Athenex’s Partner Almirall Announces EMA Acceptance for Filing of Marketing Authorization Application (MAA) for Tirbanibulin Ointment in 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.
The EMA filing is based on the analysis of two Phase III studies (KX01-AK-003 and KX01-AK-004) conducted in the
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
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
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
Founded in 2003,
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
Chief Financial Officer
Corporate Development and Investor Relations
Source: Athenex, Inc.