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

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Teva Pharmaceuticals and mAbxience collaborate on a biosimilar candidate for oncology treatment, aiming to provide cost-effective alternatives globally. The partnership supports Teva's growth strategy and mAbxience's expansion plans, emphasizing a commitment to improving healthcare access.
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The strategic partnership between Teva Pharmaceuticals and mAbxience represents a significant move in the pharmaceutical industry, particularly in the biosimilar market. Biosimilars, which are essentially generic versions of biologic drugs, offer a significant opportunity for cost savings in healthcare, as they are usually priced lower than the original brand-name products. The agreement to develop and commercialize an oncology biosimilar could potentially lead to reduced treatment costs and improved access for patients, which in turn, might increase market share and revenue for both companies.

From a financial perspective, Teva's strategy to expand its biosimilar pipeline aligns with the current market trend towards more affordable healthcare solutions. The partnership could enhance Teva's product portfolio and strengthen its position in the global oncology market. Investors might view this collaboration as a positive step towards Teva's growth and a potential driver of long-term revenue, especially considering the high costs associated with oncology treatments. It's also indicative of Teva's commitment to strategic partnerships as a means to optimize development costs and mitigate risk, which is a prudent approach in a capital-intensive industry.

The in-licensing agreement between Teva and mAbxience taps into the growing demand for biosimilars, which is driven by the need for more affordable treatment options and the expiration of patents on many biologic drugs. The global biosimilars market is expected to continue its rapid growth and this partnership positions both companies to capitalize on this trend. Teva's established commercial presence in Europe and the United States could facilitate a smoother entry for the biosimilar candidate into these lucrative markets.

However, it's important to note that the biosimilar market is becoming increasingly competitive, with multiple players seeking to capture market share. The success of this partnership will largely depend on the ability of Teva and mAbxience to navigate complex regulatory landscapes, achieve cost efficiencies in production and effectively market their product against both the original biologic and other biosimilars. Additionally, the partnership's impact on the stock market will likely be contingent on the progress of clinical trials, regulatory approvals and the eventual market acceptance of the biosimilar product.

The clinical implications of the Teva-mAbxience partnership are noteworthy. Biosimilars have the potential to significantly impact oncology care by providing more accessible treatment options for patients. The development of a new oncology biosimilar could result in a broader range of therapies available to patients, potentially improving outcomes for those with cancer. As an oncologist, the prospect of more affordable, yet equally effective treatments is encouraging, particularly in a field where the cost of medication can be a major barrier to patient care.

It is essential, however, that the biosimilar demonstrates comparable safety and efficacy to the original biologic, which will be determined through rigorous clinical trials. If successful, this could lead to a shift in prescribing patterns within oncology, with a preference for more cost-effective biosimilars over expensive brand-name biologics. This shift could have a profound effect on both patient access to care and the overall cost burden of cancer treatment on healthcare systems.

  • 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

FAQ

What is the strategic partnership between Teva and mAbxience about?

Teva and mAbxience have entered into a licensing agreement for a biosimilar candidate in oncology treatment, aiming to provide cost-effective alternatives globally.

What markets are covered under the licensing agreement between Teva and mAbxience?

The licensing agreement covers multiple global markets, including Europe and the United States, signaling a major step in mAbxience's global expansion strategy.

Who will lead the regulatory processes and commercialization in the designated regions under the agreement?

Teva will lead the regulatory processes and commercialization in the designated regions to ensure access to a broader patient population.

What are the key elements of Teva's Pivot to Growth strategy mentioned in the press release?

Teva's Pivot to Growth strategy aims to expand its biosimilar pipeline through business development and strategic partnerships.

How does mAbxience plan to develop and produce the biosimilar product under the agreement?

mAbxience will leverage its expertise in biosimilar development and its cGMP-approved facilities in Spain and Argentina to develop and produce the biosimilar product.

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