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Teva and mAbxience Expand Strategic Partnership to include an additional Oncology Biosimilar Candidate

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Teva Pharmaceuticals and mAbxience have expanded their strategic partnership to include an additional oncology biosimilar candidate. This new global licensing agreement focuses on the development of an anti PD-1 oncology biosimilar, marking their second collaboration since April 2024. The partnership aligns with Teva's Pivot to Growth strategy and enhances its biosimilar portfolio.

Under the agreement, mAbxience will lead the development and production of the biosimilar using its facilities in Spain and Argentina, while Teva will manage regulatory approvals and commercialization in designated markets, including Europe and the United States. This collaboration aims to provide cost-effective, high-quality biosimilar treatments in oncology care, addressing unmet needs and improving global healthcare accessibility.

Teva Pharmaceuticals e mAbxience hanno espanso la loro partnership strategica per includere un ulteriore candidato biosimilare in oncologia. Questo nuovo accordo di licenza globale si concentra sullo sviluppo di un biosimilare anti PD-1 per l'oncologia, segnando la loro seconda collaborazione dall'aprile 2024. La partnership si allinea con la strategia Pivot to Growth di Teva e arricchisce il suo portafoglio di biosimilari.

In base all'accordo, mAbxience guiderà lo sviluppo e la produzione del biosimilare utilizzando le proprie strutture in Spagna e Argentina, mentre Teva gestirà le approvazioni regolatorie e la commercializzazione nei mercati designati, compresi Europa e Stati Uniti. Questa collaborazione mira a fornire trattamenti biosimilari di alta qualità e a costi contenuti nella cura oncologica, affrontando bisogni insoddisfatti e migliorando l'accessibilità alla salute globale.

Teva Pharmaceuticals y mAbxience han ampliado su asociación estratégica para incluir un nuevo candidato biosimilar en oncología. Este nuevo acuerdo de licencia global se centra en el desarrollo de un biosimilar anti PD-1 en oncología, marcando su segunda colaboración desde abril de 2024. La asociación se alinea con la estrategia Pivot to Growth de Teva y enriquece su portafolio de biosimilares.

Conforme al acuerdo, mAbxience liderará el desarrollo y la producción del biosimilar utilizando sus instalaciones en España y Argentina, mientras que Teva gestionará las aprobaciones regulatorias y la comercialización en los mercados designados, incluidos Europa y Estados Unidos. Esta colaboración tiene como objetivo proporcionar tratamientos biosimilares de alta calidad y rentables en el cuidado oncológico, abordando necesidades insatisfechas y mejorando el acceso a la atención de salud a nivel mundial.

Teva Pharmaceuticals와 mAbxience가 전략적 파트너십을 확장했습니다. 이번에는 추가적인 종양학 바이오시밀러 후보를 포함합니다. 이 새로운 글로벌 라이선스 계약은 항 PD-1 종양학 바이오시밀러 개발에 중점을 두고 있으며, 2024년 4월 이후 두 번째 협업입니다. 이 파트너십은 Teva의 성장으로의 전환 전략과 일치하며 바이오시밀러 포트폴리오를 강화합니다.

계약에 따라 mAbxience는 스페인과 아르헨티나의 시설을 사용하여 바이오시밀러의 개발 및 생산을 주도하며, Teva는 유럽 및 미국을 포함한 지정된 시장에서 규제 승인 및 상업화를 관리합니다. 이 협업은 비용 효율적이고 고품질의 바이오시밀러 치료법을 제공하여 종양학 치료에서 충족되지 않은 요구를 해결하고 전 세계 건강 관리 접근성을 개선하는 것을 목표로 합니다.

Teva Pharmaceuticals et mAbxience ont élargi leur partenariat stratégique pour inclure un nouveau candidat biosimilaire en oncologie. Ce nouvel accord de licence mondial se concentre sur le développement d'un anti PD-1 biosimilaire en oncologie, marquant leur deuxième collaboration depuis avril 2024. Le partenariat s'aligne avec la stratégie Pivot to Growth de Teva et enrichit son portefeuille de biosimilaires.

Dans le cadre de l'accord, mAbxience dirigera le développement et la production du biosimilaire en utilisant ses installations en Espagne et en Argentine, tandis que Teva gérera les approbations réglementaires et la commercialisation sur les marchés désignés, y compris l'Europe et les États-Unis. Cette collaboration vise à fournir des traitements biosimilaires de haute qualité et à faible coût dans les soins oncologiques, répondant à des besoins non satisfaits et améliorant l'accès aux soins de santé à l'échelle mondiale.

Teva Pharmaceuticals und mAbxience haben ihre strategische Partnerschaft erweitert, um einen weiteren onkologischen Biosimilar-Kandidaten einzuschließen. Diese neue globale Lizenzvereinbarung konzentriert sich auf die Entwicklung eines Anti-PD-1-Onkologie-Biosimilars und markiert ihre zweite Zusammenarbeit seit April 2024. Die Partnerschaft entspricht Tevas Pivot-to-Growth-Strategie und erweitert das Biosimilar-Portfolio.

Im Rahmen der Vereinbarung wird mAbxience die Entwicklung und Produktion des Biosimilars in seinen Einrichtungen in Spanien und Argentinien leiten, während Teva die Regulierungszulassungen und die Kommerzialisierung in den festgelegten Märkten, einschließlich Europa und den Vereinigten Staaten, übernimmt. Diese Zusammenarbeit zielt darauf ab, kostengünstige, hochwertige Biosimilar-Behandlungen in der Onkologie anzubieten, um ungedeckte Bedürfnisse zu adressieren und die globale Gesundheitsversorgung zu verbessern.

Positive
  • Expansion of strategic partnership with mAbxience to develop an additional oncology biosimilar candidate
  • Exclusive rights for multiple markets, including Europe and the United States
  • Alignment with Teva's Pivot to Growth strategy
  • Enhancement of Teva's biosimilar portfolio
  • Leveraging mAbxience's development and production capabilities
  • Utilization of Teva's regulatory expertise and commercial capabilities
Negative
  • None.

Insights

This expanded partnership between Teva and mAbxience is a strategic move that strengthens Teva's position in the growing biosimilars market. The addition of an anti-PD-1 oncology biosimilar candidate to their portfolio is particularly significant, as it targets a high-value segment of cancer therapeutics.

The collaboration leverages mAbxience's development and production capabilities with Teva's regulatory expertise and global commercial reach. This model allows Teva to expand its biosimilar pipeline while managing development costs and risks. The exclusive rights in key markets like Europe and the U.S. provide Teva with substantial commercial opportunities.

For investors, this deal aligns well with Teva's "Pivot to Growth" strategy, potentially driving long-term revenue growth in the lucrative oncology space. However, it's important to note that biosimilar development and approval processes can be lengthy and complex, so the financial impact may not be immediate.

Overall, this partnership expansion reinforces Teva's commitment to biosimilars and oncology, which could help diversify its revenue streams and strengthen its market position in the coming years.

The expansion of Teva and mAbxience's partnership to include an anti-PD-1 oncology biosimilar is a significant development in the cancer treatment landscape. PD-1 inhibitors have revolutionized cancer therapy, showing remarkable efficacy across various tumor types.

Biosimilars of these agents have the potential to dramatically increase patient access to these life-saving treatments by offering more affordable options. This is particularly important in oncology, where treatment costs can be prohibitively high.

The global nature of this agreement, covering key markets like the U.S. and Europe, positions Teva to become a major player in the oncology biosimilar space. This move could help address the growing demand for cost-effective cancer treatments worldwide.

For investors, it's important to recognize that while the oncology biosimilar market presents significant opportunities, it's also highly competitive. Teva will need to navigate regulatory hurdles and potential patent litigations. However, if successful, this product could become a substantial revenue driver for Teva in the long term.

  • The expansion of the strategic partnership reinforces the solid foundation of the collaborative efforts that commenced in April 2024
  • The collaboration supports Teva's Pivot to Growth strategy and adds to the company’s biosimilar portfolio
  • Both companies reaffirm their shared commitment to making high-quality, affordable treatments accessible to patients worldwide

TEL AVIV, ISRAEL and MADRID, Oct. 03, 2024 (GLOBE NEWSWIRE) -- 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 a new global licensing agreement for the development of an anti PD-1 oncology biosimilar candidate. This marks the second agreement between the two companies, reinforcing the solid foundation of the collaborative efforts that commenced in April 2024.

The global agreement to develop an additional oncology biosimilar further strengthens the alliance between Teva and mAbxience, underscoring the shared goal to provide cost-effective, high-quality biosimilar treatments that address critical unmet needs in oncology care. By leveraging each company’s unique expertise and resources, the collaboration continues to drive innovation and accessibility in healthcare to create solutions for patients worldwide.

The licensing agreement includes exclusive rights for multiple markets, including Europe and the United States, and aligns with mAbxience's strategy for global expansion. The collaboration reflects Teva's progress advancing its Pivot to Growth strategy by adding a new biosimilar to the company’s broad portfolio of biosimilars, through focused partnerships and business development efforts.

Similar to the initial contract, under the terms of this agreement, mAbxience will lead the development and production of the biosimilar, utilizing its state-of-the-art, cGMP-compliant facilities in Spain and Argentina. Teva will manage regulatory approvals and oversee commercialization in the designated markets, ensuring that patients around the world gain access to this oncology treatment.

Angus Grant, PhD, Executive Vice President of Business Development at Teva, said, “We are excited to deepen our collaboration with mAbxience. This agreement not only strengthens our alliance but also highlights our shared dedication to expanding access to critical oncology treatments. This collaboration with mAbxience reflects Teva’s ideal strategic partnership model to optimize development costs, apply our regulatory expertise and leverage our extensive commercial capabilities to bring new treatment options to people living with serious medical conditions.

Building on our first agreement with Teva signed earlier this year, this second collaboration is a testament to the strength of our partnership and the shared vision of both companies,” added Jurgen Van Broeck, CEO of mAbxience. “This agreement reinforces our commitment to making high-quality biosimilars accessible and improving healthcare outcomes on a global scale.

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, an operating company of Fresenius, 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 effectively execute and expand our collaboration with mAbxience for the development of oncology biosimilar candidates; our ability to lead the regulatory processes and commercialization of such biosimilar candidates in the designated markets; risks that regulatory approvals and other requirements may delay the development and commercialization of the biosimilar candidates; 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; and other factors discussed in this press release, in our Quarterly Report for the second quarter of 2024, 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.

mAbxience contacts:

Media
Miguel Martínez-Cava, Global External Communication Manager: miguel.martinezcava@mabxience.com

Teva contacts

Media Contacts
Kelley Dougherty +1 (973) 832-2810
Eden Klein +972 (3) 906-2645

IR Contacts
Ran Meir +1 (267) 468-4475
Yael Ashman +972 (3) 914-8262
Sanjeev Sharma +1 (973) 658 2700


FAQ

What is the new biosimilar candidate in Teva's expanded partnership with mAbxience?

The new biosimilar candidate in Teva's expanded partnership with mAbxience is an anti PD-1 oncology biosimilar.

When did Teva and mAbxience initially start their collaboration?

Teva and mAbxience initially started their collaboration in April 2024.

What markets are included in the exclusive rights for Teva's new biosimilar agreement?

The exclusive rights for Teva's new biosimilar agreement include multiple markets, notably Europe and the United States.

How does this partnership align with Teva's (TEVA) business strategy?

This partnership aligns with Teva's (TEVA) Pivot to Growth strategy by adding a new biosimilar to the company's portfolio through focused partnerships and business development efforts.

What are the roles of Teva and mAbxience in this new biosimilar development agreement?

In this agreement, mAbxience will lead the development and production of the biosimilar, while Teva will manage regulatory approvals and oversee commercialization in the designated markets.

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