January 22, 2009
BTG plc: Interim Management Statement

London, UK, 22 January 2009

BTG plc (LSE: BGC), the specialty pharmaceuticals company, today publishes an interim management statement for the period from 1 October 2008 to 21 January. 

On 12 November 2008, prior to the acquisition of Protherics PLC, BTG reported strong interim results for the six months ended 30 September 2008. Net recurring revenues increased by 25% to £15.1m, the profit after tax was £3.2m and cash reserves were £57.5m. The Company has made good progress during the second half of the year and trading is in line with expectations.

Integration update

BTG completed the acquisition of Protherics on 4 December 2008, providing the platform to create a self-sustaining specialty pharmaceuticals business. Key initial activities include rationalising operations to achieve planned cost savings and synergies, and reviewing the development pipeline to prioritise future investment.

Significant progress has been made in integrating operations and achieving the planned cost savings and synergies. 

• The former Protherics sites in London and Runcorn will close in Q1 09 and mid-2009 respectively, and notice has been served on BTG’s current office at 10 Fleet Place, London, following a break point having been reached in the lease. All London-based employees will relocate to a new office in Q1 09, resulting in significantly reduced annual rental costs.
   
• The main US office and centre for North American sales and marketing operations will be located in the Philadelphia area.
   
• Integration of the development teams and of corporate functions including finance, business development, HR and communications is advanced.
   
• Rationalisation of the manufacturing facilities in Wales and Australia is on track.

With the restructuring decisions made to date and additional savings anticipated from the ongoing pipeline and site reviews, the Company is on track to deliver expected total annual savings of £10m in general and administrative costs and to reduce research and development costs by £10m per annum by the 2010/11 financial year.

The pipeline review is expected to be completed during the first quarter of 2009. An update will be provided in a close period statement planned for 2 April 2009, ahead of publication of the preliminary results for the year ending 31 March 2008, anticipated on 14 May 2009.

Operating and development highlights 

• In early November 2008, BTG licensed BGC 945, a novel anti-tumour compound, to Onyx Pharmaceuticals, Inc in return for an upfront payment of $13m (£7.3m net), potential development and sales milestones of up to $307m and a royalty on product sales.
   
• Final data from the Phase II safety study of Varisolve®, under development for the treatment of varicose veins, were presented at the American College of Phlebology symposium in November. The results showed no evidence of adverse subclinical effects following treatment with Varisolve® in patients with a right-to-left cardiac shunt. Varisolve® is progressing through a preparatory phase III study in the US towards the pivotal phase III trials, which are anticipated to commence around mid-2009.
   
• An Investigational New Drug application has been submitted to the US Food & Drug Administration (FDA) for BGC20-0166, a proprietary combination of two serotonin-modulating agents under development as a treatment for obstructive sleep apnoea.
   
• The US FDA has granted orphan drug status to OncoGel™ (paclitaxel) for the treatment of brain cancer.
   
• BGC20-1531 completed Phase I single and multiple ascending dose studies and was well tolerated at all doses. In addition, BGC20-1531 demonstrated significant analgesic-like activity, similar to that of NSAIDs, in an experimental medicine model of pain.
   
• Analysis of the data from a completed Phase I study of BGC20-0134, a novel structured lipid targeting the treatment of multiple sclerosis, showed anticipated effects on plasma cytokine levels, including an increase in levels of the anti-inflammatory cytokine TGFβ.
   
• Progress continued in several clinical studies:
   
  • A Phase IIb study of OncoGel™, a slow release formulation of paclitaxel for direct tumour injection, continued enrolment of a planned 124 patients with oesophageal cancer, and a phase I/II study continued to recruit patients with primary brain cancer.
     
  • Following successful dosing of the first 12 patients, recruitment continued into a Phase IIa clinical study of the angiotensin therapeutic vaccine (ATV), designed to reduce blood pressure.
     
  • Recruitment of patients continued into a Phase IIa clinical proof of concept study of Prolarix™, a targeted prodrug-based treatment for primary liver cancer.
     
  • The Phase I/II study of Acadra™ continued to recruit patients with refractory B-cell chronic lymphocytic leukaemia.

Louise Makin, BTG’s CEO, commented: “We are pleased with the progress made in integrating our businesses following the acquisition of Protherics in December, and are on track to deliver the significant planned cost savings and synergies. We have also had a strong start to the second half of the year, with overall progress in line with expectations, good momentum in the development pipeline and the licensing of BGC 945 to Onyx Pharmaceuticals.”
 

For Further information, contact:

BTG:
Andy Burrows, Director of Investor Relations

+44 (0)20 7575 1741; Mobile: +44 (0)7990 530605

Rolf Soderstrom, Chief Financial Officer
+44 (0)20 7246 9950

Financial Dynamics:
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.