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Alcami supporting commercial supply of Flexion’s first FDA-approved product

13-Jun-2018 - Last updated on 13-Jun-2018 at 13:54 GMT

(Image: Getty/svengine)

Alcami began work on Flexion Therapeutics's ZILRETTA in the fall of 2014 and today announced that it will further support commercial supply of the product, which is approved for the treatment of OA-related knee pain.

The contract development and manufacturing organization (CDMO) is expanding deployment of its “Extended Workbench” for the continuing manufacturing and development of ZILRETTA (triamcinolone acetonide extended-release injectable suspension).

Flexion initially used Alcami's “Extended Workbench” – a full-time equivalent (FTE) service program – to support Phase II clinical trials through commercial launch. Moving forward, the MA-based biopharmaceutical company will use the program for release and stability testing of commercial batches.

ZILRETTA is Flexion’s the first US Food and Drug Administration (FDA) approved product and was approved for the treatment of OA-related knee pain on October 6, 2017. It officially launched nationwide in late November of 2017.

"Our versatile Extended Workbench solution was an excellent fit for our partners at Flexion, whose accelerated timeline, robust clinical trial program, and specific testing requirements mandated dedicated laboratory resources to get their product to market," said Alcami Chief Commercial Officer, Syed T. Husain in a press release.