Exhibit 99.1
news release
NEW CLINICAL DATA CONFIRM ROLE OF VISUDYNE(R) (VERTEPORFIN)
THERAPY AS STANDARD OF CARE IN CHOROIDAL NEOVASCULARIZATION
(CNV) DUE TO AGE-RELATED MACULAR DEGENERATION (AMD)
Latest data presented at ARVO suggests benefit of Visudyne in selected patients
with Minimally Classic and confirms long-term stability in vision
for Predominantly Classic Subfoveal "wet" AMD
FOR IMMEDIATE RELEASE MAY 6, 2003
FORT LAUDERDALE, FLORIDA -- QLT Inc. (NASDAQ: QLTI; TSX: QLT) ) and Novartis
Ophthalmics, the eye health unit of Novartis AG (NYSE: NVS) announces new data
presented at the Association for Research in Vision and Ophthalmology (ARVO)
annual meeting suggest that Visudyne(R) therapy reduces the risk of vision loss
in "wet" age-related macular degeneration (AMD) patients with minimally classic
lesions, a form of wet AMD previously considered untreatable. Additional data to
support the role of Visudyne in patients with predominantly classic AMD
demonstrate that visual outcomes continue to remain stable five years after
initiating therapy, providing further evidence of the safety and long-term
efficacy of Visudyne.
VISUDYNE IN MINIMALLY CLASSIC (VIM) TRIAL
Twelve-month data from the VIM Trial shows that the mean change in visual acuity
scores of patients treated with Visudyne was better in each group compared with
patients receiving placebo (reduced fluence P=0.02; standard fluence P=0.08; all
Visudyne combined P=0.01). This data confirms six-month trial results presented
earlier this year at the Macula Society annual meeting. The trial also
demonstrated that fewer Visudyne-treated patients developed predominantly
classic choroidal neovascularization (CNV) compared to placebo. The VIM Trial is
a Phase II, multi-center study involving 117 patients.
"These data suggest that patients with minimally classic lesions treated with
Visudyne therapy had a reduced risk of vision loss compared with placebo-treated
patients," commented Dr. Neil Bressler, Chair of the Visudyne Study Advisory
Group, retina specialist and the James P. Gills Professor of Ophthalmology at
the Wilmer Eye Institute of the Johns Hopkins University School of Medicine in
Baltimore. "This is particularly good news for some patients with minimally
classic lesions as it is now thought that Visudyne therapy may be of benefit to
them. Further clinical research is needed to determine if Visudyne therapy
becomes the standard of care for those lesions."
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TREATMENT OF AMD IN PHOTODYNAMIC THERAPY (TAP) INVESTIGATIONS
Initial analyses of data from the TAP Investigation confirmed the long-term
durability (up to five years) of Visudyne in stabilizing vision and preventing
further vision loss in patients. Furthermore, the favorable safety profile of
Visudyne demonstrated previously at the three- and four-year analyses continued
up to the five-year final study visit.
Peter K. Kaiser, MD, retina specialist practicing at the Cleveland Clinic's Cole
Eye Institute, commented, "For a chronic, progressive disease such as the wet
form of AMD, further evidence to support the role of Visudyne as the standard of
care in the long-term maintenance of vision in many people with wet AMD is
excellent news for both patients and physicians. It is especially reassuring
that visual acuity stabilizes in most treated patients one to two years after
the onset of therapy. We are also confident that identification of wet lesions
early in their onset, before many have become very large in size, is an
important factor in stabilizing vision and maintaining patients' quality of
life."
Following the conclusion of the TAP Investigation, consisting of two 2-year
randomized, double-masked, placebo-controlled trials, 78% of the 609 patients
originally included were offered Visudyne therapy in an ongoing 3-year,
open-label extension trial regardless of whether they previously received
Visudyne or a placebo in the original study.
Novartis and QLT Inc., partners in developing and marketing Visudyne, are
working to enhance the benefits offered to patients by this therapy through a
comprehensive, on-going clinical trial program involving more than 1,000
patients.
ABOUT AMD
AMD is the leading cause of legal blindness in people over the age of 50. Its
associated vision loss has been shown to significantly decrease quality of life.
Everyday tasks such as driving and walking can be severely affected. Awareness
of the condition and treatment in the initial stages of the disease are
essential for patients to take the necessary steps that lead to diagnosis and
early treatment to halt progression of AMD.
Vision loss from AMD occurs in two forms: dry and wet. The dry form is
associated with atrophic cell death of the central retina. The wet form is
caused by growth of abnormal blood vessels (CNV) under the central part of the
retina or macula. These vessels leak fluid and blood and cause scar tissue that
destroys the central retina. This results in a deterioration of sight over a
period of months to years. "Occult" and "classic" are terms used to describe the
different patterns of CNV leakage as seen on fluorescein angiography. Classic
CNV appears as a well-demarcated area of hyperfluorescence in the early-phase
frames of the angiogram. The boundaries of occult CNV are often poorly defined
or difficult to demarcate and often appears as hyperfluorescence in the
late-phase frames of the angiogram.
ABOUT VISUDYNE
Visudyne therapy is a two-step procedure. Following intravenous administration,
Visudyne is activated by a non-thermal laser light. The process is known as
photodynamic therapy. Visudyne selectively targets abnormal blood vessels under
the retina, resulting in a reduction in their growth, without affecting
normal/healthy retina tissue. This, in turn, stops the leakage associated with
wet AMD.
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Through its unique mode of action, Visudyne provides the chance to reduce the
risk of visual acuity loss, to stabilize contrast sensitivity and thereby
preserve quality of vision long term. People however should be aware that AMD
patients who already have had a significant loss of vision for a long time
usually will not benefit from any treatment for wet AMD at this time.
Visudyne is the only drug approved for the treatment of some forms of wet AMD,
the leading cause of blindness in people over the age of 50, and has been used
in more than 250,000 patients worldwide. Visudyne is commercially available in
more than 70 countries for the treatment of predominantly classic subfoveal CNV
and in over 30 countries for occult subfoveal CNV caused by AMD. It is also
approved in more than 50 countries, including the EU, U.S. and Canada, for the
treatment of subfoveal CNV due to pathologic myopia (severe near-sightedness).
In some countries Visudyne is also approved for presumed ocular histoplasmosis
or other macular diseases.
Visudyne is generally well tolerated and has an excellent safety profile.
Potential side effects include injection site reactions, back pain, blurring,
decreased sharpness and gaps in vision, and in one to five per cent of patients
a substantial decrease in vision with partial recovery. After treatment,
patients should avoid direct sunlight for five days to avoid sunburn. People
with porphyria should not be treated. For more information, visit
www.visudyne.com.
Visudyne(R) is a trademark of Novartis AG.
The foregoing press release contains forward-looking statements that can be
identified by terminology such as "suggests," "may be of benefit," "may
justify," "we are confident," or by discussions regarding the evaluation of
early trial data or potential new indications or treatment methods for existing
products. Such forward-looking statements involve known and unknown risks,
uncertainties and other factors, which may cause the actual results and
assumptions to be materially different from any future results, performance or
achievements expressed or implied by such statements. Such factors include, but
are not limited to: risks associated with the development and commercialization
of the treatment, including uncertainties relating to manufacturing, clinical
trials, registration, pricing and reimbursement; patient and physician demand
for the treatment; competition; any uncertainty regarding patents and
proprietary rights; outcome of litigation claims, product liability claims and
insurance; government regulation; anti-takeover provisions; dependence on
corporate relationships; volatility of share prices; QLT Inc's rapid growth, its
history of operating losses and uncertainty of future profitability, its access
to capital; and additional information and other factors as described in detail
in QLT Inc.'s Annual Information Form on Form 10-K and recent and forthcoming
quarterly reports on Form 10Q, and Novartis AG's Form 20-F, and other filings
with the US Securities and Exchange Commission and Canadian Securities
Regulatory authorities.
Dr. Bressler has been paid as a consultant for Novartis Ophthalmics and QLT Inc.
The terms of this agreement have been managed by the Johns Hopkins University in
accordance with its conflict of interest policies.
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QLT INC. (NASDAQ: QLTI; TSX: QLT) is a global pharmaceutical company
specializing in the discovery, development and commercialization of innovative
therapies to treat cancer, eye diseases and niche areas for which treatments can
be marketed by a specialty sales force. Combining expertise in ophthalmology,
oncology and photodynamic therapy, QLT has commercialized two products to date,
including Visudyne therapy, which is the most successfully launched
ophthalmology product ever. For more information, visit our web site at
www.qltinc.com.
NOVARTIS OPHTHALMICS: With worldwide headquarters in Bulach, Switzerland,
Novartis Ophthalmics is a global leader in research, development and
manufacturing of leading ophthalmic pharmaceuticals that assist in the treatment
of age-related macular degeneration, eye inflammation, glaucoma, ocular
allergies and other diseases and disorders of the eye. Novartis Ophthalmics
products are available in more than 110 different countries. The North American
headquarters is based in Atlanta, Georgia. Novartis Ophthalmics products are
made in Switzerland, France and Canada. For more information, visit
www.novartisophthalmics.com or www.novartisophthalmics.com/us.
NOVARTIS AG (NYSE: NVS) is a world leader in pharmaceuticals and consumer
health. In 2001, the Group's businesses achieved sales of CHF 32.0 billion (USD
19.1 billion) and a net income of CHF 7.0 billion (USD 4.2 billion). The Group
invested approximately CHF 4.2 billion (USD 2.5 billion) in R&D. Headquartered
in Basel, Switzerland, Novartis Group companies employ about 74,000 people and
operate in over 140 countries around the world. For further information please
consult http://www.novartis.com.
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CONTACTS:
QLT Inc.:
Vancouver, Canada
Tamara Hicks
Telephone: +1 604 707-7000 Fax: +1 604 707-7001
Novartis Ophthalmics, North America:
Duluth, Georgia USA
Jan McClure
Telephone: +1 770 905-1020 Fax: +1 770 905-1510
Novartis Ophthalmics, World-wide:
Bulach, Switzerland
Kathrin Wyss
Telephone: +41 1 864 16 19 Fax: +41 1 862 03 86
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