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Teriparatide Now Available in the European Union

VIENNA--(BUSINESS WIRE) --Nov. 4, 2003-- Lilly (NYSE:LLY) announced today that Forsteo(R) (teriparatide (rDNA origin) injection), approved in the European Union (EU) for the treatment of established osteoporosis in postmenopausal women who are at high risk of fracture, is now available in nine of the 15 EU member states as well as the non-EU countries, Iceland, Norway and Switzerland. Forsteo is the first of a new class of drugs called bone formation agents to be approved in the EU and reduces the risk of new spinal fractures (one or more) by 65 percent and multiple spinal fractures (two or more) by 77 percent.(2) Bone formation (anabolic) agents combat osteoporosis by actually stimulating the formation of new bone, unlike other available treatments, which only work to slow or stop bone loss.

"I believe that Forsteo will be of great value to women living with established osteoporosis," said Manuel Diaz Curiel, Ph.D., M.D., Servicio de Medicina Interna/Enfermedades Metabolicas Oseas, Fundacion Jimenez Diaz, Madrid, Spain. "It provides an exciting new treatment option to help improve the lives of women with this devastating disease."

"Forsteo is now available in the majority of EU countries and represents a big step forward in the treatment of established osteoporosis," said Richard Pilnik, president of European operations for Lilly. "Forsteo complements Lilly's other osteoporosis product, Evista(R), and together these products will offer a complete continuum of care for women with osteoporosis."

How Forsteo Works
The mechanism by which bone is constantly renewed is called bone remodeling. Forsteo, a fragment of the natural parathyroid hormone protein found in the body, acts in a novel way on the bone remodeling process so that new bone is generated and added to the skeleton faster than old bone is broken down. This anabolic action occurs when Forsteo is administered once daily and is in contrast to current osteoporosis treatments that only work to slow or stop bone loss. By acting in this novel way, Forsteo increases bone strength and significantly reduces fracture risk.(3)

Forsteo: A Patient's Perspective
"I remember I found it difficult even getting out of bed. To get up in the morning I had to go onto my stomach and crawl. My osteoporosis also prevented me from playing golf with my husband, which is a hobby we both enjoyed," said Hedda a 68-year-old who received Forsteo therapy and was first diagnosed with osteoporosis more than 12 years ago. "The treatment has changed our lives. I can play golf again, and I like to let women know that there is something they can do and that there is hope."

Forsteo is licensed in the EU for the treatment of established osteoporosis at 20 micrograms, once daily for 18 months by subcutaneous injection. Following cessation of Forsteo therapy, patients may be continued on treatments that work by slowing bone loss, known as antiresorptive therapy.

Clinical Data Overview
More than 2,000 patients (1,637 women/437 men) were randomised in a pivotal study to characterise the safety and efficacy of teriparatide.(2) This Phase III study demonstrated that, in postmenopausal women with osteoporosis-related fractures, compared with placebo, Forsteo significantly reduced the risk of new spinal fractures (one or more) by 65 percent and multiple spinal fractures (two or more) by 77 percent.(2)

Forsteo will be known as Forteo(R) in the rest of the world and was launched in the United States in December 2002. It is approved in all 15 EU member states and is now available in Austria, Denmark, Finland, Germany, Greece, Ireland, Netherlands, Portugal, Sweden and the U.K. It is also available in the non-EU countries Iceland, Norway and Switzerland.

Side Effect Profile
In studies with teriparatide, the most frequent treatment-related adverse events were generally mild to moderate, dose related and did not differ statistically from placebo. The most frequently reported symptoms were nausea, arm and leg pain, headache and dizziness.

Development of this investigational drug was suspended in December 1998 to evaluate a carcinogenicity study in rodents. In the study, rats exposed to near lifetime treatment with teriparatide developed bone tumours, including osteosarcomas. No bone tumours occurred in human patients in the clinical trials. A comprehensive assessment by external oncology experts and company researchers indicated that the finding in rats was unlikely to predict an increased risk of osteosarcoma for humans receiving teriparatide for the intended clinical use. This conclusion was based, in part, on several important differences between rat and human bone biology and responses to teriparatide.

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, and as the population of the world both grows and ages, it is becoming an increasingly significant cause of mortality and morbidity. 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.(6) The condition costs national treasuries in the EU more than EUR 4.8 billion annually in hospital healthcare alone.

Source: Lilly

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