Other Visudyne indications not affected by the CHMP Opinion
VANCOUVER, April 25 /CNW/ - QLT Inc. (NASDAQ: QLTI; TSX: QLT) announced
today that it has been informed that the Committee for Medicinal Products for
Human Use (CHMP) will recommend to the European Commission that the indication
of the use of Visudyne(R) in the treatment of occult subfoveal choroidal
neovascularization (CNV) secondary to age-related macular degeneration (AMD)
The European Commission is expected to endorse the CHMP's recommendation
in a final decision that should be issued within approximately two months.
Such a decision by the European Commission is not expected to affect the
approved use of Visudyne in the predominately classic or pathologic myopia
The CHMP opinion was based on its review of data from the Visudyne in
Occult (VIO) trial that, as announced in September 2005, did not achieve the
significance level required of its primary end points. The VIO study was
undertaken in part at the request of the CHMP to confirm the results of an
earlier trial, Visudyne In Photodynamic Therapy (VIP), that demonstrated
evidence of efficacy in the occult patient population. The initial marketing
authorization in Europe was based on two-year results from the VIP study.
Although the VIO trial did not achieve statistical significance in its primary
end points, the data from the trial was not inconsistent with the positive
results seen in the VIP study. However, the CHMP has recommended the deletion
of the occult CNV indication on the Visudyne label based on lack of
confirmation of the VIP efficacy results in the VIO study. No safety concerns
were raised. The opinion is expected to be published on the EMEA web site by
Friday, April 27.
It is unclear what effect this decision will have on European Visudyne
sales. The outcome will depend on the extent to which countries in the
European Union change their reimbursement policies as well as market adoption
following the results from combination use studies currently being undertaken.
Conference call information
QLT Inc. will hold an investor conference call to discuss this news and
the first quarter 2007 results on Wednesday, April 25 at 8:30 a.m. ET (5:30
a.m. PT). The call will be broadcast live via the Internet at www.qltinc.com.
To participate on the call, please dial 1-800-525-6384 (North America) or
780-409-1668 (International) before 8:30 a.m. ET. A replay of the call will be
available via the Internet and also via telephone at 1-800-365-8354 (North
America) or 402-220-2881 (International), access code 4498188.
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-Synthelabo Inc.
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 which are not historical facts,
are "forward-looking" statements as the term is defined in the United States
Private Securities Litigation Reform Act of 1995, and "forward-looking
information" within the meaning of applicable Canadian Securities legislation.
You can identify these forward-looking statements and information by QLT's use
of words such as "expects," "plans," "estimates," "projects," "intends,"
"believes," and similar expressions that do not relate to historical matters.
Such forward-looking statements and information 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, future actions by CHMP or the European Commission, when a final
decision will issue by the European Commission, whether such decision will
affect the approved use of Visudyne in the predominantly classic or pathologic
myopia indications, the effect on European Visudyne sales and other risk
factors discussed in documents filed by QLT with the Securities and Exchange
Commission from time to time including QLT's Annual Report on Form 10-K and
QLT's Quarterly Reports on Form 10 Q or filed with the Canadian Securities
Regulatory authorities. All forward-looking statements and information in this
press release are made as of today and based upon information known to
management as of the date hereof. QLT assumes no obligation to update or
revise any of its forward-looking statements and information even if
experience or future changes show that indicated results or events will not be
For further information:
For further information: QLT Inc.: Vancouver, Canada, Tamara Hicks,
Telephone: (604) 707-7000, or 1-800-663-5486, Fax: (604) 707-7001