UK biotechnology firm Ark Therapeutics says that its losses have widened but all the focus is on whether the company’s new brain cancer treatment Cerepro, is going to be approved by European regulators in the next month.
The firm’s net loss for 2006 was £17.5 million, up 15.7%, while revenues were £344,000, down from almost £2.4 million in 2005, although the latter figure included £2 million in milestone receipts under a licensing agreement with Boehringer Ingelheim relating to a stroke programme. The sales came from Kerraboot, the firm’s novel device for diabetic foot ulcers.
Ark’s losses were a result of increased investment at its new manufacturing facility in Kuopio, Finland, and spending on the development of the three drugs it has in Phase III studies. Its lead product is Cerepro, a gene therapy-based treatment for brain cancer which is currently being assessed by the European Medicines Agency and a decision is due shortly. If approved, Ark says Cerepro will become the world's first gene therapy product and the company says that it spent 2006 responding to questions from the EMEA which is not surprising given the “many hitherto undefined regulatory and manufacturing requirements…of this new and exciting class of medicines.”
Also in Phase III is Vitor, an oral therapy for treating the weight loss and muscle wasting, or cachexia, associated with cancer, and Trinam, to prevent haemodialysis access surgery complications.
Expressing his pleasure with the results, chief executive Nigel Parker said that Ark’s business model, which concentrates on specialist areas “ where we have the expert knowledge and capability to develop and market our own products without any inherent dependency on big pharma for resources and expertise, has established significant credibility.” The company has recently raised £31.4 million in share placements and ended 2006 with cash and equivalents of £48.4 million.