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Phase III immunoglobin study begins


Swiss-based Octapharma AG has begun a series of Phase III studies for a new immunoglobulin (IVIG), paving the way for its release in Europe and the US.

The new 10% high purity IVIG is intended for use in the treatment of primary immune deficiency as well as a number of neurological and haematological conditions, including Guillain-Barra syndrome (GBS) and Kawasaki disease.

Pending successful Phase III testing and forthcoming studies over its efficacy and safety, the IVIG will be ready for regulatory filing in Europe and the US.

Kim Bjornstrup, deputy chairman of Octapharma Group said: “The development of our novel 10% IVIG is part of our ongoing commitment to invest in the development of protein based immunotherapies and in particular in IgG preparations.

“For 25 years, our cutting-edge research programme has sought to develop new biological entities tailored specifically around the needs of clinicians and patients – delivering improved quality of life for patients and ease of delivery and management for hospitals.

“Octapharma’s stated aim is not to develop just another IVIG brand but to invest extensive time and preclinical resources to ensure that the new IVIG will offer outstanding features, representing tangible added value for the patient and care giver, such as exceptional tolerability.”

Copyright Press Association 2010
Octapharma AG


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