Somaxon and CJ CheilJedang : Silenor® Collaboration in South Korea

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.

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 -

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

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.

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 -

Teva : Launch of Authorized Generic of Provigil

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 -

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

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."

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 -

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 -

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

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 -

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

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.

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 -