EPM News Update
Supplier in chemical development and manufacturing Lonza has established an agreement with Pharmacyclics, Inc. to support the commercial and clinical production of its oral oncology drug IMBRUVICA (Ibrutinib). This agreement follows a successful multi-year partnership, including the development and clinical manufacturing, which was utilised for Pharmacyclics’s NDA submission and now first FDA approval of its 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 new agent that inhibits a protein called Bruton’s tyrosine kinase (BTK). BTK is 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. IMBRUVICA has been granted three breakthrough therapy designations by the FDA, reportedly 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, Lonza Pharma & Biotech COO. “This extended partnership is an example of Lonza’s commitment to our client’s complete product lifecycle 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, Pharmacyclics Chief of Quality and Technical Operations. “Based on this successful collaboration, we are pleased to announce the partnership with Lonza in support of both our clinical and commercial supply.”
Lonza Group Ltd, +41 61 316 8540, dirk.oehlers@lonza.com, www.lonza.com.