Gene-based medicine firm Ark Therapeutics expects European regulators to decide whether to approve its Cerepro brain cancer drug early in the fourth quarter of 2009, its chief executive said.
Nigel Parker made the prediction after the British biotech company unveiled a reduced full-year loss for 2008 of Ł15.9 million ($22 million), down from a loss of Ł18.2 million in 2007.
“We would anticipate that just after the middle of the second half of this year we should have a decision,” Parker told Reuters.
Ark last month won a green light from French authorities allowing Cerepro to be prescribed to certain patients with brain cancer, even though it is not approved for general use, boosting hopes for a positive decision from the European Medicines Agency.
Cerepro will be the first gene medicine approved for use outside China, if it is cleared for sale across the European Union by the watchdog.
Parker said Ark intended to market Cerepro itself in Europe's top five markets - Germany, France, Britain, Italy and Spain - but would seek partners elsewhere.
“We have a number of discussions going on with a complete range of companies, and we will progress those discussions for minor countries,” he said.
Ark will only consider its strategy for the US market after hearing back from the European regulator, but is more likely to seek a marketng partner for that market, he added.
The company had cash and money market investments at the end of December totaling Ł40.6 million from Ł65.1 million at end-2007, enough to fund it past the end of 2010 even on a worst-case scenario, according to finance chief Martyn Williams.
Lower 2008 losses were primarily due to unrealized exchange gains on inter-company loans and gains on operational foreign exchange strategies pursued by the group in the year.
Ark, which already sells some wound-care products, said revenue last year fell to Ł0.9 million from Ł1.1 million in 2007 - less than the Ł1.97 million forecast by house broker Piper Jaffray.
“We had assumed a 1 million pounds milestone payment from BI (Boehringer Ingelheim) under its deal with Ark. However, the timing of this is impossible to gauge,” said analyst Sam Fazeli. (Reuters)