More than two years after filing a new drug application for Fortical, Unigene Laboratories Inc. received final FDA approval for the osteoporosis product.

The approval triggered a $4 million milestone payment to Unigene from its U.S. marketing partner Upsher-Smith Laboratories Inc. Fortical is Unigene's first FDA-approved product.

"For any company that is in the development stage and gets its first product approval in the U.S., it's a pivotal accomplishment," said Warren Levy, president and CEO of Fairfield, N.J.-based Unigene. "We expect it'll change the outlook that the investors, the employees and the market have for the company."

The market seemed pleased Monday. Unigene's stock (OTC BB:UGNE) moved up 19 percent, or 36 cents, to close at $2.26.

Fortical calcitonin-salmon (rDNA origin) nasal spray will be marketed and sold to treat postmenopausal osteoporosis in women who have had menopause at least five years and who have low bone mass relative to healthy premenopausal women.

The drug will be launched as soon as possible, Levy said, once Unigene has manufactured the product at its Boonton, N.J., facility. It will package the filled product, sell it to Plymouth, Minn.-based Upsher-Smith, and then take in an undisclosed royalty on all U.S. sales.

Unigene and Upsher-Smith paired up in 2002 in a $10 million marketing deal for Fortical. (See BioWorld Today, Dec. 3, 2002.)

A few months later, in March 2003, Unigene filed its new drug application for the product, which resulted in the FDA's approvable letter granted in January 2004. To gain final approval, Unigene and Upsher-Smith had to provide further information and data to the FDA.

"There was no requirement to do any new clinical studies, or even re-analyze clinical data," Levy said.

Still, once the requested information was submitted, final approval took longer than expected. The PDUFA goal date for Fortical was March 16, and when that date came and went Upsher-Smith eliminated some positions due to the lengthy approval process. The company said in July, however, that its restructuring would have no impact on its commitment to Fortical.

And why would it? The osteoporosis market is growing; it rose almost 18 percent in 2004 to reach $4 billion in the U.S.

"The osteoporosis market is expanding dramatically everywhere in the world," Levy said, adding that Fortical's nasal formulation will "compete well with a lot of the other products out there."

Calcitonin-based products have been used for many years to treat osteoporosis by preventing further bone loss. Calcitonin, a naturally occurring amidated peptide hormone composed of 32 amino acids, binds to osteoclasts to inhibit bone resorption. Salmon calcitonin is the most widely used species because of its potency in humans.

Levy said that Fortical offers a safe, effective and more economical alternative to current therapies. Studies of certain estrogen-based products suggest an increased risk of certain types of cardiovascular disease and cancer, making the opportunity greater for non-estrogen-based therapies like Fortical. And with patient compliance an issue, considering osteoporosis is not life threatening, many patients may be more willing to take the drug via a nasal spray rather than through an injection.

Novartis AG, of Basel, Switzerland, markets one other nasal calcitonin product - Miacalcin, but most other marketed products are injected and there appears to be plenty of room in the space for Fortical.

"This is obviously our most exciting commercial development," Levy said, "and this will obviously change the face of the company in the near term."

Unigene expects to use revenue from sales of Fortical to move its peptide manufacturing and oral delivery technologies into new applications. In the meantime, it has formed agreements with pharmaceutical companies such as London-based GlaxoSmithKline plc. The companies have a $150 million licensing deal for an oral parathyroid hormone analogue used to treat osteoporosis. (See BioWorld Today, April 16, 2002.)

In April 2004, Unigene signed an $18.7 million agreement giving Novartis Pharma AG, of Basel, Switzerland, worldwide rights to the recombinant production of calcitonin. The deal allows Unigene to retain the right to develop and commercialize its own calcitonin products. (See BioWorld Today, April 9, 2004.)

While Fortical is Unigene's first product to reach the market in the U.S., its first approved product is Forcaltonin, an injectable calcitonin that was approved in Europe in 1999 to treat Paget's disease and hypercalcemia of malignancy. The label was expanded in 2003 to include prevention of bone loss associated with osteoporotic fractures.

But that product has not had "appreciable sales," Levy said, noting that injectable calcitonin has been on the market for a number of years and the nasal spray formulation found with Fortical represents "the bigger market opportunity."

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