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Neutropenia: Biosimilar Product from India Moves One Step Closer to European Market
Date:4/7/2008

VIENNA, Austria, April 7 /PRNewswire/ -- A biosimilar product for treating the negative effects that cancer chemotherapy can have on the white blood cells of patients is safe and exhibits an identical pharmacokinetic and pharmacodynamic profile compared to a reference product. This is the result of a clinical phase I trial conducted jointly by the Austrian company Kwizda Pharma GmbH and the Indian manufacturer INTAS Biopharmaceuticals Ltd. (IBPL). Upon completion of an upcoming clinical phase III trial, both companies will lodge an application to get the product approved for the European market. The market launch is planned for early 2010.

Neutropenia - a condition whereby the concentration of neutrophils (a type of white blood cell) in the blood is too low - is a serious side effect of cancer chemotherapy and can prevent the treatment from being successful. Granulocyte colony stimulating factor (G-CSF) is a human protein that can reverse neutropenia by initiating the production of neutrophils. Recombinant forms of the protein have already been approved for the European market. However, due to the high costs that are involved, the relevant authority (EMEA) is encouraging applications for biosimilar products.

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Working in partnership with IBPL, the first and only biopharmaceutical company in India to comply with EU Good Manufacturing Practice (GMP), Kwizda Pharma has now completed a clinical phase I trial as part of the European application process for a biosimilar form of recombinant G-CSF known as Neukine. Neukine exhibits identical efficacy to the EU-approved reference product. Dr. Helmut Brunar, VP of Research & Business Development at Kwizda Pharma sums up the results of the trial: "Not only was Neukine cleared from the patients' blood plasma just as quickly as the reference, but the number of neutrophils also increased with identical kinetics after treatment. We are very pleased with these results." The study was a
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SOURCE Kwizda Pharma GmbH
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