Message #30 From:
NewsBot Date: March 20, 2007 05:31:00 AM
UGNE News Unigene's Site-Directed Bone Growth Technology May Have Multiple Large Market Applications According to New Market Analysis
FAIRFIELD, N.J.--(BUSINESS WIRE)--The site-directed bone growth (SDBG) technology currently being developed by Unigene Laboratories, Inc. (OTCBB: UGNE) in conjunction with Yale University may have the potential to provide clinicians with new techniques to target bone growth at the site of a fracture or at sites that are highly susceptible to fracture. This promising early-stage technology is currently being studied in animals. Unigene has identified several possible applications of this technology, each with substantial commercial potential.
The technology, which involves a minimally invasive surgical procedure in conjunction with the administration of one or more biologic agents, including a systemic anabolic agent produced by Unigene, was the subject of a detailed market analysis performed by a leading consulting group which specializes in the pharmaceutical sector. The study evaluates several clinical areas where this technology could have significant utility:
Spine
Treatment and Prevention of Vertebral Compression Fractures (2004 worldwide device market for spine - $3.5 billion)
-- Treatment - (2006 U.S. incidence - 800,000). SDBG could be performed as an alternative to the use of current cements in certain spinal stabilization procedures, such as vertebroplasty/kyphoplasty, which do not foster bone integration or growth. -- SDBG could be used in conjunction with standard vertebroplasty to protect adjacent vertebrae from subsequent compression fractures. -- Prevention - in patients who are severely osteoporotic (2006 U.S. incidence - 430,000), the physician could target vertebrae deemed susceptible to future fractures.
Treatment of Chronic Back Pain (2006 U.S. market for chronic back pain surgery - $5 billion, with 5 million surgical candidates)
-- SDBG could be used to replace more invasive surgical procedures, including spinal fusion and diskectomy. -- Vertebral instability has been identified by leading clinicians as a possible contributing factor in chronic back pain. Targeting specific vertebrae and stimulating new bone synthesis may result in a more stable vertebrae with a subsequent reduction in bone pain.
Hip
Treatment of hip fractures (2003 U.S. surgical admissions for hip fractures – 310,000). SDBG may be useful in improving the healing process and clinical outcome.
Prevention of hip fractures - in patients who are severely osteoporotic (2006 U.S. incidence – 430,000), SDBG may be useful in preventing future hip fractures by specifically increasing bone mineral density at a hip deemed susceptible to future fracture.
Long Bone
SDBG may be useful in improving the clinical outcome for non-union long bone fractures due to trauma and reducing patient recovery times (2006 U.S. incidence - 390,000). The technology may also reduce the occurrence of subsequent fractures.
“The results of the market analysis support Unigene’s commitment to this program and its potential application to reducing the costs associated with the treatment of debilitating bone disorders,” stated Dr. James Gilligan, Vice President of Product Development. “In addition, the feedback from interviews with clinical leaders in the field suggests that this technology is truly unique and may have the potential to revolutionize treatments for osteoporotic bone disease and fractures.”
About Unigene
Unigene Laboratories, Inc. is a biopharmaceutical company focusing on the oral and nasal delivery of large-market peptide drugs. Due to the size of the worldwide osteoporosis market, Unigene is targeting its initial efforts on developing calcitonin and PTH-based therapies. Fortical®, Unigene’s nasal calcitonin product for the treatment of postmenopausal osteoporosis, received FDA approval and was launched in August 2005. Unigene has licensed the U.S. rights for Fortical to Upsher-Smith Laboratories, worldwide rights for its oral PTH technology to GlaxoSmithKline and worldwide rights for its calcitonin manufacturing technology to Novartis. The Company is also manufacturing a second peptide for Novartis. Unigene’s patented oral delivery technology has successfully delivered, in preclinical and/or clinical trials, various peptides including calcitonin, PTH and insulin. Unigene’s patented manufacturing technology is designed to cost-effectively produce peptides in quantities sufficient to support their worldwide commercialization as oral or nasal therapeutics. For more information about Unigene, call (973) 882-0860 or visit www.unigene.com. For information about Fortical, visit www.fortical.com.
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