BTG plc: Annual General Meeting and Interim Management Statement

BTG plc: Annual General Meeting and Interim Management Statement

BTG plc: Annual General Meeting and Interim Management Statement

London, UK, 16 July 2008: BTG plc (LSE: BGC), the life sciences company, today publishes its interim management statement for the period from 1 April 2008 to 15 July 2008. This update summarises comments to be made today at BTG’s Annual General Meeting by Dr John Brown, Chairman, and Dr Louise Makin, Chief Executive Officer.

On 19 May, the Group reported strong financial results for the year ended 31 March 2008. Net revenues of £42.9m were 60% higher than in the previous year, resulting from strong recurring royalties and significant one-off revenues, while operating and administrative costs reduced by 11%. This enabled increased investment in research and development while delivering a third consecutive year of profit after tax – of £8.8m vs £2.4m in the previous year. Cash and equivalents at 31 March 2008 were £57.0m.

The Group’s overall operational progress and financial performance since 1 April 2008 have been in line with the Board’s expectations and the outlook for the year remains unchanged.

In the year to date, BTG has received a milestone payment from Cougar Biotechnology following initiation of Cougar’s phase III trial of CB7630 in prostate cancer. Additional one-off receipts are anticipated, including $5m on completion of the announced acquisition of Protez Pharmaceuticals by Novartis, and a milestone from Tolerx, Inc. on initiation of dosing in a phase III trial of TRX4 in type 1 diabetes planned in the current quarter. A change this year in the revenue-sharing obligations on BeneFIX®, the haemophilia B treatment marketed by Wyeth, will result in BTG retaining an increased proportion of the gross royalty revenues from this product going forward.

Investment in research and development for the year is expected to be in the range £10m-£15m, while operating expenses are anticipated to be similar to the previous year. The Group expects to maintain a strong cash position throughout the year.

Operating update

Varisolve® - polidocanol endovenous microfoam treatment for varicose veins – study update provided today

On 6 June 2008, BTG reported the successful completion of treatments and 24 hour MRI scans in the US phase II safety study. BTG today confirms that all of the required patients have now completed their 28-day MRI scans, and that no MRI lesions were detected in any of the patients as a result of treatment.

As planned following completion of the phase II study, BTG has initiated contact with potential development and commercial partners for Varisolve®.

A pilot phase III clinical study to validate endpoints for the pivotal phase III trials is expected to start during Q3 2008, and the programme is anticipated to be ready for phase III in H1 2009.

BGC20-0166 – obstructive sleep apnoea (OSA)

Encouraging results were reported in April from a proof of concept clinical study of BGC20-0166, a combination of two approved serotonin-modulating agents being developed as potentially the first pharmacological treatment for OSA. Patients who received the high-dose combination of the two drugs experienced an average 40% reduction in the apnoea-hypopnea index (AHI), a measure of the severity of the condition. Non-clinical combination pharmacokinetic and toxicology studies and clinical pharmacokinetic studies are continuing to support the planned submission of an IND to commence a formal phase II study.

BGC20-1259 – Alzheimer’s disease

Preparations are continuing to commence a phase II study later this year of this multifunctional compound as a symptomatic treatment for mild to moderate Alzheimer’s disease.

BGC20-0582 – head lice infestation

Following completion of a phase II efficacy study earlier in the year, a planned in vitro study is under way to compare the pediculocidal resistance characteristics of BGC20-0582 with leading OTC products.

BGC20-0134 – multiple sclerosis

Dosing has completed in a single and multiple dose phase I study of BGC20-0134, a structured lipid designed to restore the balance between the pro- and anti-inflammatory cytokines that become dysregulated during MS relapsing episodes. Preparations continue for a planned phase II study in patients with relapsing-remitting multiple sclerosis, which is expected to begin early in 2009.

BGC20-1531 – migraine headache

Dosing of a third and final cohort of volunteers has commenced in a single-ascending dose phase I study of BGC20-1531. This prostaglandin EP4 receptor antagonist blocks PGE2-induced trigeminal nerve sensitisation and cerebral vascular dilatation, which are believed to underlie migraine pain. Additional phase I studies are planned to help select the dose range for a phase II study, which is expected to commence early in 2009.

Louise Makin, BTG’s chief executive officer, commented: “Having successfully completed the Varisolve® phase II safety study, we are now preparing for the pivotal phase III trials and have started to look for a development and commercial partner. Our programmes in Alzheimer’s disease, obstructive sleep apnoea, multiple sclerosis and migraine pain are all progressing towards phase II studies, which are expected to be under way within the next 12 months. We are continuing to explore opportunities to further strengthen our pipeline whilst driving the business towards our goal of sustainable profitability.”

For further information contact:

Andy Burrows, Director of Investor Relations
+44 (0)20 7575 1741
+44 (0)7990 530605 (mobile)

Christine Soden, Chief Financial Officer
+44 (0)20 7575 1591

Financial Dynamics
Ben Atwell
+44 (0)20 7831 3113

About BTG
BTG in-licenses, develops and commercialises pharmaceuticals and has a broad pipeline of development programmes targeting neurological and other disorders including varicose veins. The company also has a substantial and growing revenue stream of milestone payments and royalties from out-licensed products. BTG operates from offices in London, Philadelphia and Osaka. For further information, visit:

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