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EXHIBIT 99.1
COMPANY CONTACT:
Danette R.M. Meyer, Ph.D. ([email protected])
Director of Investor Relations
ATRIX LABORATORIES, INC.
(970) 482-5868
http://www.atrixlabs.com
INVESTOR RELATIONS FIRM:
Robert Jaffe ([email protected])
PONDEL/WILKINSON GROUP
(310) 207-9300
ATRIX LICENSES LEUPROGEL(TM)
FORT COLLINS, CO (JANUARY 09, 2001) -- ATRIX LABORATORIES, INC. (NASDAQNM: ATRX)
announced today that Atrix has entered into an exclusive North American
marketing agreement with Sanofi-Synthelabo, a major international pharmaceutical
company, for Leuprogel(TM) 1-,3- and 4-month products, leuprolide acetate for
subcutaneous depot injection, for the treatment of advanced prostate cancer.
In the agreement valued at approximately $60 million, Atrix receives a license
fee, R&D support and payments for certain clinical, regulatory and sales
milestones. In addition to the milestone payments, Atrix will receive royalty
payments based on sales of the Leuprogel products upon approval for marketing by
the U.S. Food and Drug Administration (FDA). Atrix will manufacture Leuprogel at
its facility in Fort Collins, Colorado.
As part of the agreement, Sanofi-Synthelabo has purchased $15 million of Atrix's
common stock, at a premium to the market. The parties have received notice from
the Federal Trade Commission of early clearance of antitrust concerns under the
Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended. In addition to
the prostate cancer products, Sanofi-Synthelabo received an option to develop a
6-month product for prostate cancer, as well as additional Leuprogel products
for other indications.
Sanofi-Synthelabo is a major international pharmaceutical company with a market
capitalization of over $40 billion. Sanofi-Synthelabo's global corporate
headquarters are located in Paris, France with U.S. headquarters in New York
City. With annual sales in excess of $5 billion, Sanofi-Synthelabo is the
seventh largest European pharmaceutical company and ranks among the top 20
pharmaceutical companies worldwide. Sanofi-Synthelabo Inc., the U.S. subsidiary
of Sanofi-Synthelabo, employs approximately 1,000 sales representatives in the
U.S and expects to double their sales force by 2003. Sanofi-Synthelabo's stock
is traded on the Bourse de Paris stock exchange and is included in the Paris CAC
40 and the Dow Jones Euro Stoxx 50.
"Over these last number of months, I became convinced that Sanofi-Synthelabo is
the right licensing partner for Leuprogel," said David R. Bethune, chairman and
chief executive officer at Atrix. "We have been devoted to finding the best
marketing partner with the dedication, resources and commitment to promote
Leuprogel effectively. Sanofi-Synthelabo's marketing plans for Leuprogel played
a great role in our decision to license Leuprogel to them. We are especially
impressed by Sanofi-Synthelabo's commitment to urology and believe that
Sanofi-Synthelabo's efforts will ensure that Leuprogel will achieve the kind of
success that we all desire."
Gordon Proctor, president of Sanofi-Synthelabo's U.S. subsidiary commented,
"Leuprogel will be a cornerstone in our strategy of becoming an important player
in the urology market in North America. Atrix
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is doing a top-notch job developing the Leuprogel products. It is our plan for
Leuprogel, along with Xatral(TM) (alfuzosin), to become a major revenue driver
for Sanofi-Synthelabo, as we capitalize on our extensive urology marketing
experience."
The Leuprogel products utilize the company's proprietary Atrigel(R) drug
delivery system to provide sustained release of leuprolide acetate for periods
of 1-, 3- and 4-months, for the palliative treatment of advanced prostate
cancer. Sustained levels of leuprolide, a leutinizing hormone-releasing hormone
(LHRH) agonist, decreases testosterone levels to suppress tumor growth in
patients with hormone-responsive prostate cancer. The liquid Leuprogel(TM)
products are injected subcutaneously with a small gauge needle, forming a solid
implant in the body that slowly releases the leuprolide as the implant is
bioabsorbed. Atrix recently announced it has successfully completed the pivotal
Phase III clinical study on Leuprogel 1-month, 7.5 mg and early this year will
submit a New Drug Application to the FDA for marketing approval of this product.
Atrix also has completed enrollment for the Leuprogel 3-month, 22.5 mg Phase III
study ahead of schedule and enrollment for Atrix's Leuprogel 4-month, 30mg
product is expected to begin early this year. The 6-month Leuprogel product for
prostate cancer is currently in pre-clinical development.
Atrix Laboratories, Inc. is a drug delivery and drug development company whose
unique patented technologies provide drug delivery from minutes to months. Atrix
develops medical, dental and veterinary products in-house. The company also
partners with large pharmaceutical and biotechnology companies to apply its
proprietary technologies to new chemical entities or to extend the life cycle of
existing products. Atrix has strategic alliances with several pharmaceutical
companies including recent collaborations with Pfizer, Elan Pharmaceuticals and
the Novartis company - Geneva Pharmaceuticals to use its drug delivery
technologies and expertise in the development of new products. Additional
information is available on the Atrix Laboratories, Inc. Web site at
http://www.atrixlabs.com.
Statements contained in this press release, which are not historical facts, are
forward-looking statements, as the term is defined in the Private Securities
Litigation Reform Act of 1995. Such forward-looking statements are subject to
risks and uncertainties which can cause actual results to differ materially from
those currently anticipated, due to a number of factors, which include, but are
not limited to, regulatory approval, product demand, pricing, market acceptance,
changing economic conditions, risks in product and technology development, the
effect of the company's accounting policies and other risk factors discussed in
documents filed by the company with the Securities and Exchange Commission from
time to time.
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