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For a time, hormone replacement therapy (the administration of estrogen either alone or in combination with other hormones) served as the preferred treatment for post-menopausal women hoping to reduce the progression of osteoporosis, a debilitating and inevitable bone-thinning disorder. Yet the latest findings from the prematurely halted Women's Health Initiative (WHI) study on hormone replacement therapy alarmed many women. The study concluded that an estrogen and progestin combination used by thousands increased the risk of breast cancer, blood clots, heart attacks, and strokes when taken over a long period of time.

Osteoporosis is drastically accelerated during menopause and is the third leading cause of death of women over 70. By age 55, the average woman has already lost 30% of her bone mass. Eventually, bone loss can progress to the point where bones become so thin that they are susceptible to fracture from even the slightest trauma. According the National Osteoporosis Foundation, one out of every two women over the age of 50 will have an osteoporosis-related fracture in her lifetime. Caucasian and Asian women are more likely to develop osteoporosis. However, African American and Hispanic women are at significant risk for developing the disease. Additionally, small-boned and thin women (under 127 pounds) are at greater risk for osteoporosis.

Many women are now searching for a safe alternative to hormone replacement therapy to alleviate the effects of osteoporosis. Current treatments on the market such as bisphosphonates and SERMs (estrogen-related therapies) have safety issues and focus primarily on slowing bone loss. Another existing treatment option is calcitonin, a naturally occurring hormone involved in calcium regulation and bone metabolism. In women who are more than 5 years beyond menopause calcitonin slows bone loss, increases spinal bone density and, according to recent studies, reduces the risk of spinal fractures. In recent trials, calcitonin demonstrated a 62% reduction in the incidence of new vertebral fractures for a subgroup of women over 75, one of the most significant reductions demonstrated by any current osteoporosis therapy. In addition, calcitonin is the only osteoporosis therapy that can reduce the significant bone pain often associated with osteoporosis. Because calcitonin is a peptide, it cannot be taken orally because it would be digested before it could exert its therapeutic effect. Currently calcitonin is available as an injection or nasal spray. The U.S. Food and Drug Administration ('FDA') is currently reviewing FORTICAL', a unique nasal calcitonin product developed by Unigene Laboratories, and Unigene is also developing an oral form of the product.

A new therapeutic option is parathyroid hormone (PTH), which can rebuild bone mass that has been lost due to osteoporosis. PTH has proven to increase the volume and strength of honeycomb-shaped bone mass located within the bone. This inner mesh contains blood vessels and bone marrow and begins to diminish after menopause. PTH helps reduce the incidence of fractures by restoring some of the lost bone architecture. Currently, PTH therapy is available only via daily injections. Unigene Laboratories and GlaxoSmithKline are jointly developing a PTH treatment that can be administered orally.

'Calcitonin has a proven, 25-year record of safe human use with virtually no side effects, and can be taken simultaneously with other medications,' said Dr. Warren Levy, president and CEO of Unigene. 'After the WHI study, safety has become an even more important consideration because once a therapy is initiated, it should ideally be taken for life.'

For more information on osteoporosis and treatment options, please log on to www.unigene.com.