VANCOUVER, Aug. 31 /CNW/ - QLT USA, Inc., a subsidiary of QLT Inc.
(NASDAQ: QLTI; TSX: QLT), announced today that the European approval procedure
for the Eligard(R) 45 mg six-month formulation was successfully completed.
Launch of this formulation in 23 European countries is expected to follow the
implementation of this positive decision in each of the individual countries.
The 6-month formulation was launched in Germany in March 2007 following its
approval in December 2006. Eligard is already approved in Germany and other
European countries for the one-month (7.5 mg) and three-month (22.5 mg)
"The six-month formulation provides physicians with a new convenient
option for patients with prostate cancer," said Bob Butchofsky, President and
Chief Executive Officer of QLT Inc. "Eligard sales have been strong recently
and we believe that this new approval will help contribute to future product
Through the first six months of 2007, Eligard worldwide sales have been
approximately US$86.4 million. Based on the strong trend in Eligard sales
during the first half of the year in July the Company raised its annual
guidance on Eligard sales to project a range of US$160 million to US$180
million, an increase over previously announced guidance of US$140 million to
Eligard, a palliative treatment for advanced prostate cancer,
incorporates a luteinizing hormone-releasing hormone agonist, or LHRH agonist,
known as leuprolide acetate with QLT USA's proprietary Atrigel(R) Delivery
System. The Atrigel technology allows for sustained delivery of leuprolide
acetate for periods ranging from one to six months.
Eligard works by lowering the levels of testosterone in the body, which
may result in a reduction of symptoms related to the disease. Sustained levels
of leuprolide decrease testosterone levels to suppress tumor growth in
patients with hormone-responsive prostate cancer. The liquid Eligard products
are injected subcutaneously with a small gauge needle, forming a solid implant
in the body that slowly releases leuprolide as the implant is bioabsorbed.
QLT Inc. is a global biopharmaceutical company dedicated to the
discovery, development and commercialization of innovative therapies. Our
research and development efforts are focused on pharmaceutical products in the
fields of ophthalmology and dermatology. In addition, we utilize two unique
technology platforms, photodynamic therapy and Atrigel(R), to create products
such as Visudyne(R) and Eligard(R). For more information, visit our web site
Atrigel is a registered trademark of QLT USA, Inc.
Visudyne is a registered trademark of Novartis AG.
Eligard is a registered trademark of Sanofi-aventis.
QLT Inc. is listed on The NASDAQ Stock Market under the trading symbol
"QLTI" and on The Toronto Stock Exchange under the trading symbol "QLT."
Certain statements in this press release constitute "forward-looking
statements" of QLT within the meaning of the Private Securities Litigation
Reform Act of 1995 and constitute "forward-looking information" within the
meaning of the Securities Act (Ontario). Such statements include, but are not
limited to, the statement with respect to our belief that the successful
completion of the European approval procedure will contribute to future
product growth, our expectations as to the launch of the six-month formulation
in 23 other European countries, the statement projecting Eligard annual sales,
and statements containing words such as "expects," "believes," "potential" and
similar expressions that do not relate to historical matters. These
forward-looking statements are only predictions which involve known and
unknown risks, uncertainties and other factors that may cause actual events or
results to differ materially. Factors that could cause actual events or
results to differ materially include, but are not limited to: the risk that
Astellas may be unsuccessful in its efforts to market the six-month
formulation of Eligard; the anticipated market potential for Eligard may not
be realized; the outcome of the appeal in German patent litigation commenced
by Takeda Chemical Industries Ltd. and Wako Pure Chemical Industries, Ltd.
against Astellas and Medigene in Germany with respect to Eligard may be
unfavorable and could result in QLT USA, Inc. being required to pay financial
damages which could be substantial; and other risk factors which are described
in detail in QLT's Annual Information Form on Form 10-K, quarterly reports on
Form 10-Q, Registration Statement on Form S-4 and other filings with the U.S.
Securities and Exchange Commission and Canadian securities regulatory
authorities. Forward-looking statements are based on our current expectations
and QLT does not assume any obligation to update such information to reflect
later events or developments, except as may be required by law.
For further information:
For further information: QLT Inc.: Vancouver, Canada, Therese Hayes,
Telephone: (604) 707-7000 or 1-800-663-5486, Fax: (604) 707-7001