FDA clears first blood test for management of osteoporosis.

SAN DIEGO--(BUSINESS WIRE)--Sept. 6, 1996--Physicians can now check the progress of osteoporotic patients within months of starting pharmaceutical treatment.

Hybritech Inc., a wholly owned subsidiary of Beckman Instruments Inc., received clearance from the U.S. Food and Drug Administration Aug. 19 to market Tandem-R Ostase, the first blood test available for the management of postmenopausal osteoporosis.

Healthy bone continually renews itself where old bone is broken down and new bone is formed. In osteoporosis, however, there is an imbalance in this bone-turnover cycle, leading to an increase in bone fragility and susceptibility to fracture. Current osteoporosis treatments such as bisphosphonates and estrogen replacement reduce the imbalance in bone turnover, resulting in healthier bones.

Ostase uses Hybritech's patented Tandem format to measure bone turnover by measuring the level of an enzyme in the blood, bone alkaline phosphatase. Ostase test values generally decrease with effective treatment, giving physicians and patients confidence in the therapy prescribed. This is a significant advantage for physicians in managing patient treatment.

``It's always important to know how well bone is being formed,'' said Robert Lindsay, M.D., president of the National Osteoporosis Foundation. ``It's reassuring to the doctor, and the doctor can tell the patient the therapy is working. Knowing that helps the patient stay with her treatment.''

Ostase was first cleared by the FDA in 1994 for the management of patients with Paget's disease, a crippling bone disease. The second indication, the management of postmenopausal osteoporosis, has the potential to vastly expand the use of Ostase.

Porous bones threaten the health and well-being of some 25 million Americans. Four out of five osteoporosis victims are women, and more than half of all women older than 50 can expect to suffer an osteoporosis-related fracture. Men do not entirely escape the dangers of bone-mass loss: By age 75, they have a one-in-three chance of being afflicted.

Osteoporosis causes 1.5 million fractures a year, the most prevalent being in the vertebrae, hip and wrist. Broken bones represent much more than a temporary slowdown for aging patients. Studies show that almost a quarter of hip-fracture patients age 65 or older die within a year of the accident. Many more end up in nursing homes, never regaining their independence.

Nationwide, we spend $10 billion a year treating osteoporosis and related fractures. It is estimated that by 2020, when baby boomers reach old age, the price tag will have soared to $62 billion.

Technological breakthroughs such as Ostase may allow physicians to adopt more aggressive management and prevention strategies toward this debilitating disease.

``In the next few years, we'll see considerable advances in treating osteoporosis,'' Lindsay said, ``and it will be important for doctors to gain knowledge about how various new medicines work. Ostase allows therapies to be tested for effectiveness more often and with more accuracy.''

Hybritech, founded in 1978, pioneered the development of monoclonal-antibody technology. It created the Tandem line of laboratory tests used to detect, measure and monitor a variety of conditions, including pregnancy; birth defects; cancers of the prostate, colon and other organs; heart attacks; and metabolic bone disease.

One of Hybritech's most well-known products is Tandem PSA (prostate-specific antigen), the first and only blood test found to be safe and effective by the FDA for use as an aid in the detection of prostate cancer.

CONTACT: Hybritech Inc.

Karen Zatt, 619/621-4385

or

Andersen Jones Partners

Liz Dowling, 619/942-2544