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FORM 8-K
SECURITIES AND EXCHANGE COMMISSION
Washington, D. C. 20549
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report October 22, 1999
DURAMED PHARMACEUTICALS, INC.
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(Exact name of registrant as specified in its charter)
Delaware 0-15242 11-2590026
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(State or other (Commission (IRS Employer
jurisdiction of File Number) Identification No.)
incorporation)
7155 East Kemper Road, Cincinnati, Ohio 45249 (513) 731-9900
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(Address of principal executive offices)
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INFORMATION TO BE INCLUDED IN THE REPORT
Items 1, 2, 3, 4, 6 and 8 are not applicable and are omitted from this Report.
Item 5. Other Events
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The Company's press release dated October 22, 1999 is attached hereto
as Exhibit 99 and is incorporated herein by reference.
Item 7. Financial Statements Information and Exhibits
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(a) Financial Statements of Businesses Acquired.
Not Applicable
(b) Pro Forma Financial Information.
Not Applicable
(c) Exhibits.
The following exhibits are filed with this Report on
Form 8-K:
Regulation S-K
Exhibit No. Exhibit
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99 Press release dated
October 22, 1999
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SIGNATURES
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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.
Date: October 27, 1999 DURAMED PHARMACEUTICALS, INC.
By: /s/ Timothy J. Holt
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Timothy J. Holt
Senior Vice President-Finance
and Administration
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Exhibit 99
PRESS RELEASE
DURAMED PHARMACEUTICALS COMPLETES STOCK SALE TO
SOLVAY PHARMACEUTICALS
ANNOUNCES SETTLEMENT WITH SCHEIN PHARMACEUTICAL
CINCINNATI, OCTOBER 22, 1999--DURAMED PHARMACEUTICALS, INC. (Nasdaq:DRMD) today
announced that SOLVAY PHARMACEUTICALS, INC. has completed its planned purchase
of 1,666,666 shares of Duramed common stock at $9.00 per share. By December 31,
1999, Solvay Pharmaceuticals intends to purchase the remaining 1,333,334 shares
of Duramed stock available under the option granted October 6, 1999, subject to
certain conditions, including: satisfactory completion of all applicable
regulatory requirements, including Hart-Scott-Rodino antitrust review and the
future creation of an additional director position on Duramed's board of
directors to be designated by Solvay Pharmaceuticals. Duramed is being advised
by Banc of America Securities LLC on the agreements, including the stock
purchase transactions, between Solvay Pharmaceuticals and Duramed.
In addition, Duramed announced it has reached a settlement with Schein
Pharmaceutical, Inc. in a litigation between Duramed and Schein pertaining to a
1992 agreement between the companies relating to the development of a generic
version of the conjugated estrogens product Premarin(R). Both firms were to
participate in the marketing and distribution of the generic product and share
equally in the profits. Under terms of the settlement agreement, in exchange for
the payment described below, Schein has given up any further claim to rights in
Duramed's Cenestin(R) (synthetic conjugated estrogens, A) Tablets. Duramed has
made an initial $7.5 million payment to Schein. A second $7.5 million payment
must be received by Schein on or before January 20, 2000, or Schein can require
Duramed to issue shares of common stock, equal in value to $7.5 million, at the
lower of the closing price on October 22, 1999 or the date Schein requires the
shares to be issued. Further, if Cenestin achieves total product profits
(product sales less product-specific cost of goods sold, sales and marketing and
other relevant expenses) of greater than $100 million over any five year or less
period within the next 15 years, Duramed will pay Schein an additional $15
million. Today's settlement resolves all disputes between Duramed and Schein.
"We are pleased to have this litigation resolved and look forward to moving
ahead with Solvay to maximize the potential that Cenestin represents for female
consumers and Duramed," said Duramed Chairman and Chief Executive Officer E.
Thomas Arington.
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ABOUT DURAMED
Duramed Pharmaceuticals develops, manufactures and markets prescription drug
products. The company's business strategy emphasizes products with attractive
market opportunities and potentially limited competition due to technological
barriers to entry, focusing on women's health and the hormone replacement
therapy market.
On March 24, 1999, the U.S. Food and Drug Administration (FDA) approved the
company's first branded product, Cenestin(R) (synthetic conjugated estrogens, A)
Tablets, for the treatment of moderate-to-severe vasomotor symptoms. The company
is undertaking a clinical program to evaluate Cenestin in additional tablet
strengths and for the prevention of osteoporosis. One important element of these
clinical trials--the bone marker study--is complete. Preliminary results are
favorable and clearly show a reduction in bone markers, which indicates a bone
preservation effect. In addition, in the cardiovascular evaluation, a positive
lipid profile was found. The company anticipates beginning the full osteoporosis
clinical study in 2000 to confirm the beneficial results indicated by the bone
marker study. Further, Duramed anticipates receiving approval for the 1.25 mg
tablet strength of Cenestin by December 1999 and approval for the 0.3 mg tablet
strength in mid-2000.
On October 6, 1999, Duramed entered into an alliance with Solvay
Pharmaceuticals, Inc. to jointly promote three of the companies' hormone
products to obstetricians and gynecologists across the United States: Duramed
Pharmaceuticals' Cenestin and Solvay Pharmaceuticals' Estratest(R) and
Prometrium(R).
Duramed's containment manufacturing facility for the production of
hormones--with enclosed product flow and state-of-the-art environmental
controls--ensures purity, stability and tablet uniformity for Cenestin and other
hormone products. While Duramed's primary focus will be solid oral dose
hormones, the company's other areas of concentration--controlled release
technology and oncology--continue to represent attractive market opportunities
that will be pursued, as appropriate.
The company's stock is traded on Nasdaq using the symbol DRMD. Additional
information about the company can be found on the World Wide Web at
www.duramed.com.
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*Premarin is a registered trademark of Wyeth-Ayerst Laboratories, Inc.
Like all estrogen drug products, CENESTIN(R), and ESTRATEST(R)/ESTRATEST(R) H.S.
Brand Tablets should not be used in women with known or suspected pregnancy,
breast cancer, or estrogen-dependent neoplasia, undiagnosed abnormal genital
bleeding, active thrombophlebitis, or thromboembolic disorders. Estrogens have
been reported to increase the risk of endometrial carcinoma in postmenopausal
women with an intact uterus. The most common adverse events reported in clinical
experience with CENESTIN included headache, insomnia, asthenia, nervousness,
paresthesia, and depression. The most common adverse events reported with
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ESTRATEST(R)/ESTRATEST(R) H.S. Brand Tablets include those typical of estrogen
therapy (such as breast tenderness, headache, nausea, edema and abdominal pain)
and of androgen treatment (including hair loss, acne and hirsutism). Common
side effects of PROMETRIUM(R) Capsules are breast tenderness, dizziness,
abdominal bloating, and vaginal discharge. For additional information on
CENESTIN(R), ESTRATEST(R) Brand Tablets or PROMETRIUM(R) Capsules, please see
full prescribing information.
The Securities and Exchange Commission (SEC) encourages companies to disclose
forward-looking information so that investors can better understand a company's
future prospects and make informed investment decisions. Due to changing market
conditions, product competition, the nature of product development and
regulatory approval processes, the achievement of forward-looking statements
contained in this press release are subject to risks and uncertainties. For
further details and a discussion of these risks and uncertainties, see Duramed's
SEC filings, including its annual report on Form 1O-K/A.
