SECURITIES AND EXCHANGE COMMISSION
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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): July 29, 1997
KOS PHARMACEUTICALS, INC.
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(Exact name of registrant as specified in its charter)
FLORIDA 000-22171 65-0670898
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(State or other (Commission (IRS Employer
jurisdiction of File No.) Identification
incorporation) No.)
1001 BRICKELL BAY DRIVE
SUITE 2502
MIAMI, FLORIDA 33131
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(Address of principal executive offices)
305-577-3464
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(Registrant's telephone number, including area code)
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ITEM 5. OTHER EVENTS.
In a press release dated July 29, 1997, Kos Pharmaceuticals, Inc. (the
"Company") announced its receipt of clearance from the United Stated Food & Drug
Administration to market the Company's Niaspan/registered trademark/ product. A
copy of the press release is included as Exhibit 99.1 herein.
ITEM 7. FINANCIAL STATEMENTS, PRO FORMA FINANCIAL INFORMATION AND EXHIBITS.
(c) The following exhibit is filed as part of this report:
99.1 Press Release of the Company dated July 29, 1997.
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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.
KOS PHARMACEUCTICALS, INC.
By: /s/ DANIEL M. BELL
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Daniel M. Bell
President & Chief Executive Officer
Dated: July 29, 1997
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EXHIBIT INDEX
EXHIBIT
NUMBER DESCRIPTION
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99.1 Press Release of the Company dated July 29, 1997.
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KOS PHARMACEUTICALS RECEIVES FDA MARKETING CLEARANCE FOR NIASPAN/registered
trademark/ -New Cholesterol Therapy Improves Lipid Levels; Reduces The Risk Of
Recurrent Heart Attack-
MIAMI, July 29, 1997 -- Kos Pharmaceuticals, Inc. (Nasdaq: KOSP) today announced
that the U.S. Food and Drug Administration (FDA) has granted clearance to market
NIASPAN/registered trademark/, the only Once-A-Night/trademark/ niacin-based
drug approved for the treatment of mixed lipid disorders. NIASPAN/registered
trademark/, which has been shown to significantly move all major lipids in the
proper direction, is indicated for the reduction of various lipid components,
reduction in the risk of recurrent nonfatal heart attack, and, when combined
with bile-binding resins, to promote regression of atherosclerosis. Kos
internally developed NIASPAN/registered trademark/ and retains worldwide
marketing rights.
"We are extraordinarily pleased that Kos has reached this major milestone with
the FDA's approval to market our inaugural product, NIASPAN/registered
trademark/. This clearance of an internally developed drug, which is to be
marketed by our own salesforce, is a significant and somewhat rare achievement
for a development stage company," said Daniel M. Bell, President and Chief
Executive Officer of Kos. "We are particularly pleased that the clearance to
market NIASPAN/registered trademark/ includes not only the lipid-lowering
indications for which niacin has been long recognized, but also the important
clinical outcome indications for reduction in second heart attack and promoting
the regression of atherosclerosis."
Medical research has shown that a number of lipids, or cholesterol components,
are implicated in coronary heart disease. These atherogenic lipids include
primarily low-density lipoprotein (LDL) cholesterol (commonly referred to as
"bad" cholesterol), high-density lipoprotein (HDL) cholesterol (commonly
referred to as "good" cholesterol), triglycerides, and lipoprotein a [Lp(a)].
According to John R. Guyton, M.D., Head, Lipid Section, Duke University Medical
Center Department of Medicine, who has conducted clinical trials with
NIASPAN/registered trademark/ since 1992, "NIASPAN's/registered trademark/
significant improvement of multiple lipids, as well as its proven patient safety
and acceptance, offers physicians an exciting new therapeutic option for
treating patients with dyslipidemia."
Extensive clinical trials with NIASPAN/registered trademark/ have shown that
Once-A-Night/trademark/ dosing produces, on average, a reduction in LDL
cholesterol of up to 17 percent, a reduction in triglycerides of up to 35
percent, a reduction in Lp(a) of up to 24 percent, and an increase in HDL
cholesterol of up to 26 percent.
-more-
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KOS PHARMACEUTICALS RECEIVES FDA MARKETING CLEARANCE FOR NIASPAN/registered
trademark/
NIASPAN's/registered trademark/ Once-A-Night/trademark/ delivery system provides
dosing when cholesterol synthesis is at its peak, and it minimizes patient
flushing and liver enzyme elevations. In placebo-controlled clinical trials,
treatment with NIASPAN/registered trademark/ was well tolerated. "The most
common side effects associated with niacin are flushing and liver toxicity,"
said Mark McGovern, M.D., Kos' Vice President, Medical Affairs. "With
NIASPAN/registered trademark/, less than one percent of patients discontinued
therapy because of transient elevations in liver enzymes and less than six
percent of patients discontinued therapy because of flushing." Other
NIASPAN/registered trademark/ side effects were generally mild and usually
comparable to placebo. The most common adverse events in well-controlled
clinical trials were headache, rash, diarrhea, dyspepsia and other
gastrointestinal symptoms, none of which were significantly different from
placebo. As with other dyslipidemic agents, it is recommended that liver
function tests be monitored.
According to industry analysts, cholesterol-altering drugs represent one of the
largest and fastest growing segments of the U.S. prescription market, with
wholesale sales of nearly $3 billion in 1996 and estimates exceeding $10 billion
by the year 2003. "We are most pleased to report that Kos is ready to launch
NIASPAN/registered trademark/ promptly, as we have exceeded, by more than 20%,
our goal of assembling a first-class field sales organization by the time
NIASPAN/registered trademark/ was approved," said Mr. Bell. "Specifically, more
than 85 sales representatives - most of them top-performing specialists in the
cardiovascular field - have committed to join our sales organization effective
August 1. With adequate inventory of product on-hand for distribution, our
specialty sales force will begin detailing NIASPAN/registered trademark/ to
healthcare professionals before the end of this quarter."
The recommended maintenance dose range for NIASPAN/registered trademark/ is 1000
mg to 2000 mg daily. Patients should be placed on a standard
cholesterol-lowering diet before receiving NIASPAN/registered trademark/ and
should continue on this diet during treatment with the product.
NIASPAN/registered trademark/ therapy can be conveniently initiated with the
NITE System(/trademark/)(NIASPAN/registered trademark/ In The Evening) titration
starter pack, which contains 21 days of therapy. NIASPAN/registered trademark/
will be available in bottles of 100 in tablet strengths of 500 mg, 750 mg and
1000 mg.
KOS PHARMACEUTICALS, INC. IS A FULLY INTEGRATED SPECIALTY PHARMACEUTICAL COMPANY
ENGAGED IN THE DEVELOPMENT OF PRESCRIPTION PHARMACEUTICALS FOR THE TREATMENT OF
CERTAIN CHRONIC CARDIOVASCULAR AND RESPIRATORY DISEASES. KOS HAS EXTENSIVE
DRUG-DELIVERY CAPABILITIES IN BOTH SOLID-DOSE AND AEROSOLIZED FORMULATION
TECHNOLOGIES.
EXCEPT FOR THE HISTORICAL MATTERS CONTAINED HEREIN, STATEMENTS IN THIS PRESS
RELEASE ARE FORWARD LOOKING AND ARE MADE PURSUANT TO THE SAFE HARBOR PROVISIONS
OF THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995. INVESTORS ARE CAUTIONED
THAT FORWARD LOOKING STATEMENTS ARE SUBJECT TO UNCERTAINTIES THAT MAY AFFECT THE
COMPANY'S BUSINESS AND PROSPECTS, INCLUDING REGULATORY, ECONOMIC, COMPETITIVE,
GOVERNMENTAL, AND TECHNOLOGICAL UNCERTAINTIES AND OTHER RISKS DESCRIBED IN THE
COMPANY'S REGISTRATION STATEMENT FILED WITH THE SECURITIES AND EXCHANGE
COMMISSION ON DECEMBER 17, 1996, AS AMENDED, AND IN THE OTHER DOCUMENTS FILED BY
THE COMPANY WITH THE SECURITIES AND EXCHANGE COMMISSION.
