Auspex to Acquire Remaining Worldwide Rights to SD-1077 Through Purchase of Imphar AG
Clinical Proof-Of-Concept Data for SD-1077 Versus Levodopa Expected in 2016
LA JOLLA, Calif., Jan. 12, 2015 (GLOBE NEWSWIRE) -- Auspex Pharmaceuticals, Inc. (Nasdaq:ASPX), a biopharmaceutical company dedicated to developing innovative medicines for people with movement disorders and rare diseases, today announced that it has been developing SD-1077, a deuterium containing levodopa, in collaboration with Imphar AG, a private German-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 AG. 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, president and chief executive officer, Auspex. "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, 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."
About Auspex Pharmaceuticals
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, and SD-1077 for the potential treatment of Parkinson's disease. For further information, please visit the company's website www.auspexpharma.com.
Forward-Looking Statements
Statements made in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding Auspex's ability to successfully complete its ongoing clinical trials and development programs, Auspex's ability to obtain regulatory approval for its product candidates and market penetration and acceptance of its product candidates. Risks that contribute to the uncertain nature of the forward-looking statements include: Auspex's future preclinical studies and clinical trials may not be successful; changes in regulatory requirements in the United States and foreign countries may prevent or significantly delay regulatory approval of Auspex's product candidates; Auspex may change its plans to develop and commercialize its product candidates; the U.S. Food and Drug Administration (FDA) may not agree with Auspex's interpretation of the data from clinical trials of its product candidates; Auspex may decide, or the FDA may require Auspex, to conduct additional clinical trials or to modify Auspex's ongoing clinical trials; Auspex may experience delays in the commencement, enrollment, completion or analysis of clinical testing for its product candidates, or significant issues regarding the adequacy of its clinical trial designs or the execution of its clinical trials, which could result in increased costs and delays, or limit Auspex's ability to obtain regulatory approval; the third parties with whom Auspex has partnered for the development of its product candidates and upon whom Auspex relies to conduct its clinical trials and manufacture its product candidates may not perform as expected; Auspex's product candidates may not receive regulatory approval or be successfully commercialized; unexpected adverse side effects or inadequate therapeutic efficacy of Auspex's product candidates could delay or prevent regulatory approval or commercialization; Auspex may be unable to obtain and maintain intellectual property protection for its product candidates; the loss of key scientific or management personnel; Auspex's ability to obtain additional financing; and the accuracy of Auspex's estimates regarding expenses, future revenues and capital requirements. All forward-looking statements contained in this press release speak only as of the date on which they were made. Other risks and uncertainties affecting Auspex are described more fully in Auspex's filings with the Securities and Exchange Commission. Auspex undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
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