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EMBARGOED FOR RELEASE UNTIL 1:00 P.M. (PDT) ON OCT. 1

PTH IN NASAL SPRAY ABSORBED MORE EASILY, BUILDS BONE AS WELL AS SUBCUTANEOUS PTH INJECTIONS

Contact:    Melissa Haynes: (202) 367-1219; mhaynes@smithbucklin.com

Seattle (Oct. 1, 2004)—Parathyroid hormone (PTH) given in a nasal spray is more easily absorbed than PTH given by subcutaneous injection, and builds bone just as well, according to researchers speaking at the 26th Annual Meeting of the American Society for Bone and Mineral Research (ASBMR).

Although research has demonstrated that subcutaneous injections of PTH increase bone density, many patients dislike the injections and do not comply with treatment. Toshio Matsumoto of the University of Tokushima in Tokushima, Japan, led a team of researchers who developed the nasal spray as a more acceptable alternate route of administration.

The spray, called hPTH(1-34), was tested in 92 men and women with osteoporosis, aged 52 to 84. The subjects were assigned randomly to receive daily administrations at three different dosages (PTH 250, 500, and 1,000). Subjects also received daily supplements of 300 mg. of calcium and 200 IUs (international units) of vitamin D3. After three months, bone mineral density in the spine increased in all three dosage groups, with the PTH 1,000 group showing the best results. The bone formation markers PINP and osteocalcin increased steadily in all groups during the three-month period (up by 16.7 and 20.6 percent, respectively, in the PTH 1,000 group).

Two subjects in the PTH 250 group and five in the PTH 1,000 group developed very mild hypercalcemia (a high level of calcium in the blood) three hours after the nasal spray was given. Calcium levels returned to baseline for all seven participants within 24 hours after of administration. None of the subjects showed evidence of hypercalcemia before receiving hPTH. There were no significant differences in the number of side effects in the three groups.

Dr. Matsumoto said the study results “demonstrate that nasal hPTH(1-34) spray is absorbed quickly, has a short half-life, is safe and well-tolerated, and is associated with an increase in bone density in the first three months.” The team suggests that further studies be performed to examine the spray’s long-term effectiveness at increasing bone mass and preventing fractures.

For more information on this study, visit www.asbmr.org.

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The ASBMR Annual Meeting is the pre-eminent scientific meeting on bone and mineral metabolism. More than 5,000 delegates are expected to attend the October 1-5 meeting, where approximately 1,900 scientific abstracts are presented. The ASBMR is the premier professional, scientific and medical society established to promote excellence in bone and mineral research and to facilitate the translation of that research into clinical practice. The ASBMR has a membership of nearly 4,000 physicians, basic research scientists, and clinical investigators. To learn more about the Society and the field of bone and mineral research, visit the ASBMR website at www.asbmr.org.

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