Ixico Regulatory News (IXI)

18 Feb 2008 07:00

Phytopharm PLC18 February 2008 Company Contact: U.K. Investor Relations Phytopharm plc Contact: FDDr Daryl Rees CEO David YatesPiers Morgan CFO Ben Atwell+44 1480 437 697 +44 207 831 3113www.phytopharm.com 18 February 2008 Phytopharm plc Interim Management Statement for 3 months ended 31 December 2007 Phytopharm plc (PYM: London Stock Exchange) ("Phytopharm" or the "Company") istoday issuing its Interim Management Statement ("IMS") which relates to thethree month period from 1 October 2007 to 31 December 2007 and containsinformation up to the date of publication of this IMS. Portfolio Highlights Hoodia extract • Our weight management product partnered with Unilever, continues to make good progress through the final development stage prior to registration and commercial launch Phytopica(R) • Preparation continues for launching into additional territories Cogane(TM) • Successful grant of funding of $1.16 million from The Michael J. Fox Foundation in January 2008 for Parkinson's Research (MJFF) to support the development of Cogane(TM) as a treatment for Parkinson's disease Myogane(TM) • EU orphan medicinal product submission for ALS to EMEA; response anticipated H1 2008 The Hoodia programme is fully funded by Unilever, Phytopica(R) is revenuegenerating and discussions are ongoing for further financial support fromcharitable organisations to develop Cogane(TM) as a treatment for Parkinson'sdisease and Myogane(TM) as a treatment for motor neurone disease. There have beenno other significant changes in the financial position or performance of theCompany since the publication of the last audited Report and Accounts in respectof the period ended 30 September 2007. Cash and cash equivalents as at 30September 2007 was £2.24 million. Dr Daryl Rees, Chief Executive, commented: "Hoodia extract, our weightmanagement product partnered with Unilever, has continued to make good progressthrough the final stage of development prior to registration and commerciallaunch. Our canine skin health product, Phytopica(R), partnered withSchering-Plough is progressing towards launch in additional territories. Ourpharmaceutical products Cogane(TM) and Myogane(TM) continue to make good progressand we are now beginning to benefit from the strategic financial support ofcharitable organisations for the further development of these products. Thisnon-dilutive funding will reduce our net development costs and cash burn whileincreasing long term shareholder value. We look forward with confidence tobuilding on our achievements and reporting on our progress." Notes to Editors Phytopharm plc Phytopharm is a pharmaceutical development and functional food company. Ourproducts are developed from medicinal plants, thereby reducing the developmentrisk, cost and time to market. As a virtual company, Phytopharm's model iscentred on a lean cash burn with all laboratory, manufacturing and clinical workout-sourced to specialists, while core competencies such as strategy andmanagement are maintained in-house. Close collaboration with charitableorganisations enhances our interaction with worldwide specialists andaccelerates our development programmes increasing their value. Pharmaceutical products Cogane(TM) is in clinical development as a treatment for Parkinson's disease. In pre-clinical models, Cogane(TM) reverses the changes in the area of the braininvolved in Parkinson's disease by inducing the body's own production ofproteins known as neurotrophic factors. In particular, one of these factorsknown as "GDNF" has been shown to be particularly effective in re-growingdamaged nerves. Since GDNF is a protein it cannot be given orally (in tablet orliquid form) because it is degraded in the stomach and intestine, and also doesnot readily cross the blood-brain barrier. GDNF can work only when injectedinto or when produced inside the brain. Direct injection of GDNF into the areaof the brain involved in Parkinson's disease has shown substantial beneficialeffects in small-scale clinical studies but requires highly complex anddifficult surgical procedures. Cogane(TM), which can be taken orally, readilycrosses the blood-brain barrier and in pre-clinical models has been shown tostimulate the release of GDNF in the brain and therefore has the potential toovercome many of the difficulties associated with GDNF administration. The MJFF funding will support preclinical studies to determine the optimaldosing requirements for Cogane(TM) and will be carried out by Dr JonathanBrotchie, a Senior Scientist at the Toronto Western Hospital and part of theUniversity Health Network (UHN) in Toronto, Canada. Dr Brotchie is a recognisedexpert in the field of Parkinson's disease and, at UHN, runs one of the world'spremier research laboratories for the identification of novel treatments,diagnostics and cures for Parkinson's disease and related disorders. The neuroprotective, neurorestorative and neurotrophic actions of Cogane(TM)suggest potential beneficial effects in other neurodegenerative diseasesincluding Alzheimer's disease. Dysregulation of neurotrophic factors has beenimplicated in a number of neuropsychiatric disorders suggesting that Cogane(TM)may have utility in schizophrenia, depression and anxiety, which together withAlzheimer's disease have an estimated aggregate market size of $50bn. Myogane(TM) is in clinical development as a treatment for ALS (also known as LouGehrig's disease). ALS is the most prevalent motor neurone disease and resultsfrom progressive degeneration of motor neurones. This condition has a high unmetmedical need. In pre-clinical studies, Myogane(TM) protects against neuronaldamage and when administered orally to pre-clinical models of ALS, delays theloss of muscle strength and extends survival time. Myogane(TM) has successfullycompleted a Phase Ia clinical study that evaluated the safety, tolerability andpharmacokinetic profile of Myogane(TM). This residential clinical study wasconducted under an investigational new drug (IND) filed with the United StatesFood and Drug Administration (FDA). The FDA has also granted Orphan Drug andFast Track designation to Myogane(TM) for the treatment of ALS. The new liquidformulation of Myogane(TM), suitable for ALS patients, has also successfullyprogressed through a Phase Ib healthy volunteer clinical trial conducted under aclinical trial authorisation (CTA) filed with the Medicines and Healthcareproducts Regulatory Agency (MHRA). An application has been submitted for EUorphan medicinal product status for ALS to the EMEA and a response isanticipated in H1 2008. The neuroprotective, neurorestorative and neurotrophic actions of Myogane(TM)suggest potential beneficial effects in other orphan neurodegenerative diseasesincluding Huntington's disease, Friedrich's ataxia, progressive supranuclearpalsy and multiple system atrophy. The aggregate market size for these orphandiseases, including ALS, is estimated at in excess of $1bn. Functional Foods Hoodia extract is in development as a weight management functional food productbased on an extract of the succulent plant, Hoodia, which contains a novelsatiety stimulator that reduces calorie intake in overweight subjects, asdemonstrated in a double-blind, placebo-controlled clinical study. Extracts ofHoodia and the active molecules therein are the subject of a global patentingprogramme, with major patents granted in the US, UK, Europe and Japan andpending in all other major territories. The programme has successfully progressed into the final development stage ofthe Unilever Joint Development Agreement. This stage includes supply chainexpansion and consumer studies that will evaluate reductions in calorie intakeas part of a weight management programme in the general population, and is thefinal stage prior to submission for regulatory approval. As part of theagreement, Unilever is committed to fully funding the development programme. Inaddition, Phytopharm will receive an undisclosed royalty on sales of allproducts containing the extract. Separately, Unilever is also managing theagronomy programme, including scale up for launch, undertaking manufacturing andmarket research activities, and supporting the international patent programmefor the products. Phytopharm and Unilever have become aware of many companies that are sellingproducts over the Internet and in some stores claiming to contain Hoodia andcausing weight loss. Analysis of these products has demonstrated that the greatmajority of them contain little or no Hoodia. Phytopharm and Unilever have madecontact with the relevant authorities concerning this development and aresatisfied with the progress being made to limit these activities. Phytopica(R) is a natural, three plant product for canine skin health thatprovides a novel 3 in 1 approach to help maintain a normal healthy immunesystem, support normal white cell function and provide anti-oxidant benefits.The beneficial effects and excellent safety profile of Phytopica(R) have beenproven extensively in clinical trials and the product has been found to besuitable for all dogs whatever size or breed. Canine dermatological disordersare well recognised by veterinarians to be a major problem, with an estimated15% of the UK dog population (around 900,000 dogs) affected by skin conditions.Maintenance of a healthy skin and coat and alleviation of itching are of majorimportance to canine general health and quality of life. In January 2006, Phytopharm entered into an exclusive global agreement withSchering-Plough Animal Health ("Schering-Plough") for Phytopica(R). Under theterms of the agreement, Phytopharm is responsible for manufacturing Phytopica(R)whilst Schering-Plough is responsible for the global sales, marketing anddistribution. Schering-Plough launched Phytopica(R) in the UK in April 2006 andin Italy and France in March and April 2007, respectively. The product hasenjoyed firm support from veterinary dermatologists, with sales exceedingexpectations. Preparation continues with Schering-Plough for launching intoadditional territories worldwide. Forward-looking statements Certain information included in these statements is forward-looking and involvesrisk and uncertainties that could cause results to differ materially from thoseexpressed or implied by the forward looking statements. Forward-looking statements include, without limitation, projections relating toresults of operations and financial conditions, market estimates, the Company'splans and objectives for future operations, including future revenues, financialplans and expected expenditures and divestments. All forward-looking statementsin this report are based upon information known to the Company on the date ofthis IMS. The Company undertakes no obligation to publicly update or revise anyforward-looking statement, whether as a result of new information, future eventsof otherwise. It is not reasonably possible to itemise all of the many factors and specificevents that could cause the Company's forward looking statements to be incorrector that could otherwise have a material adverse effect on the future operationsor results of the Company. For further information about Phytopharm please see our website at http://www.phytopharm.com This information is provided by RNS The company news service from the London Stock Exchange