Teva’s Lonquex® (XM22 lipegfilgrastim) recommended for approval in the EU

Teva Pharmaceutical Industries Ltd (NYSE:TEVA) announced today that the Committee for Medicinal Products for Human Use (CHMP) has recommended that a Marketing Authorization may be issued in the European Union for Lonquex® (XM22 lipegfilgrastim) for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukemia and myelodysplastic syndromes). The CHMP positive opinion opens the way to a final approval decision from the European Commission expected within the next few months.

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).

Dr. Michael Hayden, Teva’s President of Global R&D and Chief Scientific Officer, commented: “Effective prophylaxis against neutropenia and febrile neutropenia is a high priority for patients undergoing cytotoxic chemotherapy. This chemotherapy attacks rapidly dividing bone marrow cells and dramatically reduces the ability to fight off infection, which can have serious consequences for patients. Loquenex reduces the neutropenia that can lead to these consequences. We look forward to receiving final approval and being able to offer this medication to patients.”

“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. Rob Koremans, President and CEO of Teva Global Specialty Medicines. “We will now await the final decision from the European Commission. Teva is highly committed in delivering innovative treatments to market and its stakeholders that meet patients’ needs.”

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 Europe.