Continuing its efforts in the lucrative osteoporosis market, Unigene Laboratories Inc. sealed a $10 million marketing deal with Upsher-Smith Laboratories Inc. for Unigene's patented nasal version of calcitonin.
The licensing deal is the second in osteoporosis for Unigene, which is focused on oral and nasal delivery of large-market peptides. Earlier this year, the company disclosed a $150 million deal with GlaxoSmithKline plc, of London, to develop an early stage oral parathyroid hormone (PTH) product. (See BioWorld Today, April 16, 2002.)
"It's an interesting situation to be developing both categories [of osteoporosis treatments]," said Warren Levy, president and CEO of Fairfield, N.J.-based Unigene. Existing calcitonin therapies "all work reasonably well to prevent further fractures, but the PTH class hopefully can actually build bone," so the two may be used together, he said.
Unigene's stock (NASDAQ:UGNE) closed Monday at 36 cents, up 1 cent.
The company's news of the deal comes days after its disclosure that the uses for its existing injectable calcitonin product, Forcaltonin, will be expanded in the European Union to include prevention of bone loss associated with osteoporotic fractures.
Forcaltonin had previously been approved for Paget's disease and hypercalcemia of malignancy.
"The uses for all calcitonin products, injected or nasal, have been harmonized throughout the 15 European states," Levy said, adding that "the injectable opportunity [for calcitonin] in the U.S. is not that significant. For nasal, it's estimated at $300 million and for injectable $10 million to $12 million tops."
He told BioWorld Today that, "although we obviously are pleased to be talking to people about further development [of injectable calcitonin] in the U.S., the real focus is Europe and outside the U.S."
And news of the Upsher-Smith deal comes less than a week after the FDA approved the first treatment in the PTH class - Indianapolis-based Eli Lilly and Co.'s Forteo (teriparatide), which, unlike the product in development with Glaxo, is injectable.
"There's no question that we think the oral has a significantly larger market," Levy said, since osteoporosis is non-life-threatening and patient compliance is an issue.
"It's one thing if you have diabetes and you have to take a shot," he said. "You can convince people to do it. But the injection is a hard thing for some [osteoporosis patients] to swallow."
The agreement with Upsher-Smith, of Plymouth, Minn., for nasal calcitonin includes an up-front payment by the latter of $3 million to Unigene, which will manufacture the product at its Boonton, N.J., plant for packaging and distribution nationwide by Upsher-Smith.
Levy said the company expects to file a new drug application for the product by the end of this year.
"Once we complete the NDA process, we're certainly planning on focusing on a European application," he said. Whether that application will win approval quicker, now that European regulators have harmonized calcitonin uses, is unclear.
"It's possible it could move faster," Levy said. "Logically, one could argue that it should," although generally "we've had experiences in Europe that indicate it is no faster than the FDA."
There is already a nasal calcitonin product on the market - Basel, Switzerland-based Novartis AG's Miacalcin - but the field is large enough for all. Unigene estimates worldwide sales of calcitonin products at $800 million annually. More users are expected when an oral form is developed, and the company is working on that, too.
Given the aging population, Levy said, the market is "growing by leaps and bounds."