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Epistem Files For Import, Sales Licence For Genedrive In India

28th Oct 2014 08:27

LONDON (Alliance News) - Epistem Holdings PLC Tuesday said it has successfully completed its clinical evaluation of Genedrive tuberculosis treatment in India, and it has filed for a licence to import and sell the drug in the country, with approval anticipated in early 2015.

"I am pleased to report the commencement and successful completion of the Genedrive Indian clinical evaluation study, a solid outcome for the year, and the delivery of several key milestones in anticipation of the launch of Genedrive for the diagnosis of Tuberculosis in India," said Chairman David Evans who is standing down after nine years in the position.

The company said it has started 'fast track' independently funded tuberculosis clinical evaluation studies in Nigeria, South Africa, Uganda and Brazil and said it has signed a collaboration agreement with the Clinton Healthcare Access Initiative to help support its global regulatory and marketing strategy for Genedrive.

The news comes as the medicine and biotechnology company reported a rise in full-year revenue to GBP5.8 million from GBP5.4 million and a pretax loss of GBP2.3 million in the year to June 30, widened from GBP1.5 million, as contract and development costs increased.

A successor to Evans has been identified and an announcement will be made in due course, the company said.

Epistem shares were quoted up 2.2% at 293.75 pence early Tuesday.

By Ian Edmondson

Copyright 2014 Alliance News Limited. All Rights Reserved.


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