Alvotech and Fuji Pharma Expand Partnership for Additional Biosimilar Candidate in Japan

Rhea-AI Summary

Alvotech and Fuji Pharma have expanded their strategic partnership to include six biosimilar products aimed at the Japanese market. The agreement grants Fuji exclusive commercial rights to an undisclosed biosimilar in early development, with Alvotech receiving upfront and milestone payments, along with a share of sales. This strengthens Alvotech's position in Japan, the third largest pharmaceutical market globally. The collaboration emphasizes both companies' commitment to enhancing patient access to biosimilars, ultimately contributing to healthcare sustainability.

Positive

• Agreement adds a sixth biosimilar product, enhancing market presence.
• Fuji Pharma provided exclusive commercial rights, indicating confidence in the partnership.
• Potential for significant milestone payments tied to development progress.

Negative

• Details on the undisclosed biosimilar are limited, raising uncertainties about its development and marketability.
• Alvotech's reliance on milestone payments could indicate potential risks in product development timelines.

Fuji and Alvotech partnership now covers six proposed biosimilar products

REYKJAVIK, Iceland & TOKYO--(BUSINESS WIRE)-- Alvotech Holdings S.A. (“Alvotech”), a global biopharmaceutical company focused solely on the development and manufacture of biosimilar medicines for patients worldwide, and Japanese pharmaceutical company Fuji Pharma (“Fuji,” Tokyo Stock Exchange: 4554) announced today that they have agreed to add to their strategic partnership for the development and commercialization of biosimilar medicines in Japan.

Under terms of the agreement, Fuji will be granted exclusive commercial rights to an undisclosed biosimilar currently in early phase development. Alvotech will receive an upfront payment and be eligible for subsequent milestone payments tied to development progression, as well as a share of the in-market sales. The new agreement adds another biosimilar candidate to the partnership between Alvotech and Fuji, first announced in 2018, bringing the total number of proposed biosimilar products that the companies are partnering on to six. The Japanese market ranks third in overall pharmaceutical spending globally (source: IQVIA Institute).

“Fuji has a been a pioneer in biosimilars in the Japanese market,” said Takayuki Iwai, Fuji’s President & CEO. “This expansion in our partnership with Alvotech demonstrates our commitment to patients and our focus on healthcare sustainability.”

“A global approach to biosimilars is fundamental to our story,” said Robert Wessman, Founder and Chairman of Alvotech. “We believe the dynamics in the Japanese market will favor biosimilars in the long-term as the health care system balances cost and patient access.”

On December 7, 2021, Alvotech and Oaktree Acquisition Corp. II (NYSE: OACB.U, OACB, OACB WS) (“OACB”), a special purpose acquisition company sponsored by an affiliate of Oaktree Capital Management, L.P., 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.”

About Fuji Pharma

Fuji Pharma Co., Ltd. is a Tokyo Stock Exchange (TSE) listed, Japan‐based pharmaceutical company mainly engaged in the manufacture and sale of prescription based pharmaceutical products. Fuji Pharma focuses on development and commercialization of hormone medicines for obstetrics and gynecology therapies, as well as injectable drugs including diagnostic pharmaceutical products. Fuji Pharma was among the pioneers in Japan to develop and obtain biosimilar approval in Japan for G-CSF in 2013. In Mid-Term Business Plan (FY9/2020-9/2024), Fuji Pharma aims to become the No. 1 biosimilar manufacturer in Japan by the FY9/2029.

About Alvotech

Alvotech is a biopharmaceutical company 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, and cancer. For more information, please visit www.alvotech.com.

Additional Information

In connection with the proposed business combination (the “Business Combination”) between OACB and Alvotech. OACB and Alvotech have filed with the U.S. Securities and Exchange Commission (the “SEC”) a Registration Statement on Form F-4 (the “Registration Statement”) containing a preliminary proxy statement of OACB and a preliminary prospectus of Alvotech Lux Holdings S.A.S., and after the Registration Statement is declared effective, OACB will mail a definitive proxy statement/prospectus related to the proposed Business Combination to its shareholders. 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, when available, the preliminary proxy statement/prospectus and the amendments thereto and 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, OACB and the proposed Business Combination. When available, the definitive proxy statement/prospectus and other relevant materials for the proposed Business Combination will be mailed to shareholders of OACB as of a record date to be established for voting on the proposed Business Combination. Shareholders of OACB will also be able to obtain copies of the preliminary proxy statement/prospectus, the definitive proxy statement/prospectus and other documents filed with the SEC, without charge, once available, at the SEC’s website at www.sec.gov, or by directing a written request to: OACB, 333 South Grand Avenue, 28th Floor, Los Angeles, California 90071.

Participants in the Solicitation

OACB and Alvotech and its directors and executive officers may be deemed participants in the solicitation of proxies from OACB’s shareholders with respect to the Business Combination. A list of the names of those directors and executive officers and a description of their interests in OACB is contained in OACB’s annual report on Form 10-K/A for the fiscal year ended December 31, 2020 (as amended December 13, 2021), which was filed with the SEC and is available free of charge at the SEC’s web site at www.sec.gov, or by directing a written request to OACB, 333 South Grand Avenue, 28th Floor, Los Angeles, California 90071. Additional information regarding the interests of such participants will be contained in the proxy statement/prospectus for the proposed Business Combination when available.

Alvotech Lux Holdings S.A.S and its directors and executive officers may also be deemed to be participants in the solicitation of proxies from the shareholders of OACB in connection with the proposed Business Combination. A list of the names of such directors and executive officers and information regarding their interests in the proposed Business Combination will be included in the proxy statement/prospectus for the proposed Business Combination when available.

Forward-Looking Statement

Certain statements in this communication may be considered “forward-looking statements.” Forward-looking statements generally relate to future events or the future financial operating performance of OACB or Alvotech. For example, Alvotech’s expectations regarding future growth, results of operations, performance, future capital and other expenditures including the development of critical infrastructure for the global healthcare markets, 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. In some cases, you can identify forward-looking statements by terminology such as “may,” “should,” “expect,” “intend,” “will,” “estimate,” “anticipate,” “believe,” “predict,” “potential” 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 OACB and its management, and Alvotech and its management, as the case may be, are inherently uncertain and are inherently subject to risks, variability and contingencies, many of which are beyond OACB’s and Alvotech’s control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: (1) the occurrence of any event, change or other circumstances that could give rise to the termination of negotiations and any subsequent definitive agreements with respect to the Business Combination; (2) the outcome of any legal proceedings that may be instituted against OACB, the combined company or others following this announcement of the Business Combination and any definitive agreements with respect thereto; (3) the inability to complete the Business Combination due to the failure to obtain approval of the shareholders of OACB, to obtain financing to complete the Business Combination or to satisfy other conditions to closing; (4) changes to the proposed structure of the Business Combination that may be required or appropriate as a result of applicable laws or regulations or as a condition to obtaining regulatory approval of the Business Combination; (5) the ability to meet stock exchange listing standards following the consummation of the Business Combination; (6) the risk that the Business Combination disrupts current plans and operations of Alvotech as a result of the announcement and consummation of the Business Combination; (7) the ability to recognize the anticipated benefits of the Business Combination, which may be affected by, among other things, competition, the ability of the combined company to grow and manage growth profitably, maintain key relationships and retain its management and key employees; (8) costs related to the Business Combination; (9) changes in applicable laws or regulations; (10) the possibility that Alvotech or the combined company may be adversely affected by other economic, business, and/or competitive factors; (11) Alvotech’s estimates of expenses and profitability; and (12) other risks and uncertainties set forth in the section entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in OACB’s Annual Report on Form 10-K/A for the fiscal year ended December 31, 2020 (as amended May 19, 2021) or in other documents filed by OACB with the SEC. There may be additional risks that neither OACB nor Alvotech presently know or that OACB and Alvotech currently believe are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. Nothing in this communication should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. Neither OACB nor Alvotech undertakes any duty to update these forward-looking statements or to inform the recipient of any matters of which any of them becomes aware of which may affect any matter referred to in this communication. Alvotech and OACB disclaim any and all liability for any loss or damage (whether foreseeable or not) suffered or incurred by any person or entity as a result of anything contained or omitted from this communication and such liability is expressly disclaimed. The recipient agrees that it shall not seek to sue or otherwise hold Alvotech, OACB or any of their respective directors, officers, employees, affiliates, agents, advisors or representatives liable in any respect for the provision of this communication, the information contained in this communication, or the omission of any information from this communication.

No Offer

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 pursuant to the proposed transaction or otherwise, 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. No offer of securities shall be made except by means of a prospectus meeting the requirements of the Securities Act of 1933, as amended.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220223005107/en/

ALVOTECH

Investor Relations

Stephanie Carrington

ICR Westwicke

Stephanie.Carrington@westwicke.com

(646) 277-1282

Media Relations

Sean Leous

ICR Westwicke

Sean.Leous@westwicke.com

(646) 866-4012

Corporate Communications

Alvotech.media@alvotech.com

FUJI PHARMA

Corporate Communications

fsk_ir@fujipharma.jp

Source: Alvotech Holdings S.A.

FAQ

What is the significance of the Alvotech and Fuji Pharma partnership?

The partnership strengthens Alvotech's position in the Japanese biosimilar market by increasing its product offerings to six biosimilars.

What are the financial implications for Alvotech in the new agreement?

Alvotech will receive an upfront payment and milestone payments, along with a share of in-market sales from the new biosimilar.

When was the original partnership between Alvotech and Fuji Pharma established?

The original partnership was announced in 2018.

How many biosimilars are now involved in the Alvotech and Fuji Pharma collaboration?

The collaboration now involves a total of six proposed biosimilar products.

What is the stock symbol for Oaktree Acquisition Corp. II?

The stock symbol for Oaktree Acquisition Corp. II is OACB, with additional symbols OACB.WS and OACB.U.