BioWorld International Correspondent

LONDON - Neuropharm Group plc raised £20 million (US$38.4 million) in a listing on London's Alternative Investment Market, enabling it to attempt to take Prozac as a treatment for autism through to market and advance the clinical development of three other products for treating pediatric central nervous system disorders.

The Leatherhead-based company placed 15.75 million shares at £1.27 per share, giving Neuropharm a market capitalization of about £40 million.

Neuropharm has U.S. orphan drug designation for NPL-2009 (fluoxetine, Prozac) in treating autism, and currently is reformulating the drug as an orally dissolving tablet in preparation for launching the product in the fourth quarter of 2009. The company licensed the rights from Mount Sinai School of Medicine in New York, which sought the orphan drug designation and has taken the compound through Phase II and Phase III trials.

CEO Robert Mansfield told BioWorld International, "There are a lot of data in the public domain that has been consolidated by the research at Mount Sinai, showing serotonin levels in the brains [of autism sufferers] are 200 times lower than normal. There are a number of criteria to measure improvements that were played out in the trials."

In particular, the treatment targets repetitive behaviors that lock patients into set routines and hinder interest in normal social interaction. The trials were funded by the FDA's Orphan Drug Office.

The company intends to apply for registration in autism spectrum disorder, a label that would cover both pediatric and adult patients. To date most treatment for autism consists of behavioral therapy.

Prozac, one of the most widely prescribed central nervous system drugs, was launched in the U.S. in 1986 by Eli Lilly and Co. and has been sold in more than 50 countries.

In addition, Neuropharm is working on four earlier-stage programs, including NPL-2005 and NPL-2008, to treat Fragile X syndrome; NPL-2003 for treating obsessive-compulsive disorder; and NPL-2007 for neurodegenerative disorders.

NPL-2008 has completed Phase I and Phase II trials in a different indication, and Neuropharm is planning a Phase II trial in Fragile X to start this year. The product is designed to address the intellectual deficits of Fragile X syndrome, the single largest cause of inherited metal retardation.

Meanwhile, the company is recruiting patients for an open-label trial of NPL-2005, which has been shown to reactivate a gene involved in the syndrome, and thus relieve symptoms of Fragile X. Neuropharm has the backing of the patient advocacy group Fraxa, the U.S. Fragile X research consortium.

NPL-2003 works by controlling glutamate levels, which are elevated in obsessive-compulsive disorder.

The company has a further collaborative program that is developing technology for screening potential candidates for treating Alzheimer's disease.

The proceeds of the placing are expected to provide sufficient funds to complete development of fluoxetine and launch the product in the U.S. by the end of 2009, and to progress the clinical trials for the Fragile X syndrome and obsessive-compulsive disorder products.

Neuropharm's commercialization strategy is to market its products itself in the U.S. and to out-license them in other territories.

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