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EXHIBIT 99.1
ZONAGEN SIGNS COLLABORATIVE OPTION AGREEMENT WITH
AMERICAN HOME PRODUCTS ON HUMAN CONTRACEPTIVE
VACCINE
POTENTIAL MILESTONE PAYMENTS TO ZONAGEN OF UP TO $22.5 MILLION
THE WOODLANDS, Texas--(BW HealthWire)--Dec. 13, 2000-- Zonagen, Inc.
(Nasdaq:ZONA - news; PCX:ZNG) is announcing that it has entered into an Option
Agreement with Wyeth-Ayerst Laboratories, the pharmaceutical division of
American Home Products Corporation (NYSE:AHP - news), to collaborate in the
development of a human immunocontraceptive vaccine. The focal point of the
collaboration is a proof-of-concept study intended to demonstrate the
effectiveness of Zonagen's human contraceptive vaccine using Zonagen's
proprietary antigen and adjuvant technologies. The Option Agreement gives
Wyeth-Ayerst the right to exercise its option for worldwide rights to the zona
pellucida contraceptive technology developed by Zonagen through the payment of
an up-front fee and entering into an exclusive license agreement. In the event
that a license agreement is entered into, Wyeth-Ayerst will bear all costs
associated with the clinical development and marketing of the product and could
pay milestones totaling $22.5 million plus royalties on product sales if the
product is ultimately approved.
Zonagen believes that a contraceptive vaccine for humans may be derived from a
recombinant human zona protein. In order to test that concept, Zonagen
scientists had to first clone the relevant gene from the appropriate model.
Zonagen has cloned and expressed the desired animal protein and is ready to
commence the study.
Joseph Podolski, President and CEO of Zonagen, says, "The development of an
effective human contraceptive vaccine has been ten years in the making. Now that
we have demonstrated the potential of the technology, we hope to accelerate the
effort and expeditiously develop a vaccine product."
Data from previous studies with this vaccine were published in the September
2000 issue of The Journal of Reproduction and Fertility indicating the potential
of Zonagen's contraceptive vaccine. Data from these studies were the first to
show that a recombinant zona pellucida immunocontraceptive vaccine consistently
induced infertility compared to controls in a primate model without permanent
disruption of the normal menstrual cycle.
L. Patrick Gage, Ph.D., President, Wyeth-Ayerst Research, adds, "This agreement
is representative of our goal to develop new approaches for contraception and
builds on the research program already underway at our Women's Health Research
Institute."
Zonagen, Inc. is engaged in the development of pharmaceutical products for the
reproductive system, including sexual dysfunction, vaccine adjuvants, products
for fertility and female health as well as urological applications, specifically
prostate cancer.
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
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uncertainties involving the Company's early stage of development, clinical trial
results and FDA approval in the U.S. and approval of regulatory authorities in
other jurisdictions, substantial dependence on one product, history of operating
losses, future capital needs and uncertainty of additional funding, uncertainty
of protection for patents and proprietary technology, litigation, governmental
regulation, limited sales and marketing experience and dependence on
collaborators, manufacturing uncertainties and reliance on third parties,
competition and technology change, product liability and availability of
insurance, and other risks identified in the Company's Annual Report on Form
10-K for the year ended December 31, 1999, as filed with the Securities and
Exchange Commission.
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Contact:
Zonagen Inc., The Woodlands
Joseph S. Podolski, 281/719-3447
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