Auspex Pharmaceuticals announces SD-1077 program for the potential treatment of Parkinson's disease

Company to acquire remaining worldwide rights to deuterium- containing levodopa through purchase of Imphar AG

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LA JOLLA, Calif.—Auspex Pharmaceuticals, Inc., a biopharmaceutical company dedicated to developing innovative medicines for people with movement disorders and rare diseases, announced that it has been developing SD-1077, a deuterium-containing levodopa, in collaboration with Imphar AG, a private Neuenhagen, Germany-based drug development company, and it has entered into a share purchase agreement to acquire the remaining rights to SD-1077, and related intellectual property, through the acquisition of Imphar. Imphar AG had previously granted Auspex exclusive U.S. and select worldwide rights and retained European and additional worldwide rights, all of which will be transferred to Auspex, along with the related intellectual property, pursuant to the share purchase agreement, subject to the satisfaction of customary closing conditions. The research conducted by Imphar was funded in part by a grant from the Michael J. Fox Foundation for Parkinson's Research
"Moving forward with SD-1077 adds to the strength of our movement disorder pipeline behind our SD-809 lead program," said Pratik Shah, Auspex president and CEO. "Based on strong preclinical data and scientific principles, we believe that SD-1077 has significant potential to treat this debilitating disorder which currently has limited effective options. We look forward to continuing to work with the scientists at Imphar and expect to advance SD-1077 into clinical development this year and announce proof-of-concept data in 2016." 
SD-1077, an investigational new drug for the potential treatment of Parkinson's disease, has been shown in preclinical models to improve the half-life of dopamine in the brain resulting in a prolonged treatment effect. Auspex is advancing SD-1077 through preclinical studies in preparation for initiation of clinical development by the end of 2015. Data from the clinical studies are expected in 2016.
"Auspex and Imphar AG have had a fruitful collaboration," said Dr. Giesbert Alken, founder and chairman of Imphar AG. "We believe Auspex's expertise in neurological diseases, coupled with its strong leadership team, will be able to accelerate SD-1077 clinical development for the benefit of patients living with Parkinson's disease around the world." 
Parkinson's disease affects one million people in the United States, and seven to 10 million people worldwide. Levodopa is considered the current gold standard for the symptomatic treatment of Parkinson's disease. However, the short half-life of levodopa results in dosing multiple times daily, as well as the development of dyskinesia, an involuntary and potentially severely debilitating movement disorder, in 30 to 80 percent of patients within a few years of treatment. SD-1077, a selective deuterium substituted form of levodopa, can potentially improve the half-life of the resulting dopamine in the brain and prolong the anti-Parkinsonian effect. These properties of SD-1077 may enable less frequent dosing, a reduction in the daily dose of levodopa and a reduction in the development of dyskinesias and other motor complications of Parkinson's disease. 
"Extending the clinical benefit provided by levodopa remains a critical need in the treatment of Parkinson's disease," said Robert A. Hauser, M.D., MBA, director of the Parkinson's Disease and Movement Disorders Center at the University of South Florida. "We need simple, easily administered medications that can be dosed just a few times daily that will provide sustained benefit through the day even as the disease progresses. A deuterium-containing levodopa represents a novel mechanism to extend the benefit of medication-derived dopamine in the brain. This effect has been demonstrated in animal models of Parkinson's disease and, if confirmed in patients, could provide a significant therapeutic advance."
Auspex Pharmaceuticals is a biopharmaceutical company dedicated to developing innovative medicines for hyperkinetic movement disorders and other rare diseases. Auspex employs its proprietary technology to create patent-protected, new chemical entities from known, clinically proven pharmacologics. The company's lead product SD-809 is in the final stages of development for the treatment of chorea associated with Huntington's disease, a neurodegenerative movement disorder that impacts cognition, behavior and movements. In addition, Auspex is investing in the broad potential of SD-809 for the treatment of other movement disorders, including tardive dyskinesia and tics associated with Tourette syndrome. The company's pipeline also includes SD-560, which is being developed for potentially treating fibrotic conditions.

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