Select Page
Home » Catalent News » Catalent to Supply BeiGene’s BTK Inhibitor BRUKINSA™ (zanubrutinib)

Catalent to Supply BeiGene’s BTK Inhibitor BRUKINSA™ (zanubrutinib)

SOMERSET, N.J. – November 21, 2019 — Catalent, the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, gene therapies, and consumer health products, today announced that it had entered into a long-term commercial supply agreement with BeiGene, Ltd., a biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer. Under the agreement, Catalent will manufacture BRUKINSA™ (zanubrutinib)[1], a Bruton’s tyrosine kinase (BTK) inhibitor that has recently received accelerated approval from the United States Food and Drug Administration (FDA), as a treatment for mantle cell lymphoma (MCL) in adult patients who have received at least one prior therapy.[2] BRUKINSA is now commercially available in the U.S.

Catalent’s Kansas City, Missouri site has supported BeiGene’s program since 2016, from formulation development and clinical trial supply, onto commercial supply for the U.S. and, subject to further approvals, other markets.

“Our Kansas City facility has an extensive track record in supporting the development and launch of multiple fast-track designation medicines, especially cancer therapies.” commented Jonathan Arnold, President of Catalent’s Oral and Specialty Delivery business. He added, “We are pleased to have worked with BeiGene toward this important first approval and we look forward to commercial launch in the U.S., and to supporting BeiGene as they seek further approvals.”

Commenting on the FDA’s accelerated approval, John V. Oyler, Chairman, Co-Founder, and CEO of BeiGene, said, “The FDA approval of BRUKINSA, following the previously granted Breakthrough Therapy designation in this indication, validates it as an important treatment option for people with relapsed or refractory MCL. We hope this is the first of many approvals for BRUKINSA as we continue to evaluate its potential in other hematologic cancers.”

[1] BRUKINSA is a trademark of BeiGene, Ltd.

[2] BRUKINSA (zanubrutinib) Prescribing Information. beigene.com/PDF/BRUKINSAUSPI.pdf. BeiGene, Ltd; November 14, 2019.

Notes for Editors

ABOUT CATALENT

Catalent is the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, gene therapies and consumer health products. With over 85 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable global clinical and commercial product supply. Catalent employs nearly 13,000 people, including approximately 2,400 scientists and technicians, at more than 35 facilities, and in fiscal year 2019 generated over $2.5 billion in annual revenue. Catalent is headquartered in Somerset, New Jersey. For more information, visit www.catalent.com

 

More products. Better treatments. Reliably supplied.™

ABOUT BEIGENE

BeiGene is a global, commercial-stage, research-based biotechnology company focused on molecularly-targeted and immuno-oncology cancer therapeutics. With a team of over 3,000 employees in China, the United States, Australia and Europe, BeiGene is advancing a pipeline consisting of novel oral small molecules and monoclonal antibodies for cancer. BeiGene is also working to create combination solutions aimed to have both a meaningful and lasting impact on cancer patients. In the United States, BeiGene markets BRUKINSA™ (zanubrutinib) and in China, the Company markets ABRAXANE® (nanoparticle albumin–bound paclitaxel), REVLIMID® (lenalidomide), and VIDAZA® (azacitidine) under a license from Celgene Corporation.i

i ABRAXANE®, REVLIMID® and VIDAZA® are registered trademarks of Celgene Corporation.