Breaking News

Lonza, Pharmacyclics Enter Long-Term Production Pact

By Kristin Brooks | January 13, 2014

To provide clinical and commercial production of IMBRUVICA

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.”
  • Packaging Equipment Technology Preview

    Packaging Equipment Technology Preview

    February 15, 2017
    Today’s complex drug products present challenges; the latest equipment capabilities help overcome them

  • The Good, the Bad, and the Donald

    The Good, the Bad, and the Donald

    January 31, 2017
    Orphan drugs, CMO continuous manufacturing and developing world sales offer biggest revenue opportunities

  • Predictive Analytics and the Future of RBM

    Rajneesh Patil, Senior Director, RBM and Analytics, QuintilesIMS||January 23, 2017
    How advances in Risk-Based Monitoring will enable a more proactive approach to identify and mitigate potential risks