HUYA Bioscience Int'l Announces Pre-IND Outcome for HBI-3000 - Promising Anti-Arrhythmia Compound Sourced ...( FDA Feedback Supports Inno...),Health

FDA Feedback Supports Innovative Co-development Model

SAN DIEGO, June 17 /PRNewswire/ -- Bio International Convention 2008 (http://www.bio2008.org) -- HUYA Bioscience International (http://www.huyabio.com), the leader in U.S./China pharmaceutical co-development, today announced the outcome of its pre-investigational new drug (IND) consultation meeting with the United States Food and Drug Administration (FDA) for HBI-3000 (Sulcardine sulphate), a promising anti-arrhythmic compound sourced from China. The Agency reviewed and agreed with HUYA's IND-enabling CMC and toxicology plans and high level Phase I plans pending review of non-clinical and clinical data to be submitted as part of the complete IND package. The FDA also agreed to accept data generated in China as 'supportive information' that will support the submission of a U.S. IND and the initiation of a U.S. Phase I trial. HUYA anticipates filing an IND application for HBI-3000 in Q1 2009.

"We're very pleased that the FDA will accept Chinese data to support clinical study design and initiation in the U.S., as this validates our co-development method," said Mireille Gingras, PhD, CEO, HUYA. "We continue to find that in working with China, we can lower the risk and increase the efficiency of drug development in areas of significant unmet need. HUYA is proud to lead the way in co-developing new and important drugs that may save lives."

HBI-3000 is a novel, multi-ion channel blocker for the treatment of atrial or ventricular arrhythmias. In April 2008, HUYA announced the completion of three Phase I protocol studies of HBI-3000 (oral) in China. These clinical studies demonstrated that oral administration of HBI-3000 was well tolerated. The compound has also been tested in an intravenous (IV) formula allowing it to address both in-hospital acute cases and long-term management of chro
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