BTG Regulatory News (BTG)

BTG plc: close period update

London, UK, 5 October 2011: BTG plc (LSE: BGC), the specialist healthcare company, today provides the following update for the six months ended 30 September 2011 ahead of the planned publication of its Interim Results on 17 November 2011.

Trading update

Trading in the Specialty Pharmaceuticals and Interventional Medicine business areas has been in line with expectations, reflecting a positive first season for CroFab® (crotalidae polyvalent immune fab (ovine)) under direct sales by BTG and a strong performance from DigiFab® (digoxin immune fab (ovine)), together with good progress following the acquisition of Biocompatibles in January 2011.

A strong performance in the Licensing & Biotechnology business area, boosted by regulatory approvals for ZYTIGA™ (abiraterone acetate) and by a strong contribution from BeneFIX® (factor IX), has resulted in the Group's overall financial performance in the first half of the year being well ahead of expectations.

Commercial update

The growth of BTG's commercial operations is proceeding as planned. In Specialty Pharmaceuticals, the acute care sales team has performed well, with revenues from CroFab® in the first season under direct sales following the transition from Nycomed to BTG in line with expectations and ahead of the prior biting season. A strong performance from DigiFab® reflects increased promotional activities and the withdrawal from production of the only competing product, GlaxoSmithKline's DigiBind®. DigiFab® received marketing approval in the UK in July 2011 and other regulatory applications are in preparation.

In July 2011, BTG acquired US commercial rights to Wellstat Therapeutics Corporation's product candidate uridine triacetate (UTA) for use as a treatment for accidental overexposure to the chemotherapeutic 5-fluorouracil (5-FU). Wellstat plans to file a New Drug Application for UTA in the US in H1 2013. BTG will market, sell and distribute UTA through its existing Specialty Pharmaceuticals commercial infrastructure for up to ten years following approval.

In the Interventional Medicine business area, recruitment of the team of medical science liaisons and account managers is advanced and other activities are on track in preparation for selling the LC Bead™ directly in the US from January 2012.

Reimbursement was granted for the DC Bead® in South Korea in August 2011 and the product was admitted to hospital purchasing lists in October 2011.

In the Licensing & Biotechnology area, ZYTIGA™ received marketing approvals in the US in April 2011, in Canada in July 2011 and in the EU in September 2011, resulting in two milestone payments and initial royalty revenues to BTG.

The strong contribution to first-half revenues from BeneFIX® relates principally to product that was in the supply chain at the time of patent expiry in March 2011.

Full-year guidance

As a result of the strong performances of ZYTIGA™ and BeneFIX® during the first half of the year, full year revenue guidance is now £160m to £165m, versus a current analyst consensus of £139.6m.

Pipeline update

The FDA has accepted for review the Biologics License Application file for Voraxaze® (glucarpidase) and granted a priority review, with a PDUFA goal date (the target date for providing initial review comments) of 17 January 2012. Glucarpidase is under development for the rapid and sustained reduction of toxic methotrexate levels due to impaired renal function. Upon approval glucarpidase will be marketed by BTG's Specialty Pharmaceuticals sales force.

Patient recruitment into the three US Phase III trials of Varisolve® (polidocanol endovenous microfoam (PEM)), an investigational treatment for moderate to severe varicose veins, has been completed several months ahead of schedule. Data from the trials are anticipated in H1 2012, leading to the planned submission of a US regulatory application by the end of 2012. This will seek approval of PEM both as a single agent to treat the symptoms and appearance of varicose veins in patients with incompetence of the great saphenous vein and for use following heat ablation to treat vein segments not treated by the heat ablation procedure.

BGC20-0134 (Pleneva™) did not meet its primary or secondary endpoints in a six-month double-blind placebo-controlled Phase IIa study in patients with relapsing remitting multiple sclerosis. Data from approximately 65% of patients who have completed an optional six-month open-label study extension will be analysed to determine if any treatment effects are evident at 12 months that were not found after 6 months.

Among partnered programmes, Sanofi and its subsidiary Genzyme reported positive top-line results from the first Phase III trial of Lemtrada™ (alemtuzumab) in patients with relapsing-remitting multiple sclerosis. Results from the second Phase III trial are expected in the fourth quarter of 2011 and a US regulatory application is expected to be submitted in early 2012. The global Phase IIb study of AZD 9773 (CytoFab™) is progressing as planned with scheduled completion in H1 2012.

Louise Makin, BTG's chief executive officer, commented: "We have had a strong financial performance in the first half of this year, boosted by first revenues from ZYTIGA™ and a strong contribution from BeneFIX®. Our strong performance also reflects the successful transition to selling our acute care products directly in the US, which in turn gives us confidence as we prepare to take over direct sales of the LC Bead™ in the US from January 2012. We've also made good progress with products in development that we are planning to market ourselves in the US, with the acquisition of rights to UTA, the Voraxaze® BLA submission and the rapid completion of recruitment into the Varisolve® Phase III trials."

About BTG

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.

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