January 21, 2010
BTG plc: Interim Management Statement
London, UK, 21 January 2010
BTG plc (LSE: BGC), the specialty pharmaceuticals company, today publishes an interim management statement for the period from 1 October 2009 to 20 January 2010.
BTG today announces that dosing has commenced in a European multicentre Phase IIa study of Pleneva™ (formerly BGC20-0134), a novel orally administered compound under development as a potential treatment for multiple sclerosis (see separate announcement issued today).
In late October 2009, BTG submitted a request to the US Food and Drug Administration (FDA) for a Special Protocol Assessment (SPA) of study VV015, one of two planned pivotal Phase III trials intended to support the approval of Varisolve® as a single agent treatment for moderate to severe varicose veins. Another SPA was submitted in December 2009 for study VV017, a third Phase III trial that is designed to support the approval of Varisolve® as an adjunct treatment of varicosities and distal greater saphenous vein (GSV) incompetence in patients with previous proximal GSV ablation. A Patient Reported Outcomes (PRO) tool, which measures a patient’s perception of symptom improvement, was also submitted for evaluation.
Comments have been received on the SPA for study VV015 and are being addressed, following which an amended protocol will be submitted. Comments on the SPA for study VV017 and on the PRO tool are awaited. Preparations continue for study VV016, the second pivotal Phase III trial supporting single agent use. Although this trial is not subject to the SPA process, the feedback received on the SPA for study VV015 and on the PRO tool will be incorporated into its design.
In November 2009, BTG announced that while continuing discussions with potential commercial partners, BTG is also considering completing US regulatory development and marketing Varisolve® itself in the US reimbursed sector if the product receives regulatory approval.
A Phase I study was initiated in November 2009 to determine a suitable dose of adjuvant to take forward into the planned Phase IIa study of the Angiotensin Therapeutic Vaccine (ATV), under development as a potential treatment for high blood pressure. The Phase I results are expected in H1 2010 and the Phase IIa study of ATV is anticipated to start in H2 2010.
Development of Voraxaze™, OncoGel™ and BGC20-1531 continues. Voraxaze™(glucarpidase), being developed for patients experiencing or at risk of toxicity following administration of high doses of the cancer therapy methotrexate, is progressing through a rolling Biologic License Application in the US with the final component expected to be filed in H2 2010. Recruitment continues into the Phase IIb study of OncoGel™, a sustained‑release formulation of the chemotherapeutic paclitaxel, in which OncoGel™ is administered in combination with pre-operative chemo‑radiotherapy in up to 124 patients with oesophageal cancer and is being compared to pre-operative chemo‑radiotherapy alone; preliminary tumour response and histopathology data are expected to be available towards the end of 2010, with survival data towards the end of 2011. Formulation work continues on BGC20-1531, a novel EP4 receptor antagonist which is progressing towards a Phase IIa study in migraine patients.
Among BTG’s partnered programmes, Tolerx, Inc., announced on 7 January 2010 the completion of patient enrolment in its Phase III clinical study DEFEND-1, which is evaluating the safety and efficacy of otelixizumab (formerly called TRX4) in patients with new-onset autoimmune type 1 diabetes. Otelixizumab is being developed by Tolerx, Inc. and GlaxoSmithKline in type 1 diabetes and potentially a range of other autoimmune disorders.
On 5 November 2009, BTG reported its interim results for the six months ended 30 September 2009. Revenue for the first six months of the financial year of £47.9m comprised recurring royalties of £26.3m, product sales of £16.1m and milestones/one-off revenues of £5.5m. The gross profit was £32.3m and the profit before tax was £2.4m. Cash and cash equivalents at 30 September 2009 were £79.2m.
In December 2009, BTG licensed exclusive worldwide rights to Allergan to develop products for diseases and conditions of the eye using BTG’s ReGel® drug delivery system, in return for an undisclosed upfront payment and potential additional future milestones and royalties on product sales.
The Group’s performance in the second half of the financial year to date has been in line with the Board’s expectations, and BTG remains on track to deliver the planned synergies and cost savings anticipated from the acquisition of Protherics.
Louise Makin, BTG’s CEO, commented: “We are pleased with progress across the business. Preparations for the return of sales and marketing rights to CroFab™ and DigiFab™ are well advanced, and we anticipate completing our rolling BLA filing for Voraxaze™ by the end of the year. We will continue to seek additional products to market ourselves, while progressing our current pipeline. Our three partnered Phase III programmes are all advancing, and we look forward to AstraZeneca commencing the Phase IIb study of CytoFab™ in patients with severe sepsis. We expect 2010 to be another important year in our evolution into a self-sustaining specialty pharmaceuticals business.”
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