London, UK, 5 April 2011: BTG plc (LSE: BGC), the specialist healthcare company, today provides the following update for the year ended 31 March 2011 ahead of publication of its Final Results on 25 May 2011.
In line with previous guidance, BTG expects to report revenue for the year ended 31 March 2011 in the range £108m-£114m including recurring revenue of £98m-£102m. BTG also expects to report cash and cash equivalents at 31 March 2011 in the range £68m-£73m.
Integration of the Biocompatibles business, acquired in January 2011, is proceeding well. The planned review of the enlarged development portfolio is under way and options for optimising the Group’s commercial operations are being explored. In addition, significant progress has been made towards achieving the targeted £3m annual cost savings.
The restructuring of BTG’s US companies to streamline and simplify the Group’s organisation and operations was completed in March 2011. Following this restructuring, BTG anticipates increased utilisation of existing tax losses accrued from previous years to offset against any future profits made in its US business.
The Acute Care sales force, established in October 2010 and expanded to 19 representatives in January 2011, is making good progress in servicing key customers for CroFab® (crotalidae polyvalent immune fab (ovine)) and DigiFab® (digoxin immune fab (ovine)).
Patient recruitment is continuing as planned into three Phase III trials of Varisolve® (polidocanol endovenous microfoam), two of which are intended to support a US regulatory application for approval as a single agent to treat the symptoms and appearance of varicose veins in patients with incompetence of the great saphenous vein. The third study is intended to support an application in the US for approval for use following heat ablation to treat vein segments not treated by the heat ablation procedure. BTG anticipates submitting a US regulatory application in H2 2012, leading to potential approval in H2 2013.
Voraxaze® (glucarpidase), under development for the rapid and sustained reduction of toxic methotrexate levels due to impaired renal function, is progressing towards completion of a rolling Biologics License Application in the US, anticipated around mid-2011.
OncoGel™ (paclitaxel gel) did not show any impact on the primary endpoint of overall tumour response in a Phase IIb study exploring its use as a neoadjuvant therapy to standard chemotherapy and radiation therapy before surgery in patients with oesophageal cancer. Study follow-up for the secondary outcome measure of patient survival has been discontinued as there can be no anticipated impact. Based on these results, BTG will not seek a partner for OncoGel™, though additional uses for the ReGel™ drug delivery technology used in OncoGel™ will be explored.
A Phase IIa study of BGC20-0134 (Pleneva™), an oral compound being developed as a potential treatment for multiple sclerosis, completed patient enrolment in January 2011 and is on track to finish around mid-2011 with data anticipated in H2 2011.
Recruitment has been completed into the clinical trial supporting the DC Bead™ regulatory submission in China. SciClone Pharmaceuticals, Inc., the distribution partner for China, intends to file the application during 2011.
The Phase II SPACE study exploring the use of sorafenib in combination with transarterial chemoembolisation (TACE) using DC Bead™ compared with TACE-DC Bead™ alone in patients with intermediate stage hepatocellular carcinoma (HCC) is progressing and the study is expected to complete in H2 2011.
A Phase I/II study to assess the safety of CellMed’s CellBeads® is ongoing in stroke patients with space-occupying intracerebral haemorrhage. CellBeads® are mesenchymal stromal cells which are embedded in an alginate bead and are designed to express therapeutic proteins; in this programme they secrete glucagon like peptide-1.
Among partnered programmes, regulatory applications were submitted in the US and the EU for abiraterone acetate (licensed to Cougar Biotechnology, a part of Johnson & Johnson) administered with prednisone for the treatment of metastatic, advanced prostate cancer in patients who have received prior chemotherapy containing a taxane, leading to potential US approval during 2011. Data from the Phase III trials of alemtuzumab (licensed to Genzyme Corporation, a subsidiary of Sanofi-Aventis) in patients with relapsing-remitting multiple sclerosis are expected to be published during 2011. The Phase IIb study of AZD9773 (CytoFab™) continues to recruit patients with severe sepsis.
Louise Makin, BTG’s chief executive officer, commented: “Integration of the Biocompatibles business is going very well and we are making good progress in reviewing the enlarged portfolio and exploring options to optimise our commercial infrastructure. Our new acute care field force is performing well, and we expect to see the full financial benefits of selling CroFab® and DigiFab® ourselves in the year ahead. Varisolve® and Voraxaze® are moving forwards as planned, and among our partnered programmes in the year ahead we anticipate the potential approval of abiraterone acetate for prostate cancer and the potential submission of a regulatory application for alemtuzumab in multiple sclerosis.”
BTG is an international specialist healthcare company that is developing and commercialising products targeting critical care, cancer and other disorders. The company is seeking to acquire new products to develop and market to specialist physicians, and is building a sustainable business financed by revenues from sales of its own marketed products and from royalties and milestone payments on partnered products.
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