VirtuOx launches a patient centered Sleep Apnea education website

September, 2010 - VirtuOx launches www.Apneabuster.com, a patient centered Sleep Apnea education website.

About Virtuox, Inc.

VirtuOx, Inc. is a privately held medical technology services company that provides diagnostic tools and services that enable a variety of healthcare organizations and professionals in diagnosing and treating Respiratory diseases through vertically integrated platforms, products and services. Virtuox’ platforms includes a Medicare approved, Independent Diagnostic Testing Facility (IDTF) that assists in the diagnosis and qualification of treatment options for Sleep Disorder Breathing and Respiratory Diseases in the home, industry leading web-based management applications that communicate with physicians, medical equipment providers and patients globally as well as product and distribution offerings.VirtuOx's Press Release -

TONIX Pharmaceuticals : Analysis of Phase 2a Study of Very Low Dosage Cyclobenzaprine in Fibromyalgia Syndrome (FMS)

November 9, 2010 – For the First Time, Correlation Demonstrated between Sleep Stability and Reductions of Fatigue in FMS - Results Presented at the American College of Rheumatology/Association of Rheumatology Health Professionals (ACR/ARHP) 2011 Annual Scientific Meeting - TONIX Pharmaceuticals (formerly known as Krele Pharmaceuticals), a specialty central nervous system (CNS) pharmaceutical company, announced results of a new analysis of a Phase 2a study, which previously demonstrated reduced pain, fatigue and tenderness in patients with Fibromyalgia Syndrome (FMS) following bedtime administration of very low dosage (VLD) cyclobenzaprine (CBP). According to the analysis, VLD CBP treatment was associated with reductions in an objective measure of non-REM sleep instability, referred to as Cyclic Alternating Patterns (CAP) A2 & A3; these reductions were statistically significantly correlated with diminished pre-sleep/p.m. fatigue in FMS. The findings are the subject of a poster presentation at the American College of Rheumatology/Association of Rheumatology Health Professionals (ACR/ARHP) 2011 Annual Scientific Meeting.

Dr. Harvey Moldofsky, President and Medical Director, Centre for Sleep and Chronobiology, Toronto, Canada, and lead author of the study, commented, “Current treatments for FMS are inadequate, and there is substantial interest in the impact of improving sleep quality in these patients. Our analysis demonstrates improvements in FMS fatigue can be correlated with a therapeutic modality that normalizes nonrestorative sleep, and we believe this provides additional confirmation of the central importance of poor sleep quality in FMS.”... TONIX Pharmaceuticals' Press Release -

Actavis : 180-day marketing exclusivity in the US for Zolpidem Tartrate extended-release tablets, USP 6,25mg CIV

19 OCT 2010 - Actavis has received approval from the FDA to market Zolpidem Tartrate Extended-Release Tablets, USP 6,25mg CIV in the United States. Distribution of the product has commenced.

As the first company to file an ANDA that contained a paragraph IV certification for Ambien® CR 6,25mg, Actavis has been awarded 180-day exclusivity to market this product.

Zolpidem Tartrate extended-release tablets 6,25mg, the generic equivalent of Ambien® CR 6,25mg by Sanofi-Aventis, had US sales of approximately USD129 million for the 12 months ending 30 June, 2010 (IMS Health data)... Actavis' Press Release -

Evotec : License and collaboration agreement with Jingxin Pharma for EVT 201

28 October 2010: Evotec AG (Frankfurt Stock Exchange: EVT, TecDAX) announced that it has entered into a license and collaboration agreement with Zhejiang Jingxin Pharmaceutical Co., Ltd ("Jingxin Pharma") for EVT 201, a novel potential treatment for insomnia. The agreement grants Jingxin Pharma exclusive rights to develop and market the drug candidate in China. In return, Evotec will receive a small upfront payment, together with commercial milestones and significant royalties.


Jingxin Pharma will initiate clinical trials with EVT 201 in China in 2011. All development costs will be borne by Jingxin Pharma. Evotec will have the right to reference clinical data produced by Jingxin Pharma to support potential further development of EVT 201 in other territories... Evotec's Press Release -

Transcept Pharmaceuticals : Preliminary Results From the Intermezzo(R) Highway Driving Study

Oct 19, 2010 - Transcept Pharmaceuticals, Inc. (Nasdaq: TSPT) announced its preliminary analysis of data from the recently completed Intermezzo(R) 3.5 mg (zolpidem tartrate sublingual tablet) highway driving study. Transcept is developing Intermezzo(R) for use as-needed for the treatment of insomnia when a middle of the night awakening is followed by difficulty returning to sleep. In the Intermezzo(R) New Drug Application (NDA), Transcept proposed to the U.S. Food and Drug Administration (FDA) that patients have at least four hours remaining in bed after dosing Intermezzo(R) in the middle of the night.

About the Intermezzo(R) highway driving study

The Intermezzo(R) highway driving study was a double-blind, randomized, placebo-controlled, four-way crossover study of 40 healthy volunteers designed to evaluate the safety profile of Intermezzo(R) with regard to next morning driving. The study evaluated standard deviation of lateral position (SDLP) in a highway driving lane, a surrogate measure for driving performance, as subjects drove an automobile 100 km, or 62 miles, on a public highway under normal traffic conditions for approximately one hour. Subjects performed test drives on placebo, zopiclone as a positive control taken at bedtime nine hours before driving, Intermezzo(R) taken three hours before driving, and Intermezzo(R) taken four hours before driving. Based on a review of the published literature, an SDLP change of 2.5 cm was specified in the protocol as the primary threshold of impairment for the purpose of performing the statistical analyses. In March 2010, the FDA informed Transcept that the statistical methodology proposed by Transcept, a symmetry analysis, was a reasonable approach to measure potential next morning driving impairment... Transcept Pharmaceuticals' Press Release -

Adeona : $17.5 Million Corporate Partnership with Meda AB for the Development and Commercialization of Flupirtine for Fibromyalgia

May 7, 2010 - Adeona to Receive Royalties on Potential Billion Dollar indication - Meda to Assume All Future Development Costs - Adeona Pharmaceuticals, Inc., (AMEX: AEN) announced that it has entered into a corporate partnership with Sweden-based Meda AB, to develop flupirtine for the treatment of fibromyalgia syndrome which contemplates the payment to Adeona of up to $17.5 million in upfront and milestone payments, plus royalties.

Under the terms of the agreement, Adeona has granted Meda an exclusive sublicense to all of Adeona’s patents covering the use of flupirtine for fibromyalgia. These patents have issued in the U.S. and are pending in Canada and Japan (the “Territory”).

Meda will assume all future development costs for the commercialization of flupirtine for fibromyalgia. Adeona received an up-front payment of $2.5 million and is entitled to milestone payments of $5 million upon filing of a New Drug Application with the Food and Drug Administration for flupirtine for fibromyalgia and $10 million upon marketing approval. Adeona is also entitled to receive royalties of 7% of net sales of flupirtine approved for the treatment of fibromyalgia covered by issued patent claims in the Territory. Adeona will share such royalties equally with Adeona’s university licensor.

Fibromyalgia is a chronic and debilitating condition characterized by widespread pain and stiffness throughout the body, accompanied by severe fatigue, insomnia and mood symptoms. Fibromyalgia affects an estimated 2-4% of the population worldwide, including an estimated 4 million patients in the United States... [PDF] Adeona Pharmaceuticals' Press Release - Meda's Press Release -

Sunovion Pharmaceuticals Inc. : Company Name Change

October 12, 2010 - Sunovion Pharmaceuticals Inc. (Sunovion), formerly Sepracor Inc. (Sepracor), announced that it has formally changed its name. The change occurs on approximately the one year anniversary of the acquisition of Sepracor by Dainippon Sumitomo Pharma Co., Ltd. (DSP), an Osaka, Japan based pharmaceutical company. Sunovion integrates under one brand the distinct competencies of Sepracor and the former Dainippon Sumitomo Pharma America, Inc. (DSPA), the two U.S. operations of DSP.

“This is an exciting time for Sunovion Pharmaceuticals Inc. and we are poised to deliver on our vision to become a leading global pharmaceutical company known for scientifically-advanced products that improve the lives of patients”
“This is an exciting time for Sunovion Pharmaceuticals Inc. and we are poised to deliver on our vision to become a leading global pharmaceutical company known for scientifically-advanced products that improve the lives of patients,” said Mark Iwicki, President and Chief Operating Officer of Sunovion. “The meaning of Sunovion combines the strength of the sun with innovation and, for us, represents the start of a great new company. Launching our new corporate identity is a meaningful next step for our employees and partners who have contributed to our past success. We remain focused on our goal to grow our current brands and advance our pipeline candidates.”

In April 2010, DSPA, based in Fort Lee, N.J., merged into Sepracor consolidating DSP’s North American footprint in Marlborough, Mass. As Sunovion, the company will maintain corporate headquarters in Marlborough and critical R&D functions will continue in both Fort Lee and Marlborough. The company will maintain sales and marketing efforts for leading central nervous system and respiratory brands including LUNESTA.. [PDF] Sunovion Pharmaceuticals' Press Release - [PDF] Dainippon Sumitomo Pharma's Press Release -

Vanda Pharmaceuticals : Phase III Clinical Study Aimed at Resetting the Body Clock

Aug 26, 2010 - Study to Evaluate Effect on Sleep/Wake Cycle in Blind Individuals with Non-24-Hour Sleep Wake Disorder - Vanda Pharmaceuticals Inc. (Nasdaq: VNDA), announced it has initiated a Phase III clinical trial to evaluate tasimelteon in patients with Non-24-Hour Sleep Wake Disorder (N24HSWD), a condition experienced primarily by totally blind individuals that results in abnormal night sleep patterns and chronic daytime sleepiness. Tasimelteon binds to high affinity melatonin receptors located in the brain that are believed to regulate circadian rhythms, or sleep/wake cycles.

"Blind individuals with no light perception do not receive external light and darkness signals that synchronize our internal body clocks... Vanda Pharmaceuticals' Press Release -

EISAI : JAPANESE CLINICAL TRIALS CONFIRM SAFETY AND EFFICACY OF INSOMNIA TREATMENT SEP-190

September 15, 2010 - EISAI PLANS TO SUBMIT MAA IN FISCAL 2010 - Eisai Co., Ltd. (Headquarters: Tokyo, President & CEO: Haruo Naito, “Eisai”) announced that clinical studies conducted in Japanese patients with insomnia have confirmed the efficacy and favorable safety profile of SEP-190 (generic name: eszopiclone). Based on these results, Eisai plans to submit a marketing authorization application in fiscal 2010 seeking approval of the agent to the Japan’s Ministry of Health, Labour and Welfare.

A Phase II/III clinical study (Study 126) with SEP-190 was conducted in Japan in patients with primary insomnia, in addition to a Phase III study (Study 150) in patients with insomnia. Study 126 evaluated the efficacy of SEP-190 in 72 adult patients with primary insomnia through an overnight polysomnography (PSG) and subjective evaluation. Results showed that, compared with placebo, SEP-190 statistically significantly reduced latency to persistent sleep (LPS), as measured by a PSG, and sleep latency (SL), as measured by subjective evaluation, the study’s two primary outcome measures. Study 150 evaluated the long term safety of SEP-190 in 325 adult and elderly patients with chronic insomnia caused by a variety of factors. Results of the study confirmed that the agent has a favorable safety profile.
SEP-190 is a non-benzodiazepine type GABAA agonist (non-benzodiazepine sedative hypnotic) discovered and developed by Sepracor Inc.,... Eisai's Press Release -

ResMed : Study Shows its New CPAP Device Increases Patient Compliance

Sept 16, 2010 - Clinical study confirms new features of S9 Series prolong patients' sleep by up to 30 minutes - ResMed (NYSE: RMD), a leading developer, manufacturer, and distributor of sleep and respiratory medical equipment announced the results of a clinical study confirming that patients' compliance with sleep therapy increases when using ResMed's new CPAP device.
The clinical study of 50 patients suffering from sleep apnoea showed an improvement of 30 minutes in average daily usage, from a mean of 6 hours 35 minutes on the patient's usual CPAP device, to 7 hours 5 minutes, when using the new S9 Series.
Sleep apnoea is one of the more common, and yet highly undiagnosed, sleep disorders. Obstructive sleep apnoea (OSA) is the most common type of sleep apnoea and is marked by the collapse or obstruction of the airway during sleep. The most effective treatment is Continuous Positive Airway Pressure (CPAP) therapy. In this non-invasive treatment, air is pressurised by a small device and delivered to the airway of the patient through a mask that fits on/over the nose, or nose and mouth. The pressurised air keeps the upper airway open and helps the person to get a restful night without interruptions caused by apnoeas... ResMed's Press Release -

SOMAXON PHARMACEUTICALS : SILENOR® CO-PROMOTION AGREEMENT WITH PROCTER & GAMBLE

August 25, 2010 − Somaxon Pharmaceuticals, Inc. (Nasdaq: SOMX) announced that Somaxon and Procter & Gamble (NYSE: PG) have entered into a co-promotion agreement for Silenor® (doxepin), a newly-approved treatment for insomnia characterized by difficulty with sleep maintenance.
Under the terms of the agreement, Somaxon and Procter & Gamble will co-promote Silenor with a combined 215 sales representatives in the U.S. market. Procter & Gamble’s professional health care sales force will promote Silenor to targeted primary care and other high-prescribing physicians.

Somaxon’s focus will be on specialists and other top-decile physicians who treat insomnia. In addition, Procter & Gamble will promote Silenor to targeted pharmacies and will provide supplemental managed care support services for Silenor. Somaxon has also granted Procter & Gamble a right of first negotiation relating to rights to develop and market Silenor as an over-the-counter medication in the U.S... [PDF] Somaxon Pharmaceuticals' Press Release -

Cardiac Concepts : First Patients in Pilot Trial in Europe for the RespiCardia System

July 7, 2010 - Trial Underway for the First Implantable System to Treat Heart Failure Patients with Central Sleep Apnea - Cardiac Concepts, Inc., a developer of medical devices to treat Heart Failure patients who experience breathing disturbances during sleep, announced enrollment of the first European patients in a Pilot Clinical Trial. The purpose of the Pilot Study is to understand the respiratory and cardiac benefits of the RespiCardia™ System when treating a breathing disorder known as Central Sleep Apnea (CSA) in Heart Failure patients. Prof. Piotr Ponikowski, Principal Investigator of the Pilot Clinical Trial at The Medical University/4th Military Hospital in Wroclaw, Poland, commented that the system was successfully implanted in 2 male patients, ages 57 and 68 years with ischemic cardiomyopathy and symptoms of moderate heart failure. Despite optimal medical management, both experienced severe sleep breathing disorders. The trial is a 40 patient study being conducted in a number of centers worldwide. Implants are expected to begin in the United States in the coming months.
The RespiCardia System is an implantable device using small, electrical pulses designed to restore more natural breathing patterns in patients with sleep disordered breathing. This respiratory management therapy may also improve Heart Failure and patients’ quality of life. The RespiCardia system is the first implantable device to treat Central Sleep Apnea... [PDF] Cardiac Concepts' Press Release -

Jazz Pharmaceuticals : Update on FDA Advisory Committee Meeting For JZP-6 (Sodium Oxybate) in Fibromyalgia

Aug 20, 2010 - Jazz Pharmaceuticals, Inc. (Nasdaq: JAZZ) announced that the Joint Advisory Committee of the U.S. Food and Drug Administration (FDA), including the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee, voted 20-2 that the benefit/risk balance did not support the approval of JZP-6 for the treatment of fibromyalgia with the currently proposed Risk Evaluation Mitigation Strategy (REMS).

"While we are disappointed with the recommendation of the Joint Advisory Committee, we plan to work closely with FDA on the continuing review of our new drug application (NDA)," said Bruce Cozadd, Chairman and CEO of Jazz Pharmaceuticals, Inc. "We will carefully consider the input of the Committee as we seek to address the needs of fibromyalgia patients for new treatment options in a safe and responsible way."... Jazz Pharmaceuticals' Press Release -

Air Liquide : Acquisitions in homecare in Australia and South Korea

07/22/2010 - Air Liquide, which ranks 1st in Europe and 3rd in the world for homecare, continues to develop its offer of services through targeted acquisitions -
The market for homecare is growing throughout the world. Air Liquide, which ranks 1st in Europe and 3rd in the world for homecare, continues to develop its offer of services through targeted acquisitions in Australia and South Korea.

Air Liquide announces the acquisition in Australia of 70% of the company Snore Australia, a major player in the field of sleep diagnosis. These diagnoses help to identify and assess the degree of disorders in conditions such as sleep apnea.


Created ten years ago, this company makes over 15,000 sleep diagnoses per year in its thirteen sleep laboratories. With 72 employees, its annual revenue amounts to €5.6 million. In Australia, it is estimated that around 480,000 people suffer from sleep apnea, of which only 25% have been diagnosed to date.

Air Liquide also announces the acquisition of 70% of Medions Homecare, the leading South-Korean company in home ventilation. Created in 1989, Medions Homecare treats around 400 patients thanks to a team of 18 people, for an annual revenue of €3 million. Air Liquide will use the acquisition of Medions Homecare as a basis for developing its home oxygen therapy and sleep apnea activities in this country of 48 million inhabitants. The market for homecare in South Korea is growing by more than 15% every year... Air Liquide's Press Release -

Nonin Medical Recognized as a Supplier to the Award-Winning Philips Respironics Alice© PDx™ System

June 10, 2010 - Nonin Medical, Inc., a leading innovator of noninvasive physiological monitoring solutions, announced that it is a named supplier for a 2010 Medical Design Excellence Award winning product—the Philips Respironics Alice© PDx™ Diagnostic System.

The Alice© PDx™ portable diagnostic recording device is intended for Obstructive Sleep Apnea screening, follow-up and diagnostic assessment of cardio-respiratory sleep disorders. It enables patients to be tested outside of the lab without compromising study results and helps clinicians avoid the costs associated with retesting.


Incorporating Nonin Medical’s proven PureSAT® pulse oximetry (SpO2) technology, the Alice PDx system uses Nonin’s OEM III SpO2 module. An easy-to-integrate oximetry solution, the OEM III module’s compact design, power efficiency and expanded output capabilities provides manufacturers with dependable, accurate performance and maximum flexibility... Nonin Medical's Press Release -

Philips Respironics : Prestigious GSMA Award

March 3, 2010 - Philips Respironics and Cinterion Wireless Modules Win Prestigious GSMA Award for Best Embedded Mobile End-to-End Service – Royal Philips Electronics (NYSE: PHG, AEX: PHI) and Cinterion Wireless Modules, the global leader in cellular machine-to-machine (M2M) communication modules, announced that the Philips Respironics System One sleep therapy solution won the prestigious Best Embedded End-to-End Service Award, part of the GSMA’s Embedded Mobile Competition. The M2M solution integrates one of Cinterion’s award-winning Evolution Platform modules and, for the first time, marries mobility and reliable two-way wireless communications with significant advancements in sleep apnea therapy to help millions of patients and their healthcare providers who must meet rigorous new reporting standards. The device currently operates on the nPhase AT&T network in the U.S. and will roll out in markets around the world over the coming year.

Sleep apnea is a potentially life threatening condition that occurs when a person repeatedly stops breathing during sleep. System One provides treatment by delivering a specific flow of pressurized air through a mask to keep the airway open. The new solution integrates Cinterion’s award-winning TC65i module to enable two-way, anywhere wireless communication between the patient’s device and doctor. The Cinterion module sends sophisticated patient breathing data from the device to a secure EncoreAnywhere™ Web-based platform. Physicians log on to EncoreAnywhere to obtain timely, detailed breathing reports and respond with prescription air pressure changes sent instantly over-the-air to the device providing immediate patient relief. Cinterion’s TC65i module provides on-board memory to store reports that detail every breath a patient takes for up to five days... Philips Respironics' Press Release - Cinterion Wireless Modules' Press Release -

Chelsea Therapeutics : Positive Interim Analysis of Phase II Trial of Droxidopa in Fibromyalgia

July 1, 2010 - Independent Data Monitoring Committee Sees Meaningful Efficacy in Multiple Treatment Arms Trial Focusing on Novel Droxidopa/Carbidopa Combination Therapy No Significant Adverse Events or Safety Concerns Observed in Any Treatment Arm - Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) announced the completion and favorable outcome of an independent Data Monitoring Committee (DMC) review of the safety and efficacy data from approximately half the target enrollment in Chelsea's Phase II trial of droxidopa in fibromyalgia.

The purpose of this scheduled DMC meeting was to review the efficacy of each dose group and determine if the efficacy data supported dropping underperforming arms in order to increase the power in those arms most likely to demonstrate a clinically relevant therapeutic benefit. Following their assessment of each of the 12 arms using the study's primary endpoint, a reduction in pain as measured by the Short Form McGill Pain Questionnaire, the DMC recommended that 7 of the 12 arms of the trial be continued to completion. This recommendation was based solely on their efficacy analysis, as there were no observed safety concerns associated with any arm of the study. As a result of this recommendation, the study will now focus primarily on multiple doses of droxidopa in combination with 50mg carbidopa.

"The DMC's recommendation aligns with our assumption going into the trial that by pairing droxidopa with carbidopa to limit peripheral metabolism of droxidopa, we should be able to drive efficacy of droxidopa in the treatment of fibromyalgia... Chelsea Therapeutics' Press Release -

Weinmann's NP 15 : New Sleep Apnea Mask

19 April 2010 - Weinmann kicks off international sales of its new nasal pillow mask NP15. The name reveals the mask's distinguishing feature: the sound level of the mask at 15 dB(A) makes it by far the quietest mask for its application.

Based on its examination of several international studies on the human face, Weinmann has developed a mask fit for NP 15 that offers great wearing comfort and thus improves patient compliance with therapy. Other innovative features that promote patient comfort and therapy efficiency include very flexible anchoring options and tube guidance, which lets the patient direct the tube over his head or along the side of his head and fix it in place. Two ball-and-socket joints give the patient unlimited freedom of movement while keeping the mask firmly on the face... [PDF] Weinmann's Press Release -

Merck : Results Presented from Phase IIb Clinical Study of its Investigational Insomnia Therapy MK-4305

June 9, 2010 - Data Reported at SLEEP 2010 24th Annual Meeting of the Associated Professional Sleep Societies – Clinical results from a Phase IIb study showed that MK-4305, Merck's investigational dual orexin receptor antagonist, was significantly more effective than placebo (p inf. 0.005) in improving overall sleep efficiency at night one and at the end of week four in patients with primary insomnia. MK-4305 was generally well-tolerated in the study. Orexins are neuropeptides (chemical messengers) that are released by specialized neurons in the hypothalamus region of the brain and are believed to be an important regulator of the brain’s sleep-wake process. The data were presented for the first time at the SLEEP 2010 24th Annual Meeting of the Associated Professional Sleep Societies.

Phase III trials studying the efficacy and safety of MK-4305 in elderly and non-elderly insomnia patients are ongoing. Merck anticipates filing regulatory applications for MK-4305 in 2012.

"Since the discovery and characterization of orexin over the past decade as an important component of the sleep-wake system, Merck has been actively committed to discovering and developing potential interventions for sleep disorders that target the orexin receptors. We are encouraged by these phase II results showing positive effects of MK-4305 in patients with primary insomnia,”... Merck's Press Release -

Covidien : Definitive Agreement to Sell Sleep Therapy Product Line

Jun 01, 2010 - Covidien Announces Portfolio Management Activities - Definitive Agreement to Sell Sleep Therapy Product Line - Completion of Sale of U.S. Radiopharmacies - Covidien (NYSE: COV), a leading global provider of healthcare products, announced a definitive agreement to sell its Sleep Therapy continuous positive airway pressure (CPAP) and Bi-level products to PH Invest, a privately held company located in Luxembourg.

PH Invest will acquire the CPAP and Bi-level products, including the Nancy, France manufacturing facility, as well as related commercial operations in Europe. Several products, which are sold under the GoodKnight(TM) and Sandman(TM) brands, are included in this agreement. The agreement excludes the sleep interface products sold and marketed under the brand names Adam(TM), Breeze(TM) and Dreamfit(TM), which will continue to be sold by Covidien. Financial terms of this transaction were not disclosed... Covidien's Press Release -

Sanofi-aventis and Nichi-Iko Pharmaceutical : New Joint Venture for Generics in Japan

May 28, 2010 - Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) and Nichi-Iko Pharmaceutical Co., Ltd. (Nichi-Iko) (Osaka Stock Exchange and Nagoya Stock Exchange: NIK) announced that they have signed an agreement to establish a new joint venture, called sanofi-aventis Nichi-Iko K.K., in order to develop a generic business in Japan.
The new joint venture will be held at 51% by sanofi-aventis K.K. and at 49% by Nichi-Iko. In addition, sanofi-aventis will acquire 1,524,500 shares of Nichi-Iko, to be issued through a third-party allocation, and as a result will hold 4.66% of Nichi-Iko. Nichi-Iko is the leader and fastest growing generics company in Japan, with 2009 sales reaching 54.8 billion JPY - around 460 million Euros...

[...]



...As a first step, the joint venture will take over the marketing and distribution rights in Japan for the antiinsomnia agent Amoban (zopiclone) from sanofi-aventis K.K. AmobanTM sales reached 5.1 billion Yen - or 43 million Euros* in 2009. Nichi-Iko will ensure the promotion and distribution of AmobanTM through its large network of pharmacies, wholesalers and medical institutions... [PDF] Sanofi-aventis' Press Release - [PDF, Japanese] Nichi-Iko Pharmaceutical's Press Release -

Allergan and Serenity Pharmaceuticals : Agreement for the Treatment of Nocturia

Apr 01, 2010 -- Allergan, Inc. (NYSE: AGN) and Serenity Pharmaceuticals, LLC announced a global agreement for the development and commercialization of Ser-120, a Phase III investigational drug currently in clinical development for the treatment of nocturia, a common yet often under-diagnosed urological disorder in adults characterized by frequent urination at night time.
Under the terms of the agreement, Allergan receives exclusive worldwide rights to develop, manufacture and commercialize Ser-120. The agreement encompasses all potential indications except Primary Nocturnal Enuresis (pediatric bedwetting). Allergan will make an upfront payment to Serenity of $43 million, potential development and regulatory milestone payments of up to $122 million, future potential sales milestones, and royalty payments on worldwide sales... Allergan's Press Release -

Circadiance : NEW Wilderness Dream Series™ CPAP Masks

May 17, 2010 - Circadiance, the world leader in soft cloth nasal CPAP masks, announces two new colors for their revolutionary SleepWeaver mask – camouflage and leopard.

These Wilderness Dream Series colors represent the company’s deliberate decision to offer users more exciting choices in nasal CPAP masks, and wake up a sleepy industry with custom designs... Circadiance's Press Releases -

SPO Medical : Agreement In Sleep Apnea Market

March 9, 2010 - SPO Medical Inc. (SPOM), a leading developer of biosensor and microprocessor technologies for use in portable monitoring devices, announced it has signed a Memorandum of Understanding (MOU) with MetroSleep Inc, a US corporation that specializes in products to diagnose and treat sleep apnea through at-home testing. The MOU enables the integration of SPO Medical’ ASIC chip-set technology in a new MetroSleep product offering for the Sleep Disturbance Breathing (SDB) monitoring market. The terms include an advance licensing fee and a subsequent royalty payment to SPO once the products are commercially available. In addition, MetroSleep will remunerate SPO on a usage-fee basis via SDB devices that are deployed by MetroSleep in the market. The MOU provides that the parties shall enter into legally binding agreements upon MetroSleep receiving required funding for launch of the products... [PDF] SPO Medical's Press Release -

SomnoMed : New Product Line to Treat Sleep Bruxism

19th January 2010 - SomnoMed, the world’s leading dental sleep appliance company, announced the launch of SomnoMed Brux (SomBrux™), an innovative new range of products treating sleep bruxism. Sleep Bruxism (“SB”) is a common sleep-related movement disorder that is characterised by clenching or grinding of the jaws or teeth.
Medical studies indicate a prevalence of approximately 8% in the adult population of western societies and an equal occurrence in men and women. The condition is currently treated with a wide range of products, mostly individually made by dental technicians. Based on company research, the global market is currently in excess of 2 million units per year, representing a wholesale value of around US$ 200 to $300 million, with an annual growth tendency of 8 to 12%.
The new SomnoMed Brux product line will be introduced in Australia in February 2010, followed during the year by launches in all major global markets where SomnoMed is represented. SomBrux™, like the leading SomnoDent® device treating sleep apnea, is custom made and offered in various designs. It is expected that one of its unique selling points is the use of SomnoMed’s SMH BFlex material, which offers unrivalled patient comfort and durability... [PDF] SomnoMed's Press Release -

Fisher & Paykel Healthcare : New CPAP Range

10 March 2010 - Fisher & Paykel Healthcare Corporation Limited (NZSX:FPH, ASX:FPH) announced that it has introduced into Australia and New Zealand its new ICON continuous positive airway pressure (CPAP) devices for the treatment of obstructive sleep apnea (OSA).
The ICON range integrates Fisher & Paykel Healthcare’s leading technologies into stylish, compact and intelligent devices to deliver a better night’s sleep for OSA patients. The F&P ICON also includes a digital clock, alarm and music playing capabilities to enhance patient adaptation to CPAP therapy.
“The ICON combines both exceptional style and technology to fit unobtrusively into the home setting. It has a very small footprint and incorporates our innovative technologies including, SmartStick, ThermoSmart and SensAwake”... [PDF] Fisher & Paykel Healthcare's Press Release -

MicroLight : laser treats fibromyalgia

April 19, 2010 - MicroLight Corporation of America : laser treats fibromyalgia - Fibromyalgia is a condition in which the brain processes pain in an abnormal way, resulting in chronic, widespread muscular-skeletal pain and chronic fatigue. This condition effects millions of Americans and has been poorly understood and under diagnosed, resulting in billions of dollars in cost to our health care system. In the past, treatments have been primarily with medications; often side effects can make the symptoms worse.

The LOW LEVEL LASER used is the Patented ML830® which was the first “low level Laser” approved by the FDA in 2002 to treat pain and swelling. The Laser produces no heat to the tissue and causes vassal dilation in the Micro Capillary bed, the treatment is PAINLESS WITH NO SIDE EFFECTS... MicroLight Corporation of America's Press Release -

Ferring Pharmaceuticals : Wake Up to Nocturia - Studies Reinforce Serious Associated Risk of Nocturia

19 April 2010 – Study results discussed at the European Association of Urology (EAU) Congress in Barcelona, have reinforced the association between nocturia and a greater risk of falls and mortality.



In a population-representative study in Japan by Nakagawa et al, it was concluded that adults who suffered from nocturia (defined as two or more episodes of voids/urination per night) had a significantly increased risk of mortality when compared to adults without nocturia, even once adjustments had been made for other contributing factors (e.g. age, gender, physiological conditions)... Ferring Pharmaceuticals' Press Release -

Cephalon : Complete Response Letter for NUVIGIL for the Treatment of Excessive Sleepiness Associated with Jet Lag Disorder

March 29, 2010 - Cephalon, Inc. (Nasdaq: CEPH) announced the company has received a Complete Response letter from the U.S. Food and Drug Administration (FDA) for its supplemental new drug application for NUVIGIL(R) (armodafinil) Tablets [C-IV] in the treatment of patients with excessive sleepiness associated with jet lag disorder resulting from eastbound travel.

As the first company to study a treatment option to improve wakefulness associated with jet lag disorder, Cephalon worked closely with the FDA to design a special protocol assessment (SPA) that would evaluate the experience of a typical eastbound airline traveler... Cephalon's Press Release -

Arena Pharmaceuticals : Initiation of Phase 1 Clinical Trial of APD916 for Narcolepsy and Cataplexy

March 24, 2010 - Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) announced the initiation of patient screening in a Phase 1 clinical trial of APD916, a novel oral drug candidate discovered by Arena that targets the histamine H3 receptor for the treatment of narcolepsy and cataplexy.

"There is a need for better tolerated, more effective therapies for narcolepsy, especially narcolepsy with cataplexy,"... Arena Pharmaceuticals' Press Release -

SOMAXON : FDA APPROVAL OF SILENOR® (DOXEPIN) FOR THE TREATMENT OF INSOMNIA

March 18, 2010 − Somaxon Pharmaceuticals, Inc. (Nasdaq: SOMX) announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Silenor® (doxepin) for the treatment of insomnia characterized by difficulty with sleep maintenance.
Sleep maintenance difficulty, defined as waking frequently during the night and/or waking too early and being unable to return to sleep, is the most commonly reported nighttime symptom of insomnia. Silenor is approved for the treatment of both transient (short term) and chronic (long term) insomnia characterized by difficulty with sleep maintenance in both adults and elderly patients. In clinical trials, Silenor demonstrated maintenance of sleep into the 7th and 8th hours of the night, with no meaningful evidence of next day residual effects... [PDF] Somaxon Pharmaceuticals' Press Release -

GE’s Virtual Sleep Lab Enables Sleep Apnea Testing in Hospitalized Cardiac Patients

March 16, 2010--GE Healthcare introduced MARS® Virtual Sleep Lab (VSL), the first device to provide a streamlined view of quantitative cardiac and sleep apnea analysis from any GE-monitored inpatient bed, helping enhance speed of diagnosis. MARS VSL is being featured at the American College of Cardiology (ACC) 59th Annual Scientific Session, held March 14 to 16 in Atlanta.

Integrating a sleep disorder diagnostic tool into hospital cardiac care represents an important advance, as obstructive sleep apnea (OSA) impacts up to 50 percent of all heart disease patients.1 When sleep disorders are diagnosed and treated early, it has been shown to improve cardiac conditions. Left undiagnosed, sleep apnea can increase heart disease risks... GE Healthcare's Press Release -

ImThera Medical Successfully Implants First Patients with Neurostimulation Device to Treat OSA

December 1, 2009 – ImThera Medical, Inc. announced that two patients have been surgically implanted with ImThera’s aura6000™ neurostimulation device for treating tongue‐based Obstructive Sleep Apnea (OSA).
Patients are being enrolled in ImThera’s pilot clinical investigation in Belgium with the first results expected to be published in the first half of 2010. The patients were implanted with the aura6000, during which the hypoglossal nerve was briefly stimulated to verify system and nerve integrity. One week postsurgery, the patients underwent an in‐laboratory Polysomnography (PSG) titration process during which stimulation parameters were determined in order to maintain proper tongue position and to provide an open airway during sleep.
“The surgical procedures went smoothly, taking approximately 90 minutes to complete. There were no surgical complications; minor surgical issues were quickly resolved. At one week, patients were not disturbed by the implanted stimulator, lead or electrode,”...[PDF] ImThera Medical's Press Release -

Lupin : FDA tentative approval for Eszopiclone tablets

March 20, 2010 - Pharma Major, Lupin Limited announced that its U.S subsidiary, Lupin Pharmaceuticals, Inc. (LPI) has received tentative approval for the Company’s Abbreviated New Drug Application (ANDA) for Eszopiclone tablets, 1 mg, 2 mg and 3 mg from the U.S. Food and Drug Administration (USFDA).

Lupin’s Eszopiclone tablets are the AB-rated generic equivalent of Sepracor’s LUNESTA® tablets, indicated for the treatment of insomnia. The brand product had annual sales of approximately $761 million for the twelve months ended December 2009, based on IMS Health sales data... Lupin Pharmaceuticals' Press Release -

Vantia Therapeutics' lead candidate VA106483 enters Phase IIb trial for nocturia.

2nd February 2010 – Vantia Therapeutics, an emerging pharmaceutical company developing novel, small molecule drugs targeting large, underserved medical markets, today announces it has begun its planned Phase IIb trial of its lead development compound VA106483 for nocturia. The study is a randomised, double‐blind, placebo‐controlled study and is expected to recruit approximately 120 male patients at 20 centres in the US. The study will primarily assess number of nocturnal voids per night. Secondary endpoints include quality of life and sleep duration measures.
Nocturia (defined as waking to urinate at night thereby significantly disturbing sleep) is a common condition, with prevalence increasing markedly with age. It is often the presenting symptom in men with benign prostatic hypertrophy (BPH) and affects at least 70% of BPH patients. There are currently significant limitations in the treatment for nocturia and it represents a potential market estimated at more than US$1 billion... [PDF] Vantia Therapeutics' Press Release -

ResMed : Next-Generation CPAP Series in Europe

Feb 22, 2010- The S9 Series Offers More Comfort & Sleek Design; New CPAP Expected to Increase Patient Compliance - ResMed (NYSE:RMD), a leading developer, manufacturer, and distributor of sleep and respiratory medical equipment, introduced its new cutting-edge sleep apnoea therapy platform called the S9 Series in Europe. The S9 Series combines a sleek design with superior functionality and more comfort. Combined climate control and humidification delivers unsurpassed comfort to the patient by controlling both the temperature and humidity that the patient breathes. The S9 Series is expected to help more sleep apnoea patients adhere to the treatment, but also help sleep professionals make more informed decisions.

The most effective treatment for sleep apnoea is Continuous Positive Airway Pressure (CPAP) therapy. In this non-invasive treatment, air is pressurised by a small device and delivered to the airway of the patient through a mask that fits on/over the nose, or nose and mouth. The pressurised air keeps the upper airway open and helps the person to get a restful night without interruptions caused by apnoeas.

"With patients across the world in mind, we are thrilled to introduce a true revolution in positive airway pressure therapy," ... ResMed's Press Release -

Apnex Medical : Additional $14 Million

December 2, 2009 - Apnex Medical, Inc., a private medical device company, announced that it has completed a second round of private equity financing totaling $14 million. The funds will be used to complete a clinical study and develop a second generation of its proprietary implantable technology designed to treat obstructive sleep apnea (OSA).
Participants in the financing include Domain Associates, New Enterprise Associates (NEA), Polaris Venture Partners and Michael Berman. The current board includes Robert Atkinson, CEO, and Michael Berman, Chairman, together with Brian Chee, John Nehra and Nimesh Shah representing Polaris, NEA and Domain, respectively. This financing brings the total investment in Apnex Medical to $30 million.
“We are very excited about the early results with the Apnex Hypoglossal Nerve Stimulation (HGNS™) System in our clinical study. Our technology really has the potential to change the lives of people suffering from OSA. This round of financing will allow us to finish our initial clinical study and get us that much closer to market,”... [PDF] Apnex Medical's Press Release -

VIVUS : Positive Results From Phase 2 Study of Qnexa in Obstructive Sleep Apnea

Jan 07, 2010 - Qnexa Treatment Results in 69% Reduction in Sleep Apnea Events - VIVUS, Inc. (Nasdaq: VVUS) announced positive results from a phase 2 study evaluating the safety and efficacy of Qnexa(R), an investigational drug, for the treatment of obstructive sleep apnea (OSA). VIVUS recently completed phase 3 development of Qnexa for the treatment of obesity and submitted a New Drug Application (NDA) to the FDA for that indication. The study announced today demonstrated statistically significant improvement in the apnea/hypopnea index ("AHI" - a measure of the severity of sleep apnea) in patients with OSA treated with Qnexa for 28 weeks. Qnexa-treated patients also experienced significant weight loss, improvements in blood pressure, and overnight blood oxygen levels. OSA is a sleep-related breathing disorder that involves a decrease or complete halt in airflow despite an ongoing effort to breathe. OSA is associated with an increased risk of hypertension, diabetes, stroke, sudden cardiac death and all-cause mortality. Approximately 18 million Americans have sleep apnea... VIVUS' Press Release -