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Treatment for Breast Cancer -- Adjuvant

Bonefos Accepted for Filing and Granted Priority Review by FDA

MONTVILLE, N.J., September 9, 2004 -- Berlex Laboratories, a U.S. affiliate of Schering AG, Germany announced today that Bonefos (clodronate) has been accepted for filing and designated for priority review by the U.S. Food and Drug Administration (FDA). Berlex is seeking approval for the use of Bonefos as an adjuvant oral treatment for reducing the occurrence of bone metastases in stage II/III breast cancer patients.

"We are extremely excited with the FDA's decision to accept Bonefos for priority review", said Reinhard von Roemeling, MD, Vice President of Clinical Development, Oncology. "This is an important milestone and recognizes the significant unmet medical need facing women with breast cancer." The FDA gives priority designation to products that are considered to be a potential significant therapeutic advancement over existing therapies and that address an unmet medical need. The priority review designation provides for a six month review from the date of filing.

Additional information
About Breast Cancer A National Cancer Institute (NCI) report estimates that about 1 in 8 women in the United States (approximately 13 percent) will develop breast cancer during her lifetime. The American Cancer Society estimates that each year nearly 175,000 American women will be diagnosed with breast cancer. 43,300 women will die from breast cancer this year. Breast cancer is the leading cause of death among women between 40 and 55 years of age and is the second overall cause of death among women (exceeded only by lung cancer). Fortunately, the mortality rate from breast cancer has decreased in recent years with an increased emphasis on early detection and more effective treatments.

Bone metastases are one of the most common forms of recurrence in breast cancer following standard adjuvant therapy. It is estimated that approximately up to 70 percent of women whose breast cancer metastasized will develop at least one skeletal lesion during the course of the disease. Epidemiological data show that once patients with breast cancer develop bone metastases their life expectancy is approximately 21 months.

About Bonefos (clodronate)
Clodronate is a bisphosphonate, and a potent inhibitor of osteoclast- mediated bone resorption. Consequently, clodronate is able to inhibit cancer cell stimulated osteolytic activity, thereby helping the structure of the bone. Bonefos is approved in 79 countries for the treatment of tumor- induced osteolysis and hypercalcemia. So far, there is approximately 260,000 patient years of experience with Bonefos as a marketed product.

Adverse Effects
Diarrhea may occur in approximately 10% of patients, but this reaction is usually mild, and did not lead to early drug discontinuation as compared to placebo control in a large, randomized, double-blind clinical trial.

About Berlex
Committed to developing novel diagnostics and therapeutics that address unmet medical needs, Berlex develops and markets diagnostic imaging agents, treatments in the areas of female healthcare, oncology and dermatology, as well as specialized therapeutics for life-threatening and disabling diseases in the fields of the central nervous and cardiovascular systems and gastroenterology. Berlex has business operations in New Jersey, California and Washington.
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Posted: September 2004

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