ANN ARBOR, Mich., June 15 /PRNewswire/ -- As it prepares to move into clinical trials on a new drug for osteoporosis, Velcura Therapeutics, Inc. has chosen to work with Hurley Consulting Associates Ltd., which will assist the biotech company with the development program design, FDA submissions and clinical trial data collection and analysis. Hurley Consulting already has successfully worked with sponsors in designing development programs and prepared osteoporosis new drug applications (NDAs) for submission in the U.S. and Europe.
Velcura Therapeutics President and CEO Michael W. Long, Ph.D. said, "No other independent consulting firm has Hurley's depth in osteoporosis drug development. Hurley Consulting also has extensive experience with European regulatory agencies and international collaborations," added Dr. Long, who recently announced Velcura has a licensing agreement with Japanese pharmaceutical company Nippon Chemiphar on a new lead compound that has proven effective in animal models of osteoporosis.
Hurley Consulting Founder and CEO Margaret E. Hurley, MD said, "Osteoporosis is a serious world-wide health problem. We look forward to working with Velcura on the development of a potentially novel compound."
About Velcura Therapeutics(R), Inc.
Velcura Therapeutics(TM), Inc. is an early-phase biotechnology company focused on developing drug therapies that stimulate bone growth for the treatment of osteoporosis, bone fractures, and other bone disorders. Velcura's first drug (Vel 0230) both stimulates human bone formation and inhibits its loss, making it a unique compound for treating osteoporosis. Vel 0230 is orally available (i.e., can be formulated as a pill), has completed animal safety studies, and is planned to start Phase I clinical trials in 2007. The company received $3.3 million in funding from the Michigan Life Sciences Corridor in 2002 and more than $3.8 million from the National Institutes of Health. For more information, visit http://www.velcura.com .
About Hurley Consulting Associates Ltd.
Located in Chatham, NJ, Hurley Consulting is an international consulting company that has served the pharmaceutical, biotechnology and medical device industries since 1987. Services include study design, report writing, data management, QA functions (including product release), preparation of summary documents, including CTD, for submission to the FDA and other regulatory authorities. The company acts as U.S. agent and authorized representative for regulated products for the entire IND thru NDA process and post-approval regulatory matters including regulatory strategy, FDA negotiations, submissions and application approvals. The company provides the strategy, planning, and analytical expertise needed for product development and/or evaluation of commercial opportunities. Hurley Consulting consists of 60 specialists who offer extensive experience in the health sciences industry as well as academia. Their broad corporate knowledge, experience, and technical expertise enable them to support all aspects of today's product development environment. For more information, visit http://www.hurleyconsulting.com .
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Michael W. Long, Ph.D.
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SOURCE Velcura Therapeutics, Inc.