Catalent Pharma Solutions has signed an agreement with Pharmacyclics to provide drug product capsules of IMBRUVICA (Ibrutinib) for ongoing clinical trials as well as commercial supply. IMBRUVICA received approval on November 13th for treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. This agreement follows a multi-year development and clinical manufacturing partnership for Pharmacyclics’ expedited NDA submission. Additionally, Catalent’s site in Kansas City, MO, has successfully completed an FDA Pre-Approval Inspection (PAI) that resulted in zero observations.
IMBRUVICA is a first in class, oral therapy that inhibits a protein called Bruton's tyrosine kinase (BTK), a key signaling molecule that plays an important role in the survival of malignant B cells. IMBRUVICA has been granted three Breakthrough Therapy Designations by the FDA, intended to expedite the development and review of drugs for serious or life-threatening conditions.
“It is important that we work with a development partner with expertise in both clinical and commercial supply as well as US and worldwide GMP regulations, to ensure reliable quality supply to patients,” said Heow Tan, chief of technical operations at Pharmacyclics. “Catalent’s extensive experience will help us meet the demands of the clinical and commercial supply of Ibrutinib.”
“We are delighted to see this important treatment approved and to have reached an agreement to continue our successful partnership with Pharmacyclics at our accelerated development programs center of excellence in Kansas City,” said Christine Dolan, vice president and general manager of Catalent’s Development and Clinical Services business. “Our experience in the development and commercial supply of a variety of dose forms, as well as our analytical and regulatory expertise, enable Catalent to quickly bring quality products to market, faster.”