Cerepro(R) Phase III results meet primary endpoint
some analyst comments ...
Ark therapeutics (AKT.L)
Marketcap: 139 million GBP ( 283 million US$ )
Cash : 65,1 million GBP ( 129 million US$ )
Price : 66p
Yesterday's trading: Biotech boosted by cancer drug
Geoff Foster, Daily Mail
31 July 2008, 7:33am
Followers of Britain's beleaguered biotech sector got a shot in the arm when Ark Therapeutics soared 32¾p to 80¼p on a hefty turnover of 6.3m shares.
Buyers dosed up with stock after hearing of positive results from the company's fourth Data Safety Monitoring Board review of the ongoing Phase III trial of its Cerepro brain cancer drug. It reported a 42-day improvement in patients' lifespan when Cerepro is added to standard of care treatment.
Ark's buoyant chief executive Nigel Parker said the firm is the first in the cutting-edge field of gene therapy to get a product into Phase III trials in cancer, and that in itself represents a significant breakthrough for medicine.
There is still a substantial amount of further information to come and the company will update the analysis in early 2009.
Samir Devani, analyst at Nomura Code, reckons the announcement significantly enhances the chances of Cerepro successfully reaching the market and gaining regulatory approval by the second half of 2009.
Fair value for the stock would then rise to £2, which compares with his current target price of around 135p.
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Ark gains on hopes for cancer drug
By Alistair Dawber
Thursday, 31 July 2008
Ark Therapeutics, the gene therapy group, gave the beleaguered UK biotech industry a shot in the arm yesterday when it said that the third phase trial of its brain cancer treatment, Cerepro, has shown good initial results and that it now expects to be able to market the drug by next year.
The company's shares rocketed on the news closing the day up 69 per cent at 80.25p. Ark had earlier said that the topline results of the tests showed that patients using the treatment were on average surviving 42 days longer than people not using Cerepro.
The results come from tests on 183 patients with the company expected to give details of another 53 cases early next year, after which it will apply to European regulators for a licence to sell the drug.
Ibraheem Mahmood, an analyst at Investec, said that while yesterday's news was encouraging, the real tonic for the group is that the positive tests validate Ark's gene based technology and that should lead to interest from some of the pharmaceutical giants. "While the news is certainly good, it is really only a by-product," he said. "Cerepro will be worth between about $500m and $1bn, but it is the first time that the technology has been shown to work and that makes it appealing to buyers."
The news will also be welcomed by the wider UK biotech market, which has a poor record of converting potential drugs in trial into commercial successes. In recent weeks two other groups, Alizyme and Oxford Biomedica, have disclosed pivotal phase three failures, which sent the share price of both companies crashing.
However, the news on Cerepro was not greeted with universal praise. KBC analyst Paul Cuddon pointed out that Cerepro will need to compete against existing medicines. "In order for the trial to be considered a success, and for the company to claim they have a blockbuster, it has to show that it is better than what is already out there, and these trials do not show that," he said. "Ark needed to show that Cerepro is more effective than Temador [another brain cancer treatment] and they have not done that. I still have major concerns."
Mr Mahmood countered that Temador, which had annual sales of $861m last year, has side effects akin to the symptoms suffered by AIDS sufferers, giving patients a poor quality of life.
