2nd Apr 2008 07:01
BTG PLC02 April 2008 BTG plc: Close Period UpdateInitial Results from Two Clinical Studies Announced Today London, UK, 2 April 2008: BTG plc (LSE: BGC), the life sciences company, todayprovides the following update for the year ended 31 March 2008, ahead of theplanned publication of its Preliminary Results on 19 May 2008. BTG also todayprovides initial results from two clinical studies. Trading update BTG expects to report a strong financial performance for the year, in line withthe results reported in the Interim Report and with the Board's expectations. Revenues are expected to increase significantly from the prior year with anotherstrong performance from marketed products and significant contributions fromone-off transactions. BeneFIX(R), the haemophilia B treatment, has showncontinued strong market penetration despite the previously reported terminationof Wyeth's marketing agreement with Baxter in the EU. Sales of the monoclonalantibodies that underlie BTG's royalties from the Medical Research Council arealso showing good underlying growth. One-off revenues, including the proceeds oftwo previously-announced licensing deals for the semiconductor chip memorycapacity technology and the milestone received from Tolerx, Inc, are expected tocontribute 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'sinternal pipeline now comprises six programmes in clinical development. Inaddition to these, BTG has nine programmes licensed to partners that are inclinical development. Varisolve(R) - polidocanol endovenous microfoam product for the treatment ofvaricose veins Positive interim data from the US Phase II safety study were reported in March2008 at the annual meeting of the Society of Interventional Radiologists, withno new MRI lesions, neurological or other visual field abnormalities or elevatedcardiac markers being observed in the first 28 of the required 50 patients withbubbles detected in the middle cerebral artery following treatment withVarisolve(R). The study continues to progress well. The structure of the overall Phase III programme and the pivotal Phase III studydesigns have been agreed with the FDA. To validate aspects of the studyprotocols and to enable a Special Protocol Assessment to be sought later in2008, BTG plans to conduct a Phase III pilot study and other key Phase IIIplanning activities over the coming 6 months. Significant progress has also been made with the product's design andmanufacturing. A smaller, lower-cost, user-friendly single canister presentationhas now replaced the bulkier two-can product. Manufacturing has been contractedto a third party, and the new process and pilot plant have been fully validated. Given the design improvements and outsourcing of the manufacturing process, theeconomics of BTG's existing manufacturing facility have been re-assessed. Theadditional capital costs of up to £4m to commission and validate the existingfacility, together with ongoing running costs of over £1m per annum up untilproduct launch, are no longer considered viable. Accordingly, BTG intends toterminate the lease on its existing facility and will write off its carryingvalue of £7.5m. As a result of these changes, the overall economics andflexibility of product manufacture will improve significantly in the period upto launch and beyond. Following the good progress made with Varisolve(R) in the current Phase IIsafety study, the outline Phase III studies being agreed with the FDA and theimportant manufacturing developments, BTG now intends to actively recommencepartnering discussions during the current quarter. BGC20-0166 - sleep apnoea - study results Encouraging results were obtained in a clinical proof of concept study ofBGC20-0166 in 39 subjects with mild to severe obstructive sleep apnoea. Subjectsreceived placebo, high or low-dose combinations of two generic serotoninmodulators or a single agent. The primary endpoint was a reduction in theApnoea-Hypopnea Index (AHI). The high-dose combination caused a statisticallysignificant 40% reduction in AHI (range 10-85%) compared to placebo at both day14 and day 28. Three of ten subjects in the high-dose group were consideredcomplete responders, with a reduction in AHI of over 50% and a final AHI scorebelow 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 resultswith the high-dose combination are positive and therapeutically relevant. BTG iscontinuing with non-clinical studies and formulation development in preparationfor US IND submission. BGC20-0582 - head lice - study results A single-centre Phase II study to investigate the safety, efficacy andtolerability of BGC20-0582, a Generally Regarded As Safe compound, was completedin 230 subjects (average age 13 years, 90% female) with newly diagnosed headlice infestation. Subjects were treated with placebo or one of three doses ofBGC20-0582 (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 increasethe cure rate at 14 days compared to placebo (64.7% cure rate at 10% dosecompared with 52.6% in placebo; p>0.05), when taking into account licere-infestation the modified combined cure / re-infestation measure of efficacywas 76.5% for the 10% dose of BGC20-0582 compared with 56.1% for placebo, whichwas statistically significant (pRelated Shares:
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