A piece on one strong competitor (so it seems) for APD125:
Blockbuster potential for Actelion insomnia drug
drugresearcher.com
By Mike Nagle
16/08/2007- Analysts are waiting with baited breath for the latest clinical data on Actelion's first-in-class insomnia drug, pointing to its blockbuster potential and deriding current insomnia drugs as 'shockingly limited'.
Actelion is due to announce Phase II results for Act-078573 at the World Sleep Congress in the first week of September. Analysts at Swiss firm Landsbanki Kepler have now issued a 'buy' rating on the stock, saying positive data could boost the biotech's valuation.
Successful results are likely though, with early Phase II results having already established proof-of-concept, according to the management at Actelion. In fact, the company is already planning to start Phase III trials by the end of this year.
Although there are quite a few new insomnia drugs in development, the majority work in the same way as established treatments. By contrast, Actelion's Act-078573 works by a new mechanism; it is a small molecule inhibitor of two orexin receptors, OX1 and OX2. Orexins are neuropeptides thought to regulate the sleep-wake cycle and help maintain daytime alertness.
In a research note, Dr Denise Anderson at Landsbanki Kepler explained: "We find the benefit of current sleep pills shockingly limited. Thus, even if ACT-078573's efficacy is not miraculous, it might easily surpass the efficacy of current products. If this is the case, and if the safety holds up, ACT-078573 could easily have blockbuster potential."
By its own admission, the analyst firm's estimate is currently quite conservative; the share price currently stands at CHF66 and Kepler thinks that could move to at CHF75. However, Anderson said: "Outstanding results could add up to CHF10 to our target price."
There are not many branded sleeping drugs available, although total sales of those on the market did add up to $3bn in 2006. However, given that many patients are treated off-label with other classes of drug - for example, antidepressants - and the major don't take any drug at all, the market for new treatments remains largely untapped.
"Management comments have demonstrated huge excitement for the product. Despite the hype surrounding the drug, we conclude that the upside remains greater than the downside going into the event," said Anderson.
As Landsbanki Kepler points out, Actelion might well not have the orexin inhibitor market all to itself; GlaxoSmithKline (GSK) also has a similar drug in development called SB-649868. However, it is not quite as advanced since Phase II clinical trials only began last December. |
