Athenex, Inc. (NASDAQ: ATNX), a leading global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer, today announced the launch of a Ready-to-Use (RTU) Bivalirudin Injection through its subsidiary Athenex Pharmaceutical Division (APD). Bivalirudin RTU Injection is indicated for use as an anticoagulant in patients undergoing percutaneous coronary intervention (PCI), including patients with heparin-induced thrombocytopenia and heparin-induced thrombocytopenia and thrombosis syndrome.
APD, a supplier of high-quality specialty injectable products to US hospitals, licensed the marketing rights to the NDA from MAIA Pharmaceuticals, a Princeton, NJ based specialty pharmaceutical company.
Bivalirudin RTU Injection is available to order from APD in a 250mg/50mL (5mg/mL concentration) Piggyback Vial.
Per IQVIA sales data, the Bivalirudin Injection market in the United States exceeds $67 million annually.
“We are delighted to introduce a unique RTU Bivalirudin Injection that does not require frozen storage into the US hospital market,” said Jeffrey Yordon, Athenex’s Chief Operating Officer. “The launch of this innovative product underlines the unique ability of Athenex to work quickly and collaboratively to bring much needed products to our customers. We’d like to thank our partners at MAIA for matching our agility, enabling our speed to market, and supporting our unwavering commitment to delivering high-quality products that can help address our customers’ ongoing needs.”
Srikanth Sundaram, Ph.D., President of MAIA, added, “We are thrilled with the launch of MAIA’s NDA product by the seasoned and exceptional team at Athenex. Bivalirudin RTU Injection, which does not need reconstitution and further dilution unlike the lyophilized version, essentially eliminates the drug preparation process. By avoiding potential errors in the drug preparation and administration process and associated adverse events, its use offers benefits to the patient.”
Athenex’s products emphasize quality and can help to enhance patient safety. Athenex’s AccuraSEE℠ Packaging and Labeling, a proprietary, patent-pending and highly differentiated approach to product packaging and labeling, features a unique label design for every product to give caregivers accurate information and help to reduce the risk of medication errors.
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 www.athenex.com.
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; risks and uncertainties related to the COVID-19 pandemic and its potential impact on our operations, cash flow and financial condition; our ability to integrate CIDAL’s assets into our existing operations; competition; intellectual property risks; risks relating to doing business internationally and in China; 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 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.
The APD product portfolio is available at www.athenexpharma.com.