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London, UK, 25 January 2012
BTG plc (LSE: BGC), the specialist healthcare company, today publishes its interim management statement for the period from 1 October 2011 to 24 January 2012.
Trading has been in line with the Board’s expectations and revenues for the full year are expected to be in the range £160m to £165m, as previously announced. This guidance excludes any royalty revenues that may be received in the second half relating to BeneFIX®(factor IX) product that was in the supply chain at the time of final patent expiry in March 2011.
The Biologics License Application for Voraxaze® (glucarpidase) that was submitted to the US Food and Drug Administration in September 2011 was granted priority review and was approved on 17 January 2012. Voraxaze® is indicated for the treatment of toxic plasma methotrexate concentrations (>1 micromole per litre) in patients with delayed methotrexate clearance due to impaired renal function. It will be marketed directly in the US by BTG through our existing acute care sales force; we anticipate peak US sales of around $15m per annum. BTG licensed the Japanese rights to glucarpidase to Ohara Pharmaceutical Co., Ltd. in December 2011.
BTG’s new team of Medical Science Liaisons and Account Managers commenced direct sales of and medical support for the LC Bead™ in the US this month following expiry of the distribution contract with AngioDynamics, Inc. on 31 December 2011. The team has made good initial progress, with all key accounts updated with new order codes and first orders received. The revenue impact of selling the LC Bead™ in the US ourselves is expected to be evident from the financial year beginning in April 2012.
Analysis of data from the Phase III trials of Varisolve® (PEM) is continuing with the results of all three studies expected within the first half of 2012.
Louise Makin, BTG’s CEO, commented: “We have continued to make good progress commercially and in our pipeline since reporting in November a strong set of results for the first half of the year. Our second US sales force is now selling the LC Bead™ and has started well. We were pleased to receive US approval for Voraxaze®, the first regulatory application we have made in the US, which we will market through our existing acute care sales force. We look forward to a busy 2012, with data from the three Phase III trials of Varisolve®, from our partner AstraZeneca’s Phase IIb study of AZD9773 (CytoFab™) in severe sepsis and the submission of US and EU regulatory applications by Sanofi for Lemtrada™ (alemtuzumab) in relapsing-remitting multiple sclerosis.”
For further information contact:
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
+44 (0)20 7831 3113
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