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Wednesday, July 4, 2012

Omron Launches Sleep Monitor With ResMed Technology

Omron
SAN DIEGO, May 23, 2012 - The Omron Sleep Design HSL-101 offers wireless sleep monitoring and connection to Wellness Link - ResMed Inc. (NYSE:RMD) announced the launch of the first product in Japan using technology from its recently acquired company, BiancaMed. The product, launched by BiancaMed partner Omron Healthcare, is a new wireless sleep monitoring device. The Omron Sleep Design HSL-101 is part of a new strategy by Omron, named "All for Healthcare."
ResMed

How Omron Sleep Design Works

The device uses ResMed technology to offer wireless, non-contact sleep monitoring which in turn connects to health care support services in Japan. To use the Omron Sleep Design HSL-101, a patient places the device beside the bed. With ResMed's non-contact sensing technology, the device measures sleep throughout the night and can report key sleep quality metrics, such as sleep onset time and total sleep time. In the morning, users can generate a full report on the night's sleep with the push of a button. When the data is connected to the cloud as part of Omron's Wellness Link service, a full picture of sleep health is provided, alongside a customized summary of health tips and advice... ResMed's Press Release -

Thursday, May 17, 2012

Somaxon and CJ CheilJedang : Silenor® Collaboration in South Korea

Somaxon Pharmaceuticals
April 27, 2012 - Somaxon Pharmaceuticals, Inc. (Nasdaq: SOMX) and CJ CheilJedang Corporation announced that they have entered into an exclusive collaboration under which CJ CheilJedang will commercialize Silenor® (doxepin) for the treatment of insomnia in South Korea.

CJ CheilJedang

Under the terms of the agreements, Somaxon will receive an up-front payment of US$600,000. CJ CheilJedang will be responsible for regulatory submissions for Silenor and will have the exclusive right to commercialize Silenor in South Korea. Once Silenor is approved in South Korea, Somaxon will also be eligible to receive sales-based milestone payments as well as a royalty based on net sales of Silenor in South Korea. Somaxon will also supply CJ CheilJedang's requirements for commercial quantities of Silenor in South Korea at a separate transfer price... Somaxon Pharmaceuticals' Press Release -

Thursday, April 19, 2012

Zephyr Sleep Technologies : FDA 510 (k) Clearance for MATRx™

Zephyr Sleep Technologies
March 28, 2012 - Zephyr Sleep Technologies Inc. (Zephyr) is pleased to announce that they have been granted 510(k) clearance from the U.S. Food and Drug Administration (FDA) to begin selling the MATRx medical device system.

The MATRx system will be used in sleep laboratories to identify patients that will be successful with oral appliance therapy while establishing the protrusive position of the lower mandible for effective therapy. “The MATRx system changes the way oral appliance therapy is prescribed, bringing the knowledge and expertise of both Sleep Physicians and Dentists into the therapy decision much earlier. This new technology will certainly change how things are done” says Paul Cataford, Zephyr’s President & CEO.

A MATRx study is performed in a sleep laboratory by a sleep technician in conjunction with a polysomnographic study (“PSG test”). Using this new technology Sleep Physicians will, for the first time, be able to reliably predict the effectiveness of oral appliance therapy as a treatment for obstructive sleep apnea patients. This clears the way for Sleep Physicians to confidently prescribe oral appliance therapy in advance of patients being fitted with an oral appliance. MATRx also provides Sleep Dentists with an effective target protrusive position for the lower mandible. This enables dentists to fit oral appliances with confidence in therapeutic outcome while eliminating the need for an iterative titration process that previously could take weeks.

“Understanding a patient’s airway response to mandibular protrusion is a critical component of confidently prescribing and administering oral appliance therapy. The MATRx study offers many features that are comparable to and commensurate with the traditional continuous positive airway pressure study (“CPAP study”). In fact, the two studies can now work hand-in-hand to optimize sleep apnea management.” says Zephyr’s Chief Medical Officer, Dr. John Remmers.

SomnoMed

In Dec 2010, Zephyr signed an exclusive worldwide distribution agreement with SomnoMed Limited to market and sell this device under the name SomnoMed MATRx... [PDF] Zephyr Sleep Technologies' Press Release -

Monday, April 2, 2012

Teva : Launch of Authorized Generic of Provigil

Teva Pharmaceutical
Mar. 30, 2012-- Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announces the launch of the authorized generic of Provigil® (modafinil). Provigil® is marketed by Cephalon, Inc., a wholly owned subsidiary of Teva Pharmaceutical Industries Ltd.

This product will continue to be manufactured under the brand product's new drug application at the same facility where it is currently produced. Shipping of the product has commenced... Teva Pharmaceutical's Press Release -

Monday, March 19, 2012

CareFusion and Fisher & Paykel Healthcare Renew Exclusive Distribution Agreement for U.S. Hospital Market

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Feb. 8, 2012 - CareFusion, a leading, global medical technology company, and Fisher & Paykel Healthcare, a leading designer, manufacturer and marketer of products and systems for use in respiratory care, acute care and the treatment of obstructive sleep apnea, announced a three-year renewal of their longstanding agreement providing CareFusion the exclusive right to distribute Fisher & Paykel Healthcare products into the U.S. hospital market.

"For more than 25 years, we have partnered with Fisher & Paykel Healthcare to bring its portfolio of clinically differentiated respiratory solutions to U.S. hospitals," said Vivek Jain, president of the Procedural Solutions segment for CareFusion. "As we extend and strengthen our strategic relationships with proven partners like Fisher & Paykel Healthcare, our customers benefit from continued access to market-leading technologies that help improve the cost, quality and safety of patient care."

Fisher and Paykel Healthcare

Under the agreement, CareFusion, through its AirLife™ Respiratory Consumables business, will continue to serve as the exclusive U.S. distributor of Fisher & Paykel Healthcare's extensive portfolio of respiratory consumable products, including the MR850 Heated Humidification System with Evaqua™ circuit technology, AIRVO™ high flow device, Optiflow™ nasal cannula, and FlexiFit™ non-invasive interfaces... CareFusion's Press Release -

Thursday, March 8, 2012

HypnoCore : SleepRate - Sleep Monitoring Solution



February 5, 2012 - SleepRate aims to revolutionize the field of sleep, utilizing web, mobile, and consumer devices, to allow accurate and affordable access to sleep diagnostics solutions for the consumer market.

SleepRate on YouTube- HypnoCore's website -

Monday, February 6, 2012

Merck : Update on Development Program for Suvorexant, an Investigational Orexin Receptor Antagonist for the Treatment of Insomnia

Merck
Feb. 6, 2012 - Company Confirms Plans to File NDA for Suvorexant in 2012 -

Merck (NYSE:MRK), known as MSD outside the United States and Canada, provided an update on the development program for suvorexant, the company's investigational orexin receptor antagonist, which, if approved, will be a new mechanism for the treatment of insomnia. The two pivotal Phase III efficacy trials for suvorexant have been completed and, based on the positive results of these studies, Merck plans to file a New Drug Application (NDA) for suvorexant with the U.S. Food and Drug Administration (FDA) in 2012.

Both Phase III studies were multicenter, randomized, double-blind, placebo-controlled clinical trials that evaluated suvorexant compared to placebo in adult patients ages 18 years and older. The primary endpoint was change from baseline in subjective total sleep time and time to sleep onset, wake time after persistent sleep onset, and latency to onset of persistent sleep at one and three months. Merck plans to submit these data for presentation at major medical meetings later this year... Merck's Press Release -

Wednesday, January 25, 2012

Alfresa Pharma and Mitsubishi Tanabe Pharma : Approval of Additional Indication for MODIODAL® Tablets 100 mg a Sleep Disorder Treatment

Alfresa Pharma
November 25, 2011 - Alfresa Holdings Corporation (head office: Tokyo, Representative Director & President: Denroku Ishiguro) and Mitsubishi Tanabe Pharma Corporation (head office: Osaka, President & CEO: Michihiro Tsuchiya) announced that Alfresa Pharma Corporation (head office: Osaka, President & CEO: Kenichiro Iwaya), a subsidiary of Alfresa Holdings engaged in manufacture of pharmaceuticals etc., received approval of a partial change in the indications of MODIODAL® Tablets 100 mg (generic name: modafinil), a sleep disorder treatment, that has been jointly developed in Japan by Alfresa Pharma and Mitsubishi Tanabe Pharma.

Mitsubishi Tanabe Pharma

Since March 2007, MODIODAL® has been jointly marketed by the two companies as a treatment for excessive daytime sleepiness associated with narcolepsy, a sleep disorder characterized by intolerable daytime sleepiness. The new indication, approved for the first time in Japan, is “excessive diurnal sleepiness accompanied with obstructive sleep apnea syndrome (OSAS) under treatment for airway obstruction by continuous positive airway pressure (CPAP) therapy and the like”. The two companies expect MODIODAL® will contribute to improve quality of life of patients whose daily lives would otherwise be disrupted by excessive diurnal sleepiness in OSAS as well as narcolepsy.

MODIODAL® is currently approved in more than 30 countries in the world, and in seven countries, including the US, it is marketed with approval for the new indication... [PDF] Alfresa's Press Release - [PDF] Mitsubishi Tanabe Pharma's Press Release -

Wednesday, January 18, 2012

EISAI RECEIVES APPROVAL TO MARKET INSOMNIA TREATMENT LUNESTA® IN JAPAN

Eisai
January 18, 2012 - Eisai Co., Ltd. (Headquarters: Tokyo, President & CEO: Haruo Naito, “Eisai”) announced that it received approval from Japan's Ministry of Health, Labour and Welfare (MHLW) on January 18, 2012 to market Lunesta® (eszopiclone), a product the company has been developing in Japan, as a treatment for insomnia.

Lunesta, originally discovered and developed by Sunovion Pharmaceuticals Inc. (“Sunovion”; formerly Sepracor Inc., “Sepracor”; a U.S. subsidiary of Dainippon Sumitomo Pharma Co., Ltd.), has been marketed in the United States since April 2005. The agent was approved as the first insomnia treatment not to have restrictions on its length of use, and is widely used by individuals suffering from insomnia. Eisai has been pursuing the development of Lunesta since acquiring the exclusive rights to develop and market it in Japan from Sunovion (at the time known as Sepracor) in July 2007. The company submitted a marketing authorization application to the MHLW in November 2010.

Lunesta is a non-benzodiazepine type GABAA agonist that is believed to enhance GABA activity while exerting hypnotic and sedative effects. Results from clinical studies conducted in Japan and overseas demonstrated that the agent is effective in those patients who have trouble falling asleep or wake up often during the night, two major symptoms of insomnia. A distinctive feature of Lunesta is that patients do not experience clinically problematic issues such as dependency or carry-over effects or develop a tolerance (experience diminished efficacy) with long-term use... Eisai's Press Release -

Monday, January 9, 2012

Pfizer : Positive Results From Phase 3 Trial Of Lyrica (pregabaline) Capsules CV In Restless Legs Syndrome

Pfizer
December 16, 2011 - Top-Line Results Show Lyrica Met All Co-Primary Endpoints -
Pfizer Inc. (NYSE: PFE) announced that a Phase 3 study for Lyrica (pregabalin) in patients with Restless Legs Syndrome (RLS) met each of its three co-primary endpoints, showing significant benefit as compared with placebo and pramipexole. Pfizer will continue to further analyze these top-line results.

The study, A0081186, was a randomized, double-blind, 12-month trial. It enrolled more than 700 patients, who received either a placebo, Lyrica at 300 mg/day, pramipexole at 0.25 mg/day or pramipexole at 0.5 mg/day.

Patients treated with Lyrica experienced a statistically significant improvement compared with placebo in RLS symptom severity as measured by the International Restless Leg Group Rating Scale following 12 weeks of treatment. The Lyrica group also demonstrated a statistically significant improvement following 12 weeks of treatment in the proportion of patients responding to treatment compared with those on placebo as measured by the Clinical Global Impression Improvement scale. In addition, Lyrica treatment resulted in a statistically significant reduction in the rate of augmentation (worsening of RLS symptoms that occur after starting a medication to treat RLS) compared with pramipexole 0.5 mg/day over 12 months.

The results for this study indicate that the most common adverse events in Lyrica-treated patients were dizziness, somnolence, fatigue, headache and nasopharyngitis (inflammation of the nasal cavity and throat). The adverse event profile is consistent with that known for pregabalin.

Restless Legs Syndrome is a neurological condition that is characterized by an unpleasant irresistible urge to move the legs and, in severe cases, other parts of the body. The symptoms have a circadian pattern and occur mostly in the evening and bedtime. It often results in difficulty falling or staying asleep and can result in periodic limb movements while sleeping, causing partial awakenings that disrupt sleep. RLS has profound negative impact on patients’ quality of life... Pfizer's Press Release -