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Catalent Signs Commercial Supply Agreement with Blueprint Medicines Following FDA Approval of GAVRETOT (pralsetinib)

Catalent




SOMERSET, N.J. – November 23, 2020 — Catalent, the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products, today announced that it had entered into a commercial supply agreement with Blueprint Medicines following FDA approval of GAVRETO™ (pralsetinib). Developed by Blueprint Medicines, GAVRETO is a new therapy indicated for the treatment of adults with metastatic RET fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test.

This agreement will continue Catalent’s involvement in the GAVRETO program, which has been supported by Catalent’s Nottingham, U.K., site since 2015.

GAVRETO is a once-daily oral RET-targeted therapy that is designed to selectively and potently inhibit RET alterations that drive many cancer types, including approximately one to two percent of patients with metastatic NSCLC. Currently, RET is one of seven NSCLC biomarkers that can be targeted with an FDA-approved therapy.

“We have a long-standing relationship with Blueprint Medicines, and this approval marks an amazing accomplishment, reflecting the hard work, dedication and determination of the entire team,” commented Jonathan Arnold, President of Oral and Specialty Delivery at Catalent. “The expertise that our scientists in Nottingham brought to the development program supported Blueprint Medicines’ efforts to rapidly gain regulatory approval, and through expedient tech transfer within our company’s global network, our team in Kansas City can effectively support commercial supply.”

In February 2020, Catalent announced a commercial supply agreement for Blueprint Medicines’ AYVAKIT™ (avapritinib) for the treatment of adults with unresectable or metastatic gastrointestinal stromal tumor harboring a PDGFRA exon 18 mutation, including PDGFRA D842V mutations.

Catalent’s Kansas City, Missouri site is home to the company’s Oral & Specialty Drug Delivery business, where it provides a range of integrated services for oral solid dosage forms, from formulation development and analytical testing to clinical and commercial-scale manufacture. The 421,665-square-foot facility is the commercial manufacturing Center-of-Excellence for accelerated development programs and roller compaction. It also houses large-molecule analytical services and provides clinical supply services.
phone +1 888 765 8846
email info@catalent.com
web www.catalent.com
email 14 Schoolhouse Road, Somerset 08873 NJ , USA
 
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