Unigene Laboratories has issued a statement in response to an FDA announcement of an upcoming advisory committee meeting scheduled for March 5, 2013 to discuss whether the benefits of calcitonin salmon outweigh the risk. The company manufactures Fortical calcitonin nasal spray for the treatment of osteoporosis.
Unigene CEO Ashleigh Palmer commented, “We are pleased that an Advisory Committee will be assembled to weigh the benefit of calcitonin salmon for the treatment of postmenopausal osteoporosis. In particular, we applaud the FDA for its willingness to receive input from external experts and concerned citizens in a public forum. [. . .] As noted previously, the decision of the EMA to limit the use of calcitonin-containing medicines in Europe due to a potential perceived cancer risk was based on a retrospective analysis of long-finished clinical trials involving certain calcitonin products unrelated to Unigene or its licensees. ”
In November 2012, Unigene described the EMA’s recommendation against the use of calcitonin nasal sprays, issued in July of that year, as “catastrophic” for the company and said that it could run out of cash by the first quarter of 2013 as a result.
Read the Unigene press release.
