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|June 03, 2013 1:00 a.m.|
|Teva’s Lonquex®(XM22 lipegfilgrastim) Recommended for Approval in the EU for the Reduction of Chemotherapy-Induced Neutropenia (CIN)|
Lonquex® (lipegfilgrastim) is a long-acting recombinant granulocyte colony-stimulating factor (G-CSF) based on novel GlycoPEGylation technology. Lipegfilgrastim is a novel, pegylated and glycosylated long-acting form of filgrastim, intended for once-per-cycle fixed dose, subcutaneous injection for neutrophil support in patients receiving myelosuppressive chemotherapy (with the exception of chronic myeloid leukemia and myelodysplastic syndromes).
“The CHMP positive opinion is an important milestone in Teva’s efforts to provide new treatment options for patients in oncology, which is a key area of focus for Teva”, stated Dr.
The positive CHMP opinion was published at: http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion_-_Initial_authorisation/human/002556/WC500143789.pdf.
About Chemotherapy-Induced Neutropenia (CIN)
Neutropenia is a common and potentially hazardous complication of chemotherapy treatment characterized by a decreased level of white blood cells (known as neutrophils), which can expose the patient to serious bacterial infections. This makes prophylactic treatment against neutropenia essential to avoid the significant risks associated with a compromised ability to combat such infections. CIN causes chemotherapy dose modifications, disrupting the treatment schedule causing patients to not fully benefit from chemotherapy, leading to reduced outcomes.
European clinical guidelines recommend that recombinant G-CSFs should be given on a prophylactic basis to patients with an intermediate or high risk of febrile neutropenia (FN). Pegfilgrastim is the long acting recombinant G-CSFs currently available in
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 Lonquex® (XM22 lipegfilgrastim) or additional pharmaceutical products, competition for our innovative products, especially Copaxone® (including competition from innovative orally-administered alternatives, as well as from potential purported 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, the effects of increased leverage as a result of recent acquisitions, 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