Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) has obtained a positive opinion from the European Medicines Agency's scientific committee, CHMP, for its human granulocyte colony stimulating factor (G-CSF) product. This is the first biosimilar G-CSF to receive a positive opinion in the European Union.
Teva expects the European Commission to grant marketing authorization for the product, which Teva will market in the EU under the brand name TevaGrastim.
G-CSF is mostly used to treat chemotherapy-induced neutropenia, low white blood cell count. Teva jointly developed the drug with a partner. According to IMS sales data, the innovator product, Neupogen Filgrastim, had $300 million in sales in the EU in the year through September 2007.
Teva EVP global resources Amir Elstein said, “We are very pleased to receive the first positive opinion for a biosimilar G-CSF product in the EU and believe that it shows the strength of our biotechnology R&D capabilities. Our successful development of this product reflects our commitment to bringing high quality and affordable biopharmaceutical products to patients and payers. Coupled with our recent acquisition of CoGenesys, which significantly enhances our capabilities, our strong biogeneric pipeline reflects our determination to capture the considerable long-term prospects we believe the biogeneric market will offer.”
On Thursday, Teva unveiled a strategic plan that set a goal of doubling its business to $20 billion revenue by 2012.
Teva rose 2% on Nasdaq on Friday to close at $48.84.
Published by Globes [online], Israel business news - www.globes-online.com - on February 24, 2008
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