New data demonstrating the strength of Novartis' hematology portfolio to be presented

NovartisDec 2 2009

Novartis announced today that new data, including a late-breaking presentation on Tasigna® (nilotinib) 200 mg capsules in a form of chronic myeloid leukemia, demonstrate the strength of the company's hematology portfolio in advancing the care of patients.

The new data, at the 51st American Society of Hematology (ASH) Annual Meeting and Exposition, highlight the company's current therapies and investigational agents in 195 studies including 39 oral presentations. Data will be presented on Tasigna, Afinitor® (everolimus) tablets, Exjade® (deferasirox) and pipeline agents including PKC412 (midostaurin), LBH589 (panobinostat), BHQ880 and INCB18424, an oral, selective Janus kinase (JAK) inhibitor that was recently added to the oncology pipeline through a licensing agreement.

"Data presented at ASH will demonstrate the vigorous research underway to explore the best treatment approaches for patients with rare blood cancers and conditions," said David Epstein, President and CEO, Novartis Oncology and Novartis Molecular Diagnostics. "We expect these data to lay the groundwork for regulatory submissions and provide a roadmap for the initiation of late-stage and pivotal trials."

The ASH Annual Meeting will feature results from a pivotal head-to-head study comparing the efficacy and safety of Tasigna versus Gleevec® (imatinib mesylate) tablets in adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (Abstract #LBA-1; Tuesday, December 8, 2009 at 7:30 AM CST).

Data from this Phase III clinical trial, ENESTnd (Evaluating Nilotinib Efficacy and Safety in Clinical Trials of Newly Diagnosed Ph+ CML Patients), will show that Tasigna produced faster and deeper responses than Gleevec when used as first-line therapy.

Other key presentations at ASH include:

• Everolimus Phase II data to show efficacy and safety in patients with Waldenstrom's macroglobulinemia (WM) who had relapsed or become resistant to prior treatment (Abstract #587; Monday, December 7, 2009 at 3:45 PM CST)(1)
• Panobinostat data from two early phase studies to show efficacy in heavily pre-treated patients with multiple myeloma and Hodgkin lymphoma (Abstract #3852; Monday, December 7, 2009 at 6:00 PM CST; Abstract #923; Tuesday, December 8, 2009 at 8:30 AM CST)(2)(7)
• Midostaurin early stage data will demonstrate benefit in patients with FLT3-mutated acute myeloid leukemia when used in combination with chemotherapy (Abstract #634; Monday, December 7, 2009 at 5:15 PM CST)(3)
• INCB18424 data from a Phase II study in advanced polycythemia vera (PV) and essential thrombocythemia (ET) refractory to hydroxyurea (Abstract #311; Monday, December 7, 2009, 8:00 AM CST)(5)( )
• INCB18424 long-term follow-up data to demonstrate durable clinical, functional and symptomatic responses with excellent hematological safety in patients with myelofibrosis (Abstract #756; Monday, December 7, 2009 at 5:45 PM CST)(4)
• Exjade two-year data from EPIC (Evaluation of Patients Iron Chelation with Exjade) trial to show benefit of Exjade for chronically transfused beta-thalassemia patients by continuing to significantly reduce toxic iron that can damage the heart (Abstract #4062; Monday, December 7, 2009 at 6:00 PM CST)(6)
• BHQ880 preliminary Phase I study data in combination with Zometa(®) (zoledronic acid) and an approved anti-myeloma therapy in patients with relapsed or refractory multiple myeloma who experienced a prior skeletal-related event (Abstract #750; Monday, December 7, 2009 at 5:45 PM CST)(8)(9)

The Novartis Oncology pipeline features compounds in all phases of development, including six in late-stage development, and encompasses a broad array of therapeutic strategies for fighting cancer.