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Re: None

Monday, 06/03/2013 9:18:32 AM

Monday, June 03, 2013 9:18:32 AM

Post# of 4817
One of the potential drugs - device delivery that has been talked about.


Teva's Lonquex Recommended For Approval In EU - Quick Facts

6/3/2013 1:12 AM ET



Teva Pharmaceutical Industries Ltd. (TEVA: Quote) reported that the Committee for Medicinal Products for Human Use or CHMP has urged that a Marketing Authorization may be issued in the European Union for Lonquex for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy. The CHMP positive opinion opens the way to a final approval decision from the European Commission anticipated within the next few months.

Lonquex is a long-acting recombinant granulocyte colony-stimulating factor 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.

Michael Hayden, Teva's President of Global R&D and Chief Scientific Officer, said: "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."