Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) announced today that lipegfilgrastim (INN; internal code - XM22) achieved its primary endpoint of reducing the duration of severe neutropenia in a Phase III study designed to evaluate the efficacy and safety of lipegfilgrastim (XM22) compared to pegfilgrastim (Amgen's Neulasta™).

Lipegfilgrastim (XM22), a long acting granulocyte colony-stimulating factor (G-CSF), was added to Teva's portfolio through the acquisition of ratiopharm. It is being developed to reduce the duration of severe neutropenia in 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.

"We are pleased with the successful results of this Phase III study. Teva is committed to the development of biologics and biosimilars, which make up one of the fastest growing segments of the global pharmaceutical market and offer efficacious yet more affordable treatment to all patients," said Professor Yitzhak Peterburg, Teva's Group Vice President, Global Branded Products.

World-wide sales in 2010 of G-CSF totaled $4.2 billion, of which Neulasta™ sales represented $3.56 billion.

The Phase III, multinational, randomized, double-blind controlled study was conducted in over 200 breast cancer patients receiving four cycles of chemotherapy (doxorubicin/docetaxel). Patients were randomized to receive treatment with either 6mg of lipegfilgrastim (XM22) or with the active comparator, pegfilgrastim 6mg (Neulasta™).

Initial study results demonstrate that the duration of severe neutropenia (DSN) was similar in both treatment groups and the difference was well below the limit of 1 day, as required by the EMA, and below 0.62 days, as required by the U.S. FDA. Additionally, no significant differences were observed in treatment-emergent adverse events between the two treatment groups.

Further analysis of the study results is ongoing.

An additional efficacy and safety study comparing lipegfilgrastim (XM22) to placebo in preventing chemotherapy-induced neutropenia in non-small cell lung cancer patients is currently ongoing, with results expected later this year.

About Lipegfilgrastim

Lipegfilgrastim (INN; internal code - XM22) is a glyco-PEGylated recombinant human G-CSF being developed to reduce the duration of severe neutropenia and incidence of febrile neutropenia in cancer patients undergoing chemotherapy.

Lipegfilgrastim (INN; internal code - XM22) was added to the Teva's portfolio through the acquisition of ratiopharm and is a long-acting G-CSF based on glyco-PEGgylation technology, which leads to a prolonged plasma half-life. The product is designed to provide clinical efficacy and safety profiles which are fully comparable to Neulasta™.

About The Study

This multinational, multicenter, randomized, double-blind, controlled Phase III study was designed to evaluate the efficacy and safety of lipegfilgrastin 6mg compared to pegfilgrastim 6mg (Neulasta™) in preventing chemotherapy-induced neutropenia in breast cancer patients receiving 4 cycles of doxorubicin and docetaxel.

Approximately 24 hours after the initiation of chemotherapy, 101 patients received a single subcutaneous injection of lipegfilgrastim on each of the 4 cycles. In parallel, 101 patients were treated accordingly with pegfilgrastim. Study results show that the primary outcome measure of reducing the duration of severe neutropenia in cycle 1 was well met. No relevant differences in safety parameters were observed. Further analysis is ongoing.

Source:
Teva Pharmaceutical Industries Ltd.