London, UK, 20 July 2011: BTG plc (LSE: BGC), the specialist healthcare company, today holds its Annual General Meeting (AGM) and announces its interim management statement for the period from 1 April 2011 to 19 July 2011. The following summarises comments to be made by Dr John Brown, Chairman, and Louise Makin, CEO, at the Company’s AGM, which takes place at 10.30am today.
Trading has been in line with our expectations and the Company has made good commercial and clinical progress during the period.
In the specialty pharmaceuticals focus area, the US acute care sales team is performing well and sales of the antidote products CroFab® (crotalidae polyvalent immune fab (ovine)) and DigiFab® (digoxin immune fab (ovine)) are on budget.
On 6 July 2011, BTG announced the acquisition of US commercial rights to Wellstat Therapeutics Corporation’s product candidate uridine triacetate for use as a treatment for accidental overexposure to the chemotherapeutic 5-fluorouracil (5-FU). This product candidate is an excellent fit with BTG’s existing acute care business. A New Drug Application (NDA) is anticipated in the US in H1 2013, with the product continuing to be available to patients under emergency use INDs and an expanded access protocol in the intervening period.
On 14 July 2011, BTG received notification from the UK’s Medicines and Healthcare products Regulatory Agency that it has granted a Marketing Authorisation for DigiFab®, a treatment for patients with life-threatening digoxin toxicity or overdose. The product is already approved in the US, Canada and Switzerland.
BTG notified the US Food and Drug Administration (FDA) on 18 July 2011 that it had submitted the final components of the rolling Biologics License Application for Voraxaze® (glucarpidase), an experimental treatment for the rapid and sustained reduction of toxic methotrexate levels due to impaired renal function.
Within the interventional medicine focus area, recruitment has commenced for the team of medical science liaisons and account managers to support direct sales of LC Bead™ in the US from January 2012.
Varisolve® (polidocanol endovenous microfoam), under development as a novel treatment for varicose veins, continues to make good progress in its US phase III trials. Two studies are fully recruited: study VV017, which is designed to support an application for use following heat ablation of the great saphenous vein (GSV) to treat vein segments not treated by the ablation procedure, and VANISH-2 (study VV016), one of two pivotal studies intended to support a US regulatory application for approval as a single agent to treat the symptoms and appearance of varicose veins in people with incompetence of the GSV. VANISH-1 (study VV015), the second pivotal study, has now recruited over 50% of patients. All studies are on schedule for completion by the end of 2011, with data anticipated in H1 2012 and an NDA submission in H2 2012.
In the licensing and biotechnology area, treatment of patients with relapsing-remitting multiple sclerosis is nearing completion in the six month double-blind part of the Phase IIa study of BGC20-0134 (Pleneva™). Database lock is expected in Q3 2011 with additional data to follow from a six month open label study extension.
Among partnered programmes, Sanofi and its subsidiary Genzyme announced in July 2011 positive top-line results from the first of two Phase III studies comparing the use of alemtuzumab (Lemtrada™) with Rebif® (high dose subcutaneous interferon beta-1a) in patients with relapsing-remitting multiple sclerosis. There was a 55% reduction in relapse rate compared to Rebif® over the two years of the study. Top-line results from the second pivotal Phase III study are expected in Q4 2011.
In May 2011, Centocor Ortho Biotech Inc. announced that the FDA had approved ZYTIGA™ (abiraterone acetate), an oral, once-daily medication for use in combination with prednisone for the treatment of men with metastatic castration-resistant prostate cancer who have received prior chemotherapy containing docetaxel. BTG received an undisclosed milestone payment following US approval and will receive a royalty on worldwide sales.
AstraZeneca’s Phase IIb study of AZD9773 (CytoFab™) is continuing to recruit patients with severe sepsis and/or septic shock, with data anticipated in H1 2012.
Louise Makin, chief executive officer of BTG, commented: “We are making good progress against our key priorities for the year and in executing our strategy. Our US acute care sales team is performing well and we are now recruiting a new interventional medicine team to support direct sales of the LC Bead™ in the US from January 2012. We anticipate further clinical progress in both our own and our partnered pipelines during the coming year, with data expected from Pleneva™, Varisolve®, Lemtrada™ and CytoFab™.”
For further information contact:
BTG Financial Dynamics
Andy Burrows, Director of Investor Relations
Ben Atwell
+44 (0)20 7575 1741;
Mobile: +44 (0)7990 530605
+44 (0)20 7831 3113
Rolf Soderstrom, Chief Financial Officer
+44 (0)20 7575 0000
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. For further information about BTG please visit our website at www.btgplc.com.
Mo Noonan
Senior Manager
Financial Dynamics
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