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 -

Sunovion Pharmaceuticals Inc. : Company Name Change

October 12, 2010 - Sunovion Pharmaceuticals Inc. (Sunovion), formerly Sepracor Inc. (Sepracor), announced that it has formally changed its name. The change occurs on approximately the one year anniversary of the acquisition of Sepracor by Dainippon Sumitomo Pharma Co., Ltd. (DSP), an Osaka, Japan based pharmaceutical company. Sunovion integrates under one brand the distinct competencies of Sepracor and the former Dainippon Sumitomo Pharma America, Inc. (DSPA), the two U.S. operations of DSP.

“This is an exciting time for Sunovion Pharmaceuticals Inc. and we are poised to deliver on our vision to become a leading global pharmaceutical company known for scientifically-advanced products that improve the lives of patients”
“This is an exciting time for Sunovion Pharmaceuticals Inc. and we are poised to deliver on our vision to become a leading global pharmaceutical company known for scientifically-advanced products that improve the lives of patients,” said Mark Iwicki, President and Chief Operating Officer of Sunovion. “The meaning of Sunovion combines the strength of the sun with innovation and, for us, represents the start of a great new company. Launching our new corporate identity is a meaningful next step for our employees and partners who have contributed to our past success. We remain focused on our goal to grow our current brands and advance our pipeline candidates.”

In April 2010, DSPA, based in Fort Lee, N.J., merged into Sepracor consolidating DSP’s North American footprint in Marlborough, Mass. As Sunovion, the company will maintain corporate headquarters in Marlborough and critical R&D functions will continue in both Fort Lee and Marlborough. The company will maintain sales and marketing efforts for leading central nervous system and respiratory brands including LUNESTA.. [PDF] Sunovion Pharmaceuticals' Press Release - [PDF] Dainippon Sumitomo Pharma's Press Release -

Vanda Pharmaceuticals : Phase III Clinical Study Aimed at Resetting the Body Clock

Aug 26, 2010 - Study to Evaluate Effect on Sleep/Wake Cycle in Blind Individuals with Non-24-Hour Sleep Wake Disorder - Vanda Pharmaceuticals Inc. (Nasdaq: VNDA), announced it has initiated a Phase III clinical trial to evaluate tasimelteon in patients with Non-24-Hour Sleep Wake Disorder (N24HSWD), a condition experienced primarily by totally blind individuals that results in abnormal night sleep patterns and chronic daytime sleepiness. Tasimelteon binds to high affinity melatonin receptors located in the brain that are believed to regulate circadian rhythms, or sleep/wake cycles.

"Blind individuals with no light perception do not receive external light and darkness signals that synchronize our internal body clocks... Vanda Pharmaceuticals' Press Release -