-19 pandemic and its ongoing impact on our operations, supply chain, cash flow and financial condition; competition; intellectual property risks; uncertainties around our ability to successfully integrate acquired and merged businesses in a timely and cost-effective manner and to achieve synergies; risks relating to doing business internationally and in China; the risk of development, operational delays, production slowdowns or stoppages or other interruptions at our manufacturing facilities as well as our ability to find alternative sources of supply to meet our obligations and requirements; and the other risk factors set forth from time to time in our SEC filings, copies of which are available for free in the Investor Relations section of our website at http://ir.athenex.com/phoenix.zhtml?c=254495&p=irol-sec or upon request from our Investor Relations Department. All information provided in this release is as of the date hereof and we assume no obligation and do not intend to update these forward-looking statements, except as required by law.

Athenex Contacts

Investors

Daniel Lang, MD
Athenex, Inc.
Email: [email protected]

Caileigh Dougherty
Athenex, Inc.
Email: [email protected] 

References

1. Blauvelt A, Kempers S, Lain E, et al. Phase 3 Trials of Tirbanibulin Ointment for Actinic Keratosis. New England Journal of Medicine. 2021 Feb 11;384(6):512-520.
2. Skin Cancer Foundation. Actinic Keratosis Overview. Available at: https://www.skincancer.org/skin-cancer-information/actinic-keratosis/#:~...(AK)%20is%20the,to%20ultraviolet%20(UV)%20radiation January 2021.