Unigene Reports That Oral Calcitonin Phase III Clinical Study for Osteoarthritis Treatment is Initiated
- Category: Proteins and Peptides
- Published on Wednesday, 06 June 2007 04:00
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FAIRFIELD, NJ, USA | June 5, 2007 | Unigene Laboratories, Inc. (OTCBB: UGNE) reported that Novartis Pharma AG and its development partner Nordic Bioscience have initiated a multi-center Phase III clinical study to evaluate the use of their oral formulation of calcitonin to treat osteoarthritis. The calcitonin to be used in the study was produced by Novartis using Unigene’s patented manufacturing process, and Unigene will receive royalty payments if the product is successfully commercialized using this calcitonin.
This is the second pivotal study involving an oral calcitonin dosage form that Novartis and Nordic Bioscience have commenced this year. On February 27th, Unigene announced that the formulation was being evaluated in a Phase III trial for the treatment of osteoporosis.
Osteoarthritis is a progressively degenerative and often painful disease that affects approximately 20 million people in the U.S. It is the most common form of arthritis and results in the destruction of cartilage, primarily in the weight-bearing joints.
“Preliminary reports in the medical literature suggest that calcitonin treatment has beneficial effects on both cartilage tissue and subchondral bone, and hence has the potential to be the first therapeutic agent that can modify the course of the disease,” stated Dr. Ronald S. Levy, Executive Vice President of Unigene. “Current osteoarthritis treatments primarily provide only symptomatic relief to patients.”
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 has also manufactured 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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SOURCE: Unigene Laboratories, Inc.