Unigene Laboratories, Inc. (OTCBB: UGNE) reports that a comparative analysis of various osteoporosis therapies has been published, concluding that there is insufficient evidence to support claims of superior effectiveness among the drugs reviewed.
The study, commissioned by the Agency for Healthcare Research and Quality, Department of Health and Human Services, is entitled "The Comparative Effectiveness of Treatments to Prevent Fractures in Men and Women with Low Bone Density or Osteoporosis." The study was performed by the Southern California/RAND Evidence-based Practice Center to assist physicians, patients, private- and public-sector organizations in making informed decisions about pharmaceutical alternatives for osteoporosis and reviewed data for bisphosphonates, calcitonin, parathyroid hormone, estrogen, selective estrogen receptor modulators and testosterone.
The leading category of osteoporosis drugs is the bisphosphonates, with established efficacy in reducing fractures in osteoporosis patients. However, according to the report, not enough scientific evidence exists to establish whether bisphosphonates are better at preventing fractures than calcitonin, estrogen or raloxifene. Additionally, certain bisphosphonates have been associated with osteonecrosis. Separately, the FDA is currently conducting a safety review of all bisphosphonate products and their possible link to atrial fibrillation, an established risk factor for stroke.
Findings in the report cite evidence that calcitonin has also demonstrated a reduction in fracture risk among post-menopausal women as well as men. The global history of calcitonin products demonstrates an impressive safety profile, with products being administered to patients for more than 35 years with virtually no significant side effects.
Calcitonin is the active ingredient in Fortical®, a nasal calcitonin product developed by Unigene and marketed by Upsher-Smith Laboratories.
"The study suggests that many of the available products are effective in treating osteoporosis sufferers, yet there is little evidence to support differentiation of the products based on effectiveness," commented Dr. Warren Levy, President and CEO of Unigene. "The study also indicates that adherence to the therapy is an important factor in patient outcome. We hope that this study will encourage physicians and patients to recognize that, if there are acceptable alternatives for patients with osteoporosis or low bone density, and long-term therapy is desirable, then the side effect/safety profile of each drug should be considered carefully before treatment decisions are made."
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. 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, visit unigene. For information about Fortical, visit fortical.
Safe Harbor statements under the Private Securities Litigation Reform Act of 1995: This press release contains forward-looking statements as defined in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Such forward-looking statements are based upon Unigene Laboratories, Inc.'s management's current expectations, estimates, beliefs, assumptions, and projections about Unigene's business and industry. Words such as "anticipates," "expects," "intends," "plans," "predicts," "believes," "seeks," "estimates," "may," "will," "should," "would," "potential," "continue," and variations of these words (or negatives of these words) or similar expressions, are intended to identify forward-looking statements. In addition, any statements that refer to expectations, projections, or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. These forward-looking statements are not guarantees of future performance and are subject to certain risks, uncertainties, and assumptions that are difficult to predict. Therefore, our actual results could differ materially and adversely from those expressed in any forward-looking statements as a result of various risk factors. These risks and uncertainties include the risks associated with the effect of changing economic conditions, trends in the products markets, variations in Unigene's cash flow, market acceptance risks, technical development risks and other risk factors detailed in Unigene's Securities and Exchange Commission filings.
unigene
Комментариев нет:
Отправить комментарий