Lonza has entered an agreement with Pharmacyclics to provide commercial and clinical production of Pharmacyclics’ oral oncology drug, IMBRUVICA (Ibrutinib). Lonza previously provided development services and clinical manufacture, which was used for Pharmacyclics’ NDA submission and approval. Lonza will continue to support the production of commercial and clinical material under a long-term agreement.
Pharmacyclics received FDA approval of IMBRUVICA in November for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy. IMBRUVICA is a new agent that inhibits Bruton's tyrosine kinase (BTK), a key signaling molecule that plays an important role in the survival of malignant B cells.
“We are proud to support Pharmacyclics through both clinical and commercial supply of their breakthrough oncology drug,” said Dr. Stephan Kutzer, chief operating officer of Lonza Pharma & Biotech. “This extended partnership is an example of Lonza’s commitment to our client’s complete product life cycle and our dedication to the advancement of potentially life-saving treatments like IMBRUVICA.”
“Our multi-year 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.”