Teva's lipegfilgrastim-pegfilgrastim comparative Phase III study in breast cancer meets primary endpoint

Jun 7 2011

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™).

“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”

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.