The US Food and Drug Administration (FDA) today gave Unigene Laboratories, Inc. (OTCBB:UGNE) the green light for one of two proposed improvements to the manufacturing process of its hallmark osteoporosis drug, Fortical. Specifically, Unigene received the go-ahead to modify a key enzyme in its patented manufacturing process for calcitonin, an active ingredient in the nasal spray. The FDA is reviewing another production modification that could boost batch yields of the drug by a factor of three, according to the company.
“In addition to reducing our manufacturing costs, these improvements should enable us to more easily increase our capacity if Fortical demand increases,” Unigene Chief Executive Dr. Warren Levy said in a press release. “We believe the comparability in efficacy of many osteoporosis products, as reported last month in a study commissioned by the Department of Health and Human Services, along with the safety concerns reported for several of the leading osteoporosis products, may ultimately create a larger commercial opportunity for calcitonin-based therapies.”
More than 10 million Americans have osteoporosis, and almost 34 million are at risk for developing the disease due to low bone mass, according to the National Osteoporosis Foundation. Many treatments are available, but unlike Fortical, other popular remedies are bisphosphonates, a class of drugs that are effective in preventing bone loss but have been associated with severe joint pain and stomach upset. Calcitonin-based therapies have not been associated with these side effects.
Unigene, which specializes in manufacturing small proteins for oral and nasal delivery, licensed US rights to Fortical to Upsher-Smith Laboratories. The company also sells an injectable osteoporosis drug in the European Union and recently announced a $15 million joint venture in China to take advantage of what it calls the world’s largest osteoporosis market.
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