Teva and mAbxience Announce Strategic Global Licensing Agreement for Oncology Biosimilar Candidate

Published
  • Teva and mAbxience enter into a strategic global partnership for in-licensing of an oncology biosimilar candidate
  • Agreement signals a major step in mAbxience's global expansion strategy and advances a key element of Teva’s Pivot to Growth strategy to expand its biosimilar pipeline through business development
  • Teva-mAbxience partnership reflects the companies' shared commitment to expand access to critical healthcare solutions to more patients who need them

TEL AVIV, Israel, & MADRID--(BUSINESS WIRE)-- Teva Pharmaceuticals International GmbH, a subsidiary of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) and mAbxience, a Fresenius Kabi majority-owned group with partial ownership from Insud Pharma, today announced they have entered a strategic licensing agreement for a biosimilar candidate currently in development for the treatment of multiple oncology indications. Biosimilars show promising potential in providing more cost-effective alternatives to existing oncology therapies, thereby addressing a critical need in global oncology care.

The licensing agreement covers multiple global markets, including in Europe and the United States, signaling a major step in mAbxience’s global expansion strategy, and supports a key element of Teva’s Pivot to Growth strategy, announced in 2023, to expand its biosimilar pipeline through business development and strategic partnerships.

Under the terms of the licensing agreement, mAbxience will leverage its expertise in biosimilar development and its state-of-the-art, current Good Manufacturing Practice (cGMP)-approved facilities in Spain and Argentina, to develop and produce the biosimilar product. Teva will lead the regulatory processes and commercialization in the designated regions, to ensure access to a broader patient population.

“Teva is pleased to form this strategic alliance with mAbxience, who share our commitment to accelerate the delivery of impactful medicines to patients worldwide,” says Angus Grant, PhD, Executive Vice President of Business Development at Teva. “This collaboration reflects Teva’s ideal strategic partnership model to optimize development costs, mitigate risk and leverage our extensive commercial capabilities.”

“Partnering with Teva not only reinforces mAbxience's position as a global biosimilar company but also aligns with our mission to deliver high-quality, affordable healthcare solutions across continents,” says Jurgen Van Broeck, Global Commercial Director of mAbxience. “This agreement will assist healthcare systems in reducing costs, ensuring the provision of these vital cancer treatments to all patients who require them.”

About Teva

Teva (NYSE and TASE: TEVA) is a global pharmaceutical leader with a category-defying portfolio, harnessing our generics expertise and stepping up innovation to continue the momentum behind the discovery, delivery, and expanded development of modern medicine. For over 120 years, Teva's commitment to bettering health has never wavered. Today, the company’s global network of capabilities enables its ~37,000 employees across 58 markets to push the boundaries of scientific innovation and deliver quality medicines to help improve health outcomes of millions of patients every day. To learn more about how Teva is all in for better health, visit www.tevapharm.com.

About mAbxience

mAbxience is a Spanish-based company specializing in the development, production, and commercialization of biopharmaceuticals. In August 2022, Fresenius Kabi and Insud Pharma entered into an agreement whereby Fresenius Kabi acquired a majority stake of mAbxience, making it a global, vertically integrated biotechnology company. With over a decade of expertise, our mission is clear: to provide accessible, affordable medicines across the globe, aiming to enhance the quality of life by ensuring universal access to high-caliber medicines. With two market-approved products and a robust pipeline in development, we have established a B2B presence in over 100 markets. Alongside this, we have formed a network with more than 30 partners and built a dedicated team of over 1,000 professionals. Our three multi-product facilities, located in Europe and South America, have obtained GMP approval from esteemed regulatory bodies, including the FDA, EMA, and others. Furthermore, as a global biopharmaceutical expert, mAbxience specializes in Contract Development and Manufacturing Organization services (CDMO), utilizing advanced technology and innovative platforms to deliver integrated manufacturing solutions. For more insights into mAbxience, our biosimilars and CDMO business, please visit our website (www.mabxience.com) or connect with us on LinkedIn.

Teva Cautionary Note Regarding Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. You can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “intend,” “plan,” “believe” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to: our ability to successfully launch and execute our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and profitably commercialize the innovative medicines and biosimilar portfolio, whether organically or through business development; our ability to effectively execute our licensing agreement with mAbxience; our ability to lead the regulatory processes and commercialization of the biosimilar candidate in the designated region; risks that regulatory approvals and other requirements may delay the development and commercialization of the biosimilar candidate for the treatment of multiple oncology indications; and other factors discussed in this press release, and in our Annual Report on Form 10-K for the year ended December 31, 2023, including in the sections captioned “Risk Factors.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.

For Teva Media Kelley Dougherty +1 (973) 832-2810 Eden Klein +972 (3) 906-2645 IR Ran Meir +1 (267) 468-4475 Yael Ashman +972 (3) 914-8262 Sanjeev Sharma +1 (973) 658 2700 For mAbxience: Comercial Jurgen Van Broeck, Global Commercial Director: jurgen.vanbroeck@mabxience.com Media Miguel Martínez-Cava, Global External Communication Manager: miguel.martinezcava@mabxience.com

Source: Teva Pharmaceutical Industries Limited

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