European Commission Approves FORSTEO(R) (teriparatide [rDNA origin] injection) for the Treatment of Osteoporosis in Men

INDIANAPOLIS, Indiana, July 11 /PRNewswire/ --

- Bone-Building Treatment Now Approved to Treat Osteoporosis in Men at Increased Risk of Fracture

Eli Lilly and Company (NYSE: LLY) announced today that the European Commission has granted approval to expand the indication of FORSTEO(R) (teriparatide [rDNA origin] injection) to include the treatment of osteoporosis in men who are at increased risk of fracture. The indication has also been expanded to include a statement that in postmenopausal women, a significant reduction in the incidence of non-vertebral fractures but not hip fractures has been demonstrated. The Commission Decision follows a positive opinion adopted on May 24, 2007 by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency.

FORSTEO's initial Marketing Authorization was granted in 2003 for the treatment of established osteoporosis in postmenopausal women. FORSTEO is the first in a new class of medications that works to stimulate new bone formation by increasing the number and action of bone-building cells called osteoblasts. FORSTEO is administered in a disposable pen delivery system that can be used for up to 28 days in once-daily, self-administered injections.

"We are delighted to be able to provide a new osteoporosis treatment option for men, given that men over the age of 50 face a serious lifetime risk of fracture," said Abbas Hussain, president of European Operations for Lilly.

The CHMP based its positive opinion on evaluation of clinical data from 437 males with hypogonadal or idiopathic osteoporosis. In these trials, FORSTEO was associated with significant improvements in bone health. Lumbar spine bone mineral density (BMD) significantly increased at three months. After 12 months, BMD had increased in the lumbar spine and total hip by five percent and one percent, respectively, compared with placebo.

The approval of the new statement on reduction in non-vertebral fractures in postmenopausal women was based on the pivotal study that included 1637 postmenopausal women with a prior vertebral fracture. In the study, treatment with FORSTEO resulted in a significant 53% reduction in the risk of non-vertebral fragility fractures. Further, there was a significant 62% reduction in the risk of major non-vertebral fragility fractures including the hip, wrist, arm, ribs and pelvis. However, a significant effect on hip fracture alone was not demonstrated.

Information about FORSTEO

FORSTEO, marketed as FORTEO in the U.S. since 2002, was first approved in the E.U. in 2003 for the treatment of established osteoporosis in postmenopausal women. FORSTEO is available by injection in a 20-mcg dose, taken once daily and should be taken for a period of up to 18 months.

Important Safety Information

In clinical studies, the most common side effects in patients treated with FORSTEO are feeling sick, headache and dizziness and pain in limb. For the full list of all side effects reported for FORSTEO, see the Summary of Product Characteristics.

About Parathyroid Hormone (PTH1-34)

Parathyroid hormone (PTH1-84) is the natural hormone that regulates calcium and phosphate in bone and kidney. FORSTEO is the active fragment (1-34) of the human parathyroid hormone and acts to stimulate bone formation by directly affecting bone forming cells (osteoblasts), indirectly increasing the intestinal absorption of calcium and increasing the re-absorption of calcium and excretion of phosphate by the kidney.

About Osteoporosis

Osteoporosis is a debilitating disease that affects an estimated 75 million people in Europe, U.S. and Japan.(1) Osteoporosis, which means "porous bone", is a disease in which the density and quality of bone are reduced. As the bones become more porous and fragile, the risk of fracture is greatly increased. The loss of bone occurs "silently" and progressively and no symptoms are apparent until the first fracture occurs.(2)

The most common fractures associated with osteoporosis occur at the hip, spine and wrist. The incidence of these fractures, particularly at the hip and spine, increases with age in both women and men.(3)

Vertebral fractures can result in serious consequences, including loss of height, intense back pain and deformity.

About Lilly

Lilly, a leading innovation-driven corporation, is developing a growing portfolio of first-in-class and 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.

Forward Looking Statement

This press release contains forward-looking statements about the safety and efficacy of FORSTEO and reflects Lilly's current beliefs. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of research and commercialization.

There is no guarantee that FORSTEO will continue to be commercially successful for the treatment of osteoporosis. For further discussion of these and other risks and uncertainties, see Lilly's filings with the United States Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.

PPY-LLY

(1) International Osteoporosis Foundation. "Facts and statistics about osteoporosis and its impact." Available at http://www.iofbonehealth.org/facts-and-statistics.html#factsheet-category-22 . Accessed on June 18, 2007

(2) International Osteoporosis Foundation. "What is osteoporosis?" Available at http://www.iofbonehealth.org/patients-public/about-osteoporosis/what-is-osteoporosis.html . Accessed on February 28, 2007

(3) International Osteoporosis Foundation. "What is osteoporosis?" Available at http://www.iofbonehealth.org/patients-public/about-osteoporosis/what-is-osteoporosis.html . Accessed on February 28, 2007

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