London, UK, 24 January 2008: BTG plc (LSE: BGC), the life sciences company, today publishes an Interim Management Statement, providing an update on progress in the business since 1 October 2007. The results for the full year to 31 March 2008 will be reported on 19 May 2008. The overall performance of the business during the period has been in line with the Board’s expectations. In particular, recruitment of patients in the Varisolve® phase II safety study is on track for the planned finish by June 2008.
Louise Makin, BTG’s chief executive officer, commented: “BTG has made good progress in the first nine months of the year. Momentum in our own development pipeline has been supplemented by progress in licensed programmes, including Campath® in CLL and MS, TRX4 in type 1 diabetes and abiraterone in prostate cancer. Over the coming months we expect to report results from our sleep apnoea and head lice clinical studies, initiate the first clinical studies for our migraine and MS programmes, and conclude the US safety study of Varisolve®.
“We are in a strong financial position with significant revenue streams and cash reserves, and we are well positioned to create shareholder value by further developing and strengthening our pipeline.” Financial update Sales and growth rates of licensed products underpinning BTG’s recurring royalty revenues for the three months to 31 December 2007 are anticipated to generate income broadly in line with expectations.
Factors that may influence sales of certain individual products during the period and for the remainder of the second half of the financial year are:
· As previously disclosed, Wyeth’s distribution agreement with Baxter in the EU for BeneFIX®, the treatment for haemophilia B, has ended and although the demand for this product remains strong sales may be affected temporarily; · The label for MabCampath® (trademarked as Campath® in the US) was extended in the EU in January 2008 to include treatment of patients with B-cell chronic lymphocytic leukaemia (CLL) for whom fludarabine combination therapy is not appropriate. This followed the approval in September 2007 of Campath® in the US as a single agent therapy for B-cell CLL, and together these approvals are expected to increase product sales over time; and · Sales of the antibody products that underpin BTG’s royalties from the Medical Research Council are expected to continue to increase as the products become more established.
Research and development expenditure has increased as planned during the period as programmes have progressed further through preclinical and clinical development. Full-year expenditure is anticipated to be in the range £12-14m. Operating and administrative costs are stable and over the full year are anticipated to be around £18-19m.
Cash and equivalents of over £46m at 1 October 2007 have been augmented by the receipt of $10m gross/$5m net from Tolerx, Inc. in connection with its agreement with GlaxoSmithKline on TRX4. The business has otherwise operated on a broadly cash neutral basis over the three month period, with cash and cash equivalents of £48.2m at 31 December 2007.
Pipeline update
Varisolve® – varicose veins and venous stasis ulcers The US phase II safety study continues as planned. This study is investigating whether patients who have right-to-left cardiac shunts experience microinfarction or other subclinical events following treatment. Six treatment sites have now been initiated, and it is anticipated that the required 50 patients with detected microbubbles in the middle cerebral artery during treatment will have been evaluated by the end of H1 2008. To date, treatment with Varisolve® has not been associated with evidence of microinfarction. An interim report will be presented at a scientific meeting in March 2008 describing 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 BGC20-1259 to take into Alzheimer’s patients in a phase IIa study, which is anticipated to start in H2 2008. Dosing in the PET study is anticipated to begin during the current 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 inform the future clinical and commercial options for the programme. It is anticipated that the results and next steps will be published around the end of the current quarter. Development is continuing of a proprietary formulation to deliver the most 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 anticipated during the current quarter, and in parallel BTG is planning the future clinical and commercial strategy for this product which promises safe, effective pediculocidal and ovicidal activity with reduced expectation of resistance build-up.
BGC20-1531 – migraine Site initiation was completed for a phase I clinical study of this EP4 receptor antagonist, which offers a potential new mechanism to treat migraine headaches. First doses are now scheduled to be administered this quarter rather than before Christmas 2007.
BGC20-0134 – multiple sclerosis MHRA and ethics approvals are expected for commencement of a phase I study in healthy volunteers of BGC20-0134, a novel structured lipid that aims to treat multiple sclerosis by rebalancing the body’s pro- and anti-inflammatory cytokines 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 funds will be used to further optimise and progress preclinical development of the company’s small molecule compounds, licensed to Senexis by BTG, as a potential disease-modifying treatment for Alzheimer’s disease. BTG currently owns 48% of Senexis.
For further information contact: BTG Financial Dynamics Andy Burrows, Director of Investor Relations +44 (0)20 7575 1741; mobile: +44 (0)7990 530605 Christine Soden, Chief Financial Officer +44 (0)20 7575 1591 Ben Atwell +44 (0)20 7831 3113
About BTG BTG in-licenses, develops and commercialises pharmaceuticals principally in the areas of neuroscience and oncology. The company has a substantial and growing revenue stream of royalties from out-licensed products and a broad, expanding internal pipeline of development programmes. BTG operates from offices in London, Philadelphia and Osaka. For further information, visit: www.btgplc.com.
