Preos osteoporosis drug

On March 30, 2004 NPS Pharmaceuticals Inc. said that its Phase III osteoporosis drug, Preos, significantly reduced spinal fractures or worsening of fractures in a study of 2, 600 postmenopausal women. The 18-month study on Preos involved postmenopausal women with mild to moderate osteoporosis. 81% of participants had no previous history of vertebral fracture. The trial consisted of a treatment arm (patients received daily injections of Preos and supplements of calcium and vitamin D) and a control arm (patients received placebos along with the same supplements). NPS said its drug met the main goal of a statistically significant reduction in the incidence of new or worsened vertebral fractures. It reported a 59% reduction in new or worsened fractures in the treatment versus control arms of the study. That is, 1.4% of women taking Preos had new or worsened fractures by the end of the trial compared to the fracture rate of 3.4% among those taking placebos. Patients taking Preos who had not had a fracture prior to entering the trial experienced a relative reduction of 68%. NPS indicated that it would seek U.S. approval this year for Preos. Preos would compete with Eli Lilly and Co.’s Forteo, a similar injectable drug.

Preos is an injectable, bioengineered version of human parathyroid hormone. Parathyroid hormone is secreted by the thyroid gland and regulates the level of calcium in various body tissues. A similar drug, Eli Lilly’s Forteo, was approved in November 2002 for the treatment of osteoporosis in the United States. Forteo, an injectable bioengineered human parathyroid hormone fragment, is reported to have had sales of $65 million last year. Estimated future annual sales of both injectable drugs has been gauged at about $400 million by several Wall Street analysts.

According to the National Osteoporosis Foundation (NOF), osteoporosis is responsible for more than 1.5 million fractures annually in the United States. The most common fractures are vertebral (700, 000), hip (300, 000), and wrist (250, 000).

Biohorizon has maintained its Moderate Impact Technology designation for Preos. Available treatment options for clinicians treating osteoporosis are considerable with bisphosphonates (Fosamax®, Actonel®), calcitonin (Miacalcin®), estrogen/hormone therapies, parathyroid hormone (Forteo®), and selective estrogen receptor modulators (Evista®). No assessment activities are currently recommended for Preos.

Technology Details
Target Disease / Indication
Osteoporosis

Technology Classification
Drug

Body System
Musculoskeletal System

Program Area
Medicine/Rheumatology

Regulatory Status
Phase III

BioHorizon Impact Score
56/100 – Moderate