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Stonegate Report About Unigene Laboratories Inc.

osteonecrosis of the jaw (ONJ). More recently, researchers have reported a possible link between bisphosphonates and increased brittleness in the bones leading to tiny fractures. Additionally, the New England Journal of Medicine has reported a possible link between SERMs and increased risk of heart attack and stroke. Also, the FDA is currently seeking additional data to allow for an in-depth evaluation of reports of atrial fibrillation in patients who take bisphosphonates. The evaluation should be completed in the latter half of 2008, at which time FDA will communicate the conclusions and any resulting recommendations to the public. At this point, most physicians have determined that the benefits of these therapies outweigh the side effects; however, if there is a documented increase in long-term complications associated with these therapies, we believe physicians will seek safer alternatives. Because calcitonin has shown an excellent safety profile over its 30+ years of use, we believe that sales of calcitonin-based products, such as Fortical(R), could dramatically increase.

New study by the AHRQ shifts the risk/reward argument in the favor of lower risk - In December 2007, the Agency for Healthcare Research and Quality (AHRQ) published the results of an important study that compared the effectiveness and risks of osteoporosis therapies including bisphosphonates, estrogen, calcitonin, calcium, vitamin D, testosterone, parathyroid hormone and selective estrogen receptor modulators (SERMs). The results indicated that bisphosphonates are not more effective than alternative osteoporosis treatments. With this AHRQ study revealing that potencies of the various treatments are indistinguishable, the risk/reward argument clearly shifts in favor of seeking safer alternatives. The timing of this study could not be more optimal for Unigene, as reports of negative side effects associated with bisphosphonates continue to garner media coverage.

Unigene's broad pipe

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