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|June 29, 2012 5:00 p.m.|
|Teva Announces Progress of Biologic Investigational Drugs Evaluated to Treat Neutropenia in Breast Cancer Patients Undergoing Chemotherapy|
- Clinical Results for Lipegfilgrastim and Balugrastim Highlighted at
Lipegfilgrastim and balugrastim are long-acting granulocyte colony-stimulating factors (G-CSF) being evaluated for their ability to reduce the duration of severe neutropenia in breast cancer patients undergoing chemotherapy. Neutropenia is a condition in which the number of white blood cells is decreased, leaving patients more susceptible to potentially life-threatening bacterial infections.
Both product candidates have completed phase III clinical trials. In both phase III breast cancer studies the primary endpoint was achieved, demonstrating reduction in the duration of severe neutropenia (DSN) in cycle 1, comparable to pegfilgrastim results in both efficacy and safety measures. Additional data from the phase I, II and III clinical studies of these products, will be presented at the MASCC/ISOO symposium in both oral and poster presentations
"Teva is committed to advancing these investigational biologic drugs, which are the most advanced of several biologic products that we have in development," said Dr.
Granulocyte colony-stimulating factor (G-CSF) is a naturally occurring hormone that is produced by the body to stimulate the bone marrow to produce neutrophils, a type of white blood cell that helps the immune system fight infection. Chemotherapy can damage the body's ability to produce neutrophils, thereby causing neutropenia, an abnormally low number of neutrophils. A common side effect of chemotherapy, neutropenia makes patients prone to infection and sepsis. A recombinant form of G-CSF (known as a biologic) is used to treat cancer patients with neutropenia in order to stimulate the bone marrow to produce more white blood cells.
About Lipegfilgrastim and Balugrastim
Lipegfilgrastim is a glycopegylated, recombinant form of G-CSF. Pegylation extends the half-life of the drug so that less frequent dosing is required compared with nonpegylated G-CSF. Balugrastim is a recombinant G-CSF fused to human albumin. Both lipegfilgrastim and balugrastim were designed to stimulate the bone marrow to produce white blood cells to reduce the duration of severe neutropenia, but have different mechanisms for achieving the longer half life in the blood.
Teva's Safe Harbor Statement under the
This release contains forward-looking statements, which express the current beliefs and expectations of management. Such statements are based on management's current beliefs and expectations and involve a number of known and unknown risks and uncertainties that could cause our future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to: our ability to develop and commercialize additional pharmaceutical products, competition for our innovative products, especially Copaxone® (including competition from innovative orally-administered alternatives, as well as from potential generic equivalents), competition for our generic products (including from other pharmaceutical companies and as a result of increased governmental pricing pressures), competition for our specialty pharmaceutical businesses, our ability to achieve expected results through our innovative R&D efforts, the effectiveness of our patents and other protections for innovative products, decreasing opportunities to obtain U.S. market exclusivity for significant new generic products, our ability to identify, consummate and successfully integrate acquisitions (including the acquisition of Cephalon), the effects of increased leverage as a result of the acquisition of Cephalon, the extent to which any manufacturing or quality control problems damage our reputation for high quality production and require costly remediation, our potential exposure to product liability claims to the extent not covered by insurance, increased government scrutiny in both the U.S. and