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Important factors that could cause or contribute to such differences include: risks relating to the expansion of our strategic partnership with Alvotech and the ability to achieve expected results from investments in bio

Key Takeaway: Teva Pharmaceuticals and Alvotech are expanding their strategic partnership to enhance the commercialization efforts of biosimilar medicines. The agreement includes exclusive rights for Teva to commercialize two new biosimilar candidates in the U.S. while also facilitating shared profits. Teva is investing $40 million in subordinated convertible bonds to support Alvotech's biosimilars pipeline, which includes ongoing regulatory approvals for products like AVT02 and AVT04. Both companies express confidence in their collaborative efforts to bring these products to market successfully.

Market Sentiment Analysis

POSITIVE FACTORS

  • Expansion of strategic partnership between Teva and Alvotech.
  • Teva's commitment to support Alvotech's manufacturing capabilities.
  • Optimism about the potential approval and commercialization of biosimilar candidates.

Full Press Release Details

Teva Pharmaceuticals and Alvotech
Provide Update on Strategic Biosimilars
TEL AVIV, ISRAEL & PARSIPPANY, NJ & REYKJAVIK,
ICELAND (July 24, 2023) - Teva Pharmaceuticals, Inc., a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and
TASE: TEVA), a global leader in generic and innovative medicines and Alvotech (NASDAQ: ALVO), a global biotech company specializing in
the development and manufacture of biosimilar medicines for patients worldwide, today announced that they have agreed to expand their
existing strategic partnership agreement. Teva will also acquire subordinated convertible bonds to be issued by Alvotech.
The partners continue working closely on matters concerning pending
approval in the U.S. for AVT02, an interchangeable high-concentration biosimilar candidate for Humira (adalimumab). The existing
strategic partnership agreement also includes four other biosimilar candidates, one of which is AVT04, a proposed biosimilar for Stelara
(ustekinumab), which is currently pending U.S. Food and Drug Administration (FDA) approval.
The expansion to the existing strategic partnership agreement
pertains to exclusive commercialization in the U.S. by Teva of two new biosimilar candidates and line extensions of two current biosimilar
candidates in the partnership, to be developed, and manufactured by Alvotech. The agreement includes milestone payments, the majority
paid following product approvals and upon achieving significant sales milestones. Teva and Alvotech will share profit from the commercialization
of the biosimilars. All other financial terms and product details remain confidential.
The agreement also includes increased involvement by Teva regarding
manufacturing and quality at Alvotech's manufacturing facility. Teva is actively supporting Alvotech on-site in Iceland to be fully
ready for an FDA inspection.
Teva has agreed to acquire subordinated convertible bonds to be issued
by Alvotech pursuant to a convertible bond instrument, dated December 20, 2022, for $40 million. Teva's investment will be used
by Alvotech as part of the funding for continued development of its biosimilars pipeline over the near-term.
"We welcome Teva's continued partnership and this expansion
of our partnership agreement," said Robert Wessman, Chairman and CEO of Alvotech. "We remain focused on preparing for a successful
pre-approval inspection and resolving any outstanding issues identified by the FDA to be able to bring our biosimilar candidates to patients
in the U.S. with Teva as soon as possible."
S mundargata 15-19 Phone +354 422 4500 alvotech.media@alvotech.com
102 Reykjav k, Iceland www.alvotech.com
"Teva remains fully committed to its leadership in biosimilars
and the partnership with Alvotech," said Sven Dethlefs, Executive Vice President, North America
Commercial. "We remain optimistic about additional compounds in the pipeline and continued progress with AVT02 and ATV04."
AVT02 is a monoclonal antibody and has been approved as a biosimilar
to Humira (adalimumab) in several countries globally, including the 27 member states of the European Union, Norway, Lichtenstein,
Iceland, the UK, Switzerland, Canada, Australia, and Saudi Arabia. It is currently marketed in multiple European countries and in Canada.
Dossiers are also under review in multiple countries globally.
About AVT04 (ustekinumab)
AVT04 is a monoclonal antibody and a biosimilar candidate to Stelara
(ustekinumab). Ustekinumab binds to two cytokines, IL-12 and IL-23, that are involved in inflammatory and immune responses [1]. AVT04
is an investigational product and has not received regulatory approval in any country. Biosimilarity has not been established by regulatory
authorities and is not claimed. Stelara is a registered trademark of Johnson & Johnson.
This communication is not a public offer of securities for sale
in the United States. This communication is for informational purposes only and does not constitute an offer to sell or a solicitation
of an offer to buy any securities in the United States or elsewhere, nor shall there be any sale of any such securities in any state or
jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities
laws of such state or jurisdiction.
Alvotech is a biotech company, founded by Robert Wessman, focused solely
on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in the biosimilar
space by delivering high quality, cost-effective products, and services, enabled by a fully integrated approach and broad in-house capabilities.
Alvotech's current pipeline includes eight disclosed biosimilar candidates aimed at treating autoimmune disorders, eye disorders,
osteoporosis, respiratory disease, and cancer. Alvotech has formed a network of strategic commercial partnerships to provide global reach
and leverage local expertise in markets that include the United States, Europe, Japan, China, and other Asian countries and large parts
of South America, Africa and the Middle East. Alvotech's commercial partners include Teva Pharmaceuticals, a US affiliate of Teva
Pharmaceutical Industries Ltd. (US), STADA Arzneimittel AG (EU), Fuji Pharma Co., Ltd (Japan), Advanz Pharma (EEA, UK, Switzerland, Canada,
Australia and New Zealand), Cipla/Cipla Gulf/Cipla Med Pro (Australia, New Zealand, South Africa/Africa), JAMP Pharma Corporation (Canada),
Yangtze River Pharmaceutical (Group) Co., Ltd. (China), DKSH (Taiwan, Hong Kong, Cambodia, Malaysia, Singapore, Indonesia, India, Bangladesh
and Pakistan), YAS Holding LLC (Middle East and North Africa), Abdi Ibrahim (Turkey), Kamada Ltd. (Israel), Mega Labs, Stein, Libbs, Tuteur
and Saval (Latin America) and Lotus Pharmaceuticals Co., Ltd. (Thailand, Vietnam, Philippines, and South Korea). Each commercial partnership
covers a unique set of product(s) and territories. Except
S mundargata 15-19 Phone +354 422 4500 alvotech.media@alvotech.com
102 Reykjav k, Iceland www.alvotech.com
as specifically set forth therein, Alvotech disclaims responsibility
for the content of periodic filings, disclosures and other reports made available by its partners. For more information, please visit
www.alvotech.com. None of the information on the Alvotech website shall be deemed part of this
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has been developing
and producing medicines to improve people's lives for more than a century. We are a global leader in generic and innovative 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 innovative
medicines and biopharmaceutical products. Learn more at www.tevapharm.com.
Forward Looking Statements (Alvotech)
Certain statements in this communication may be considered "forward-looking
statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements generally
relate to future events or the future financial operating performance of Alvotech and may include, for example, Alvotech's expectations
regarding competitive advantages, business prospects and opportunities including pipeline product development, future plans and intentions,
results, level of activities, performance, goals or achievements or other future events, regulatory submissions, review and interactions,
including the resubmission of a BLA for AVT02 and a potential reinspection of Alvotech's manufacturing facility, the satisfactory
responses to the FDA's inspection findings and resolution of other deficiencies conveyed following the inspection of Alvotech's
manufacturing site, the potential approval and commercial launch of its product candidates, the timing of regulatory approval, including
for AVT04, and market launches, the estimated size of the total addressable market of Alvotech's pipeline products, the availability
of financing options, including the size, timeline, securities, terms and conditions of, and use of proceeds from, a potential financing.
In some cases, you can identify forward-looking statements by terminology such as "may", "should", "expect",
"intend", "will", "estimate", "anticipate", "believe", "predict",
"potential", "aim" or "continue", or the negatives of these terms or variations of them or similar
terminology. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to
differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon
estimates and assumptions that, while considered reasonable by Alvotech and its management, are inherently uncertain and are inherently
subject to risks, variability, and contingencies, many of which are beyond Alvotech's control. Factors that may cause actual results
to differ materially from current expectations include, but are not limited to: (1) the outcome of any legal proceedings that may be instituted
against Alvotech or others following the business combination between Alvotech Holdings S.A., Oaktree Acquisition Corp. II and Alvotech;
(2) the ability to raise substantial additional funding, which may not be available on acceptable terms or at all; (3) the ability to
maintain stock exchange listing standards; (4) changes in applicable laws or regulations; (5) the possibility that Alvotech may be adversely
affected by other economic, business, and/or competitive factors; (6) Alvotech's estimates of expenses and profitability; (7) Alvotech's
ability to develop, manufacture and commercialize the products and product candidates in its pipeline; (8) actions of regulatory
S mundargata 15-19 Phone +354 422 4500 alvotech.media@alvotech.com
102 Reykjav k, Iceland www.alvotech.com
authorities, which may affect the initiation, timing and
progress of clinical studies or future regulatory approvals or marketing authorizations; (9) the ability of Alvotech or its partners
to respond to inspection findings and resolve deficiencies to the satisfaction of the regulators; (10) the ability of Alvotech or its
partners to enroll and retain patients in clinical studies; (11) the ability of Alvotech or its partners to gain approval from regulators
for planned clinical studies, study plans or sites; (12) the ability of Alvotech's partners to conduct, supervise and monitor existing
and potential future clinical studies, which may impact development timelines and plans; (13) Alvotech's ability to obtain and
maintain regulatory approval or authorizations of its products, including the timing or likelihood of expansion into additional markets

Frequently Asked Questions

What is Teva's recent partnership update with Alvotech?

Teva and Alvotech are expanding their partnership, acquiring bonds and focusing on biosimilars.

Which biosimilars are involved in Teva and Alvotech's partnership?

The collaboration includes AVT02, a biosimilar for Humira, and AVT04 for Stelara.

What financial commitment has Teva made to Alvotech?

Teva will invest $40 million in subordinated convertible bonds for Alvotech's development.

What is AVT04 and its current status?

AVT04 is a proposed biosimilar for Stelara, currently under FDA review.

How does Teva support Alvotech's manufacturing readiness?

Teva is assisting Alvotech on-site in Iceland for FDA inspection readiness.

Last updated: Jul 24, 2023