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London, United Kingdom, 2012/07/17 - BTG plc (LSE: BTG), the specialist healthcare company, today announces its interim management statement for the period from 1 April 2012 to 16 July - BTGplc.com. LSE: BTG
Trading within the Specialty Pharmaceuticals and Interventional Medicine business areas has been in line with the Board’s expectations. Revenue in the Licensing & Biotechnology business area is ahead of expectations following receipt of a $22m final royalty payment from Pfizer relating to BeneFIX® (factor IX). As a result, BTG is raising its revenue estimate for the year ended 31 March 2013 from previous guidance of £180m-£190m to £190m-£200m including total BeneFIX® revenue of c. £14m.
The Group continues to make good clinical and commercial progress. Following positive data from the two pivotal US Phase III trials of Varisolve® (polidocanol endovenous microfoam (PEM)), regulatory and manufacturing development activities are continuing while compiling a New Drug Application, which BTG aims to submit in the US at the end of 2012.
In June 2012, the US Food and Drug Administration (FDA) granted humanitarian use device designation for BTG’s PRECISION Bead® for the treatment of patients with uveal melanoma with hypervascularised hepatic metastases. An application for a Humanitarian Device Exemption, the next step towards a potential marketing approval for this indication, is currently being prepared.
The US nationwide roll-out of Voraxaze® (glucarpidase), a treatment for life-threatening high-dose methotrexate toxicity due to impaired renal function, was completed following its launch at the end of April 2012 and initial sales have been in line with expectations.
Among partnered programmes, in June 2012 Sanofi submitted a supplemental Biologics License Application to the FDA and a marketing authorisation application to the European Medicines Agency seeking approval of Lemtrada™ (alemtuzumab) for treatment of relapsing multiple sclerosis (RMS). Also in June 2012, Janssen Research & Development, LLC submitted a supplemental New Drug Application to the FDA and Janssen-Cilag International NV submitted a type II variation to the European Medicines Agency for Zytiga® (abiraterone acetate), seeking to extend its use administered with prednisone to include the treatment of patients with metastatic castration resistant prostate cancer who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy and before chemotherapy.
Louise Makin, Chief Executive Officer, commented: “We have made a strong start to the new financial year and there is good momentum across the business. Our Acute Care and Interventional Medicine sales and support teams are performing well and the Varisolve® team is fully engaged with the regulatory submission. During the second half of 2012, we anticipate top-line results from AstraZeneca’s Phase IIb study of AZD9773 in severe sepsis and the first results from our PARAGON Bead® studies, which are an important step towards a planned regulatory Phase II study in metastatic colorectal cancer. We are in a good position to continue to build our business both through organic development and expansion and through licensing and acquisition activities.”
BTG’s Annual General Meeting takes place at 2pm today at the offices of Stephenson Harwood LLP, 1 Finsbury Circus, London EC2M 7SH.
For further information please contact:
Andy Burrows, Director of Investor Relations
T: +44 (0)20 7575 1741 / M: +44 (0)7990 530605
Rolf Soderstrom, Chief Financial Officer
T: +44 (0)20 7575 0000
T: +44 (0)20 7269 7382