Teriparatide is a third-line agent in osteoporosis, after calcium/vitamin D supplementation and bisphosphonates. The bisphosphonates are effective in a large majority of osteoporosis patients, and only a minority would normally require teriparatide.

Mechanism of action

Teriparatide is the portion of human parathyroid hormone (PTH),amino acid sequence 1 through 34 of the complete molecule which contains amino acid sequence 1 to 84. Endogenous PTH is the primary regulator of calcium and phosphate metabolism in bone and kidney. Daily injections of teriparatide stimulate new bone formation leading to increased bone mineral density.

Teriparatide is the first FDA approved agent for the treatment of osteoporosis that stimulates new bone formation.

FDA approval

Forsteo was approved by the FDA on 26 November 2002, for the treatment of osteoporosis in postmenopausal women who are at high risk for having a fracture. The drug is also approved to increase bone mass in men with primary or hypogonadal osteoporosis who are at high risk for fracture.

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Lilly's Teriparatide Gets Positive Opinion From European Cpmp
From Worldwide Biotech, 2/1/03

Lilly (NYSE:LLY) has announced that the European Committee for Proprietary Medicinal Products (CPMP) has issued a positive opinion for teriparatide (rDNA origin) injection (proposed European brand name FORSTEO(R)), a bone formation agent for the treatment of established osteoporosis in postmenopausal women who are at high risk of a fracture. The CPMP has recommended to the European Commission that approval for teriparatide should be granted. Teriparatide, which will be known in the rest of the world as FORTEO(R), has already received U.S. Food and Drug Administration (FDA) approval.

"We are extremely pleased by the CPMP's recommendation for approval of teriparatide in Europe," said John C. Lechleiter, Ph.D., Lilly executive vice president, pharmaceutical products and corporate development. "The adoption of a positive opinion for teriparatide by the CPMP underscores the strength of the scientific data supporting the use of this unique and innovative product to treat a devastating disease."

The CPMP, comprised of regulators from the European Union countries, based its positive opinion on its review of the comprehensive data package for teriparatide. More than 2,800 women and men were randomized in studies to characterize the safety and efficacy of teriparatide.

Following the CPMP's positive opinion, the application will be reviewed by the European Commission (EC), which has authority to grant marketing authorization for the European Union. Lilly anticipates a decision from the EC in Spring 2003.

"There is a great need for new treatment options for severe osteoporosis. Every 30 seconds someone in Europe has a fracture as a result of osteoporosis," said Richard Pilnik, president of European operations for Lilly. "If approved by the European Commission, teriparatide would be the first bone formation agent available for marketing in all of the EU, providing a new treatment approach for those with established osteoporosis who are at high risk of osteoporosis-related fracture."

A Critical Need

Osteoporosis is a global problem, affecting more than 150 million people worldwide. One in three postmenopausal women will be affected by osteoporosis(1), and as the population of the world both grows and ages it is becoming an increasingly significant cause of mortality and morbidity(2). Studies suggest that osteoporosis may be a quickly progressing disease once a fracture occurs. The accumulation of multiple spinal fractures may result in pain, height loss, deformity, functional limitations and diminished quality of life(3). The condition costs national treasuries in the EU more than EURO 4.8 billion annually in hospital healthcare alone.

About Lilly

Lilly, a leading innovation-driven corporation, is developing a growing portfolio of best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers - through medicines and information -- for some of the world's most urgent medical needs.

For more information, call 317/985-4045.

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