ATH 25.0% 0.5¢ alterity therapeutics limited

By Life Scientist Staff | Posted in Drug discovery on 01 June,...

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    By Life Scientist Staff | Posted in Drug discovery on 01 June, 2015

    ..."Orphan designation is granted by the EC to encourage the development of medicine to treat rare diseases. It provides for 10 years of market exclusivity in the European Union from the granting of a marketing authorisation (approval for sale), as well as assistance in developing clinical protocols, reduced fees and access to EU-funded research grants.

    The approval of PBT2 was based on the recommendation of a positive opinion from the European Medicines Agency’s (EMA) Committee for Orphan Medicinal Products (COMP). According to the minutes of a COMP committee meeting, the intention to use the product to treat Huntington’s disease “was justified based on pre-clinical in vivo data and preliminary clinical data showing improvement in parameters associated with the condition."

    This document also provides a nice overview of the changes...
    http://www.ema.europa.eu/docs/en_GB..._procedural_guideline/2015/07/WC500190556.pdf
    Last edited by interestingtome: 31/08/15
 
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