PVG.L Regulatory News (PVG)

17 Jan 2005 07:00

Ark Therapeutics Group PLC17 January 2005 Ark Therapeutics Group plc Trading Update and Date of Preliminary 2004 Results London, UK, January 17 2005: Ark Therapeutics Group plc today provides a tradingupdate at the commencement of the close period preceding the preliminaryannouncement of its Annual Results for the year ending 31 December 2004, to bemade on 10 March 2005. Continued good progress has been made in all sectors of the business and furthersignificant milestones have been achieved, most notably the receipt of GoodManufacturing Practice Certification for Ark's gene based medicine productionfacility in Finland. This certificate allows the Company to progress itsapplication for marketing approval under exceptional circumstances of our braincancer product, CereproTM, and we expect to submit the dossiers to theregulatory authorities during the first half of 2005, once we have completed themanufacturing runs. Expenditure has been kept to budget and the Company's balance sheet remainsstrong, with approximately £47m of cash at the end of the year. Kerraboot(R) - Increased sales and continued interest UK sales have shown a steady upward trend with some slowing over the Christmasholiday period. Whilst weekly-based ordering remains volatile, as predicted atthe time of the interim results, 8 week moving average data indicate a doublingof sales since the interims. Progress has also been made with wholesalernegotiations, with all three main UK wholesalers now stocking and regularlyplacing orders. Company sales representatives continue to report high interest,trial product usage and clinical successes in the field. In response to marketfeedback, the Company plans to introduce three new versions of the productduring 2005: an extra large size, a non-see-through version and asuper-absorbent version designed to manage very highly exudative wounds.Negotiations with potential licensees remain ongoing in Europe, the US andJapan. Ark Therapeutics is also pleased to report that following the recent tenderinginitiative in the UK, Kerraboot(R) has been selected for inclusion in the newNHS Framework Agreement1 for the provision of Advanced Wound Care products tohospitals throughout England, on the same pricing and purchasing termspreviously agreed with the NHS. We are optimistic about the sales potential and internationalisation of theKerraboot(R). CereproTM - Manufacturing commences and solid regulatory progress continues Certification by the Finnish National Agency of Medicines of our manufacturingfacility in November has allowed us to commence production of clinical suppliesand we remain on track to begin the main corroborative study in the first halfof this year. Following the receipt in the UK of unconditional approval forthis study (announced last year), we have now received both national agency andgene therapy advisory committee approvals from seven out of the nineparticipating countries. This should further enhance confidence regarding theregulatory pathway for the conduct of such gene based medicine studies.Achievement of GMP certification also allows us to finalise the dossiers forpresentation to the EMEA as part of our process to request consideration forapproval of CereproTM under exceptional circumstances in Europe and we plan tosubmit the dossiers in the first half of this year. VitorTM - Phase III recruitment shortly to complete and named patient supplyintroduced Our decision announced at the time of the interim results to open new centres inPoland, Czech Republic and Hungary has resulted in recruitment into the trialaccelerating and, as at 31 December 2004, 125 of the 160 patients had beenentered into the trial. Recruitment rates thus doubled in the period and, basedon the December average of approximately 5 patients per week, the trial isexpected to be fully recruited by the end of the first quarter, giving aninitial results date projected during Q3 2005. No safety issues of concern havearisen in the period, confirming earlier findings. The Company was also pleasedto announce its agreement to supply VitorTM to named patients, at the request ofUS and UK investigators, so that patients completing the trial will be able tocontinue on active therapy. Trinam(R) - Steady progress Duke University has successfully entered five patients into the 20 patient PhaseII study in haemodialysis access surgery and to date the trial continues to makeprogress. The new centres in Miami and Norfolk (Virginia) have now beeninitiated and have opened for recruitment. With the opening of the new centresand the experience gained at Duke to date, the Company expects recruitment toaccelerate and to report initial results at the end of the year. EG005 - Phase II study completes recruitment and compassionate use requestscontinue The Company announced in November 2004 that the recruitment of 50 patients forthe Phase II study in HIV-related Lipodystrophy Syndrome had been completed. TheCompany continues to be encouraged by the majority of patients entering the oneyear extension phase and requesting compassionate use supplies to continue theirtherapy thereafter. The Company expects to announce the preliminary results ofthis study at the end of Q1 2005. Commenting on today's announcement, Nigel Parker, Chief Executive of ArkTherapeutics, said: "We continue to make very good progress and are systematically achieving ourmilestones in this, our first year as a listed Company. We have an excitingyear of newsflow ahead and Ark remains on track to evolve as one of Europe's newbreed of specialist healthcare companies, with a diversified portfolio ofproducts meeting areas of clear unmet clinical need." Notes 1 Framework Agreements, established by the NHS Purchasing and Supply Agency(PASA) which acts for the NHS Logistics Authority, are aimed at reducing costsin high expenditure categories in the NHS. This follows on from the initiativetaken by the Commercial Directorate of the Department of Health under the SupplyChain Excellence Programme (SCEP). Enquiries: Ark Therapeutics Group plc 020 7388 7722Dr Nigel Parker, CEOMartyn Williams, CFO Financial Dynamics 020 7831 3113David YatesLucy Briggs Ark Therapeutics Group plc Ark is a specialist healthcare group (the "Group") with one marketed product andthree further lead products in late stage clinical development. Capitalising onover ten years of research in vascular biology and gene-based medicine, Ark hasa balanced portfolio of proprietary healthcare products targeted at specificunmet clinical needs within vascular disease and cancer. These are large andgrowing markets, where opportunities exist for effective new products togenerate significant revenues. Ark's products are sourced from related but largely non-dependent technologieswithin the Group and have been selected to enable Ark to take each productthrough development and to benefit from Orphan Drug Status and/or Fast TrackDesignation, as appropriate. The Group generally retains ownership of itsproduct candidates throughout clinical development. Ark has secured patents orhas patent applications pending for all its lead products in principalpharmaceutical markets and retains the right to market its lead products inthe key North American and European markets. Ark has its origins in businesses established in the mid-1990s by Professor JohnMartin and Dr Stephen Barker of University College London and Professor SeppoYla-Herttuala of the AI Virtanen Institute at the University of Kuopio,Finland, all of whom play leading roles in the Company's research anddevelopment programmes. Ark's shares were successfully listed through an initial public offering on theLondon Stock Exchange in March 2004 (AKT.L). This announcement includes "forward-looking statements" which include allstatements other than statements of historical facts, including, withoutlimitation, those regarding the Group's financial position, business strategy,plans and objectives of management for future operations (including developmentplans and objectives relating to the Group's products and services), and anystatements preceded by, followed by or that include forward-looking terminologysuch as the words "targets", "believes", "estimates", "expects", "aims","intends", "will", "can", "may", "anticipates", "would", "should", "could" orsimilar expressions or the negative thereof. Such forward-looking statementsinvolve known and unknown risks, uncertainties and other important factorsbeyond the Group's control that could cause the actual results, performance orachievements of the Group to be materially different from future results,performance or achievements expressed or implied by such forward-lookingstatements. Such forward-looking statements are based on numerous assumptionsregarding the Group's present and future business strategies and the environmentin which the Group will operate in the future. Among the important factors thatcould cause the Group's actual results, performance or achievements to differmaterially from those in forward-looking statements include those relating toArk's funding requirements, regulatory approvals, clinical trials, reliance onthird parties, intellectual property, key personnel and other factors. Theseforward-looking statements speak only as at the date of this announcement. TheGroup expressly disclaims any obligation or undertaking to disseminate anyupdates or revisions to any forward-looking statements contained in thisannouncement to reflect any change in the Group's expectations with regardthereto or any change in events, conditions or circumstances on which any suchstatements are based. As a result of these factors, prospective investors arecautioned not to rely on any forward-looking statement. This information is provided by RNS The company news service from the London Stock Exchange