================================================================================
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
------------------------------------
FORM 8-K
Current Report Filed Pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934
Date of Report
(Date of earliest event reported): November 14, 1997
ZONAGEN, INC.
(Exact name of registrant as specified in its charter)
<TABLE>
<S> <C> <C>
Delaware 0-21198 76-0233274
(State or other jurisdiction of (Commission File Number) (I.R.S. Employer Identification No.)
incorporation or organization)
</TABLE>
2408 Timberloch Place, Suite B-4
The Woodlands, Texas 77380
(Address of principal
executive offices
and zip code)
(281) 367-5892
(Registrant's telephone number,
including area code)
------------------------------------
================================================================================
<PAGE>
Item 5. Other Events
On November 14, 1997, Zonagen, Inc. (the "Company") entered into
Exclusive License Agreements with two affiliates of Schering-Plough Corporation
(including such affiliates, "Schering-Plough") with respect to the exclusive
license of the Company's Vasomax(TM) product to Schering-Plough.
On November 17, 1997, the Company issued a press release which
announced the agreements with Schering-Plough. The press release is filed as an
exhibit to this Current Report on Form 8-K and is incorporated by reference
herein.
Item 7. Exhibits
Exhibit 99.1 -- Press Release
-2-
<PAGE>
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.
Zonagen, Inc.
Date: November 24, 1997
By:/s/ Louis Ploth, Jr.
-----------------------------
Louis Ploth, Jr.
Vice President--Business
Development and Chief
Financial Officer
-3-
Exhibit 99.1
FOR IMMEDIATE RELEASE
<TABLE>
<CAPTION>
Contacts:
<S> <C> <C>
Jean Anne Mire Cindy Miller (Investor) William O'Donnell (Media)
Vice President, Investor Relations Patricia Gitt (Media) (973) 822-7476
Zonagen, Inc. Dewe Rogerson, Inc. Geraldine U. Foster (Investor)
(281) 367-5892 (212) 688-6840 (973) 822-7410
Lisa W. DeBerardine (Investor)
(973) 822-7437
Janet Barth (Investor)
(973) 822-7437
Schering-Plough Corporation
</TABLE>
SCHERING-PLOUGH IN AGREEMENT WITH ZONAGEN
FOR WORLDWIDE MARKETING RIGHTS TO VASOMAX(TM)
FOR TREATMENT OF MALE ERECTILE DYSFUNCTION
Madison, N.J. and The Woodlands, Texas, November 17, 1997 -- Schering-Plough
Corporation (NYSE: SGP) and Zonagen, Inc. (Nasdaq: ZONA; Pacific: ZNG) today
announced an agreement giving Schering-Plough exclusive worldwide marketing
rights to Vasomax(TM), Zonagen's novel, immediate-release, oral formulation of
phentolamine mesylate, in late-stage development for the treatment of male
erectile dysfunction.
Under the agreement, Schering-Plough will pay Zonagen an upfront payment of $10
million with subsequent milestone payments once specified regulatory goals are
achieved. With the upfront payment and if all milestones are met, the agreement
is valued at $57.5 million, exclusive of royalties. Zonagen will receive
escalating royalties on all product sales. In addition, under certain
conditions, Zonagen will have the right to co-promote Vasomax to urologists in
the United States. Further details of the agreement are not being disclosed.
"We believe Vasomax as an oral therapy represents a therapeutic advance in the
treatment of erectile dysfunction for patients seeking effective therapy for
this condition," said Thomas C. Lauda, executive vice president, global
marketing, Schering-Plough Pharmaceuticals. "Acquiring worldwide rights to
Vasomax strengthens Schering-Plough's portfolio of compounds in late-stage
development, and when approved, should be a significant addition to our growing
product line, building on our long-established presence in the urological
therapy area. We are impressed with the quality of the work Zonagen is doing in
the field of reproductive health, and we are looking forward to a long-term
relationship," he said.
"We believe Schering-Plough is an ideal partner for Vasomax," said Joseph
Podolski, president and chief executive officer of Zonagen. "Schering-Plough has
an extensive worldwide sales force in all major markets and a specialty sales
organization that has developed a strong working relationship with urologists.
In addition, Schering-Plough has demonstrated expertise in promoting
prescription pharmaceuticals targeted at large patient populations. We are
confident that Schering-Plough's total marketing capabilities will provide the
necessary global reach to successfully promote Vasomax to both urology
specialists and primary care physicians who treat patients with male erectile
dysfunction."
- more -
-1-
<PAGE>
Page 2
Vasomax is a novel, immediate-release oral version of phentolamine mesylate, an
established alpha blocking agent. Vasomax produces an alpha-adrenergic block of
short duration, leading to vasodilation of the vascular smooth muscles that
enhances blood flow and helps to restore normal penile function in patients
suffering from erectile dysfunction. Phase III clinical trials with the product
have been completed. In order to facilitate rapid commercialization of Vasomax,
Schering-Plough and Zonagen expect to develop a global regulatory filing
strategy, which includes international filings and a New Drug Application (NDA)
with the U.S. Food and Drug Administration.
Utilizing data derived from the Massachusetts Male Aging Study, published in
1994, an estimated 48 million men between the ages of 40 to 70 in the United
States, Canada and Europe could suffer from erectile dysfunction. Of these,
approximately a third have mild dysfunction, almost half have moderate
dysfunction and about 20 percent have severe dysfunction.
Of all the cases that occur, it is estimated that currently only 5 percent of
men with erectile dysfunction receive treatment. The low treatment rate is
attributed to low public awareness of available treatment options and a lack of
convenient, patient-friendly treatments such as oral products. The most common
current therapies include intraurethral suppositories, injection therapies,
devices and surgical implants.
Zonagen, Inc. specializes in products and services for the management of
reproductive health. Its technologies focus on the areas of urology, female
health and contraception. In addition to Vasomax, its oral therapeutic for male
erectile dysfunction, the Company is developing novel fertility diagnostics and
therapeutics, contraceptives and new therapeutics for benign prostatic
hyperplasia, sexually transmitted diseases and prostate cancer. Through its
wholly owned subsidiary, Fertility Technologies, Inc. (FTI), Zonagen sells
devices, instruments and supplies to the fertility specialist and the OB/GYN.
Schering-Plough Pharmaceuticals is the worldwide pharmaceutical research and
marketing unit of Schering-Plough Corporation, a research-based company engaged
in the discovery, development, manufacturing and marketing of pharmaceutical and
health care products worldwide.
Any statements that are not historical facts contained in this release are
forward looking statements that involve risks and uncertainties, including but
not limited to those relating to the Company's future capital needs and
uncertainty of additional funding, uncertainties related to early stage of
development, uncertainties related to clinical trial results, substantial
dependence on one product, history of operating losses, uncertainty of
protection for patents and proprietary technology, governmental regulation,
limited sales and marketing and dependence on future collaborators,
manufacturing uncertainties and reliance on third parties, competition and
technological change, product liability and availability of insurance, and other
risks identified in the Company's reports and registration statements., as filed
with the Securities and Exchange Commission.
# # #
-2-
