* FDA reviewers express doubt about benefit of calcitonin
* Novartis, Unigene/Upsher Smith products under review
* FDA advisory committee to meet March 5
By Toni Clarke
March 1 Staff reviewers for the U.S. Food and
Drug Administration said that a potential increased risk of
cancer with drugs containing calcitonin salmon appears
In briefing documents released on Friday, the reviewers said
the risk raises concerns about the overall risk versus benefit
of calcitonin products to treat osteoporosis in postmenopausal
Calcitonin products include Novartis AG's
Miacalcin injection and nasal spray and Unigene Laboratories
Inc's nasal spray. Privately held Upsher Smith
Laboratories Inc distributes Unigene's product in the United
States. Generic calcitonin products are also available.
Calcitonin salmon is a man-made version of the hormone
calcitonin that is found in salmon.
The reviewers said significant questions remain about
calcitonin salmon's effectiveness in reducing fractures in the
treatment of postmenopausal osteoporosis.
An advisory panel to the FDA is scheduled to discuss the
products on March 5 and will make a recommendation to the agency
on whether to allow the continued marketing of these products
for that use.
Last July European regulators recommended that long-term use
of calcitonin be curtailed after a review found evidence of a
small increased risk of cancer with long-term use of the drugs.
They recommended that they should only be authorized for
short-term use in Paget's disease, a bone disorder; for acute
bone loss due to sudden immobilization; and for excess calcium
in the blood caused by cancer. They ruled that the benefits of
calcitonin-containing medicines did not outweigh their risks in
the treatment of osteoporosis and that they should no longer be
used for this condition.
Unigene officials declined to comment on the FDA staff
review as they do not distribute a calcitonin product in the
United States. Upsher Smith officials were not immediately
available for comment. Novartis said in a statement that it
"places the highest priority on patient safety and the
appropriate use of its medicines and is looking forward to the
opportunity to engage in the discussion at the upcoming
Unigene shares were down 20.65 percent at $0.12 on the pink
sheets. Novartis shares were up 1 percent.