- Strong sales growth from Fortical(R) - Since its 2005 launch with partner Upsher-Smith Laboratories, Fortical(R) has captured a near-dominant (49%) share of the U.S. nasal sCT market that is estimated to be in the $200 million range.
- Safety concerns in the osteoporosis market - Bisphosphonate-based therapies, the leaders in the $7 billion osteoporosis market, have come under scrutiny following reports of links to multiple serious side effects. The FDA is in the process of reviewing the safety profile of bisphosphonates, and the agency should issue a decision over the next 6-12 months. If the FDA expresses concerns, the medical community will likely begin to consider safer alternatives to bisphosphonates. Given calcitonin's excellent safety profile (over 30 years of proven safety), Unigene could stand to benefit substantially.
- Blockbuster potential - Unigene's partner, Novartis, has initiated a
Phase III trial to evaluate oral calcitonin's disease-modifying properties
against osteoarthritis, a disease that affects over 21 million Americans,
for which there is no curative treatment. Novartis has also initiated a
Phase III trial evaluating oral calcitonin against osteoporosis, which
|SOURCE Unigene Laboratories Inc.|
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