Orexo and Meda AB : The FDA has accepted for filing the registration application for Sublinox

July 29, 2008 - The submitted registration application for Sublinox^TM (OX22) has been accepted by the FDA as complete for substantive review after initial evaluation. Sublinox^TM contains the well-known active substance zolpidem and is based on Orexo´s sublingual technology, involving a rapidly disintegrating tablet placed under the tongue.



Meda AB acquired the exclusive world-wide commercialization rights for Sublinox^TM on April 14, 2008...
... The data supporting the product includes a clinical study in insomnia patients that was completed in October 2007... Orexo´s Press Release - [PDF] Meda AB's Press Release -

GE Healthcare : to Acquire Vital Signs, Inc., Expanding GE's Monitoring, Anesthesia and Respiratory Care Offerings

July 24, 2008 – GE Healthcare, a unit of General Electric Company (NYSE: GE), and Vital Signs, Inc. (NASDAQ: VITL) announced that they have entered into a definitive merger agreement for GE to acquire Vital Signs. Under the terms of the agreement, shareholders of Vital Signs will receive $74.50 per share in cash for each Vital Signs share they own.

Vital Signs is a global provider of medical products applicable to a wide range of care areas such as anesthesia, respiratory, sleep therapy and emergency medicine. Vital Signs has a broad product offering of innovative single-patient use products which offer significant cost advantages and improved patient care features, including reducing the potential of transmitting infections from one patient to another.

Vital Signs will become part of GE Healthcare’s Clinical Systems business, a world-class provider of advanced technologies for patient monitoring, anesthesia delivery and acute respiratory care. The strong strategic fit between the two businesses will offer substantial customer benefits through complementary product and service offerings... GE Healthcare's Press Release - Vital Signs' Press Release -

Chelsea Therapeutics : MHRA Approval to Begin Phase II Trial of Droxidopa in Fibromyalgia

July 23, 2008 - Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) has received approval from the United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) to begin a Phase II trial of Droxidopa, alone and in combination with carbidopa, for the treatment of Fibromyalgia.

Fibromyalgia is a chronic and debilitating condition that is characterized by widespread pain and stiffness throughout the body, accompanied by severe fatigue, insomnia and mood symptoms. While the precise etiology of fibromyalgia remains unknown, current research has focused on the role of norepinephrine (NE) reuptake and availability in the central nervous system. NE, a widely used neurotransmitter in the central and peripheral nervous systems has long been linked to both chronic pain and depression. Droxidopa, a synthetic amino acid, is converted by the body into norepinephrine and as a prodrug of NE, provides replacement therapy for NE deficiency. While NE, as a catecholamine does not penetrate the blood-brain barrier, droxidopa, as a neutral amino acid, is able to do so thus providing both a peripheral and central affect on circulating NE levels... Chelsea Therapeutics' Press Release -

Takeda : to Appeal EMEA Negative Opinion on ramelteon for the Treatment of Primary Insomnia

June 17, 2008 – Takeda Pharmaceutical Company Limited (“Takeda”) announced that its wholly owned subsidiary, Takeda Global Research & Development Centre (Europe) Ltd. (“TGRD(EU)”), has requested a re-examination of the opinion given by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA).

This request is in response to the negative opinion of May 30, 2008, in which the CHMP recommended the refusal of the marketing authorization in the EU for ramelteon in the treatment of patients with primary insomnia, since the CHMP was concerned that the effectiveness of ramelteon had not been demonstrated, which was measured considering only one aspect of insomnia, the time to fall asleep... Takeda's Press Release -

Neurogen : Suspension of Insomnia Study with Adipiplon

July 13, 2008 - Neurogen Corporation (Nasdaq: NRGN) announced that, as planned, it commenced a Phase 2/3 clinical trial in chronic insomnia patients with the Company's insomnia agent, adipiplon and that, based upon reports from initial dosing of a higher than anticipated rate of unwanted next day effects, the Company has suspended dosing in the study. Neurogen believes that the bilayer tablet formulation of adipiplon being used in the study may not be performing as expected.

The Company plans additional investigation of the bilayer tablet before proceeding further. In prior studies Neurogen has simultaneously administered various doses of both immediate release and controlled release forms of adipiplon. The current study is the first trial in which it has used the two forms laminated together into one bilayer tablet. In previous testing in over 600 subjects, adipiplon has been well tolerated... Neurogen's Press Release -

Actelion and GlaxoSmithKline : exclusive collaboration to realise the full potential of almorexant in sleep disorders and beyond

14 July 2008 - Actelion Ltd (SWX: ATLN) and GlaxoSmithKline (LSE and NYSE: GSK) announced that they have entered into an exclusive worldwide collaboration (excluding Japan) for Actelion's almorexant, an orexin receptor antagonist in phase III development with first-in-class potential as a treatment for primary insomnia.

Under the terms of the agreement, GSK will receive exclusive worldwide rights to co-develop and co-commercialise almorexant. Actelion will continue to lead the ongoing development programme and potential registration for almorexant in the first indication, primary insomnia, with GSK contributing 40 per cent of the costs.
Almorexant will also be studied in other orexin-related disorders and all costs related to these programmes will be shared equally... Actelion's Press Release - GSK's Press Release -

Vanda Pharmaceuticals : Phase III Data Show Tasimelteon (VEC-162) Significantly Improves Sleep in Patients with Chronic Insomnia

June 26, 2008 - Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) (Vanda) announced positive top-line results from a Phase III trial showing that its investigational drug candidate, tasimelteon (VEC-162), a novel melatonin agonist, met the primary endpoint of the trial and significantly improved sleep in adult patients with chronic insomnia.

We are excited that the results of this Phase III chronic insomnia study demonstrate the clinical utility of tasimelteon and the ability of the compound to treat sleep disorders over a period of four weeks. The mechanism of action of tasimelteon as a circadian regulator gives Vanda the opportunity to explore its use for the treatment of circadian rhythm sleep disorders as well as chronic primary insomnia... Vanda Pharmaceuticals' Press Release -