The confirmatory clinical, safety and efficacy study for AVT04, biosimilar candidate to Stelara® (ustekinumab) met its primary endpoint
AVT04 (ustekinumab) is part of a broader pipeline of Alvotech’s biosimilars and biosimilar candidates, which includes AVT02 (adalimumab), a biosimilar to Humira®
Alvotech is the second company to announce positive top-line results from a patient study utilizing a biosimilar candidate to Stelara®

REYKJAVIK, Iceland--(BUSINESS WIRE)-- Alvotech Holdings S.A. (“Alvotech”), a global biotech company focused solely on the development and manufacture of biosimilar medicines for patients worldwide, today announced positive results from a confirmatory clinical study for AVT04, Alvotech’s proposed biosimilar to Stelara® (ustekinumab). Alvotech is the second company to announce positive results from a patient study utilizing a biosimilar candidate to Stelara®. Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is the exclusive strategic partner for the commercialization of AVT04 in the United States. STADA is the company’s exclusive strategic partner for AVT04 for the European market.

In 2021, Stelara’s® worldwide net sales exceeded US$9 billion, making it one of the highest grossing biologic medicines. Ustekinumab is a human IgG1κ monoclonal antibody that binds with specificity to the p40 protein subunit present in both the IL-12 and IL-23 cytokines. Stelara® is prescribed to treat a variety of inflammatory conditions including psoriatic arthritis, Crohn’s disease, ulcerative colitis, and plaque psoriasis.

The confirmatory clinical trial (AVT04-GL-301) is a randomized, double-blind, multicenter study designed to demonstrate equivalent efficacy and to compare safety and immunogenicity between AVT04 and Stelara® in patients with moderate to severe chronic plaque-type psoriasis. The study met its primary endpoint, with results demonstrating therapeutic equivalence between Alvotech’s biosimilar candidate and Stelara®. In addition, no clinically meaningful differences in safety were observed through week 28. Earlier this month, Alvotech announced positive top-line results from a pharmacokinetic (PK) similarity study for AVT04.

“The progress of our proposed biosimilar to Stelara® highlights the advantage of our global, vertically integrated platform,” said Robert Wessman, Founder and Chairman of Alvotech. “Completing this clinical milestone, less than one year since we recruited the first subject, truly demonstrates the success of our clinical development and integrated approach to rapidly advancing multiple high-quality biosimilar candidates.”

Mark Levick, Chief Executive Officer of Alvotech, added: “We believe that using the same type of host cell line as the reference product enables matching the post-translational modifications to the best extent possible.”

Alvotech’s portfolio of eight products and product candidates includes AVT02 (adalimumab), a biosimilar to Humira® and seven proposed biosimilars, inclusive of AVT04 (ustekinumab), a proposed biosimilar to Stelara®. Alvotech has built a highly integrated platform focused on development and manufacturing and has established a global network of commercial partnerships in all major markets, with the goal of expeditiously delivering its cost-effective biosimilar medicines to patients worldwide.

On December 7, 2021, Alvotech and Oaktree Acquisition Corp. II (NYSE:OACB, OACB, OACB WS))), a special purpose acquisition company sponsored by an affiliate of Oaktree Capital Management, L.P., (“OACB”) announced they had entered into a definitive business combination agreement. Upon completion of the transaction, the combined company’s securities are expected to be traded on NASDAQ under the symbol “ALVO.” On May 11, 2022, Alvotech S.A. and OACB announced that the extraordinary general meeting of shareholders of OACB to approve the pending business combination between Alvotech, OACB and the legal entity named Alvotech, previously named Alvotech Lux Holdings S.A.S., (“TopCo”) is scheduled to be held on June 7, 2022.

About the AVT04-GL-301 efficacy, safety, and immunogenicity study

The AVT04-GL-301 study was conducted in four countries in Europe and enrolled 581 patients. It was a randomized, double-blind, multicenter study designed to demonstrate equivalent efficacy and to compare safety and immunogenicity between AVT04 and Stelara® (ustekinumab) in patients with moderate to severe chronic plaque-type psoriasis. The study met its primary endpoint, with results demonstrating therapeutic equivalence between Alvotech’s biosimilar candidate and Stelara®. In addition, no clinically meaningful differences in safety were observed through week 28. The primary efficacy endpoint was Psoriasis Area and Severity Index (PASI) percent improvement from Baseline at Week 12. The key secondary endpoints include additional efficacy parameters, like quality-of-life scores, safety, immunogenicity, tolerability parameters, and pharmacokinetic (PK) data.

About AVT04 (ustekinumab)

AVT04 is a monoclonal antibody and a biosimilar candidate to Stelara® (ustekinumab). AVT04 was developed using an Sp2/0 host cell line and is manufactured using a continuous perfusion process. The Sp2/0 host cell line allows for more efficient sialyation of the molecule as compared to Chinese hamster ovary (CHO) cells and is the same type of host cell line used to produce Stelara®. Ustekinumab binds to two cytokines, IL-12 and IL-23, that are involved in inflammatory and immune responses. Abnormal regulation of these cytokines has been associated with immune mediated diseases, such as psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis.

About AVT02 (adalimumab)

AVT02 is a monoclonal antibody and a biosimilar to Humira® (adalimumab). AVT02 is approved in the EU, the United Kingdom, Switzerland, Norway, Iceland, Lichtenstein (Hukyndra®) and Canada (Simlandi™). AVT02 dossiers are under review in multiple countries; in the U.S. the initial BLA for approval as a biosimilar is in deferred status, pending the result of FDA inspections.

About Alvotech

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 contains eight biosimilar candidates aimed at treating autoimmune disorders, eye disorders, osteoporosis, respiratory disease, and cancer. For more information, please visit www.alvotech.com.

Additional Information

In connection with the proposed business combination between OACB, Alvotech Holdings S.A. and TopCo, the parties have filed with the U.S. Securities and Exchange Commission a Registration Statement on Form F-4 (as amended or supplemented through the date hereof, the “Registration Statement”) containing a proxy statement of OACB and a prospectus of TopCo. The Registration Statement has been declared effective by the SEC and OACB has mailed a definitive proxy statement/prospectus related to the proposed Business Combination to its shareholders. The extraordinary general meeting of shareholders of OACB to approve the business combination is scheduled to be held on June 7, 2022. This communication does not contain all the information that should be considered concerning the proposed Business Combination and is not intended to form the basis of any investment decision or any other decision in respect of the proposed Business Combination. OACB’s shareholders and other interested persons are advised to read the definitive proxy statement/prospectus and other documents filed in connection with the proposed Business Combination, as these materials will contain important information about Alvotech Holdings S.A., OACB and the proposed Business Combination. Shareholders of OACB can also obtain copies of the definitive proxy statement/prospectus and other documents filed with the SEC, without charge at the SEC’s website at www.sec.gov, or by directing a written request to: Oaktree Acquisition Corp. II, 333 South Grand Avenue, 28th Floor, Los Angeles, California 90071.

Oaktree Acquisition Corp. II Combination Partner Alvotech Highlights AVT04 Clinical Study