Orphan Drug Status Granted

Phytopharm PLC 26 July 2004 26 July 2004 Phytopharm plc Orphan drug designation granted by the FDA for drug candidate to treat ALS Phytopharm plc (PYM: London Stock Exchange) ('Phytopharm') announces today that the United States Food and Drug Administration (FDA) has granted orphan drug designation to its drug candidate PYM50018 for the treatment of amyotrophic lateral sclerosis (ALS, also known as Lou Gehrig's disease). Phytopharm has recently registered the trademark Myogane(TM) as a name for this product. Orphan drug designation can be granted by the FDA for treatments that might provide significant benefit to patients with serious, life-threatening diseases that affect less than 200,000 persons in the United States. The Orphan Drug Act was created by the United States Congress to provide assistance and incentives for sponsors to develop drugs judged to be of potential benefit for a qualifying disease. Orphan drug designation qualifies a product for possible financial incentives, including seven years of marketing exclusivity upon FDA approval, and the potential of an expedited approval. In addition to market exclusivity, orphan drug status provides possible tax incentives for a company's investment in U.S. clinical research. ALS, the most common motor neurone disease, results from progressive degeneration of both upper and lower motor neurones and is usually fatal within five years. PYM50018 is a patented, orally active, neuroprotective and neuroregenerative compound from the P59 programme. In pre-clinical models, PYM50018 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, PYM50018 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 PYM50018. This residential clinical study was conducted under an investigational new drug (IND) application filed with the FDA. The results of this clinical study will support the conduct of a repeat dose phase Ib clinical study to evaluate the safety, tolerability and pharmacokinetic profile of PYM50018 in healthy volunteers. Commenting on today's announcement, Richard Dixey, Chief Executive of Phytopharm, said: 'We are pleased that upon a review of our pre-clinical data and rationale for developing PYM50018 (Myogane(TM)) as a potential treatment of ALS, the FDA found cause to grant orphan drug designation at this stage of development. We will continue to work with them to advance this product to clinical evaluation in ALS patients as quickly as possible.' -ENDS- Enquiries: Phytopharm plc Dr Richard Dixey, Chief Executive Tel: 01480 437697 Mobile: 07867 782000 Financial Dynamics David Yates / Ben Atwell Tel: 0207 831 3113 NOTES TO EDITORS Phytopharm plc Phytopharm is a leading company in the development of Botanical pharmaceuticals. These plant-based medicines, manufactured to pharmaceutical standards, can be clinically evaluated in chronic and poorly understood diseases. Where novel modes of action are discovered, such research can form the basis for drug discovery platforms, which enable the development of new medicines and the isolation of single chemical entities of clinical importance. Phytopharm has four drug discovery platforms in full development, for metabolic disease, neurodegeneration, inflammation and dermatology. Phytopharm is developing nine programmes based on its four drug discovery platforms alongside a number of other projects in early evaluation. ALS is a fatal neurodegenerative disease that most commonly strikes people between 40 and 60 years of age. The underlying cause of ALS is unknown, although approximately 5-10% of cases appear to be of familial origin. It is characterized by progressive loss of both lower (spinal cord and brainstem) and upper (cerebral cortex) motor neurones, which leads to severe muscle weakness and wasting, followed by paralysis and death, generally caused by respiratory failure. Phytopharm has developed a large group of patented compounds whose properties provide a platform for the development of novel therapeutic approaches for neurodegenerative disorders. PYM50018 has neuroprotective and neuroregenerative effects demonstrated using various pre-clinical models that make it a promising treatment for ALS. 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 information is provided by RNS The company news service from the London Stock Exchange

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