Athenex Announces Progress Update from Partner Almirall on Tirbanibulin Ointment

BUFFALO, N.Y., Oct. 28, 2019 (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, today announced a progress update from partner Almirall on tirbanibulin ointment (also known as ALM14789, formerly known as KX-01 or KX2-391) for the treatment of actinic keratosis (AK).

ALM14789 for actinic keratosis

As announced in the 2019 American Academy of Dermatology Annual Meeting in Washington, DC (on March 2, 2019), both Phase III studies, KX01-AK-003 and KX01-AK-004, achieved their primary endpoint, which was defined as 100% clearance of the AK lesions at Day 57 within the face or scalp treatment areas: Complete Clearance was observed in 44% and 54% of the patients for tirbanibulin respectively while it was 5% and 13% for vehicle treated groups.

Only patients showing complete clearance at the primary evaluation endpoint on day 57 were followed quarterly in the extension period until recurrence was observed in the treatment area. Recurrence rates were defined as proportion of patients in whom at least one treated or new actinic keratosis lesion was identified in the treated area throughout one year follow up.

The recurrence rates in patients treated with tirbanibulin 1% ointment were 74% and 72% in the pivotal trials KX01-AK-003 and KX01-AK-004, respectively. Overall, at the recurrence follow up study visit when actinic keratosis (maximum eight initial number of lesions) in the treated area was first observed, 86% had only one or two lesions and 48% reported at least one lesion that was not identified at the time of the initial treatment i.e. newly occurring lesions that were considered as recurrences.

These results represent the last piece of information to submit the New Drug Application (NDA) in the US and the Marketing Authorization Application (MAA) in Europe that are expected to be launched in Q1 2021 and Q2 2021 respectively.

Dr. Rudolf Kwan, Chief Medical Officer of Athenex, stated, “We are pleased with the continued progress of the tirbanibulin ointment program. We recently completed pre-NDA consultation with the U.S. FDA and our preparations for the NDA submission in the U.S. are on track. We look forward to working with our partner, Almirall, towards commercializing this product, if approved.”

In December 2017, Athenex granted Almirall, S.A., a leading skin-health focused global pharmaceutical company, an exclusive license to research, develop and commercialize tirbanibulin in the U.S. and European countries, including Russia. Athenex is responsible for the U.S. FDA regulatory for tirbanibulin ointment in AK. Almirall will employ its expertise to support the development in Europe and also to commercialize the product in the defined 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 platform technologies: (1) Orascovery, based on non-absorbed 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; and Manchester, UK. 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,” “evaluate,” “expect,” “foresee,” “guidance,” “intend,” “investigate,” “likely,” “may,” “plan,” “potential,” “predict,” “preliminary,” “prepare,” “potential,” “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; competition; intellectual property risks; risks relating to doing business in China; the uncertainty of when, if at all, we will be able to resume producing API in our Chongqing plant; 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.

CONTACTS

Investor Relations:
Tim McCarthy
Managing Director, LifeSci Advisors, LLC
Tel: +1 716-427-2952
Direct: +1 212-915-2564

Athenex, Inc.:
Randoll Sze
Chief Financial Officer
Email: randollsze@athenex.com

Jacqueline Li
Corporate Development and Investor Relations
Email: jacquelineli@athenex.com