24th Jan 2008 07:00
BTG PLC24 January 2008 BTG plc: Interim Management Statement London, UK, 24 January 2008: BTG plc (LSE: BGC), the life sciences company,today publishes an Interim Management Statement, providing an update on progressin the business since 1 October 2007. The results for the full year to 31 March2008 will be reported on 19 May 2008. The overall performance of the business during the period has been in line withthe Board's expectations. In particular, recruitment of patients in theVarisolve(R) phase II safety study is on track for the planned finish by June2008. Louise Makin, BTG's chief executive officer, commented: "BTG has made good progress in the first nine months of the year. Momentum inour own development pipeline has been supplemented by progress in licensedprogrammes, including Campath(R) in CLL and MS, TRX4 in type 1 diabetes andabiraterone in prostate cancer. Over the coming months we expect to reportresults from our sleep apnoea and head lice clinical studies, initiate the firstclinical studies for our migraine and MS programmes, and conclude the US safetystudy of Varisolve(R). "We are in a strong financial position with significant revenue streams and cashreserves, and we are well positioned to create shareholder value by furtherdeveloping and strengthening our pipeline." Financial update Sales and growth rates of licensed products underpinning BTG's recurring royaltyrevenues for the three months to 31 December 2007 are anticipated to generateincome broadly in line with expectations. Factors that may influence sales of certain individual products during theperiod and for the remainder of the second half of the financial year are: • As previously disclosed, Wyeth's distribution agreement with Baxterin the EU for BeneFIX(R), the treatment for haemophilia B, has ended andalthough the demand for this product remains strong sales may be affectedtemporarily; • The label for MabCampath(R) (trademarked as Campath(R) in the US)was extended in the EU in January 2008 to include treatment of patients withB-cell chronic lymphocytic leukaemia (CLL) for whom fludarabine combinationtherapy is not appropriate. This followed the approval in September 2007 ofCampath(R) in the US as a single agent therapy for B-cell CLL, and togetherthese approvals are expected to increase product sales over time; and • Sales of the antibody products that underpin BTG's royalties fromthe Medical Research Council are expected to continue to increase as theproducts become more established. Research and development expenditure has increased as planned during the periodas programmes have progressed further through preclinical and clinicaldevelopment. Full-year expenditure is anticipated to be in the range £12-14m.Operating and administrative costs are stable and over the full year areanticipated to be around £18-19m. Cash and equivalents of over £46m at 1 October 2007 have been augmented by thereceipt of $10m gross/$5m net from Tolerx, Inc. in connection with its agreementwith GlaxoSmithKline on TRX4. The business has otherwise operated on a broadlycash neutral basis over the three month period, with cash and cash equivalentsof £48.2m at 31 December 2007. Pipeline update Varisolve(R) - varicose veins and venous stasis ulcers The US phase II safety study continues as planned. This study is investigatingwhether patients who have right-to-left cardiac shunts experiencemicroinfarction or other subclinical events following treatment. Six treatmentsites have now been initiated, and it is anticipated that the required 50patients with detected microbubbles in the middle cerebral artery duringtreatment will have been evaluated by the end of H1 2008. To date, treatmentwith Varisolve(R) has not been associated with evidence of microinfarction. Aninterim report will be presented at a scientific meeting in March 2008describing the results of the study in patients treated up to early March. BGC20-1259 - Alzheimer's disease Approval was granted in Sweden to conduct a positron emission tomography (PET)study in healthy volunteers to estimate the efficacious dose range of BGC20-1259to take into Alzheimer's patients in a phase IIa study, which is anticipated tostart in H2 2008. Dosing in the PET study is anticipated to begin during thecurrent quarter. BGC20-0166 - sleep apnoea The 39-patient clinical proof of mechanism study was completed and the results,which are being analysed and will be discussed with expert advisers, will informthe future clinical and commercial options for the programme. It is anticipatedthat the results and next steps will be published around the end of the currentquarter. Development is continuing of a proprietary formulation to deliver themost effective dose form of the two serotonin modulators. BGC20-0582 - head lice Treatment of 225 subjects in a phase II study of this Generally Regarded As Safe(GRAS) designated compound was completed in Q4 2007. The results are anticipatedduring the current quarter, and in parallel BTG is planning the future clinicaland commercial strategy for this product which promises safe, effectivepediculocidal and ovicidal activity with reduced expectation of resistancebuild-up. BGC20-1531 - migraine Site initiation was completed for a phase I clinical study of this EP4 receptorantagonist, which offers a potential new mechanism to treat migraine headaches.First doses are now scheduled to be administered this quarter rather than beforeChristmas 2007. BGC20-0134 - multiple sclerosis MHRA and ethics approvals are expected for commencement of a phase I study inhealthy volunteers of BGC20-0134, a novel structured lipid that aims to treatmultiple sclerosis by rebalancing the body's pro- and anti-inflammatorycytokines during MS episodes. First dosing is anticipated this quarter. Senexis Limited, a private drug development company in which BTG is an investor,secured £2.9m of new funding from the Wellcome Trust in January 2008. The fundswill be used to further optimise and progress preclinical development of thecompany's small molecule compounds, licensed to Senexis by BTG, as a potentialdisease-modifying treatment for Alzheimer's disease. BTG currently owns 48% ofSenexis. For further information contact: BTG Financial DynamicsAndy Burrows, Director of Investor Relations Ben Atwell+44 (0)20 7575 1741; mobile: +44 (0)7990 530605 +44 (0)20 7831 3113Christine Soden, Chief Financial Officer+44 (0)20 7575 1591 About BTG BTG in-licenses, develops and commercialises pharmaceuticals principally in theareas of neuroscience and oncology. The company has a substantial and growingrevenue stream of royalties from out-licensed products and a broad, expandinginternal pipeline of development programmes. BTG operates from offices inLondon, Philadelphia and Osaka. For further information, visit: www.btgplc.com. This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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