Upsher-Smith licensed the product, called Fortical, from nasal drug delivery specialist Unigene in 2002. This $10 million (€8.3m) agreement gave Upsher-Smith exclusive US rights to distribute and sell the finished product, with Unigene retaining manufacturing rights.
In January last year, Unigene received an approvable letter from the FDA for Fortical, asking for additional information, including clinical data. These data were submitted later in 2004.
Mark Robbins, vice president of legal and regulatory affairs at Upsher-Smith, described the FDA's delay in delivering a verdict on the Fortical application as 'unconscionable', and is stopping osteoporosis sufferers in the US from accessing what is intended to be the 'most affordable' therapy for the condition. Intranasal calcitonin has been shown to increase spinal bone mass in postmenopausal women with established osteoporosis.
"The Prescription Drug User Fee Act (PDUFA) date for the FDA to issue a final action on the submission of this product was March 16, 2005," he said, adding: "When Upsher-Smith launches this new drug therapy, the annual savings to consumers are estimated to be over 100 million dollars." Robbins also suggested that many osteoporosis sufferers pay cash for alternative therapies, with US consumers spending over $4 billion annually for the treatment and prevention of the disease.
Calcitonin is a hormone produced by the parathyroid gland that acts primarily on bone. A nasal formulation of the hormone is already marketed in the US as Miacalcin by Swiss drugmaker Novartis, bringing in sales of $58m - and $92m worldwide - in the first quarter of this year. Upsher-Smith is making use of Unigene's improved recombinant production process for calcitonin to produce a lower-cost product.
Upsher-Smith and Unigene said that neither company has received any communication of a decision by the FDA regarding the approval of Fortical, but remain optimistic that a final decision will be rendered by the FDA shortly.
Upsher-Smith also emphasized that the restructuring and elimination of positions resulting from the lengthy approval process will have no impact on their commitment to Fortical.