First Breakthrough Bone Formation Agent, Lilly's Forsteo, Now Available for the Treatment of Established Osteoporosis in the European Union.

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VIENNA--(BUSINESS WIRE)--Nov. 4, 2003

Physicians excited about offering new treatment option

that actually forms new bone

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,(4) and as the population of the world both grows and ages, it is becoming an increasingly significant cause of mortality and morbidity.(5) 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.(4)

Lilly is committed to providing "Answers that Matter" to address the unmet needs of women at risk for or diagnosed with osteoporosis. In fact, Lilly is also responsible for developing and making available Evista, the first selective estrogen receptor modulator (SERM) for the prevention and treatment of osteoporosis in postmenopausal women.

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.

This news release contains forward-looking statements that reflect management's current beliefs about the potential for teriparatide in the treatment of osteoporosis. There are no guarantees that the product will prove to be commercially successful. The company's results may also be affected by such factors as competitive developments affecting current growth products, rate of growth of the company's key products, the timing of anticipated regulatory approvals and launches of new products, regulatory developments involving current and future products and manufacturing facilities, the impact of governmental actions regarding coverage and reimbursement for pharmaceuticals, and the impact of exchange rates. For additional information about the factors that affect the company's business, please see Exhibit 99 to the company's latest Form 10-Q, filed November 2002. The company undertakes no duty to update forward-looking statements.

B-roll of Forsteo footage is also available for download via the Reuters World Health network. Please contact Eva Holland on [phone] for further information.

References

(1) Jiang et al. Three-Dimensional Microarchitecture of the

Trabecular and Cortical Bone in the Iliac Crest of

Postmenopausal Osteoporotic Women Treated with Teriparatide

(rhPTH(1-34)): Reproducibility of Micro CT Quantification.

Abstract presented at American Society for Bone and Mineral

Research (ASBMR) Meeting, September 19-23, 2003, Minneapolis,

Minnesota, USA

(2) Neer et al. Effect of Parathyroid Hormone (1-34) on Fractures

and Bone Mineral Density in Postmenopausal Women with

Osteoporosis. New England Journal of Medicine, Volume

344:1434-144

(3) Forsteo Summary of Product Characteristics

(4) International Osteoporosis Foundation "Call to Action" Report

2001

(5) International Osteoporosis Foundation Annual Report 1998

(6) Boning Up on Osteoporosis: A Guide to Prevention and

Treatment. National Osteoporosis Foundation; 2000

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