Flanders Investment and Trade Names Legend Biotech Newcomer of the Year
Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global biotechnology company developing, manufacturing and commercializing novel therapies to treat life-threatening diseases, was named Newcomer of the Year at the tenth annual Foreign Investment Trophy ceremony hosted by Flanders Investment & Trade (FIT).
Flanders Investment and Trade is a Flemish government organization that facilitates investment projects in Flanders, a northern region of Belgium, and supports Flemish companies. The Foreign Investment Trophy recognizes international firms with investment projects in Flanders, and FIT’s Newcomer of the Year award is conferred upon organizations who have recently embarked on substantial investment projects in the region.
Legend Biotech earned the honor for its joint investment in a state-of-the-art manufacturing facility in Flanders with Janssen Pharmaceutica N.V. (Janssen). The cell therapy facility is the first-ever cell therapy manufacturing site located in Flanders, and it will serve as a regional hub for the companies’ cell therapy production for patients in Europe, the Middle East and Africa.
The 26,000-square-meter manufacturing hub is part of Legend’s collaboration with Janssen to advance the manufacturing of ciltacabtagene autoleucel (cilta-cel), a B cell maturation antigen-directed CAR-T treatment being evaluated for the treatment of relapsed or refractory multiple myeloma by the European Medicines Agency. In April 2019, cilta-cel was granted PRIME (Priority Medicines) designation. PRIME offers enhanced interaction and early dialogue with the developers of promising medicines to optimize drug development plans and speed up the evaluation of cutting-edge, scientific advances that target a high unmet medical need.
The European manufacturing hub is anticipated to come on-line in 2023 and will be managed by Legend Biotech.
As he accepted the award in Belgium, Ying Huang, PhD, CEO and CFO of Legend Biotech, said: “This award is special recognition of our investment in Flanders, one of Europe’s most exciting biotechnology hubs. The Newcomer of the Year award marks how far we’ve come in since Legend was established to apply cell therapy to rare and uncommon diseases. We look forward to advancing that goal and to playing a meaningful role in the Ghent ecosystem for years to come.”
About Legend Biotech
Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide.
About Flanders Investment & Trade
Flanders Investment & Trade (FIT) actively promotes sustainable international business in Flanders as a key element of the region’s socio-economic development. FIT accomplishes this by supporting Flanders-based companies in their international business ventures and by attracting foreign investors. FIT assists businesses across Flanders in their international endeavors and provides custom advice and support. Companies can call on the agency’s local and international networks of contacts, while FIT also offers financial support and information about the financial incentives available.
Cautionary Note Regarding Forward-Looking Statements
Statements in this press release 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 Legend Biotech’s strategies and objectives; statements relating to CARVYKTI™, including Legend Biotech’s expectations for CARVYKTI™, such as Legend Biotech’s manufacturing and commercialization expectations for CARVYKTI™ and the potential effect of treatment with CARVYKTI™; statements about submissions for cilta-cel to, and the progress of such submissions with, the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), the Chinese Center for Drug Evaluation of National Medical Products Administration (CDE) and other regulatory authorities; the anticipated timing of, and ability to progress, clinical trials, including patient enrollment; the submission of Investigational New Drug (IND) applications to, and maintenance of such applications with, regulatory authorities; the ability to generate, analyze and present data from clinical trials; and the potential benefits of Legend Biotech’s product candidates. 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. Legend Biotech’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 Legend Biotech’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 Legend Biotech’s Annual Report filed with the Securities and Exchange Commission on April 2, 2021. 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 press release as anticipated, believed, estimated or expected. Any forward-looking statements contained in this press release speak only as of the date of this press release. Legend Biotech specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.
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