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Tuesday, November 24, 2009

Astellas and XenoPort : Submission of a New Drug Application in Japan Requesting PMDA Approval of ASP8825/XP13512 for Restless Legs Syndrome

Astellas PharmaNov. 19, 2009-- Astellas Pharma Inc. and XenoPort, Inc. (NASDAQ:XNPT) announced that a new drug application (NDA) has been filed with the Pharmaceuticals and Medical Device Agency (PMDA) in Japan for ASP8825 (gabapentin enacarbil), also known as XP13512, as a potential treatment for restless legs syndrome (RLS).

XenoPortThe data supporting safety and efficacy in the NDA filing comes from the successful Phase 2 study in RLS patients and long-term safety study conducted by Astellas in Japan and the RLS clinical program conducted by XenoPort in the United States. The acceptance of filing of the NDA triggers a $5 million milestone payment from Astellas to XenoPort... [PDF] Astellas Pharma's Press Release - XenoPort's Press Release -

HiTech Pharmacal and NovaDel : Exclusive Agreement to Commercialize Sleep Aid in Oral Spray Form

Hi-Tech PharmacalNov. 16, 2009-- Hi-Tech Pharmacal Co., Inc. (NASDAQ: HITK) announced the signing of an exclusive licensing agreement between Hi-Tech’s ECR Pharmaceuticals subsidiary and NovaDel Pharma, Inc., a drug development company, through which ECR obtained the rights to market zolpidem tartrate oral spray, 5mg per spray, in the United States and Canada. Under the terms of the agreement ECR paid NovaDel $3 million upon closing. In addition NovaDel will receive a royalty of up to 15% on net sales, and a milestone payment if net sales reach a specific level in a calendar year.

NovaDel
The product, branded “Zolpimist™“ will be marketed by ECR Pharmaceuticals, Hi-Tech’s branded prescription pharmaceutical company. Zolpimist™ is an FDA approved product that is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation, and will be available only by prescription. Zolpimist™ is the only approved sleep aid which contains zolpidem tartrate in an oral spray form. In October 2009, NovaDel received a Notice of Allowance from the United States Patent and Trademark Office for claims under U.S. Patent Application No. 10/671,715, related to Zolpimist™. Once issued, the patent will expire in 2018. ECR plans to launch the product in the United States in the first half of calendar 2010... Hi-Tech Pharmacal's Press Release - NovaDel's Press Release -

CleveMed : International Distribution by Obtaining Sleep Diagnostic Product Registrations in More Nations Overseas

CleveMedMay 22, 2009 – Cleveland Medical Devices Inc. (CleveMed) announced that it has registered its sleep diagnostic devices in Colombia, Taiwan, Singapore, Malaysia and the Philippines, opening the door to product distribution in these countries.

CleveMed’s Division of Sleep Disorders offers complete wireless PSG systems, such as the 14-channel Crystal Monitor® PSG Series and the 22-channel Sapphire PSG™. The SleepScout™ is a type III monitor for home sleep testing. All four systems include Crystal PSG™ software, a user-friendly software package for data acquisition, scoring and reporting that are used by clinicians in the diagnosis of sleep disorders. The Crystal Monitor 20-S, Crystal Monitor 20-B and Sapphire PSG systems can all be upgraded with the iPSG Inpatient PSG System to allow for remotely attended sleep studies in hospital rooms. Due to the systems' compact size, wireless design, fast and simple system setup and rearrangement, they are uniquely suited not just for studies in the traditional sleep lab setting, but also for nontraditional sleep applications such as hospital inpatient testing for pre-surgical evaluation, nursing homes, "hotel sleep labs" and patients' homes... CleveMed's Press Release -

Friday, November 13, 2009

ResMed : Laboratoires Narval Acquisition

laboratoires narvalOct. 5 - 2009 - ResMed Inc. (NYSE: RMD), a leading developer, manufacturer and distributor of sleep and respiratory medical equipment, announced that it has acquired Laboratoires Narval. Based in France, Laboratoires Narval manufactures and distributes the Narval O.R.M.(TM), an innovative mandibular repositioning device (MRD) that offers a solution to patients for snoring and obstructive sleep apnea (OSA), especially for those with mild OSA.

ResMedWith this acquisition, ResMed adds another therapy to supplement its existing positive airway pressure-based solutions, providing a broader offering for this patient group. ResMed plans to commercialize this device in selected European markets... ResMed's Press Release -