FDA grants Fast Track designation to NPL-2008

Neuropharm Group plc (AIM: NPH), a speciality pharmaceutical company focused on neurodevelopmental disorders, is pleased to announce that the US Food and Drug Administration (FDA) has granted Fast Track designation for Neuropharm’s program to develop NPL-2008 in the treatment of Autism Disorder.

NPL-2008, a new orally disintegrating tablet of low-dose fluoxetine, is currently in Phase III development for the treatment of the core symptom of repetitive behaviours in patients five years of age or older with Autistic Disorder.

On its website, www.fda.gov, FDA states: “Because fast track products are intended to treat serious or life-threatening conditions and must demonstrate the potential to address unmet medical needs for such conditions, an NDA for a product in a fast track development program ordinarily will be eligible for priority review and FDA may consider for review, portions of a marketing application before the complete NDA is submitted. Fast Track is intended to facilitate development and expedite review of drugs to treat serious and life-threatening conditions so that an approved product can reach the market expeditiously.”

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. In addition the FDA Office of Orphan Drug funded a clinical study in children and adolescents at Mount Sinai School of Medicine in New York followed by a second study in adults.

Neuropharm’s current Phase lll study (SOFIA) underwent Special Protocol Assessment by FDA in 2007. The study is currently ongoing at 17 sites in the US in collaboration with Autism Speaks, the US advocacy organization, and its Clinical Trials Network of expert investigators. The results from this randomised, double-blind trial in more than 120 child and adolescent patients with Autistic Disorder will form part of the NPL-2008 New Drug Application, which is targeted for submission to FDA in Q4 2008.

Robert Mansfield, Neuropharm’s CEO, commented: “We are delighted to announce that FDA has granted Fast Track designation for our program. The point was made earlier this month on World Autism Awareness Day that more children will be diagnosed with autism this year than with diabetes, cancer and AIDS combined. Fast Track designation emphasises the importance we believe should be accorded to this condition.”

For further information please contact:

Neuropharm
+ 44 (0) 1372 371 171
Robert Mansfield, Chief Executive Officer
Julie Hutchison, Project Director

Investec Bank (UK) Limited
+ 44 (0) 20 7597 5970
Patrick Robb
Gary Clarence

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 the development of medicines for the treatment and management of neurodevelopmental disorders. Please visit www.neuropharm.co.uk for further information.