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

Rhea-AI Summary

Athenex, Inc. (NASDAQ: ATNX) announced that its Marketing Authorization Application (MAA) for oral paclitaxel and encequidar for the treatment of advanced breast cancer has been validated by the UK’s MHRA for review. The MAA is set for a 150-day assessment period which will determine the product's approvability. This milestone underscores Athenex's commitment to providing innovative treatment options for patients. The MAA is based on a pivotal Phase III study that demonstrated significant improvements in safety and efficacy, achieving its primary endpoint against IV paclitaxel.

Positive

• MAA validation indicates progress in the regulatory process for Oral Paclitaxel.
• Pivotal Phase III study showed statistically significant improvement in overall response rate (ORR).
• Lower incidence of neuropathy compared to IV paclitaxel enhances treatment profile.

Negative

• None.

BUFFALO, N.Y., Nov. 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 related conditions, announced today that its Marketing Authorization Application (MAA) for oral paclitaxel and encequidar (Oral Paclitaxel) for the treatment of advanced breast cancer has been validated by the United Kingdom’s (UK) Medicines and Healthcare products Regulatory Agency (MHRA) for review . The application qualifies for a 150 day assessment by which a decision on approvability of the product will be provided.

“We have been working diligently on the MAA submission to bring Oral Paclitaxel to patients with advanced breast cancer,” said Dr. Rudolf Kwan, Chief Medical Officer of Athenex. “This is a key milestone for Oral Paclitaxel, the most advanced program in our Orascovery platform. The MAA validation is an important step forward in the regulatory process and underscores our commitment to making Oral Paclitaxel available to patients.”

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

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 mainly from the following core technologies: (1) Orascovery, based on P-glycoprotein inhibitor, (2) Src kinase inhibition, and (3) Cell 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, including NKT Cell Therapy and related risks involved in drug development, clinical trials, regulation, uncertainties around regulatory reviews and approvals; our ability to pivot our business and to find new uses for the capacity at our Dunkirk manufacturing facility, once operational; 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 to continue as a going concern; uncertainties around our ability to enter into new financing agreements as we are unable to meet funding conditions under our existing 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: danlang@athenex.com 

Caileigh Dougherty
Athenex, Inc.
Email: cdougherty@athenex.com

FAQ

What is the significance of Athenex's MAA validation for ATNX?

The validation signifies a critical step in the regulatory process for Athenex's oral paclitaxel, potentially leading to approval and market access.

How long will the assessment period be for Athenex's MAA?

The assessment period for Athenex's MAA is set for 150 days.

What were the results of the Phase III study for oral paclitaxel?

The Phase III study achieved its primary endpoint, demonstrating a statistically significant improvement in overall response rate compared to IV paclitaxel.

What condition is Athenex's oral paclitaxel intended to treat?

Oral paclitaxel is intended for the treatment of advanced breast cancer.