Lonza partners with Pharmacyclics to produce oncology drug

Lonza, a supplier in chemical development and manufacturing, has established an agreement with Pharmacyclics to support the commercial and clinical production of its oral oncology drug Imbruvica (Ibrutinib).

The agreement follows a multiyear partnership, including development and clinical manufacturing, which was utilised for Pharmacyclics’ NDA submission and FDA approval of their oncology treatment product. Under the long-term agreement, Lonza will continue to support the production of commercial and clinical material.

“Our multiyear partnership with Lonza helped us rapidly move Imbruvica from clinical development to our first FDA filing,” said Heow Tan, chief of quality and technical operations at Pharmacyclics. “Based on this successful collaboration, we are pleased to announce the partnership with Lonza in support of both our clinical and commercial supply.”

Pharmacyclics received final FDA approval of Imbruvica on 13 November 2013 for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy. The oral therapy drug is a new agent that inhibits a protein called Bruton’s tyrosine kinase (BTK) - a key signalling molecule of the B-cell receptor signalling 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.

The product has been granted three breakthrough therapy designations by the FDA, said to be a first for an oncology drug. These designations are intended to expedite the development and review of drugs for serious or life-threatening conditions. Nine phase III clinical trials have been initiated with Imbruvica and 38 clinical trials are currently registered on www.clinicaltrials.gov.

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