Inside This Issue: Insomnia Top News Alerts: Product Updates, Deals & Financings Company Spotlight: Intra-Cellular Therapies Subscribe now to access over 50 articles covering developments in drugs, devices and diagnostics for the brain and nervous system.
Market Highlights: Intermezzo Approved at Long Last, Geron Waves White Flag
Transcept finally got FDA approval for Intermezzo to treat middle of the night awakenings. The company submitted its first NDA in October 2008 and this month prevailed over FDA concerns regarding next day
impairment and extra pill taking. Intermezzo is simply a lower dose (about
1/3) of Ambien (zolpidem). Market
uptake is expected to be limited (see
story, page 6). Geron said it would halt its study of embryonic
stem cells for spinal cord injury and is seeking a partner or buyer for the
program. It would have spent $25 million per year to continue development and
cited the bad economy as the reason for jumping ship. Maybe in a good economy
Geron would have continued bleeding money into this program but more likely, a
logical assessment would have persuaded them either way to save the $180
million they have in the bank ....
Insomnia's Shrinking Pipeline
A wide variety of disorders interfere with normal sleep. These can be classified as primary or secondary depending on etiology. Sleep disorders are common in neurological and psychiatric conditions but also occur in heartburn, asthma, arthritis, diabetes, congestive heart failure, cancer, chronic pain, blindness, and substance abuse. Drugs commonly used for insomnia include
benzodiazepines, antidepressants, imidazopyridines, chloral hydrate,
meprobamate, antihistamines, and combination products. All these are limited by
similar side-effects such as daytime sleepiness, a hangover-like daze, lower
alertness, and motor impairment. Despite this, drug development programs for insomnia have been
dropping out precipitously. More than 20 compounds that were in active
development in mid-2008 have now been whittled to only ten. This article outlines diagnostics and treatments in development for insomnia...
Intra-Cellular Therapies' Bright Future
Intra-Cellular Therapies (ITI) is a private New York based company founded in
2002 to commercialize technology developed at Nobel Laureate Paul Greengard's
lab at Rockefeller University. "The idea was to create a platform
out of the work of many postdoc's at Paul's lab who looked at intra-cellular
pathways," says Sharon Mates, CEO and co-founder. "We wanted a
platform so we could look at several pathways at the same time, take many
proteins and many phosphorylation sites on these and put them in one platform,"
she states....
Companies Covered In This Issue Include: Sleepmed, Dormir, Natus, Compumedics, Advanced Brain Monitoring, Zeo, Cleveland Medical Devices, Neurovigil, Novasom, Ligand, Lundbeck, Eli Lilly, Merck, Sanofi, Arena, GlaxoSmithKline, Vanda, Actelion, Neurim, Alexza, Evotec, Somnus, Nautilus, Roche, PTC Therapeutics, Civitas, RhinoCyte, Sapiens Steering Brain Stimulation, Sygnis, CogState, TCG Lifesciences, Cenix, Avraham Pharma, Physiosonics, Otsuka, Medtronic, Knopp Biosciences, Prana Biotechnology, Regeneron Pharma, Chelsea Therapeutics, NeurogesX, Pfizer, Neuroderm, IntelGenx, Boehringer Ingelheim, Acadia, Rexahn, IntraPace, Targacept, Janssen, QRzPharma, Opexa, Nuron Biotech, Synapse Biomedical, Roche, Vivus, Diagenic
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