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Phytopharm Plc; Fast Track Designation Granted By the FDA for ALS Drug Candidate Myogane

Posted on: Tuesday, 9 November 2004, 09:00 CST

Phytopharm plc (NASDAQ:PHYOF)(LSE:PYM) ("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."

NOTES TO EDITORS

Phytopharm plc

Phytopharm is a pharmaceutical company specializing in the discovery and development of novel therapeutic agents in neurodegeneration, obesity, inflammation and dermatology. It has lead products in development for Alzheimer's disease, obesity and Amyotrophic Lateral Sclerosis. The Company's strategy is to develop first-in-class drug products through Phase II testing, then to secure pharmaceutical partners for late-stage development, sales and marketing. Cogane(TM) is in a Phase II trial as a potential therapy to reverse neurodegeneration in the brain of patients with Alzheimer's disease. Myogane(TM) is in Phase I testing as a neuroregenerative agent for treating ALS, an always-fatal disease, and has received Orphan Drug designation. Phytopharm is also developing a product for the dietary control of obesity within the P57 program. The Company has preclinical programs in several other disease areas including eczema, asthma and metabolic disease. Further, there are two marketed products: Phytopica(TM) for canine skin disorders, and Zanthofen(TM) for canine joint disorders.

Amyotrophic Lateral Sclerosis

ALS is the most common motor neurone disease resulting from progressive degeneration of both upper and lower motor neurones which lead to severe muscle weakness and wasting, followed by paralysis and death, generally caused by respiratory failure. It is estimated that as many as 30,000 Americans may have the disease at any given time with 5,000 new cases diagnosed each year (source: ALS Association). For the families of ALS patients, the burden of providing supportive care is exceedingly high and it is estimated that, in the advanced stage of the disease, supportive care can cost an average of $200,000 per year (source: International Alliance of ALS Associations). Treatment with the only drug currently indicated for ALS typically increases the average survival time by only three months (source Datamonitor). Thus, there is an urgent need for the development of new and more effective therapies for this devastating condition.

More information concerning Phytopharm's activities can be found on its web site at http://www.phytopharm.com.

This press release may contain forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933 and Section 21E of the U.S. Securities Exchange Act of 1934 with respect to the financial condition, results and business achievements/performance of Phytopharm and certain of the plans and objectives of its management. These statements are statements that are not historical facts. Words such as "should", "expects", "anticipates", "estimates", "believes" or similar expressions, as they relate to Phytopharm, are intended to identify forward-looking statements. By their nature, forward-looking statements involve risk and uncertainty because they reflect Phytopharm's current expectations and assumptions as to future events and circumstances that may not prove accurate. There is no guarantee that the expected events, trends or results will actually occur. Any changes in such assumptions or expectations could cause actual results to differ materially from current expectations.

Source: Business Wire

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