IPSEN : The 17th Jean-Louis Signoret Neuropsychology Prize of la Fondation Ipsen is awarded to Doctor Pierre Maquet for ... “Sleep and cognition"

30 november 2009 – IPSEN : The 17th annual Jean-Louis Signoret Neuropsychology Prize has been awarded to Doctor Pierre Maquet (Cyclotron Research Centre, Liege, Belgium) for his work on the domain of “Sleep and cognition” by an international jury* led by Professor Albert Galaburda (Harvard Medical School, Boston, USA). He received the €20,000 prize on 16 november 2009 at the Journée Jean-Louis Signoret (Paris, France).
About the winner
Pierre Maquet is Research Director at the National Fund for Scientific Research (Brussels, Belgium), and works at the Cyclotron Research Centre (Liege, Belgium) on the relationships between sleep and cognition... [PDF] IPSEN's Press Release -

Astellas and XenoPort : Submission of a New Drug Application in Japan Requesting PMDA Approval of ASP8825/XP13512 for Restless Legs Syndrome

Nov. 19, 2009-- Astellas Pharma Inc. and XenoPort, Inc. (NASDAQ:XNPT) announced that a new drug application (NDA) has been filed with the Pharmaceuticals and Medical Device Agency (PMDA) in Japan for ASP8825 (gabapentin enacarbil), also known as XP13512, as a potential treatment for restless legs syndrome (RLS).

The data supporting safety and efficacy in the NDA filing comes from the successful Phase 2 study in RLS patients and long-term safety study conducted by Astellas in Japan and the RLS clinical program conducted by XenoPort in the United States. The acceptance of filing of the NDA triggers a $5 million milestone payment from Astellas to XenoPort... [PDF] Astellas Pharma's Press Release - XenoPort's Press Release -

HiTech Pharmacal and NovaDel : Exclusive Agreement to Commercialize Sleep Aid in Oral Spray Form

Nov. 16, 2009-- Hi-Tech Pharmacal Co., Inc. (NASDAQ: HITK) announced the signing of an exclusive licensing agreement between Hi-Tech’s ECR Pharmaceuticals subsidiary and NovaDel Pharma, Inc., a drug development company, through which ECR obtained the rights to market zolpidem tartrate oral spray, 5mg per spray, in the United States and Canada. Under the terms of the agreement ECR paid NovaDel $3 million upon closing. In addition NovaDel will receive a royalty of up to 15% on net sales, and a milestone payment if net sales reach a specific level in a calendar year.


The product, branded “Zolpimist™“ will be marketed by ECR Pharmaceuticals, Hi-Tech’s branded prescription pharmaceutical company. Zolpimist™ is an FDA approved product that is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation, and will be available only by prescription. Zolpimist™ is the only approved sleep aid which contains zolpidem tartrate in an oral spray form. In October 2009, NovaDel received a Notice of Allowance from the United States Patent and Trademark Office for claims under U.S. Patent Application No. 10/671,715, related to Zolpimist™. Once issued, the patent will expire in 2018. ECR plans to launch the product in the United States in the first half of calendar 2010... Hi-Tech Pharmacal's Press Release - NovaDel's Press Release -

CleveMed : International Distribution by Obtaining Sleep Diagnostic Product Registrations in More Nations Overseas

May 22, 2009 – Cleveland Medical Devices Inc. (CleveMed) announced that it has registered its sleep diagnostic devices in Colombia, Taiwan, Singapore, Malaysia and the Philippines, opening the door to product distribution in these countries.

CleveMed’s Division of Sleep Disorders offers complete wireless PSG systems, such as the 14-channel Crystal Monitor® PSG Series and the 22-channel Sapphire PSG™. The SleepScout™ is a type III monitor for home sleep testing. All four systems include Crystal PSG™ software, a user-friendly software package for data acquisition, scoring and reporting that are used by clinicians in the diagnosis of sleep disorders. The Crystal Monitor 20-S, Crystal Monitor 20-B and Sapphire PSG systems can all be upgraded with the iPSG Inpatient PSG System to allow for remotely attended sleep studies in hospital rooms. Due to the systems' compact size, wireless design, fast and simple system setup and rearrangement, they are uniquely suited not just for studies in the traditional sleep lab setting, but also for nontraditional sleep applications such as hospital inpatient testing for pre-surgical evaluation, nursing homes, "hotel sleep labs" and patients' homes... CleveMed's Press Release -

ResMed : Laboratoires Narval Acquisition

Oct. 5 - 2009 - ResMed Inc. (NYSE: RMD), a leading developer, manufacturer and distributor of sleep and respiratory medical equipment, announced that it has acquired Laboratoires Narval. Based in France, Laboratoires Narval manufactures and distributes the Narval O.R.M.(TM), an innovative mandibular repositioning device (MRD) that offers a solution to patients for snoring and obstructive sleep apnea (OSA), especially for those with mild OSA.

With this acquisition, ResMed adds another therapy to supplement its existing positive airway pressure-based solutions, providing a broader offering for this patient group. ResMed plans to commercialize this device in selected European markets... ResMed's Press Release -

Covidien : Sale of Sleep Diagnostics Product Line

Sep. 21, 2009-- Covidien, a leading global provider of healthcare products, announced that it had completed the previously announced sale of its Sleep Diagnostics assets to Embla Systems. Financial terms of the transaction were not disclosed.

The sale of the Sleep Diagnostics product line, which includes several products sold under the Sandman™ brand, was made following a thorough review and evaluation of a number of strategic alternatives. The decision is consistent with Covidien’s strategy to streamline its portfolio and reallocate resources to its faster-growing, higher-margin businesses, where the Company has or can develop a global competitive advantage... Covidien's Press Release -

Cortex : Clinical Study in Sleep Apnea With Its AMPAKINE CX1739

January 27, 2009 — Cortex Pharmaceuticals, Inc. (NYSE Alternext US (COR)) announced that the UK’s Medicines and Healthcare product Regulatory Agency (MHRA) gave it permission to proceed with the clinical development of CX1739 in subjects with moderate to severe sleep apnea. The study will be conducted in a UK sleep unit using a double-blind, placebo-controlled design in 20 subjects.

Sleep apnea is a chronic disorder characterized by pauses in breathing during sleep, with the most common type being obstructive sleep apnea. Each episode, called an apnea, lasts long enough so that one or more breaths are missed. Such episodes occur repeatedly throughout sleep and may result in significantly reduced blood oxygenation. If left untreated, sleep apnea can lead to an increased risk of stroke, heart attacks, hypertension, obesity and Type II, maturity onset diabetes, as well as an increased risk of accidents due to excessive sleepiness. The National Institute of Health estimates that over 12 million American adults have sleep apnea. There is currently no drug treatment option available for sleep apnea and the market is considered a multi-billion dollar opportunity in North America alone...

...Data obtained from animal studies have demonstrated that AMPAKINE compounds can specifically stimulate breathing by activating regions in the brain stem. In 2008, Cortex announced positive results of two clinical studies that demonstrated the AMPAKINE CX717 could prevent the depression of breathing induced by an opioid analgesic. Further analyses of these clinical studies also showed that CX717 reduced both the number and duration of apnea events caused by the opioid. Studies in animals suggest that CX1739 is approximately three times better than CX717 at reversing breathing depressed by opioids. CX1739 also stimulates another brain region that regulates muscle tone in the upper airways... Cortex Pharmaceuticals' Press Release -

Mylan : FDA Approval for Additional Strength of Generic Restoril®

June 17 , 2009 - Mylan Inc. (NASDAQ: MYL) announced that its subsidiary Mylan Pharmaceuticals Inc. has received approval from the U.S. Food and Drug Administration (FDA) for its supplemental Abbreviated New Drug Application (ANDA) for Temazepam Capsules USP, 22.5 mg. This strength is in addition to Mylan's currently marketed 15 mg and 30 mg strengths of the product.

Temazepam Capsules are the generic version of Mallinckrodt's Restoril®, a sleep aid, which had total U.S. sales of approximately $6 million for the 12 months ending March 31, according to IMS Health. Mylan has begun shipping this product...

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Mylan Inc., which provides products to customers in more than 140 countries and territories, ranks among the leading diversified generics and specialty pharmaceutical companies in the world. The company maintains one of the industry's broadest - and highest quality - product portfolios, supported by a robust product pipeline; owns a controlling interest in the world's third largest active pharmaceutical ingredient manufacturer; and operates a specialty business focused on respiratory and allergy therapies... Mylan's Press Release -

Neurim Pharmaceuticals : Long Term Efficacy and Safety for Circadin(R) for Insomnia in Elderly Patients

June 11, 2009 - Neurim Pharmaceuticals presented the preliminary results of a large-scale Phase III study of Circadin(R) 2mg, prolonged release melatonin in insomnia, demonstrating long term efficacy and safety in elderly patients. The results were reported in the Late Breaking Abstracts session of SLEEP 2009, the 23rd Annual Meeting of the Associated Professional Sleep Societies, (APSS) held at Seattle, Washington. The SLEEP meeting attracts the largest audience of sleep specialists in world.

Circadin(R) is a novel sleep medicine that has been approved by the European Commission pharmaceutical regulatory agency and the Israeli Ministry of Health for the short-term treatment of primary insomnia, characterized by poor quality of sleep in patients who are aged 55 and over. The approval is based on clinical studies showing positive effects on sleep quality, sleep induction, and most importantly next day alertness and functioning...

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About Neurim Pharmaceuticals

Neurim Pharmaceuticals is headquartered in Israel with offices in Switzerland and the UK. The company was founded in 1991 and is focused on drug discovery and development of treatments for age-related disorders, primarily in the central nervous system (CNS)... Neurim Pharmaceuticals' Press Release -

Kai Sensors : Contract for Wireless Sleep Monitor

June 14, 2009 -- Kai Sensors, an award winning developer of wireless, noncontact vital signs monitoring products, including the recently FDA cleared Kai RSpot, has won a National Science Foundation (NSF) SBIR Phase I contract to develop an innovative wireless sleep monitoring system for detecting sleep apnea and other sleep disorders.
Sleep is widely understood to play a key role in physical and mental health. Yet research indicates that 40 million Americans suffer from insomnia and chronic sleep disorders, with over 12 million Americans suffering from obstructive sleep apnea OSA). Serious consequences including increased mortality rate can result from untreated sleep disorders. The direct annual cost for OSA in the United States is estimated to be $16 billion.
Kai Sensors will use the $100,000 NSF SBIR Phase I contract to develop a prototype wireless sleep monitoring system. Upon successful completion of a working prototype in Phase I, Kai Sensors could qualify for a $500,000 Phase II award that would support completion of the device...

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About Kai Sensors, Inc.
Headquartered in Honolulu, Hawaii, Kai Sensors develops products designed to measure and monitor vital signs wirelessly, with no contact, and from a distance. Kai Sensors’ products are designed for use in medical, national security, and other markets... [PDF] Kai Sensors' Press Release -

Ventus Medical : New Data Support Effectiveness of its PROVENT® Therapy In Treating Obstructive Sleep Apnea

(June 9th, 2009) - Data Presented at SLEEP 2009 Conference - Discreet, Nightly-Use Prescription Device for the Treatment of Obstructive Sleep Apnea – Ventus Medical, a privately-held medical device company focused on improving the lives of patients with sleep-disordered breathing, announced that clinical data from three poster presentations presented at the SLEEP 2009 23rd Annual Meeting of the Associated Professional Sleep Societies further confirm PROVENT® Sleep Apnea Therapy’s clinical utility in treating mild, moderate and severe obstructive sleep apnea (OSA)...

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About Ventus Medical
Ventus Medical is a medical device company focused on improving the lives of patients with sleep-disordered breathing. Located in Belmont, California, Ventus Medical has developed and markets PROVENT Therapy, an innovative, clinically-proven treatment for OSA. Existing OSA solutions do not always meet patients’ needs. Through truly innovative technology, solid clinical evidence, and a focus on the patient, Ventus Medical seeks to deliver consumer-preferred, physician-recommended solutions. The company is privately-held and funded by De Novo Ventures, Mohr Davidow Ventures, and Johnson & Johnson Development Corporation... [PDF] Ventus Medical's Press Release -

Somnus Therapeutics : New Controlled-Release Formulations of Proven Drug Being Developed for Middle-of-the-Night Awakening

June 08, 2009 - Advances in Sleep Research Help Speed Somnus Therapeutics’ Development of Zaleplon-Based Sleep-Maintenance Treatment - Research sponsored by Somnus Therapeutics, Inc. demonstrates that new controlled-release formulations of a marketed insomnia medication have shown a pharmacodynamic profile indicative of a potential therapy that could address a frequent complaint of insomnia sufferers: preventing middle-of-the-night (MOTN) awakening without next-morning hangover.

Findings include specifically demonstrating that three controlled-release formulations produced maximum sedation 3 to 5 hours after administration with no residual effects observed after 8 hours. The studies applied technical advances in sleep monitoring to support clinical development and allow fine-tuning of dose and delivery during clinical studies, which may help bring an improved therapy to market more quickly and at a lower development cost.

The research, reported at SLEEP 2009, the 23rd Annual Meeting of the Associated Professional Sleep Societies, LLC – a premier event for sleep research and sleep medicine professionals – was sponsored by Somnus Therapeutics, Inc. (“Somnus”), a private specialty pharmaceutical company that is developing controlled-release formulations of zaleplon to prevent MOTN awakening... [PDF] Somnus Therapeutics' Press Release -