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London, UK, 01 April 2010
Strong financial performance
US commercial operations established
BTG plc (LSE: BGC), the specialty pharmaceuticals company, today provides the following update for the year ended 31 March 2010, ahead of the planned publication of its Preliminary Results on 21 May 2010.
The Group’s financial performance is anticipated to be ahead of analyst consensus expectations and to include the following features:
Good progress has been made in building BTG’s US commercial operations. Experienced senior personnel have been recruited in sales and marketing and medical affairs, and a compliance function is being established. BTG has signed an agreement with an established contract sales organisation to assist with the recruitment and administration of a dedicated field sales force of Acute Care Specialists that will be transferred to BTG in the future. Regional business directors are being recruited to oversee the sales representatives’ activities and assist in building BTG’s internal commercial sales capabilities. An agreement with a third-party logistics provider is in place, and US trade and distribution services are being established. All arrangements are being finalised in preparation for marketing and selling CroFab™ (Crotalid anti-venom) and DigiFab™ (Digoxin antidote) from 1 October 2010, when the current distribution arrangement with Nycomed ends, or earlier if BTG acquires other products to sell itself.
In March 2010, approval was received from the US Food and Drug Administration (FDA) to supplement the biologics licence application for CroFab™ (Crotalidae Polyvalent Immune Fab (Ovine)) to remove the phrase "minimal or moderate" from the currently approved indication, thereby allowing CroFab™ to be used for all degrees of severity of Crotalid envenomations.
Voraxaze™, in development for patients at risk of toxicity following administration of high doses of the cancer drug methotrexate, is progressing on schedule through a rolling Biologic License Application in the US. The final component is expected to be filed at the end of 2010. Voraxaze™ is currently available in the US under a Treatment Protocol and in Europe and elsewhere on a named patient basis.
Varisolve®, the investigational polidocanol endovenous microfoam therapy for varicose veins, is progressing towards initiation of US Phase III pivotal trials. BTG has had encouraging discussions with the FDA following two Special Protocol Assessment submissions. Amendments to the trial protocols as well as refinement of the symptoms Patient Reported Outcomes (PRO) tool are being made.
At the same time, BTG is conducting additional detailed research into the US reimbursed and self-pay market sectors while continuing discussions with potential commercial partners. As previously stated, BTG is considering funding and completing the Phase III programme itself and, following product approval, marketing Varisolve® itself in the US reimbursed sector, while exploring partnering for the US self-pay and rest-of-world markets.
A Phase I dose ranging study of a proprietary adjuvant is underway to determine a suitable dose to take forward into a Phase IIa study of Angiotensin Therapeutic Vaccine (ATV) in high blood pressure. BTG expects to complete the adjuvant study around mid-2010. Preparations for the Phase IIa study will continue in conjunction with seeking a partner for future development.
A Phase IIb study of OncoGel™, a sustained-release formulation of the cancer drug paclitaxel, is progressing in patients with oesophageal cancer. Preliminary tumour response and histopathology data are expected to be available towards the end of 2010, with survival data towards the end of 2011.
Dosing of patients has commenced in a European multicentre Phase IIa study of Pleneva™ (formerly BGC20-0134), in development for relapsing-remitting multiple sclerosis. Pleneva™ is an orally administered compound designed to restore the balance between pro-inflammatory and anti-inflammatory cytokines. If clinical proof of principle is demonstrated in the Phase IIa study, development partners will be sought to conduct Phase IIb and subsequent studies.
Formulation work is continuing on schedule with BGC20-1531, the lead molecule in a portfolio of prostanoid EP4 receptor targeting compounds, in development for migraine and a number of other potential indications.
Several of BTG’s partnered programmes are progressing through late-stage clinical trials. Data from two Phase III trials of Campath® (alemtuzumab), in development by Genzyme Corporation for the treatment of multiple sclerosis, are anticipated in 2011.
In March 2010, positive four-year follow-on data from a Phase II study of otelixizumab(formerly TRX4; under development by Tolerx, Inc. and GlaxoSmithKline) in patients with type I diabetes were published in the journal Diabetologia. Treatment with otelixizumab delayed the rise in insulin requirements of patients with recent-onset diabetes and reduced its amplitude over 48 months. A pivotal Phase III trial completed enrolment in January 2010, and the second pivotal trial is due to commence in H1 2010.
CytoFab™, which is under development with AstraZeneca for severe sepsis, completed a Phase IIa study and is progressing towards an international Phase IIb study.
Louise Makin, BTG’s CEO, commented: "We have made good progress over the past year. We have successfully integrated the Protherics business, and we are well on track to achieve the targeted £20m synergies from the acquisition. We have laid the foundations to build a top-flight specialist sales and marketing operation in the US, as we prepare to sell CroFab™ and DigiFab™ ourselves from October. We will continue to seek to acquire additional specialist products to market in the US. We look forward to an exciting year ahead, with Varisolve® poised to start pivotal Phase III trials in the US and other internal and partnered programmes also approaching key milestones."
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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