SOURCE: NeuroInvestment

June 05, 2006 09:00 ET

Alertness/EDS Treatments Reviewed by NeuroInvestment

CARDIFF, CA -- (MARKET WIRE) -- June 5, 2006 -- NeuroInvestment today announced the release of its June issue, which reviews novel analgesics being developed for the treatment of alertness and excessive daytime sleepiness (EDS). This category covers a broad range of pathology, ranging from the truly devastating effects of narcolepsy, to the widespread but modest effects of circadian rhythm disruption, due to shiftwork changes or jet lag. Cephalon (NASDAQ: CEPH) has almost single-handedly defined and carved out this space with Provigil, and through their highly adept elimination of near-term generic competition, has guaranteed Cephalon a virtual lock on the market from now to 2012. The triumvirate of Provigil/Sparlon/Nuvigil will increase the revenues they provide annually to Cephalon from $600 million to over $1 billion over the next two years, particularly as ADHD contributes more heavily to those sales when Sparlon is eventually approved. As is the case with anything that smacks of a 'lifestyle' disorder, there is controversy simmering regarding the possibility of misuse/and overuse of any drug aimed at improving alertness. No reasonable observer of the field would quarrel with the desirability of improving the energy and functional level of those suffering due to MS or depression. It is in the lifestyle applications that the question comes up whether the 'cure' might be worse than the 'disease.' No one can wholeheartedly embrace the image of college students, truckdrivers, medical residents, and late-night partiers pushing themselves to the limit with these drugs. Sleep deprivation can lead to its own set of health consequences, overdriving the system with alertness drugs is not going to ameliorate those issues, and could well exacerbate them. But the toll that fatigue takes in a society prone to excess also includes decreased productivity and increased safety risks, such as when driving, performing surgery, or managing airliner flight paths from a control tower. Since Americans do not seem inclined and/or able to alter their lifestyles to better conform to their biological imperatives, alertness drugs -- beginning with caffeine -- are likely to continue to be a part of our societal compromise between culture and biology, and represent a pharmaceutical market which will exceed a billion dollars annually in the US alone.

As is also the case with any therapeutic category of this size 'in the making,' there will be no shortage of competitors lining up to challenge Provigil -- once they have traversed the clinical and regulatory minefields that lie before commercialization. The most promising next-generation drug is Cortex's (AMEX: COR) CX717, which has shown well in clinical testing thus far, with another DARPA study due to report this month. CX717 is early in development, and even when its current clinical hold is lifted in early fall, as we expect, it still will have to be brought through pivotal trials by whichever major pharmaceutical company licenses it by year-end. Abbott, Hypnion, Arena Pharmaceuticals, and Vanda Pharmaceuticals are also active in this field, and we expect many more to enter as the commercial viability of the area becomes established.

The June issue of NeuroInvestment also assesses the problems recently encountered by Pfizer and Neurocrine Bioscience's (NASDAQ: NBIX) indiplon on its way to the marketplace; Cortex's CX717 and its status with the FDA; and comments on the FDA's recent regulatory muscle-flexing.

NI Research is the leading publisher of independent research on the neuropharmaceutical/therapeutic industry. NI Research has published NeuroInvestment since 1995, the Private CNS Company Review since 2003, and provides corporate development consultation and custom research for large and small pharmaceutical firms. NI Research has developed an unmatched information base regarding both publicly and privately held neuro-oriented companies.

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