BTG plc: Close Period Update
London, UK, 2 April 2008: BTG plc (LSE: BGC), the life sciences company, today provides the following update for the year ended 31 March 2008, ahead of the planned publication of its Preliminary Results on 19 May 2008. BTG also today provides initial results from two clinical studies.
BTG expects to report a strong financial performance for the year, in line with the results reported in the Interim Report and with the Board’s expectations.
Revenues are expected to increase significantly from the prior year with another strong performance from marketed products and significant contributions from one-off transactions. BeneFIX®, the haemophilia B treatment, has shown continued strong market penetration despite the previously reported termination of Wyeth’s marketing agreement with Baxter in the EU. Sales of the monoclonal antibodies that underlie BTG’s royalties from the Medical Research Council are also showing good underlying growth. One-off revenues, including the proceeds of two previously-announced licensing deals for the semiconductor chip memory capacity technology and the milestone received from Tolerx, Inc, are expected to contribute more than £17m in net revenues and gains before withholding taxes.
BTG’s net cash at the year end was over £55m.
Operating and clinical update
With two programmes commencing clinical development during the year, BTG’s internal pipeline now comprises six programmes in clinical development. In addition to these, BTG has nine programmes licensed to partners that are in clinical development.
Varisolve® - polidocanol endovenous microfoam product for the treatment of varicose veins
Positive interim data from the US Phase II safety study were reported in March 2008 at the annual meeting of the Society of Interventional Radiologists, with no new MRI lesions, neurological or other visual field abnormalities or elevated cardiac markers being observed in the first 28 of the required 50 patients with bubbles detected in the middle cerebral artery following treatment with Varisolve®. The study continues to progress well.
The structure of the overall Phase III programme and the pivotal Phase III study designs have been agreed with the FDA. To validate aspects of the study protocols and to enable a Special Protocol Assessment to be sought later in 2008, BTG plans to conduct a Phase III pilot study and other key Phase III planning activities over the coming 6 months.
Significant progress has also been made with the product’s design and manufacturing. A smaller, lower-cost, user-friendly single canister presentation has now replaced the bulkier two-can product. Manufacturing has been contracted to a third party, and the new process and pilot plant have been fully validated.
Given the design improvements and outsourcing of the manufacturing process, the economics of BTG’s existing manufacturing facility have been re-assessed. The additional capital costs of up to £4m to commission and validate the existing facility, together with ongoing running costs of over £1m per annum up until product launch, are no longer considered viable. Accordingly, BTG intends to terminate the lease on its existing facility and will write off its carrying value of £7.5m. As a result of these changes, the overall economics and flexibility of product manufacture will improve significantly in the period up to launch and beyond.
Following the good progress made with Varisolve® in the current Phase II safety study, the outline Phase III studies being agreed with the FDA and the important manufacturing developments, BTG now intends to actively recommence partnering discussions during the current quarter.
BGC20-0166 – sleep apnoea – study results
Encouraging results were obtained in a clinical proof of concept study of BGC20-0166 in 39 subjects with mild to severe obstructive sleep apnoea. Subjects received placebo, high or low-dose combinations of two generic serotonin modulators or a single agent. The primary endpoint was a reduction in the Apnoea-Hypopnea Index (AHI). The high-dose combination caused a statistically significant 40% reduction in AHI (range 10-85%) compared to placebo at both day 14 and day 28. Three of ten subjects in the high-dose group were considered complete responders, with a reduction in AHI of over 50% and a final AHI score below 10. BGC20-0166 was well-tolerated and had no detrimental impact on sleep. An expert advisory panel has reviewed the data and concluded that the results with the high-dose combination are positive and therapeutically relevant. BTG is continuing with non-clinical studies and formulation development in preparation for US IND submission.
BGC20-0582 – head lice – study results
A single-centre Phase II study to investigate the safety, efficacy and tolerability of BGC20-0582, a Generally Regarded As Safe compound, was completed in 230 subjects (average age 13 years, 90% female) with newly diagnosed head lice infestation. Subjects were treated with placebo or one of three doses of BGC20-0582 (2.5%, 10% or 12.5% w/v) administered as a topical gel formulation. Top-line results show that, although BGC20-0582 did not significantly increase the cure rate at 14 days compared to placebo (64.7% cure rate at 10% dose compared with 52.6% in placebo; p>0.05), when taking into account lice re-infestation the modified combined cure / re-infestation measure of efficacy was 76.5% for the 10% dose of BGC20-0582 compared with 56.1% for placebo, which was statistically significant (p<0.05). This level of efficacy compares favourably to the 40-50% efficacy rate exhibited by a leading OTC product in studies of similar design and patient demographics. The high level of placebo response was unexpected and detailed analysis of the results continues.
BGC20-1259 – Alzheimer’s disease
BGC20-1259 is a multifunctional compound targeting the cognition and behavioural aspects of Alzheimer’s disease. A human positron emission tomography study in healthy volunteers has now completed. Data from this study are being used to estimate the efficacious dose range to take into a Phase IIa clinical study in patients with mild-moderate Alzheimer’s disease, which is anticipated to start in H2 08.
BGC20-1531 – migraine
BGC20-1531 is an prostaglandin EP4 receptor antagonist that offers a potentially novel mechanism to treat migraine headaches. Dosing of the first cohort in a single ascending dose Phase I clinical study is complete, and safety and pharmacokinetic data are being collected. Dosing has commenced for the second cohort, and the full study report is expected in H2 08.
BGC20-0134 – multiple sclerosis
Dosing commenced in March 08 in a Phase I study of BGC20-0134, a novel structured lipid being developed to treat relapsing multiple sclerosis. The study is also due to report in H2 08.
Louise Makin, BTG’s chief executive officer, commented: “We are pleased with the progress in the business during the year. With the Varisolve®, sleep apnoea and head lice studies yielding encouraging data and the first clinical studies of both our multiple sclerosis and migraine treatments starting, we have built good clinical momentum. With over £55m of cash we are also in a strong financial position, and therefore able to support our goal of further strengthening our pipeline through in-licensing and acquisition.”
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 1596
+44 (0)20 7831 3113
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.