Athenex Announces UK MHRA Validation of Marketing Authorization Application for Oral Paclitaxel and Encequidar for Review

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BUFFALO, NY, November 29, 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 medical conditions Partners, today announced that its Marketing Authorization Application (MAA) for oral paclitaxel and enequidar (oral paclitaxel) for the treatment of advanced breast cancer has been validated by the Regulatory Agency Medicines and Health Products (MHRA) from United Kingdom (UK) for review. The application is eligible for a 150-day evaluation during which a decision on product approval will be made.

“We have worked diligently on submitting the MAA to bring oral paclitaxel to patients with advanced breast cancer,” said Dr Rudolf Kwan, medical director of Athenex. “This is a key milestone for Oral Paclitaxel, the most advanced program in our Orascovery platform. The validation of the MAA is an important step in the regulatory process and underscores our commitment to make oral paclitaxel available to patients. “

A single pivotal phase III study on oral paclitaxel (KX-ORAX-001) served as the basis for the Marketing Authorization. The study was a randomized, controlled clinical trial designed to compare the safety and efficacy of oral paclitaxel as monotherapy versus IV paclitaxel as monotherapy in patients with metastatic breast cancer. As previously reported, the study successfully met its primary endpoint, showing a statistically significant improvement in overall response rate (ORR), as well as a lower incidence of neuropathy, for oral paclitaxel compared to paclitaxel IV.

About Athénex, 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 business platform and a global supply chain platform. The Company’s current clinical pipeline is mainly derived from the following core technologies: (1) Orascovery, based on a P-glycoprotein inhibitor, (2) Src kinase inhibition and (3) Cell therapy. Athenex employees around the world 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 statements, expectations and assumptions contained in this press release are forward-looking statements. These forward-looking statements are generally identified by words such as “anticipate”, “believe”, “continue”, “could”, “’estimate”, “’ ” ‘expect’ ” ” ” ‘, ‘” an objective “, ” . , “” probable “,” may “,” plan “,” potential “,” foresee “,” preliminary “,” probable “,” project “,” promising “,” seek “,” should “,” will “, “Would like” and similar expressions. Actual results may differ materially from those expressed or implied in forward-looking statements. Important factors that could cause actual results to differ materially include: the stage of development of our major clinical candidates, including NKT cell therapy and the associated risks involved in drug development, clinical trials, regulation, uncertainties regarding reviews and regulatory approvals; our ability to pivot our business and find new uses for our ability to Dunkirk manufacturing plant, once operational; our ability to evolve our manufacturing and commercial supply operations for products approved act current and future, and our ability to market our products, once approved; the ability to successfully demonstrate the safety and efficacy of its drug candidates and to obtain approval of its drug candidates in a timely manner, if at all; the preclinical and clinical results of Athenex’s drug candidates, which may not support the further development of these drug candidates; risks related to our ability to successfully integrate Kuur’s business into our existing business, including uncertainties associated with maintaining relationships with customers, suppliers and employees, as well as differences in operations, cultures and management philosophies that may delay successful integration and our ability to bear the burden of the additional costs of Kuur’s business; risks relating to the performance of counterparties, including our reliance on third parties to be successful in certain areas of Athenex’s business; our history of operating losses and our need and ability to raise additional capital to continue our operations; uncertainties about our ability to enter into new financing arrangements as we are unable to meet the financing conditions under our existing financing arrangements and to access capital under them; the risks and uncertainties inherent in litigation, including alleged collective actions of shareholders; the risks and uncertainties associated with the COVID-19 pandemic and its continued impact on our operations, supply chain, cash flow and financial condition; competetion; intellectual property risks; uncertainties regarding our ability to successfully integrate the acquired and merged businesses in a timely and profitable manner and to achieve synergies; risks associated with doing business internationally and in China; the risk of development, operational delays, slowdowns or production stoppages or other interruptions in our manufacturing facilities as well as our ability to find alternative sources of supply to meet our obligations and requirements; and other risk factors set out from time to time in our documents filed with the SEC, copies of which are available free of charge in the Investor Relations section of our website at http://ir.athenex.com/phoenix.zhtml?c=254495&p=irol-sec or on request from our Investor Relations Department. All information provided in this press release is as of the date hereof and we do not assume any 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]


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