GODMANCHESTER, United Kingdom--(BUSINESS WIRE)--Nov. 9, 2004--

Phytopharm announces today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its drug candidate PYM50018 (Myogane(TM)) for the treatment of amyotrophic lateral sclerosis (ALS, also known as Lou Gehrig's disease).

The Fast Track program is designed to expedite the review of drug candidates for the treatment of patients with serious or life-threatening diseases with unmet medical needs for new therapeutic approaches. The Fast Track designation allows a company to file a New Drug Application (NDA) on a rolling basis as data become available and to request the evaluation of studies using surrogate endpoints. This permits the FDA to review the filing as it is received and can lead to a decrease in the typical review period.

Myogane is a patented, orally active, neuroprotective and neuroregenerative compound. In pre-clinical models, Myogane has been observed to protect against neuronal damage, increase neurite outgrowth, reverse oxidative damage and reverse neuronal apoptosis in vitro. When administered orally to a transgenic pre-clinical model of ALS, Myogane delays the loss of muscle strength and extends survival time.

In April 2004, Phytopharm announced the successful completion of a phase I clinical study to evaluate the safety, tolerability and pharmacokinetic profile of Myogane. This study was conducted under an investigational new drug (IND) application filed with the FDA. A repeat dose phase Ib clinical study to evaluate the safety, tolerability and pharmacokinetic profile of Myogane in healthy volunteers is expected to commence in the first half of 2005.

Commenting on today's announcement, Richard Dixey, Chief Executive of Phytopharm, said: "This is an important step in the development of Myogane and may help us bring this potentially promising drug to patients more quickly."