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No Bones About It

NEW YORK--(BUSINESS WIRE)--Jan 17, 2008 - A recent government study reports that while many osteoporosis medications prevent fractures, none has been proven best. The study, commissioned by the Agency for Healthcare Research and Quality (AHRQ), part of U.S. Department of Health and Human Services, looked at many existing drugs, including bisphosphonates, calcitonin, parathyroid hormone, estrogen, selective estrogen receptor modulators, and testosterone.

The leading category of osteoporosis drugs is bisphosphonates, non-hormonal drugs that bind to bones to protect against tissue breakdown. Bisphosphonates have an established efficacy in reducing fractures in osteoporosis patients. Findings in the report cite evidence that calcitonin demonstrated a reduction in fracture risk among post-menopausal women as well as men, and that there is insufficient scientific evidence to establish whether bisphosphonates are better at preventing fractures than estrogen, calcitonin, or raloxifene.

"The study suggests that many available products are effective in treating osteoporosis sufferers, yet there is little evidence to support differentiation of the products based on effectiveness," says noted expert Warren Levy, PhD, President and CEO of Unigene Laboratories. "The study also indicates that adherence to therapy is an important factor in patient outcome. Since the existence of side effects can reduce patient compliance, the selection of drugs that have better safety profiles could lead to better outcomes."

Osteoporosis is a skeletal disease that affects about forty-four million Americans, especially women who have undergone menopause. It occurs when deteriorating tissue reduces bone density in the spine, hip, and other areas. Overall, about half of women age fifty or older will suffer an osteoporosis-related bone break in their lifetime. Men are not immune, either: according to the National Osteoporosis Foundation, twelve million males are at risk of getting the disease.

Unigene Laboratories has developed a product that provides osteoporosis sufferers with a safe, effective treatment using calcitonin. Calcitonin is the active ingredient in Fortical, a nasal calcitonin treatment developed by Unigene and marketed by Upsher-Smith Laboratories.

"We hope that this study will encourage physicians and patients to recognize the various treatment options that are available," says Dr. Levy, who believes that as life expectancy rates continue to rise, osteoporosis will have a greater impact on national health and quality of life. "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."

For more information, log on to www.unigene.com.

Contact

IRG for Unigene Laboratories
Lynn Granito, 212-825-3210

Posted: January 2008

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