Home Somerset business Legend Biotech Completes Milestone Payments in BCMA CAR-T Collaboration with Janssen

Legend Biotech Completes Milestone Payments in BCMA CAR-T Collaboration with Janssen


SOMERSET, NJ–(BUSINESS WIRE)–Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global clinical-stage biotechnology company that develops and manufactures novel therapies, has achieved two milestones in its collaboration agreement with Janssen Biotech, Inc. for ciltacabtagene autoleucel (cilta-cel), resulting in aggregate payments to Legend Biotech of $50 million. Cilta-cel is a chimeric antigen receptor (CAR-T) chimeric T-cell therapy directed by B-cell maturation antigen (BCMA).

Legend Biotech has entered into an agreement with Janssen to develop, manufacture and commercialize cilta-cel for the treatment of multiple myeloma. Under the agreement, Legend Biotech received an upfront payment of $350 million and is entitled to receive additional payments upon completion of development, production performance, regulatory and sales milestones.

The global agreement specifies a 50-50 cost and benefit sharing arrangement in all markets except Greater China, where the split is 70% for Legend and 30% for Janssen. Including the payments announced above, Legend made $250 million in milestone payments during the collaboration.

About Cilta-cel

Cilta-cel is an investigational chimeric antigen receptor (CAR-T) cell therapy, formerly identified as JNJ-4528 in the United States and Europe and LCAR-B38M CAR-T cells in China, which is being studied in a development comprehensive clinical treatment program for patients with relapsed or refractory multiple myeloma and in the first lines of treatment. The design consists of a structurally differentiated CAR-T with two single domain antibodies targeting BCMA. In addition to a Breakthrough Therapy Designation (BTD) granted in the United States in December 2019, cilta-cel received a Priority Drug Designation (PRiME) from the European Commission in April 2019, and a BTD designation in China in August 2020. Additionally, Orphan Drug Designation was granted to cilta-cel by the U.S. Food and Drug Administration (FDA) in February 2019 and by the European Commission in February 2020. A Biologics License Application requesting approval of cilta-cel has been submitted to the US FDA and a marketing authorization application has been submitted to the European Medicines Agency.

About Legend Biotech

Legend Biotech is a global clinical-stage biotechnology company dedicated to treating and, one day, curing life-threatening diseases. Based in Somerset, New Jersey, we develop advanced cell therapies on a wide range of technology platforms, including autologous and allogeneic chimeric antigen receptors, T-cell receptors (TCR-Ts) and T-cells. natural killers (NK). based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, effective and cutting-edge therapies for patients around the world.

We are currently engaged in a strategic collaboration to develop and commercialize our lead product candidate, ciltacabtagene autoleucel, an investigational BCMA-targeted CAR-T cell therapy for patients with multiple myeloma. Applications for approval of cilta-cel for the treatment of patients with MMRR are currently undergoing regulatory review by several health authorities around the world, including the United States Food and Drug Administration and the European Medicines Agency. .

Learn more at www.legendbiotech.com and follow us on Twitter and LinkedIn.

Caution :

The statements in this press release regarding future expectations, plans and prospects, and 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 future milestone payments under our collaboration agreement with Janssen. The words “anticipate”, “believe”, “continue”, “could”, “estimate”, “expect”, “intend”, “may”, “plan”, “potential”, ” predict”, “project”, “should”, “target”, “shall”, “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain such identifying words. Actual results may differ materially from those indicated by these forward-looking statements due to a variety of important factors. Legend Biotech’s expectations could be affected by, among other things, uncertainties related to the development of new pharmaceutical products; unexpected results of clinical trials or preclinical studies, including as a result of additional analysis of existing data or unexpected new data; unexpected regulatory actions or delays, including requests for additional safety and/or efficacy data or data analysis, or government regulation generally; unforeseen delays as a result of actions taken or inaction by our third-party partners; uncertainties arising from challenges to Legend Biotech’s patent or other proprietary intellectual property protection, including uncertainties related to the litigation process in the United States; competition in general; government, industry and public awards and other political pressures; the duration and severity of the COVID-19 pandemic and the governmental and regulatory measures put in place in response to the evolving situation; as well as the other factors discussed in the “Risk Factors” section of Legend Biotech’s Annual Report on Form 20-F filed with the Securities and Exchange Commission on April 2, 2021. Should one or more of these risks or uncertainties materialize, or if underlying assumptions prove incorrect, actual results may differ materially from those described in this press release as anticipated, believed, estimated or expected. Legend Biotech specifically disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.