Teva Pharmaceutical Industries Ltd. (NYSE: and TASE: TEVA) and biopharmaceutical company Alvotech today announced that they have entered into an exclusive strategic partnership for the commercialization in the U.S. of five biosimilar product candidates. This strategic partnership combines Tevas long-standing commercial presence and extensive infrastructure in the U.S. market with Alvotechs scientific experience and state-of-the-art biologics manufacturing. The initial pipeline contains biosimilar candidates addressing multiple therapeutic areas.
Robert Wessman, Alvotechs founder and Chairman said, We are very proud to announce our strategic alliance with Teva “ a leading global pharmaceutical company, to accelerate the introduction and adoption of new biosimilar medicines for patients in the U.S. market. This is not only a big moment for the biosimilar industry but also a very special moment for Alvotech, as we continue to join forces with leading global and regional partners around the world.
This commercial partnership with Alvotech will enable Teva to lend its technical expertise in working with the FDA to bring products to the U.S. market while broadening its growing biosimilar portfolio and continuing to leverage its unique cross-functional expertise across both specialty and generic medicines, said Brendan OGrady, Executive Vice President and Head of North America Commercial at Teva. This collaboration is another step in our unwavering commitment to develop and enable access to quality medications to help improve the lives of patients.”
Under this partnership agreement, Alvotech will be responsible for the development, registration and supply of the biosimilars, while Teva will be exclusively commercializing the products in the U.S. The originator products of these five candidates currently generate around $35 billion in U.S. sales. The agreement includes an upfront payment, with subsequent milestone payments over the next several years. Teva and Alvotech will share profit from the commercialization of the biosimilars. All other financial terms and product details remain confidential.
Alvotech is a global biopharmaceutical company focused on the development and manufacture of high quality biosimilars for global markets. We are specialists in biotechnology, seeking to be a global leader in the biosimilar space by delivering high quality, cost-competitive products and services to our partners and to patients worldwide. Our fully integrated approach, with high-quality in-house competencies throughout the value chain, enables the accelerated development of biosimilar medicines.
Alvotech˜s initial pipeline contains several monoclonal-antibody and fusion-protein biosimilar candidates aimed at treating autoimmunity, oncology, ophthalmology and inflammatory conditions to improve quality of life for patients around the world. For more information, please visit our website, www.alvotech.com or follow us on LinkedIn, Twitter and Facebook.
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has been developing and producing medicines to improve peoples lives for more than a century. We are a global leader in generic and specialty medicines with a portfolio consisting of over 3,500 products in nearly every therapeutic area. Around 200 million people around the world take a Teva medicine every day, and are served by one of the largest and most complex supply chains in the pharmaceutical industry. Along with our established presence in generics, we have significant innovative research and operations supporting our growing portfolio of specialty and biopharmaceutical products. Learn more at http://www.tevapharm.com.
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 regarding the strategic partnership with Alvotech for the commercialization in the U.S. of biosimilar product candidates, which are based on managements 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. Important factors that could cause or contribute to such differences include risks relating to:
the potential that the expected benefits and opportunities related to our collaboration with Alvotech may not be realized or may take longer to realize than expected;
challenges inherent in product research and development, including uncertainty of clinical success and obtaining regulatory approvals for the biosimilar product candidates;
the commercial success of the biosimilar product candidates, if approved;
our ability to successfully compete in the marketplace, including: that we are substantially dependent on our generic products; consolidation of our customer base and commercial alliances among our customers; the increase in the number of competitors targeting generic opportunities and seeking U.S. market exclusivity for generic versions of significant products; competition for our specialty products, especially COPAXONE, our leading medicine, which faces competition from existing and potential additional generic versions, competing glatiramer acetate products and orally-administered alternatives; the uncertainty of commercial success of AJOVY or AUSTEDO; competition from companies with greater resources and capabilities; delays in launches of new products and our ability to achieve expected results from investments in our product pipeline; ability to develop and commercialize biopharmaceutical products; efforts of pharmaceutical companies to limit the use of generics, including through legislation and regulations and the effectiveness of our patents and other measures to protect our intellectual property rights;
our substantial indebtedness, which may limit our ability to incur additional indebtedness, engage in additional transactions or make new investments, may result in a further downgrade of our credit ratings; and our inability to raise debt or borrow funds in amounts or on terms that are favorable to us;
our business and operations in general, including: duration, and geographic reach of the COVID-19 pandemic and its impact on our business, financial condition, operations, cash flows, and liquidity and on the economy in general; interruptions in our supply chain, including due to potential effects of the COVID-19 pandemic on our operations and business in geographic locations impacted by the pandemic and on the business operations of our customers and suppliers; adequacy of and our ability to successfully execute and maintain the activities and efforts related to the measures we have taken or may take in response to the COVID-19 pandemic and associated costs therewith; implementation of our restructuring plan announced in December 2017; challenges associated with conducting business globally, including adverse effects of the COVID-19 pandemic, political or economic instability, major hostilities or terrorism; our ability to attract, hire and retain highly skilled personnel; our ability to develop and commercialize additional pharmaceutical products; compliance with anti-corruption sanctions and trade control laws; manufacturing or quality control problems; disruptions of information technology systems; breaches of our data security; variations in intellectual property laws; significant sales to a limited number of customers; our ability to successfully bid for suitable acquisition targets or licensing opportunities, or to consummate and integrate acquisitions; our prospects and opportunities for growth if we sell assets and potential difficulties related to the operation of our new global enterprise resource planning (ERP) system;
compliance, regulatory and litigation matters, including: increased legal and regulatory action in connection with public concern over the abuse of opioid medications in the U.S. and our ability to reach a final resolution of the remaining opioid-related litigation; costs and delays resulting from the extensive governmental regulation to which we are subject or delays in governmental processing time including due to modified government operations due to the COVID-19 pandemic and effects on product and patent approvals; the effects of reforms in healthcare regulation and reductions in pharmaceutical pricing, reimbursement and coverage; governmental investigations into S&M practices; potential liability for patent infringement; product liability claims; increased government scrutiny of our patent settlement agreements; failure to comply with complex Medicare and Medicaid reporting and payment obligations; and environmental risks;
other financial and economic risks, including: our exposure to currency fluctuations and restrictions as well as credit risks; potential impairments of our intangible assets; potential significant increases in tax liabilities; and the effect on our overall effective tax rate of the termination or expiration of governmental programs or tax benefits, or of a change in our business;
and other factors discussed in Form 10-K for the year ended December 31, 2019, and subsequent quarterly reports on Form 10-Q, including in the sections captioned “Risk Factors and Forward Looking Statements. 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.
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