Washington Editor

In a deal valued at more than $90 million, Nycomed Group signed on as NPS Pharmaceuticals Inc.'s pan-European marketing partner for the investigational osteoporosis drug Preos.

Nycomed, of Roskilde, Denmark, will be responsible for European clinical development, registration and marketing of Preos, a recombinant human parathyroid hormone (PTH). Injections of PTH have been shown to stimulate the growth of structurally normal new bone in cases in which bone has been lost to osteoporosis, NPS said.

Nycomed will make a $40 million equity investment in NPS, of Salt Lake City, via the purchase of about 1.3 million common shares of NPS stock. Wednesday, the stock (NASDAQ:NPSP) climbed 6 cents to close at $26.63.

Furthermore, NPS will receive up to $25 million in milestones upon regulatory approvals and achievement of certain sales targets. NPS also is poised to receive "attractive double-digit royalties commensurate with this kind of an opportunity," David Clark, NPS's vice president of corporate affairs, told BioWorld Today.

Beyond an osteoporosis indication, NPS expects to study Preos in other areas, but to date it has not specified any particular diseases or conditions.

Nycomed has agreed to invest at least $25 million in Phase IIIb and Phase IV trials aimed at label expansion in Europe, the Commonwealth of Independent States and Turkey.

NPS views Nycomed as an attractive up-and-coming European firm, Clark said.

"They will use Preos as one of their flagship products as they expand their marketing presence in Europe," he said. "They are very committed to this product, and that was something that was attractive to us. This is something they will be enthusiastic about and attentive to, so we think it is a good deal for us and them."

Nycomed's largest product is CalciChew, a calcium product used in the treatment and prevention of osteoporosis. CalciChew is sold under the name Orocal in France and Calcimagon in Germany.

NPS expects to seek FDA approval of Preos late this year based on data from a favorable 2,600-patient Phase III trial released in the last few weeks. The study (known as Treatment of Osteoporosis, or TOP) demonstrated a reduction in vertebral fracture risk in post-menopausal women with mild to moderate osteoporosis who received once-daily injections of Preos for 18 months. FDA action likely would take 10 to 12 months. (See BioWorld Today, March 31, 2004.)

Nycomed will use the same data to file in the pan-European countries after the FDA receives the application.

Clark said NPS is evaluating partnering possibilities in the U.S., but has yet to make a decision.