Arena : Phase 2b Clinical Trial of APD125 for the Treatment of Insomnia

April 8, 2008 - Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) announced that it initiated screening in a Phase 2b clinical trial of APD125 in patients with primary insomnia. APD125 is an oral drug candidate discovered by Arena with the potential to reduce insomnia symptoms and improve sleep maintenance and quality.

The Phase 2b trial of APD125 is a double-blind, randomized, placebo- controlled subjective study evaluating the efficacy and tolerability of APD125 in patients with primary insomnia characterized by difficulty maintaining sleep. The trial, which is expected to enroll a total of approximately 675 male and female patients in about 70 clinical sites in the United States, will evaluate two doses (20 mg and 40 mg) and placebo over 14 nights of treatment. The trial will evaluate standard subjective measurements of sleep, including change from baseline in subjective number of awakenings after sleep onset (sNAASO), which is the primary endpoint... Arena Pharmaceuticals' Press Release -

Medtronic : Agreement to Acquire Restore Medical

April 22, 2008 – Medtronic, Inc. (NYSE: MDT) and Restore Medical, Inc. (NASDAQ: REST) announced that the companies have signed a definitive agreement under which Medtronic will pay $1.60 per share in cash for each share of Restore Medical stock. The total value of the transaction, including payment of Restore Medical debt will be approximately $29 million.
The transaction, which is anticipated to close within 90 days, is expected to be accretive to Medtronic earnings in the first full fiscal year after closing. Restore Medical’s Pillar Palatal Implant System (Pillar System) is an innovative, minimally invasive, implantable medical device used to treat the soft palate component of sleep breathing disorders, including mild to moderate obstructive sleep apnea (OSA) and snoring... Medtronic' Press Release -

Astro-Med : Home Sleep Screener as Medicare Issues New Guidelines for Home Sleep Study Reimbursement

Mar 17, 2008 - Astro-Med, Inc. (NASDAQ: ALOT) announced the availability of a new lightweight sleep screener for use in home sleep studies, to be sold under its Grass Technologies brand. The unit, called SleepTrek(R)3, was developed over a period of years in anticipation of approval for reimbursement by the Centers for Medicare and Medicaid Services (CMS) in Washington, D.C. On March 14, 2008, CMS announced its decision to provide for Medicare reimbursement of home sleep studies using devices such as Astro-Med's SleepTrek3...


...SleepTrek3 home sleep screener is the latest in the Grass Technologies family of sleep diagnostic products, which include full in-lab sleep screening systems, wireless sleep screeners, and type II sleep screeners. The Grass brand has developed PSG, EEG, and other neurophysiological monitoring systems since 1935, manufacturing and directly selling and supporting systems for use by hospitals and labs.... Astro-Med's Press Release -

Southern Home Medical Equipment : Another Record Month for ApneaRX

Apr 14, 2008 - Southern Home Medical Equipment, Inc. (PINKSHEETS: SHMM) announced today that its subsidiary ApneaRX generated sales of $69,495.00 for the month of March. Greg Tucker, President and CEO of Southern Home Medical, stated, "We are pleased with our results for the month of March. There continues to be a huge demand for sleep and respiratory related equipment in this market." ApneaRX's primary business is supplying durable medical equipment for the treatment of long-standing or severe sleep-disordered breathing, also known as sleep apnea, with a secondary focus on respiratory products.

Sleep Apnea causes persons to involuntarily stop breathing dozens of times each night, waking them up gasping for breath. More than 18 million Americans suffer from the most common form of sleep apnea, Obstructive Sleep Apnea (OSA), and up to 90% of persons with the disorder remain undiagnosed... Southern Home Medical Equipment's Press Release -

Meda : exclusive world-wide commercialization rights from Orexo of two patented drugs in late development phase; Sublinox and OX-NLA.

April 14, 2008 - Meda (STO:MEDAA) has acquired exclusive world-wide commercialisation rights from Orexo of two patented drugs in late development phase; Sublinox and OX-NLA.

Sublinox (treatment of insomnia) contains the well-documented active substance zolpidem, one of the world’s most used substances for this disorder. Sublinox uses a unique and patented sublingual tablet formulation for fast and effective absorption. A recent phase III study confirmed that Sublinox gave faster onset of action than other zolpidem tablet formulations.

Regulatory submission to the Food and Drug Administration (FDA) in the United States is expected before the 3rd quarter 2008... [PDF] Meda's Press Release - Orexo's Press Release -

Neurogen : $30.6 Million Financing to Advance Clinical Development Programs

Apr 09, 2008 - Neurogen Corporation (Nasdaq: NRGN) announced it has entered into definitive agreements for a private placement offering of exchangeable preferred stock and warrants with selected institutional investors for gross proceeds of approximately $30.6 million before fees and expenses...
..."Our clinical portfolio is expanding and advancing as we leverage the potential of adipiplon and aplindore in several indications. We began Phase 2 studies in both Parkinson's disease and RLS with aplindore earlier this year. An upcoming Phase 2/3 study with adipiplon for insomnia enables us to examine how our drug compares to the current market leader, Ambien CR(TM), in a side-by-side comparison study. We will also run a human proof-of-concept study in anxiety to examine adipiplon's ability to relieve anxiety at doses substantially below those that produce sedation--an exciting finding we have observed in animal studies. We anticipate data from all four programs by the end of the year."... Neurogen's Press Release -

BTG : Positive Results from First Study Investigating BGC20-0166 in Obstructive Sleep Apnoea Patients

10 April 2008 : BTG (LSE: BGC), the life sciences company, reports additional details from its positive clinical proof of concept study of BGC20-0166 in subjects with mild to severe obstructive sleep apnoea.BGC20-0166 is a novel combination of two marketed serotonin modulating drugs being developed for the treatment of obstructive sleep apnoea syndrome (OSA). OSA is a sleep-related breathing disorder that affects more than 12 million adults in the US, according to the National Institutes of Health, making OSA as common as adult diabetes. BGC20-0166 has the potential to significantly advance the management of OSA as there are currently no approved drug therapies to treat this disorder... BTG's Press Release -

Itamar Medical : Watch-PAT to be included as an accepted ambulatory device for Medicare and Medicaid beneficiaries

March 15 , 2008 - Itamar Medical Inc. is pleased to report that the Centers for Medicare and Medicaid Services (CMS) has released (March 14^th, 2008) its final National Coverage Decision (NCD) where it has decided to cover the Watch-PAT for home diagnosis of obstructive sleep apnea. This decision will make the Watch-PAT available to Medicare beneficiaries nationwide.
The CMS Final Decision Memorandum discussed the Watch-PAT and the clinical evidence supporting its efficacy in very positive detail. Of particular note is CMS’s response to comments that asserted that the Watch-PAT is a useful diagnostic tool and should not be required to provide additional data under Coverage with Evidence Development... Itamar Medical's Press Release -

SleepEx : Agreement with the Atlanta School of Sleep Medicine and Technology for Online Physician Education!

March 6, 2008 - New management and product development pays off early as SleepEx signs a development and marketing agreement with the Atlanta School of Sleep Medicine and Technology; the premier sleep medicine school in the country. SleepEx, a leading provider of Sleep lab management software and data solutions founded in 2002 has developed a proprietary browser based product intended for the secure online review of sleep studies by sleep specialists and technologists.
This software product, the SleepXML Browser (developed as part of a Small Business Innovative Research grant funded by the NIH), has been selected by the Atlanta School and Director Russell Rosenberg, PhD. for incorporation into their curriculum to provide an interactive e-Learning portal for physicians for pre-board exam PSG and MSLT review and training... SleepEx's Press Release with Video -

SOMAXON PHARMACEUTICALS : NEW DRUG APPLICATION FOR SILENOR FOR THE TREATMENT OF INSOMNIA

January 31, 2008 - – Somaxon Pharmaceuticals, Inc. (Nasdaq: SOMX), a specialty pharmaceutical company focused on the in-licensing and development of proprietary product candidates for the treatment of diseases and disorders in the fields of psychiatry and neurology, announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for SILENOR™ (doxepin hydrochloride). Somaxon is seeking marketing approval of SILENOR™ for the treatment of insomnia... [PDF] Somaxon's Press release -

Graymark Healthcare : Letter of Intent to Acquire Nocturna Sleep, LLC

March 25, 2008—Graymark Healthcare, Inc. (OTCBB: GRMK), through its wholly owned subsidiary SDC Holdings LLC, is pleased to announce it has signed a letter of intent to acquire Nocturna Sleep, LLC located in Las Vegas, Nevada. Nocturna performs over 3000 sleep studies a year in the Las Vegas market, which is one of the fastest growing cities in the United States.

"The Letter of Intent to acquire Nocturna is another substantial addition to our sleep diagnostic business... Graymark Healthcare's Press Release -

Jazz Pharmaceuticals, Inc. : Development Pipeline Progress

March 13, 2008 - Jazz Pharmaceuticals, Inc. (Nasdaq: JAZZ) provided a comprehensive update on its commercial activities and near-term product development pipeline, and provided 2008 financial guidance, for investors and analysts at its Investor Day meeting in New York City...
(...)
...Jazz Pharmaceuticals' sales representatives currently promote XYREM(R) (sodium oxybate) for the treatment of excessive daytime sleepiness and cataplexy in patients with narcolepsy to sleep specialists, neurologists and psychiatrists. XYREM net sales increased by 34 percent, from $29 million in 2006 to $39 million in 2007. XYREM net sales are expected to be in the range of $45 million to $55 million during 2008....
(...)
... Jazz Pharmaceuticals announced that JZP-7, a proprietary transdermal gel formulation of ropinirole, is designed to provide an effective, once-a-day treatment of moderate to severe restless legs syndrome. JZP-7 has been successfully evaluated in one pharmacokinetic (PK) study, and a second PK study is near completion. Available results from both studies demonstrate that the product is well tolerated. Jazz Pharmaceuticals is currently planning to initiate a Phase III clinical trial in the fourth quarter of 2008. Restless legs syndrome affects up to 10 percent of the U.S. population... Jazz Pharmaceuticals' Press Release -

Philips : completion of Respironics acquisition

March 17, 2008 - — Royal Philips Electronics (NYSE:PHG, AEX:PHI) (“Philips”) and Respironics, Inc. (NASDAQ:RESP) (“Respironics”) announced that Philips has completed the acquisition of Respironics through the merger of its indirect wholly owned subsidiary with and into Respironics. As a result of the merger, Respironics has become an indirect wholly owned subsidiary of Philips... Philips' Press Release -