UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the Month of October 2022
Commission File Number: 001-41421
Alvotech
(Translation of registrants name into English)
9, Rue de Bitbourg,
L-1273 Luxembourg,
Grand Duchy of Luxembourg
(Address of principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:
☒ Form 20-F ☐ Form 40-F
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ☐
INFORMATION CONTAINED IN THIS REPORT ON FORM 6-K
Press Release
On October 11, 2022, Alvotech announced that Sarah Tanksley will join its corporate leadership team as Chief Quality Officer, effective October 14.
This Report on Form 6-K, including Exhibit 99.1 hereto, shall be deemed to be incorporated by reference into the registration statement on Form S-8 (File No. 333-266881) of Alvotech and to be a part thereof from the date on which this report is furnished, to the extent not superseded by documents or reports subsequently filed or furnished.
EXHIBIT INDEX
Exhibit No. |
Description | |
99.1 | Press Release dated October 11, 2022. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
ALVOTECH | ||||||
Date: October 11, 2022 | By: | /s/ Tanya Zharov | ||||
Name: Tanya Zharov | ||||||
Title: Deputy Chief Executive Officer |
Exhibit 99.1
Alvotech Appoints Sarah Tanksley as Chief Quality Officer
REYKJAVIK ICELAND (October 11, 2022) Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that Sarah Tanksley will join its corporate leadership team as Chief Quality Officer, effective October 14. Ms. Tanksley succeeds Reem Malki, who is stepping down for personal reasons.
Sarah has been actively working with Alvotech as a consultant and we are very pleased that she will join our team in this new capacity, said Mark Levick, Chief Executive Officer of Alvotech. Her familiarity with our operation facilitates a smooth transition and we are excited to benefit further from her experience in regulatory compliance and GMP. Sarah brings strong capabilities to the role of Chief Quality Officer, having excelled in regulatory agency roles as well as a respected industry practitioner. I also want to thank Reem for her vital contribution to the Alvotech team, as we built a world-class biosimilars development and manufacturing platform and achieved successful market launches of our first biosimilar in both Europe and Canada.
Ms. Tanksley has 20 years of experience within the U.S. National Institutes of Health (NIH), the U.S. Food and Drug Administration (FDA), and as an industry consultant. She teaches graduate courses in GMP compliance and Regulatory Affairs as an Adjunct Professor in the Graduate Biochemistry and Molecular Biology Program at Georgetown University School of Medicine and with the Advanced Academic Program at Johns Hopkins University. Sarah has an MS degree in Bioscience Regulatory Affairs from Johns Hopkins University, as well as an MS degree in Biochemistry and Molecular Biology from Georgetown University School of Medicine.
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. Alvotechs current pipeline contains eight 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. Alvotechs commercial partners include Teva Pharmaceuticals, a US affiliate of Teva Pharmaceutical Industries Ltd. (US), STADA Arzneimittel AG (EU), Fuji Pharma Co., Ltd (Japan), 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 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 press release.
Sæmundargata 15-19 | Phone +354 422 4500 | alvotech.media@alvotech.com | ||||
Page 1 of 2 | 102 Reykjavík, Iceland | www.alvotech.com |
Forward-Looking Statements
This press release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including with respect to the Alvotechs partnerships, pipeline and regulatory approvals, and the transition of Ms. Tanksley into her role as Chief Quality Officer. Any statement describing Alvotechs goals, expectations, financial or other projections, intentions or beliefs, or management changes is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to a number of risks, uncertainties and assumptions, including those related to the impact that the COVID-19 pandemic could have on Alvotechs business, and including the scope, progress and expansion of Alvotechs clinical trials and ramifications for the cost thereof; clinical, scientific, regulatory and technical developments; management changes and those inherent in the process of developing and commercializing product candidates that are safe and effective, and in the endeavor of building a business around such product candidates. In light of these risks and uncertainties, and other risks and uncertainties that are described in the sections entitled Risk Factors and Cautionary Note Regarding Forward-Looking Statements in documents that Alvotech may from time to time file or furnish with the SEC, the events and circumstances discussed in such forward-looking statements may not occur, and Alvotechs actual results could differ materially and adversely from those anticipated or implied thereby. Although Alvotechs forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Alvotech. As a result, you are cautioned not to rely on these forward-looking statements.
CONTACTS
Alvotech Investor Relations and Global Communication
Benedikt Stefansson
alvotech.ir[at]alvotech.com
Sæmundargata 15-19 | Phone +354 422 4500 | alvotech.media@alvotech.com | ||||
Page 2 of 2 | 102 Reykjavík, Iceland | www.alvotech.com |