Legend Biotech USA Inc. Enters into Master Technology Transfer, Manufacturing and Clinical Supply Services Agreement with Novartis Pharmaceuticals Corporation
On April 12, 2023, Legend Biotech USA Inc. (“Legend”) together with Janssen Research & Development, LLC (“Janssen” and together with Legend, the “Collaboration Partners”) and Novartis Pharmaceuticals Corporation (“Novartis”) entered into a Master Technology Transfer, Manufacturing and Clinical Supply Services Agreement for BCMA CAR-T Product (the “Agreement”), pursuant to which the Collaboration Partners and Novartis will initiate technology transfer activities necessary for Novartis to perform the Collaboration Partners’ process for manufacturing ciltacabtagene autoleucel (cilta-cel) to supplement the Collaboration Partners’ own manufacturing capabilities.
The Agreement is effective as of April 12, 2023 and continues for a period of three years.
This Form 6-K, including Exhibit 99.1 hereto, is hereby incorporated by reference into the Registration Statements of Legend Biotech Corporation (the “Company”) on Form F-3 (File Nos. 333-257625 and 333-257609) and the Company’s Registration Statement on Form S-8 (File No. 333-239478).
Cautionary Note Regarding Forward-Looking Statements
Statements in this report on Form 6-K about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, constitute “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to the Company’s strategies and objectives; and statements relating to CARVYKTI® (ciltacabtagene autoleucel), including the Company’s expectations for CARVYKTI®, such as the Company’s manufacturing and commercialization expectations for CARVYKTI® and statements related to contracting with and engaging third-parties, including contract manufacturers. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. the Company’s expectations could be affected by, among other things, uncertainties involved in the development of new pharmaceutical products; unexpected clinical trial results, including as a result of additional analysis of existing clinical data or unexpected new clinical data; unexpected regulatory actions or delays, including requests for additional safety and/or efficacy data or analysis of data, or government regulation generally; unexpected delays as a result of actions undertaken, or failures to act, by our third party partners; uncertainties arising from challenges to the Company’s patent or other proprietary intellectual property protection, including the uncertainties involved in the U.S. litigation process; competition in general; government, industry, and general public pricing and other political pressures; the duration and severity of the COVID-19 pandemic and governmental and regulatory measures implemented in response to the evolving situation; as well as the other factors discussed in the “Risk Factors” section of the Company’s Annual Report on Form 20-F filed with the Securities and Exchange Commission on March 30, 2023. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described in this Form 6-K as anticipated, believed, estimated or expected. Any forward-looking statements contained in this Form 6-K speak only as of the date of this Form 6-K. The Company specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.
