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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 MARCH 9, 1998
BARR LABORATORIES, INC.
(Exact name of registrant as specified in its charter)
New York 1-9860 22-1927534
(State or other jurisdiction (Commission (IRS Employer
of incorporation) File Number) Identification No.)
Two Quaker Road, P.O. Box 2900, Pomona, New York 10970-0519
(Address of principal executive offices) (Zip code)
(914) 362-1100
(Registrant's telephone number, including area code)
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BARR LABORATORIES, INC.
CURRENT REPORT DATED MARCH 9, 1998
Item 5. Other Events
See attached Exhibit 99.1; press release announcing that the Company
has filed an anti-trust suit against DuPont Merck Pharmaceutical
Company.
Item 7. Financial Statements and Exhibits
(c) Exhibit Number Exhibit
99.1 Registrant's March 9, 1998 press release
announcing that the Company has filed an
anti-trust suit against DuPont Merck
Pharmaceutical Company.
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BARR LABORATORIES, INC.
CURRENT REPORT DATED MARCH 9, 1998
SIGNATURES
Pursuant to the requirements of the Securities and Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
BARR LABORATORIES, INC.
Date: March 9, 1998 /S/ William T. McKee
--------------------
William T. McKee
Chief Financial Officer
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Exhibit 99.1
2 Quaker Road, P.O. Box 2900 N E W S R E L E A S E
Pomona, NY 10970
914-362-1100
CONTACT: Mark Corbae, 914-353-8451 EMAIL: [email protected]
BARR FILES ANTI-TRUST SUIT AGAINST DUPONT MERCK
DuPont Merck's Actions Show Consistent Pattern of Anti-Competitive Behavior
POMONA, NY, MARCH 9, 1998 -- Barr Laboratories, Inc. (NYSE-BRL) today announced
that it has filed an anti-trust suit against DuPont Merck Pharmaceutical
Company, charging that DuPont Merck has acted unlawfully to impede the
marketplace acceptance of Barr's generic version of the anti-coagulant Coumadin.
Coumadin is the 11th most prescribed product in the United States and has annual
sales in excess of $535 million.
The suit was filed today in United States District Court for the Southern
District of New York. Barr's suit charges that DuPont Merck's actions violated
federal anti-trust laws, as well as the Lanham Act and the New York Deceptive
Acts and Practices Act.
The Company said that although it currently has approximately 12% of the market,
DuPont Merck's anti-competitive practices have materially slowed market
acceptance. The Company said that in the absence of these unlawful actions, it
would have a much more significant share of the $535 million Coumadin market.
"DuPont Merck's activities show a consistent and deliberate pattern of
monopolization and trade disparagement. Barr is asserting its anti-trust claims
to end this pattern of abuse. We will prosecute this case vigorously," said
Bruce L. Downey, Barr's Chairman, President and CEO.
The complaint charges that DuPont Merck has engaged in such activities as
attempting to prevent and delay the introduction of Barr's product at the
federal level; making false and disparaging statements about Barr's product to
the public, pharmacies, health care professionals, legislators and regulators;
and entering into market retention and inventory management agreements with
customers designed to exclude Barr's product from being dispensed and
distributed.
Ongoing Campaign to Block Generic Warfarin
Barr's anti-trust suit charges that DuPont Merck has engaged in an ongoing
campaign of disparagement in which it published false and misleading statements
concerning the bioequivalence, therapeutic efficacy, substitutability and safety
of generic Warfarin Sodium. "DuPont Merck asked FDA, United States Pharmacopoeia
(USP), state boards of pharmacy and legislatures across the nation to join them
in blocking a generic product," Downey continued. "Their requests have been
repeatedly turned down because there is no scientific evidence to support their
claims. DuPont Merck's efforts have one motive -- to unfairly block competition
that would result in lower health care costs for consumers at the expense of
DuPont Merck's profits."
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BARR FILES ANTI-TRUST SUIT... PAGE 2
In summer 1996 DuPont Merck submitted a petition to FDA requesting that the
Agency change the bioequivalence standards for the generic product. DuPont
Merck's petition was rejected by the Agency in March 1997, when FDA stated:
"...there is no documented scientific evidence of safety or efficacy problems
with these drugs. In the absence of such evidence, it is not necessary at this
time to require studies that are more stringent than those that have been
accepted in the past to establish bioequivalence in drugs with narrow
therapeutic ranges."
DuPont Merck also asked the USP to change current limits for dosage uniformity.
This request was rejected in March 1997, with the USP noting that "panel members
are not aware of any clinical problems that have arisen from current
requirements."
In January 1997, DuPont Merck sponsored the formation of the Health Alliance for
NTI patient safety, a group created to advance the concept that generics are not
as safe as branded pharmaceuticals. This organization became the standard-bearer
for efforts to enact legislation on a state-by-state basis that would restrict
consumer access to generic NTI medicines, including Warfarin Sodium. In response
to these state legislative initiatives, the FDA stated: "(NTI drugs) can be
substituted with the full expectation by the patient and physician that they
will have the same clinical effect and safety profile as the innovator drug. If
one therapeutically equivalent drug is substituted for another, the physician,
pharmacist, and patient have FDA's assurance that the physician should see the
same clinical results and safety profile." In addition, Barr has expended
significant efforts to defeat these initiatives in more than two dozen states.
The FDA recently reaffirmed its support of generic substitution, in light of
DuPont Merck's continuing campaign of false and misleading statements. Stuart L.
Nightingale, M.D., FDA's Associate Commissioner for Health Affairs, issued a
"Dear Colleague" letter in January 1998 that concluded, "Products evaluated as
therapeutically equivalent can be expected to have equivalent clinical effect
whether the product is brand name or generic drug product. It is not necessary
for the health care provider to approach one therapeutic class of drug products
differently from any other class, when there has been a determination of
therapeutic equivalence by FDA for the drug products under consideration."
Barr received FDA approval to market generic Warfarin Sodium on March 26, 1997,
and has been shipping the product since July 1997.
Barr Laboratories, Inc. is engaged in the development, manufacture and marketing
of generic and proprietary pharmaceuticals.
EDITOR'S ADVISORY: Barr Laboratories, Inc. news releases and corporate
information are available on Barr's home page (www.barrlabs.com). The most
serious risks associated with anticoagulant therapy with Warfarin Sodium are
hemorrhage in any tissue or organ and, less frequently (less than 0.1%),
necrosis and/or gangrene of skin and other tissues. Numerous factors (alone or
in combination), including travel, changes in diet, environment, physical state,
and medication may influence response of the patient to anticoagulants. Coumadin
is a registered trademark of the DuPont Merck Pharmaceutical Company. For full
prescribing information, contraindications and side effects, call
1-888-WARFARIN.
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