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SECURITIES AND 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) December 9, 1998
MERCK & CO., Inc.
(Exact Name of Registrant as Specified in Its Charter)
New Jersey
(State or Other Jurisdiction of Incorporation)
1-3305 22-1109110
(Commission File Number) (I.R.S Employer Identification No.)
One Merck Drive, PO Box 100, Whitehouse Station, NJ 08889-0100
(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
Incorporated by reference is a press release issued by the Registrant on
December 9, 1998, attached as Exhibit 99.
Item 7. Financial Statements and Exhibits
(c) Exhibits
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Exhibit 99 Press release issued Filed with
December 9, 1998 regarding this document
business briefing to analysts
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SIGNATURES
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.
Date: December 9, 1998 By: /s/ Dolores O. Rosinski
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DOLORES O. ROSINSKI
Senior Assistant Secretary
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EXHIBIT INDEX
Exhibit
Number Description
99 Press release issued December 9, 1998
regarding business briefing to analysts
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EXHIBIT 99
FOR IMMEDIATE RELEASE John Doorley, Public Affairs - (908)423-4081
Laura Jordan, Inv. Relations - (908)423-5185
NEW PRODUCTS TO DRIVE REVENUE AND EARNINGS
GROWTH, MERCK TELLS ANALYSTS
NEW DATA RELEASED ON INVESTIGATIONAL MEDICINE FOR OSTEOARTHRITIS AND PAIN
Whitehouse Station, N.J., December 9, 1998 -- Everything is in place for the
company to achieve its long-term growth objectives and it is now a matter of
"continuing to execute," Merck told 300 securities analysts today at its annual
business briefing.
The company also revealed new data on VIOXX(TM) (rofecoxib) -- its once-daily,
anti-inflammatory COX-2-specific inhibitor for the treatment of the signs and
symptoms of osteoarthritis and the relief of pain -- and confirmed it had
submitted a New Drug Application to the U.S. Food and Drug Administration on
November 23. Merck expects to have filed similar regulatory applications
worldwide by the end of the year.
Merck has introduced 14 new products since April 1995, a record for the company.
"Breakthrough research has been the hallmark of Merck's success in the past,"
said Raymond V. Gilmartin, Chairman, President and CEO, "and we know that it
will continue to be the driving force behind our success in the future."
Merck plans to invest $2.1 billion in 1999 (a 14 percent increase over the
projected amount for 1998) to discover and develop innovative, unique-in-class
medicines. The 14 new drugs and vaccines are accounting for an increasingly
large percentage of the company's total revenues, while the Merck medicines that
will lose patent protection in 2000 and 2001 are declining in significance. The
company is therefore confident it can overcome the patent expiration challenge,
Mr. Gilmartin said. He added that Merck introduced five of the 14 new products
this
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year, and all are at the very early stages of their product life cycles with
room for significant growth.
Mr. Gilmartin listed patent expirations, increasing market competition and cost
containment pressures as the three biggest challenges facing the company.
Joining him in expressing confidence in the company's ability to meet those
challenges were: David W. Anstice, President, Human Health - The Americas; Per
Wold-Olsen, President, Human Health - Europe, Middle East & Africa; Per G. H.
Lofberg, President, Merck-Medco Managed Care; Judy C. Lewent, Senior Vice
President and Chief Financial Officer, and Edward M. Scolnick, M.D., President,
Merck Research Laboratories, and Executive Vice President, Science and
Technology.
Merck will add 700 new professional representatives to its U.S. sales force in
1999 to support the growth of its new products and build promotional support for
VIOXX, Mr. Anstice announced.
Mr. Gilmartin said all of the five medicines introduced this year -- SINGULAIR
for asthma, MAXALT for migraines, AGGRASTAT for cardiovascular disorders,
PROPECIA for male pattern hair loss and COSOPT for glaucoma -- are performing at
or above the company's targets.
STRONG GROWTH OF KEY FRANCHISES
In the highly competitive cholesterol-lowering market, market share for ZOCOR
stabilized in 1998. Company executives attributed this, in part, to the
promotion of new indications for stroke prevention and triglycerides reduction.
In 1998, Merck sales representatives also began promoting the new 20 mg starting
dose, which was used in the landmark 4S study, as well as the new ZOCOR 80 mg
dose.
FOSAMAX, Merck's medicine to treat and prevent postmenopausal osteoporosis and
reduce the risk of fractures due to osteoporosis, continues to be the leading
non-hormonal treatment for osteoporosis worldwide despite new competition.
COZAAR/HYZAAR, Merck's angiotensin II antagonist, also continued its market
leadership in 1998 due to its excellent tolerability profile and proven efficacy
in treating high blood pressure despite new competition in this class. In
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1998, CRIXIVAN, available in more than 80 countries, remained the most widely
prescribed protease inhibitor for the treatment of HIV/AIDS worldwide.
Despite the complex, challenging and highly regulated market environment, Merck
continues to do well in Europe, said Mr. Wold-Olsen. In 1998, Merck is growing
at 14 percent in Europe. Merck is now the number two pharmaceutical company
there, with revenues that have more than doubled over the last five years.
Mr. Lofberg reported that Merck-Medco continued its strong performance in 1998
and strengthened its position as the nation's leading pharmacy benefit manager.
He said Merck-Medco's growth was fueled by major new accounts gained in all
market segments. Mr. Lofberg outlined a number of Merck-Medco initiatives that
employ its clinical, information management and communications capabilities to
improve patient care and reduce overall health care costs. For instance, he
reported on the growing acceptance of Merck-Medco's health management programs
in the market and reviewed results of studies that demonstrate how these
programs contribute to better health and lower costs. He also described
Merck-Medco's efforts to employ technologies, such as physician point-of-care
systems and the Internet, to enhance services for health care providers and
patients.
NEW DATA ON VIOXX
Dr. Scolnick presented for the first time results from two six-month safety
studies on VIOXX, the Company's investigational, once-daily, anti-inflammatory
COX-2 specific inhibitor. COX-2 specific inhibitors are being studied to
determine whether they cause fewer serious gastrointestinal side effects than
nonsteroidal anti-inflammatory drugs (NSAIDs), the most commonly used therapy
available for the treatment of osteoarthritis (OA) and pain.
In the two studies, which evaluated a total of 1,427 OA patients, the cumulative
rate of ulcers for once daily VIOXX (25 and 50 mg) was similar to the rate on
placebo and significantly less than the rate on ibuprofen (800 mg, dosed three
times a day), a widely used NSAID. Ulcers were observed using an endoscope, a
medical instrument that allows physicians to view the esophagus, stomach and a
small part of the upper intestine. Endoscopies were performed at the start of
the study, and at weeks six, 12, and 24.
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At the primary endpoint of week 12, 7.3 percent of patients on placebo had
ulcers compared to 4.7 percent on VIOXX 25 mg and 8.1 percent on VIOXX 50 mg. Of
patients on ibuprofen, 28.5 percent had ulcers. At week 24, the cumulative ulcer
rates for both doses of VIOXX (9.7 percent for 25 mg and 13.5 percent for 50 mg)
remained significantly lower than the rate for ibuprofen (46.4 percent). The
placebo arm of the study was discontinued at week 16 by design.
Dr. Scolnick also summarized results from two acute pain studies in which VIOXX
relieved dental pain and post-orthopedic surgery pain comparable to widely used
prescription NSAIDs and superior to placebo. In the 151-patient dental pain
study, a single 50 mg dose of VIOXX was comparable to a single 400 mg dose of
ibuprofen and superior to placebo in relieving pain at eight hours after dosing,
and pain relief was sustained for the full 24-hour study period. In the
218-patient post-orthopedic surgery pain study, a single dose of VIOXX 50 mg was
comparable to a single dose of naproxen sodium 550 mg and superior to placebo at
eight hours, and pain relief was sustained at 12 hours, the last time point
measured. In both studies, VIOXX was similar to NSAIDs in time to onset of
action, with pain relief occurring within 45 minutes. The primary endpoint in
the two studies was total pain relief at eight hours after dosing.
Dr. Scolnick also noted that kidney effects seen with VIOXX are comparable to
those seen with other drugs, including NSAIDs, known to act on similar
biochemical targets. The incidence of mild fluid retention was low and similar
among those taking VIOXX (less than 3.5 percent) and those taking ibuprofen (4
percent). Other specialized safety studies evaluating the effect of VIOXX on the
kidney, joints and lower GI tract have been completed, as has a comprehensive
analysis on GI outcomes such as perforations, ulcers and bleeds. Results of
those studies will be presented at a later date.
OTHER RESEARCH PROJECTS DISCUSSED
In addition to VIOXX, Dr. Scolnick discussed nine other compounds out of the
many under investigation in Merck Research Laboratories. Merck's substance P
antagonist (MK-869), which treats depression in an entirely new way, is
currently in Phase IIb clinical dose ranging trials. The once-a-day, oral
compound has a novel mechanism of action, and in Phase IIa clinical trials
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demonstrated excellent antidepressant and anti-anxiety activity. It also showed
efficacy and excellent tolerability compared with a selective serotonin
re-uptake inhibitor from the leading class of antidepressants. The optimal dose
is being identified and Merck expects to start Phase III clinical studies in
1999. A "second entry" substance P antagonist is in Phase IIb.
Other products in development include MK-663, a second entry COX-2 inhibitor;
CANSIDAS, a once-a-day intravenous antifungal compound; MK-826, a once-a-day,
long-acting antibiotic of the carbapenem class; a VLA-4 antagonist, an inhaled
drug for asthma that Merck has licensed from Biogen; a promising anti-cancer
compound that inhibits the activity of the ras protein enzyme involved in
pancreatic, colon, lung and breast cancers; a rotavirus vaccine to prevent
infant diarrhea and malabsorption; and the company's human papillomavirus
vaccine.
* * *
In terms of performance for the remainder of this year, Mr. Gilmartin said Merck
is comfortable with the 1998 earnings range as the company sees it on First Call
of $4.27 to $4.34 on a fully diluted basis. For next year, he said it would be
reasonable to expect earnings to be within the range of $4.85 to $4.95 on a
fully diluted basis.
This press release contains "forward-looking statements" as that term is defined
in the Private Securities Litigation Reform Act of 1995. The forward-looking
statements include Mr. Gilmartin's statements regarding the Company's expected
growth rates, and Dr. Scolnick's statements regarding product pipeline. No
forward-looking statement can be guaranteed and actual results may differ
materially from those projected. Additional detailed information concerning a
number of factors that could cause actual results to differ materially is
readily available in Item 1 of the Company's Annual Report on Form 10-K for the
year ended December 31, 1997. Copies of this Form 10-K are available on request
directed to Merck's Office of Stockholder Services.
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