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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 6, 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 releases dated October 6, 1999 and October 19, 1999
are attached hereto as Exhibit 99.1 and 99.2, respectively, and are
incorporated herein by reference.
Item 7. Financial Statements Information and Exhibits
---------------------------------------------
(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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99.1 Press release dated
October 6, 1999
99.2 Press release dated
October 19, 1999
-2-
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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 20, 1999 DURAMED PHARMACEUTICALS, INC.
By: /s/ Timothy J. Holt
--------------------------------------
Timothy J. Holt
Senior Vice President-Finance
and Administration
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Exhibit 99.1
PRESS RELEASE
FOR IMMEDIATE RELEASE
DURAMED PHARMACEUTICALS AND SOLVAY PHARMACEUTICALS
ANNOUNCE ALLIANCE
CINCINNATI, OH AND MARIETTA, GA (OCTOBER 6, 1999) -- DURAMED PHARMACEUTICALS,
INC. (Nasdaq:DRMD) and SOLVAY PHARMACEUTICALS, INC. today announced an alliance
to jointly promote three of the companies' hormone products in the United
States: Duramed Pharmaceuticals' CENESTIN(R) (synthetic conjugated estrogens, A)
Tablets and Solvay Pharmaceuticals' ESTRATEST(R)/ESTRATEST(R) H.S. Tablets
(esterified estrogens and methyltestosterone) and PROMETRIUM(R) (progesterone)
Capsules.
CO-PROMOTION EFFORTS PLANNED FOR OCTOBER
A combined national sales force of more than 300 Duramed Pharmaceuticals and
Solvay Pharmaceuticals sales representatives will begin October 11, 1999 to
promote the alliance products to obstetricians and gynecologists across the
United States. Solvay Pharmaceuticals' resources also include teams of regional
marketing managers, field trainers, medical liaison teams and a medical advisory
committee comprised of leading women's health physicians.
"This alliance means more expansive, more visible market coverage for both
Duramed and Solvay Pharmaceuticals women's health products, starting with
Duramed Pharmaceuticals' CENESTIN," said Duramed Pharmaceuticals Chairman and
Chief Executive Officer E. Thomas Arington. He added, "We have been extremely
pleased with the physician/patient response to CENESTIN since our marketing
efforts began in mid-summer. We believe, however, that Solvay Pharmaceuticals'
demonstrated strength in this marketplace makes it a perfect ally for Duramed
Pharmaceuticals."
CENESTIN is designated as the primary product in the Duramed/Solvay
Pharmaceuticals alliance while the Solvay Pharmaceuticals products will address
additional important therapeutic requirements in women's health. All three
products are expected to benefit from the broadened exposure in the marketplace.
Under the terms of the alliance, Duramed Pharmaceuticals, Inc. and Solvay
Pharmaceuticals, Inc. will retain all revenue from their respective products.
David A. Dodd, President and Chief Executive Officer, Solvay Pharmaceuticals,
said, "We see this alliance enhancing our franchise in women's health,
increasing the value of our efforts in the obstetric and gynecological offices
and further demonstrating our strong commitment to
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the U.S. women's healthcare market. Duramed Pharmaceuticals is an excellent
strategic partner due to its demonstrated success in bringing new products to
the market and its shared commitment to women's health care, as evidenced by its
investment in developing hormone products and technology."
CENESTIN(R) was approved by the U.S. Food and Drug Administration (FDA) in March
1999. CENESTIN offers millions of women and their physicians a new, appealing
plant-derived synthetic conjugated estrogens product with a slow-release
formulation. Solvay Pharmaceuticals is a leader in the women's health market.
Its products, ESTRATEST(R)/ESTRATEST(R) H.S. Brand Tablets and PROMETRIUM(R)
Capsules will complement CENESTIN in the pharmaceutical sales effort.
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
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.
SOLVAY PHARMACEUTICALS GRANTED EQUITY OPTION IN DURAMED
Duramed has given Solvay Pharmaceuticals an option to purchase a minimum of
1,666,666 shares and a maximum of 3,000,000 shares of common stock of Duramed at
a price of $9.00 per share. The closing price of Duramed common stock on October
5, 1999 was $7 1/16 per share. If completed, the sale of the minimum number of
1,666,666 shares will be closed by the end of October. The sale of any
additional shares is expected to be closed by the end of the year.
ABOUT SOLVAY PHARMACEUTICALS, INC.
Solvay Pharmaceuticals, Inc., based in Marietta, Ga., is a research-based
pharmaceuticals company, active in the therapeutic areas of cardiology,
gastroenterology, mental health and women's health. It is a member of the
worldwide Solvay Group of chemical and pharmaceutical companies, headquartered
in Brussels, Belgium. The Group's members employ some 33,000 people in 46
countries. Its 1998 revenue worldwide was 7.5 billion EUR ($8.7 billion) from
four operating sectors: Chemicals, Plastics, Processing, and Pharmaceuticals.
Additional information about the Group can be found on the World Wide Web at
http://www.solvay.com.
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ABOUT DURAMED PHARMACEUTICALS, INC.
Duramed Pharmaceuticals, Inc. 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.
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
http://www.duramed.com.
###
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.
<PAGE> 1
Exhibit 99.2
PRESS RELEASE
FOR IMMEDIATE RELEASE
SOLVAY PHARMACEUTICALS EXERCISES OPTION TO PURCHASE
DURAMED PHARMACEUTICALS COMMON STOCK
CINCINNATI, OCTOBER 19, 1999 -- DURAMED PHARMACEUTICALS, INC. (Nasdaq:DRMD)
today announced that it has been notified that SOLVAY PHARMACEUTICALS, INC. is
exercising the option granted October 6, 1999, and intends to purchase the
maximum number of 3,000,000 shares of Duramed common stock at $9.00 per share
made available under the option, subject to certain conditions. On or before
October 22, 1999, Solvay Pharmaceuticals will purchase 1,666,666 shares of
Duramed common stock. Duramed expects to satisfy the conditions of that
purchase.
Purchase of the remaining 1,333,334 shares available under the option is subject
to additional conditions, including: satisfactory completion of all applicable
regulatory requirements, including Hart-Scott-Rodino antitrust review; the
future creation of an additional director position on Duramed's board of
directors to be designated by Solvay Pharmaceuticals; and, final approval by the
Solvay America, Inc. board of directors.
The sale of 1,666,666 shares of newly issued stock will increase Duramed's total
fully diluted shares outstanding to approximately 29 million. The closing market
price of Duramed common stock on October 18, 1999 was $8 11/16 per share.
DURAMED PHARMACEUTICALS AND SOLVAY PHARMACEUTICALS
IN PRODUCT PROMOTION ALLIANCE
On October 6, 1999, the companies announced an alliance to jointly promote three
of the companies' hormone products in the United States: Duramed
Pharmaceuticals' CENESTIN(R) (synthetic conjugated estrogens, A) Tablets and
Solvay Pharmaceuticals' ESTRATEST(R)/ESTRATEST(R) H.S. Tablets (esterified
estrogens and methyltestosterone) and PROMETRIUM(R) (progesterone) Capsules.
On October 11, 1999, a combined national sales force of more than 300 Duramed
Pharmaceuticals and Solvay Pharmaceuticals sales representatives began promoting
the alliance products to obstetricians and gynecologists across the United
States. Solvay Pharmaceuticals' resources also include teams of regional
marketing managers, field trainers, medical liaison teams and a medical advisory
committee comprised of leading women's health physicians.
<PAGE> 2
CENESTIN is designated as the primary product in the Duramed/Solvay
Pharmaceuticals alliance while the Solvay Pharmaceuticals products will address
additional important therapeutic requirements in women's health. All three
products are expected to benefit from the broadened exposure in the marketplace.
Under the terms of the alliance, Duramed Pharmaceuticals, Inc. and Solvay
Pharmaceuticals, Inc. will retain all revenue from their respective products.
CENESTIN(R) was approved by the U.S. Food and Drug Administration (FDA) in March
1999. CENESTIN offers millions of women and their physicians a new, appealing
plant-derived synthetic conjugated estrogens product with a slow-release
formulation. Solvay Pharmaceuticals is a leader in the women's health market.
Its products, ESTRATEST(R)/ESTRATEST(R) H.S. Brand Tablets and PROMETRIUM(R)
Capsules will complement CENESTIN in the pharmaceutical sales effort.
ABOUT SOLVAY PHARMACEUTICALS, INC.
Solvay Pharmaceuticals, Inc., based in Marietta, Ga., is a research-based
pharmaceuticals company, active in the therapeutic areas of cardiology,
gastroenterology, mental health and women's health. It is a member of the
worldwide Solvay Group of chemical and pharmaceutical companies, headquartered
in Brussels, Belgium. The Group's members employ some 33,000 people in 46
countries. Its 1998 revenue worldwide was 7.5 billion EUR ($8.7 billion) from
four operating sectors: Chemicals, Plastics, Processing, and Pharmaceuticals.
Additional information about the Group can be found on the World Wide Web at
http://www.solvay.com.
ABOUT DURAMED PHARMACEUTICALS, INC.
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.
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.
<PAGE> 3
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
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.
