Unigene Faces Do-or-Die FDA Panel Tuesday
BOONTON, NJ (TheStreet) -- While a lot of investor attention will hopefully be focused on Depomed's (DEPO) FDA panel and the live-blogging exploits of Adam Feuerstein, Jason Napodano and yours truly today, I wanted to share some thoughts about a penny stock with a different but still very important FDA advisory panel taking place tomorrow.
Unigene Laboratories (UGNE) faces an uncertain future. The past 12 months have been a real challenge -- marked by accounting irregularities, delays in securing license agreements for pipeline assets and diminishing cash unlikely to last past the second quarter. Last December, Unigene (not surprisingly), announced plans to "explore strategic alternatives."
The genesis for Unigene's troubles was an announcement last July by the European Medicines Agency (Europe's equivalent to the FDA) relating to use of the hormone calcitonin to treat osteoporosis. European regulators approved calcitonin in 1973, but following an extensive review, the EMA concluded its long-term use was associated with a small but increased risk of cancer. The benefits of using calcitonin-containing products to treat osteoporosis no longer outweighed the safety risks, the EMA concluded.
When the EMA decision on calcitonin was announced, Unigene's stock price fell 75%.Current formulations of calcitonin include subcutaneous injections and nasal sprays, so an oral formulation is obviously attractive. Unigene owns an oral calcitonin product, which was licensed to privately held Tarsa Therapeutics. Unigene owns a 20% stake in Tarsa and is eligible to receive sales-related milestone payments and royalties on worldwide sales, if the drug is ever approved. Top-line, positive results from Tarsa's phase III trial of oral calcitonin were presented in March 2011. The study, conducted pursuant to a Special Protocol Assessment (SPA) agreement with the FDA, demonstrated that oral salmon calcitonin was significantly superior to placebo and non-inferior to nasal salmon calcitonin spray in increasing bone mineral density at the lumbar spine after one year of treatment. Unigene had originally targeted a quick FDA approval submission in the fourth quarter 2011, but that never happened. In January 2012, Unigene said Tarsa delayed the FDA filing to the second half of 2012. Tarsa also appealed the EMA's decision to curtail use of calcitonin in Europe, to no avail. To date, the Unigene/Tarsa oral calcitonin has still not been filed with FDA.
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