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SECURITIES & EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported) October 2, 1995
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MERCK & CO., Inc.
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(Exact name of registrant as specified in its charter)
New Jersey
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(State or other jurisdiction of incorporation)
1-3305 22-1109110
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(Commission File Number) (IRS Employer Identification No.)
One Merck Drive, PO Box 100, Whitehouse Station, NJ 08889-0100
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(Address of Principal Executive Offices) (Zip Code)
Registrant's telephone number, including area code (908) 423-1000
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Item 5. Other Events
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Incorporated by reference is a press release issued October 2, 1995 concerning
the Registrant's announcement that the U.S. Food and Drug Administration has
cleared for marketing Fosamax(R) (alendronate sodium) to treat osteoporosis in
women after menopause.
Item 7. Financial Statements and Exhibits
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(c) Exhibit
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Exhibit 99 - Press release issued October 2, 1995.
SIGNATURE
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Pursuant to the requirements of the Securities Exchange Act of 1934,
the Registrant has duly caused this Report to be signed on its behalf by the
undersigned hereunto duly authorized.
MERCK & CO., Inc.
By: /s/ Nancy V. Van Allen
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Nancy V. Van Allen
Assistant Secretary
October 4, 1995
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EXHIBIT INDEX
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Exhibit
Number Description
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99 Press release issued October 2, 1995.
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EXHIBIT 99
[LOGO] MERCK News Release
_____________________________________________________________________
FOR IMMEDIATE RELEASE
Contact: Maria Evans Jan Weiner
(215) 652-5628 (215) 652-6462
(215) 766-2331 (Home) (610) 664-8722 (Home)
FDA CLEARS MERCK'S FOSAMAX(R) AS THE FIRST NONHORMONAL DRUG
TO TREAT OSTEOPOROSIS IN WOMEN AFTER MENOPAUSE
WEST POINT, Pa., Oct. 2, 1995 -- Merck & Co., Inc. today announced
that the U.S. Food and Drug Administration has cleared for marketing Fosamax(R)
(alendronate sodium) to treat osteoporosis in women after menopause. Fosamax, a
breakthrough prescription medicine, builds healthy bone, restoring some of the
bone lost as a result of osteoporosis. Fosamax is a new treatment choice and
the first nonhormonal medicine for women after menopause who have this bone-
weakening disease, which leads to osteoporotic fractures in more than one in
three women over age 50.
"Until recently, the only treatments for osteoporosis, a potentially
painful, disabling and sometimes life-threatening disease, were hormonal.
Finally, there is a new treatment choice women can discuss with their
physicians," said Ethel Siris, M.D., director of osteoporosis programs at the
Center for Women's Health, Columbia-Presbyterian Medical Center, New York, and a
clinical investigator for Fosamax. "Fosamax is a highly effective treatment
that increased the amount of bone in women in clinical trials. As a result,
Fosamax also reduced the risk of new spinal fractures. This treatment should
help the 20 million American women with osteoporosis remain active, strong and
independent throughout their lives."
The FDA clearance of Fosamax is based on efficacy data from five
clinical trials involving 1,827 women after menopause with osteoporosis in 16
countries who were followed for at least two years. The women ranged in age from
41 to 85, with an average age of 64.3.
In individuals with osteoporosis, bone loss can lead to spinal
fractures, which can gradually collapse the bones of the spine and cause height
loss, pain and a deformed back (dowager's hump).
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Fosamax -- pronounced FOS-sah-max -- is the Merck registered trademark for
alendronate sodium.
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Results from two three-year pivotal trials with 994 postmenopausal
women with osteoporosis supported the conclusion that Fosamax built healthy
bone. In patients treated with Fosamax, a progressive increase in bone mineral
density (a measure of bone strength) occurred at the spine (8.2 percent) and hip
(7.2 percent), compared with patients treated with placebo, in whom bone mineral
density decreased by between 0.65 and 1.16 percent. Fosamax also significantly
increased bone mineral density at other sites, suggesting that the gains in bone
mineral density at the spine and hip did not occur because of a loss of bone
mineral density elsewhere in the skeleton.
While the studies were not designed to detect fracture risk, further
analysis supports that Fosamax reduced by nearly half (48 percent) the number of
women who suffered new spinal fractures compared with women treated with
placebo. Treatment with Fosamax also led to a 63 percent reduction in the total
number of new spinal fractures. Patients who fracture a bone in their spine are
more likely to fracture another than patients who have no spinal fractures.
In the trials, women treated with Fosamax lost an average of 3.0 mm in
height, compared with women on placebo who lost an average of 4.6 mm -- a 35
percent reduction in overall height loss. In women with at least one new spinal
fracture, those treated with Fosamax lost an average of 5.9 mm (less than a
quarter-inch) while women on placebo lost an average of 23.3 mm (approximately
one inch) in height. This results from a reduction in both the number and
severity of fractures.
SIDE EFFECTS GENERALLY MILD
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Side effects observed in clinical trials were generally mild and
generally have not caused patients to stop taking Fosamax. Of patients taking
placebo, 6.0 percent (24 of 397) discontinued treatment due to adverse
experiences, compared with 4.1 percent (8 of 196) taking Fosamax 10 mg. The
most commonly reported drug-related side effects in patients taking Fosamax were
abdominal and musculoskeletal pain. Less frequently reported were other
digestive disturbances such as nausea, heartburn, and irritation or pain of the
esophagus. Patients with low levels of calcium in their blood, severe kidney
disease or who are pregnant or nursing should not take Fosamax. As with other
drugs in its class, caution should be used when Fosamax is given to patients
with active upper gastrointestinal problems. The safety of treatment with
Fosamax for longer than four years has not been studied; extension studies are
ongoing.
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The recommended dosage of Fosamax is 10 mg once daily for treatment
of osteoporosis in women after menopause. Fosamax must be taken at least one-
half hour before the first food, beverage or medication of the day with a full
glass of plain water only to ensure adequate absorption. Patients should not
lie down for at least 30 minutes after taking Fosamax.
OSTEOPOROSIS: ONE OF AMERICA'S MOST PREVALENT DISEASES
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Fosamax is indicated for the treatment of osteoporosis in
postmenopausal women. Osteoporosis is a progressive disease of the skeleton
caused by an imbalance in the body's bone-rebuilding cycle. Osteoporosis is
characterized by low bone mass, which results in bones that are prone to
fracture, or by the presence or history of an osteoporotic fracture. Bone mass
is closely related to bone strength; the greater the bone mass, the stronger the
bones and the less likely they are to fracture. A woman's bones can become so
fragile that even bending to pick up a newspaper can cause bones in the spine to
fracture.
Osteoporosis affects more than 25 million Americans, 80 percent of
them women. Each year, osteoporosis causes more than 1.3 million fractures,
including 500,000 spinal fractures, 250,000 hip fractures and 240,000 wrist
fractures. The disease costs the U.S. healthcare system more than $10 billion
annually, primarily due to these fractures of the hip, wrist and spine.
"Because women with osteoporosis may find it difficult to conduct
normal daily activities, such as getting in and out of a car or getting dressed,
many women can feel isolated and dependent on others," said Deborah T. Gold,
Ph.D., assistant professor of medical sociology at Duke University Medical
Center and an expert in the psychological and social effects of osteoporosis.
"Few people realize that chronic pain due to osteoporotic fractures can
physically limit a woman's life and affect her socially and emotionally."
OSTEOPOROSIS: TYPICALLY WITHOUT SYMPTOMS FOR MANY YEARS
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Because bone loss occurs without symptoms, osteoporosis often goes
unrecognized. In many cases, it is not diagnosed until after one or several
fractures have occurred. However, several types of tests, all of which are
quick, painless and non-invasive, can detect low bone mass.
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"Contrary to popular belief, osteoporosis is not just a disease of
elderly women, but can affect women at any age, even those who exercise
regularly and take calcium," said Dr. Siris. "All women who are past menopause
or who have had a total hysterectomy should talk to their doctor to evaluate
their personal risk for osteoporosis and determine if a bone mass measurement
would be helpful. Those who already have the disease should talk to their
doctor about treatments and other measures to prevent fractures."
BONE LOSS ACCELERATES AT MENOPAUSE
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Bone is constantly being rebuilt (or remodeled) throughout life in a
process in which old bone tissue is broken down (or resorbed) by cells called
osteoclasts and replaced with new bone tissue by cells called osteoblasts. In
healthy young adults, the overall rate of remodeling is usually in balance so
that the amount of bone lost is about equal to the amount that is replaced.
However, after menopause, more bone is broken down than is replaced,
causing bone loss to occur and bones to become weaker. This is due to a drop in
the level of estrogen. In the first five years after menopause, women may lose
as much as 25 percent of their bone mass. In fact, menopause is the single most
important risk factor for osteoporosis in women.
"Fosamax builds healthy bone; it inhibits bone breakdown, decreasing
the amount of bone lost. The effect of continuous treatment with Fosamax is a
net increase in bone mass in women with osteoporosis after menopause," said
Laurence J. Hirsch, M.D., executive director of clinical research, Merck
Research Laboratories. "To date, a progressive increase in bone mass has been
observed for at least three years in the clinical trials of Fosamax."
FOSAMAX ALSO CLEARED FOR TREATMENT OF PAGET'S DISEASE OF BONE
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The FDA also cleared Fosamax for the treatment of Paget's disease of
bone, a chronic disorder that affects up to 1.3 million Americans and may result
in enlarged and deformed bones in one or more regions of the skeleton. In
patients with Paget's disease of bone, excessive remodeling causes the bone to
be enlarged but fragile, and may result in bone pain, deformities, fractures
and, in some cases, arthritis and neurological complications.
In patients taking Fosamax 40 mg a day, most side effects were similar
to those seen in the treatment of postmenopausal women with osteoporosis.
However, there was an apparent increase in upper gastrointestinal experiences
and musculoskeletal pain.
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The recommended dosage of Fosamax for Paget's disease of bone is 40 mg
once daily for six months. Patients should be periodically evaluated to
determine their response to therapy.
Merck's catalog price to pharmacies for a 10 mg tablet of Fosamax (the
recommended daily dose for treatment of osteoporosis in postmenopausal women)
will be $1.39. Merck estimates that the retail price for 10 mg will be between
$1.65 and $1.80 a day ($50 to $55 monthly, $600 to $660 annually), which
includes markups of 20 to 30 percent that are based on historical audit data.
Prices at the retail level are established by pharmacies, not by Merck, and can
vary.
Fosamax was licensed to Merck & Co., Inc. by Istituto Gentili SPA of
Pisa, Italy, in 1988 and is approved in 18 other countries. The New Drug
Application for Fosamax was submitted to the FDA on March 31, 1995.
Merck has entered into a promotion agreement with Wyeth-Ayerst
Laboratories, a division of American Home Products Corp., under which Wyeth-
Ayerst will promote Fosamax to obstetricians and gynecologists in the United
States. Merck will concentrate its promotional and educational efforts on other
key specialty groups, such as endocrinologists, rheumatologists, and orthopedic
surgeons, and primary-care physicians.
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.
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