Philips strengthens home healthcare portfolio with acquisition of main business of medSage Technologies

January 6, 2011 - Royal Philips Electronics (AEX: PHI, NYSE: PHG) announced that it has acquired substantially all of the assets of medSage Technologies LLC, a leading provider of patient interaction and management applications (“medSage Technologies”). The acquisition will allow Philips to offer a web-based solution that enables home care providers to manage ongoing compliance and replenishment services for individuals under treatment for obstructive sleep apnea (OSA), diabetes, respiratory and other conditions. The acquired business will become part of the Sleep business within Philips Home Healthcare Solutions.

“We believe the need to manage chronic diseases by an aging population, coupled with health economics, will continue to drive a greater need for healthcare delivery at home,” said Steve Rusckowski, CEO of Philips Healthcare. “This acquisition is fully aligned to our strategy of providing home care providers with new opportunities to enhance their service offerings with an effective and cost-efficient application.” Philips' Press Release -

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 -