Fda Committee Recommends Fosamax®, Merck's Osteoporosis Drug

Business Wire, July 13, 1995

WEST POINT, Pa.--(BUSINESS WIRE)--July 13, 1995--An advisory committee of the U.S. Food and Drug Administration Thursday unanimously recommended that the FDA clear for marketing Fosamax(R) (alendronate sodium) for the treatment of osteoporosis in postmenopausal women.

Fosamax is the first in a class of medicines called aminobisphosphonates being developed as a nonhormonal treatment for osteoporosis in women after menopause. Aminobisphosphonates decrease the rate of bone resorption -- the process by which bone is broken down. After menopause, the rate of bone resorption accelerates, thinning the bones by reducing bone mineral density and leaving the bones more susceptible to fracture.

In data from clinical trials involving 994 postmenopausal women with osteoporosis in 16 countries, Fosamax was shown to significantly and progressively increase bone mineral density at the lumbar spine (primary study endpoint), proximal femur and total body after three years of treatment. Bone mineral density is closely related to bone strength, and people with higher bone mineral density are less likely to have fractures.

In these trials, the drug has been generally well tolerated. Side effects, mostly upper gastrointestinal in nature, were mild and generally did not result in discontinuation of treatment.

Osteoporosis is a bone-thinning disease that affects about 25 million Americans, predominantly women. It costs the U.S. health-care system more than $10 billion a year, due primarily to the 1.3 million fractures a year it causes. About one in four of those fractures result in hospitalization and rob people of their mobility and independence and, in the long run, lead to disability and sometimes death.

The New Drug Application for Fosamax was submitted to the FDA on March 31, 1995, and also seeks an indication for the treatment of Paget's disease of the bone; the FDA did not request the advisory committee's consideration of this subject.

Fosamax was licensed to Merck & Co. Inc., Whitehouse Station, N.J., by Istituto Gentili SPA, of Pisa, Italy, in 1988. Merck & Co. Inc. is a leading research-driven pharmaceutical products and services company. Merck discovers, develops, manufactures and markets a broad range of innovative products to improve human and animal health. -0- NOTE: Recommendations of the Advisory Committee are not necessarily indicative of final FDA decisions on clearance to market a drug. Fosamax is the Merck registered trademark for alendronate sodium

CONTACT: Merck & Co. Inc., West Point

Press Contacts:

Michael Seggev Maria Evans

215/652-6931 (work) 215/652-5628 (work)

215/646-7439 (home) 215/766-2331 (home)

or

Investor Contact:

Jim Hinrichs

908/423-6883