Basel, Switzerland, 13 January 2014 – Lonza, a leading supplier in Chemical Development and Manufacturing, announced today it has established an agreement with Pharmacyclics, Inc. to support the commercial and clinical production of its first-in-class oral oncology drug, IMBRUVICA™ (Ibrutinib). This agreement follows a successful multi-year partnership, including the development and clinical manufacturing, which was utilized for Pharmacyclics’ NDA submission and now first FDA approval of their lead product for oncology treatment. Under the long term agreement, Lonza will continue to support the production of commercial and clinical material.
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. 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 the FDA, a first for an oncology drug. These designations are intended to expedite the development and review of drugs for serious or life-threatening conditions. To date, nine Phase III clinical trials have been initiated with IMBRUVICA and 38 clinical trials are currently registered on www.clinicaltrials.gov.
“We are proud to support Pharmacyclics through both clinical and commercial supply of their breakthrough oncology drug,” said Dr. Stephan Kutzer, COO 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.”