London, UK, 13 July 2010: BTG plc (LSE: BGC), the specialty pharmaceuticals company, today publishes its Annual General Meeting (AGM) and Interim Management Statement for the period from 1 April 2010 to 12 July 2010. This update summarises comments to be made by Dr John Brown, Chairman, and Louise Makin, Chief Executive Officer, at the Company’s AGM, which takes place today at 10.30am.
On 21 May 2010, BTG reported its Final Results for the year ended 31 March 2010. Revenue increased by 16.2% to £98.5m which comprised recurring revenue of £88.4m and milestones/one-off revenue of £10.1m. BTG reported a profit before tax of £9.1m compared with a loss before tax in the prior year of £11.3m. Cash and cash equivalents at the year-end increased by £4.4m to £82.6m. Trading since 1 April 2010 is in line with the Board’s expectations.
BTG has made good progress since the start of the current financial year. Following a positive meeting with the US Food & Drug Administration (FDA) in April 2010, BTG announced its decision to progress Varisolve® through US Phase III trials and to market the product itself in the US reimbursed sector. Two trials designed to gain approval as a single agent to treat both the symptoms and appearance of varicose veins, and a third trial to gain approval for use alongside heat ablation, are anticipated to commence by the end of the year. Amended Special Protocol Assessments have been submitted to the FDA for two of the trials. As previously disclosed, the anticipated costs to regulatory approval are approximately $55m and will be invested over three years.
BGC20-0134 (Pleneva™), a novel oral compound under development for treating relapsing-remitting multiple sclerosis, is progressing through a Phase IIa study as planned. Recruitment of patients continues on schedule, and data from the six-month placebo-controlled phase of the study are anticipated in H1 2011.
Preparations continue for submitting the final components of a rolling Biologics License Application (BLA) in the US for Voraxaze™ (glucarpidase), which is under development for patients at risk of toxicity following administration of high doses of the anticancer drug methotrexate. The BLA submission is expected to be finalised at the end of 2010.
The Phase IIb study of OncoGel™, a sustained release formulation of the anticancer drug paclitaxel, continues in patients with oesophageal cancer. Preliminary tumour response data are expected at the end of 2010 or in early 2011, with overall survival data towards the end of 2011.
Plans are now being finalised for BTG’s launch of the antivenin CroFab™ (Crotalidae Polyvalent Immune Fab (Ovine)) and DigiFab™ (Digoxin Immune Fab (Ovine)), for treating patients with life-threatening digoxin toxicity or overdose. Sales and marketing, medical affairs and regional business directors have all been appointed, and agreements are in place or being finalised with contract sales, 3rd party logistics and wholesale distribution organisations. All state licences are expected to be in place by the end of August, ahead of BTG starting to sell the products in October 2010.
In May 2010, BTG secured a key part of its supply chain for its monoclonal antibody products by acquiring the land in Australia on which it manages its sheep for a consideration of A$13.7m.
Among partnered programmes, AZD9773 (CytoFab™) continues to make good progress towards a global Phase IIb study in around 300 patients with severe sepsis, and Tolerx, Inc. announced the initiation of the confirmatory DEFEND-2 Phase III clinical trial to further evaluate otelixizumab in new-onset type 1 diabetes. In June 2010, Genzyme Corporation’s Campath® (alemtuzumab) was granted Fast Track status by the FDA for its development as a treatment for patients with relapsing-remitting multiple sclerosis; two Phase III trials are now fully recruited with data from both anticipated in 2011.
CEO Louise Makin commented: “There is continued good momentum across the business. We look forward to selling CroFab™ and DigiFab™ from October this year, and to seeing the full financial benefits of this from next year. Our pipeline is progressing well, with Varisolve® expected to start three Phase III trials by the end of the year and completion of the Voraxaze™ US BLA submission anticipated at the end of 2010. We will continue to seek opportunities to further strengthen our product portfolio and pipeline, as we continue our transition towards becoming a sustainably profitable specialty pharmaceuticals business.”
For further information contact:
BTG Financial Dynamics Andy Burrows, Director of Investor Relations +44 (0)20 7575 1741; mobile: +44 (0)7990 530605 Rolf Soderstrom, Chief Financial Officer +44 (0)20 7575 0000 Ben Atwell +44 (0)20 7831 3113
About BTG
BTG is an international specialty pharmaceuticals company that is developing and commercialising products targeting critical care, cancer, neurological and other disorders. The company is also seeking to acquire new products to develop and market to hospital specialists, and is building a sustainable business financed by revenues from sales of its critical care products and from royalties and milestone payments on partnered products. For further information, visit: www.btgplc.com.
Mo Noonan Senior Manager Financial Communications
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