Athenex’s Partner Almirall Announces EMA Acceptance for Filing of Marketing Authorization Application (MAA) for Tirbanibulin Ointment in Actinic Keratosis

Monday, 02. March 2020 16:19

BUFFALO, N.Y., March 02, 2020 (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, provided an update today that its partner, Almirall, announced that the European Medicines Agency (EMA) has accepted the filing of the Marketing Authorization Application (MAA) for tirbanibulin ointment for the treatment of actinic keratosis.

“We are delighted by the EMA’s acceptance for filing of the MAA for tirbanibulin ointment, which includes data from our two pivotal Phase III studies and represented the diligent efforts of our clinical, preclinical and regulatory teams together with the support of our partner Almirall,” said Dr. Rudolf Kwan, Chief Medical Officer of Athenex. “We have also submitted the tirbanibulin ointment NDA to the U.S. Food and Drug Administration, so this positive news from the EMA is an important milestone for the development program of tirbanibulin ointment in the U.S. as well as Europe.”

Volker Koscielny, MD, Chief Medical Officer of Almirall, commented, “If approved by the EMA, tirbanibulin could be an important step towards significantly improved treatment of actinic keratosis in Europe, as it has the potential to provide a marked improvement of the quality of life for patients suffering from this disease. Almirall’s commitment to unmet needs in dermatology, in partnership with Athenex’s expertise in drug development in this space, will significantly transform the approach towards this disease.”

The EMA filing is based on the analysis of two Phase III studies (KX01-AK-003 and KX01-AK-004) conducted in the U.S. that evaluated the efficacy and safety of tirbanibulin ointment 1% (10 mg/g) in adults with actinic keratosis on the face or scalp, as well as clinical, preclinical and CMC data generated by Athenex, included in nine clinical studies. Tirbanibulin ointment met the primary endpoint of complete clearance of actinic keratosis lesions at day 57 within the face or scalp treatment areas, each study achieving statistical significance (p<0.0001) on this endpoint.

Athenex and Almirall, S.A. entered into a license agreement in which Athenex granted Almirall an exclusive license to research, develop and commercialize tirbanibulin ointment in the U.S. and European countries, including Russia. Almirall will employ its expertise to support the development in Europe and commercialize the product in the defined territories. 

About the Phase III Clinical Program of Tirbanibulin Ointment
Two double-blind, randomized, vehicle-controlled, parallel group, multi-center studies (KX01-AK-003 and KX01-AK-004) were designed to support the registration of tirbanibulin ointment as field therapy for AK of the face or scalp. The studies enrolled a total of 702 patients across 62 sites in the U.S. Tirbanibulin ointment 1% or vehicle (randomized 1:1) was self-administered to 25 cm2 of the face or scalp encompassing 4-8 typical AK lesions, once daily for 5 consecutive days.

About Actinic Keratosis
Actinic Keratosis is a common skin condition that is induced through ultra-violet light damage, resulting in patches of thick, scaly or crusty skin. Left untreated, the lesions may progress to squamous cell carcinoma and consequently treatment by a dermatologist is recommended. AK is the most common pre-cancerous condition in dermatology and affects more than 55 million Americans, and accounts for between 14-29% of dermatologist visits in the U.S.1

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 platform technologies: (1) Orascovery, based on P-glycoprotein inhibitor, (2) Src kinase inhibition, (3) T-cell receptor-engineered T-cells (TCR-T), 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. Athenex has offices in Buffalo and Clarence, New York; Cranford, New Jersey; Houston, Texas; Chicago, Illinois; Hong Kong; Taipei, Taiwan; multiple locations in Chongqing, China; Manchester, UK; Guatemala City, Guatemala and Buenos Aires, Argentina. For more information, please visit

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, manufacturing and commercialization; our reliance on third parties for success in certain areas of Athenex’s business; our history of operating losses and need to raise additional capital to continue as a going concern; our ability to integrate CIDAL’s assets into our existing operations; competition; intellectual property risks; risks relating to doing business internationally and in China, including the impact of public health epidemics such as the coronavirus; the uncertainty of when, if at all, we will be able to resume full API production operations in Chongqing; 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 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.


1. E. Stockfleth et al. Physician perceptions and experience of current treatment in actinic keratosis. JEADV 2015, 29, 298–306

Investor Relations:
Tim McCarthy
Managing Director, LifeSci Advisors, LLC
Direct: 212-915-2564

Athenex, Inc.:
Randoll Sze
Chief Financial Officer

Jacqueline Li
Corporate Development and Investor Relations

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