Pharmacyclics and Catalent Solidify Partnership on Imbruvica

Catalent Pharma Solutions, a global leader in development solutions and advanced delivery technologies for drug, biologic and consumer health products, has signed an agreement with Pharmacyclics for the oncology drug IMBRUVICA (Ibrutinib). This follows a successful multiple-year development and clinical manufacturing partnership that aided Pharmacyclics’ expedited New Drug Application (NDA) submission and approval by FDA.

Under the agreement, Catalent will provide drug product capsules for both commercial supply and ongoing clinical trials. After review by FDA, IMBRUVICA received approval on 13 November 2013, for treatment of patients with mantle cell lymphoma who have received at least one prior therapy. This indication is based on overall response rate. An improvement in survival or disease-related symptoms has not been established.

IMBRUVICA is a first in class, oral therapy and is a new agent that inhibits a protein called Bruton's tyrosine kinase (BTK). BTK is a key signaling molecule of the B-cell receptor signaling complex that plays an important role in the survival of malignant B cells. IMBRUVICA blocks signals that tell malignant B cells to grow and divide uncontrollably. IMBRUVICA has been granted three Breakthrough Therapy Designations by FDA, intended to expedite the development and review of drugs for serious or life-threatening conditions, a first for an oncology drug. To date, seven Phase III trials have been initiated with IMBRUVICA and a total of 30 trials are currently registered on www.clinicaltrials.gov.

“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,” commented 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 programmes 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.”

The agreement was reached after a successful FDA Pre-Approval Inspection at Catalent’s site in Kansas City, MO, that resulted in zero observations. The 450,000 sq. ft. facility provides a range of fully integrated support services, from formulation development and analytical testing, to clinical and commercial scale manufacturing and packaging of a variety oral dose forms. Its co-located end-to-end drug development solutions provide speed and flexibility to help Catalent’s customers accelerate their drug development to market.