NPH Neuropharm

    RNS Number : 4860E
  Neuropharm Group PLC
  29 September 2008
   

 For immediate release   29 September 2008



    


    Neuropharm Group Plc 
    ("Neuropharm" or "the Company")

    Neuropharm Announces Submission of Rolling NDA for NPL-2008 in Autistic Disorder

    Neuropharm Group plc (AIM: NPH), a speciality pharmaceutical company focused on neurodevelopmental disorders, is pleased to announce it
has begun submission of a New Drug Application (NDA) seeking marketing approval from the US Food and Drug Administration (FDA) for NPL-2008
in the treatment of Autistic Disorder. 

    FDA has agreed to Neuropharm's request for a Rolling NDA for NPL-2008. This decision follows FDA's granting of Fast Track designation
for NPL-2008 earlier this year. Fast Track designation is awarded only to drugs that treat serious or life-threatening conditions and
address unmet medical needs.  

    The Rolling NDA submission allows components of the NDA to be submitted for review as they are completed, in advance of completion of
the entire regulatory dossier.  Neuropharm has commenced the Rolling NDA with submission of the CMC section relating to the NPL-2008
low-dose Zydis� formulation.  

    Neuropharm expects to complete its Rolling NDA submission in Q2 2009 on completion of its SOFIA trial of NPL-2008 with the Autism Speaks
Clinical Trials Network in the US.  

    FDA has also indicated that Neuropharm is eligible to apply for Priority Review when the submission is complete. FDA's timetable for
completing a Priority Review is six months. 

    Robert Mansfield, Neuropharm's CEO, commented: "This Rolling NDA submission is a significant milestone for Neuropharm. It is also a
major step forward towards our goal of making NPL-2008 available to patients in the US and ultimately in Europe and other worldwide
markets."


    For further information please contact: 

 Neuropharm                                      + 44 (0) 1372 371 171
 Robert Mansfield, Chief Executive Officer
 Dr Mike Snape, Chief Scientific Officer

 Piper Jaffray Limited                           + 44 (0) 203 142 8700
 Neil Mackison, Rupert Winckler

 Buchanan Communications                         + 44 (0) 20 7466 5000
 Mark Court, Mary-Jane Johnson, Catherine Breen

    Notes to Editors:

    About Neuropharm

    Neuropharm is a speciality pharmaceutical company focused on improving patient lives by delivering medicines for high unmet needs in the
treatment and management of neurodevelopmental disorders. Please visit www.neuropharm.co.uk for further information.

    NPL-2008 is currently in Phase III development for the treatment of repetitive behaviours in Autistic Disorder. Formulated especially
for autistic children, the low dose, fast melt tablets have been designed specifically to make precision titration and everyday
administration easier for parents.

    Neuropharm's Phase III study of NPL-2008 in SOFIA is currently ongoing at 19 sites in the US that comprise the Autism Speaks Clinical
Trials Network of expert investigators.  Autism Speaks is the world's largest autism advocacy organisation. The results from this
randomised, double-blind trial in more than 120 children and adolescents with Autism Disorder will form part of the Rolling NDA submission.

    The NPL-2008 program received Orphan Drug Designation from FDA in 1999, giving the product the potential for seven years of market
exclusivity on receipt of regulatory approval. This programme received Fast Track Designation from FDA in April 2008. Submission of a
Rolling NDA and Priority Review are among a range of measures that may be granted within Fast Track Designation.  Priority Review is given
to drugs that offer major advances in treatment, or provide a treatment where no adequate therapy exists.  A Priority Review means that the
time it takes FDA to review a new drug application is reduced.  




This information is provided by RNS
The company news service from the London Stock Exchange
 
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