 |
Press Releases
|
| QLT and Novartis Ophthalmics Reach Key Milestone in their Comprehensive Clinical Trial Program for Visudyne® |
PATIENT ENROLLMENT COMPLETED FOR VISUDYNE IN EARLY RETREATMENT (VER) TRIAL FOR WET AGE-RELATED MACULAR DEGENERATION (AMD)
FOR IMMEDIATE RELEASE AUGUST 27, 2002
VANCOUVER, CANADA and BASEL, SWITZERLAND —QLT Inc. (NASDAQ: QLTI; TSE: QLT) and Novartis Ophthalmics, the eye health unit of Novartis AG (NYSE: NVS) announced today the completion of patient enrollment for the Visudyne® (verteporfin) in Early Retreatment (VER) Phase IIIB clinical trial, in patients with predominantly classic subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD). The VER trial investigates the importance of an earlier, more aggressive treatment regimen to potentially improve the visual outcome for patients with AMD, the leading cause of blindness in people over the age of 50.
The VER trial compares the standard regimen of Visudyne therapy—every three months—to a more frequent regimen—every six weeks for the first six months of treatment. Total enrollment is 323 patients at 31 sites throughout North America and Europe. The rationale for this trial is based on anecdotal data suggesting better treatment outcomes if CNV leakage is treated with a more aggressive treatment regimen of Visudyne in the first six months. Results from the study are expected to be available in the fourth quarter of 2003.
"Visudyne is already a highly effective treatment for certain forms of wet AMD patients," said Michael Stur, MD, associate professor of the department of ophthalmology at the University of Vienna and principal investigator of the VER trial. "In this trial, we hope to confirm the anecdotal evidence that using Visudyne more aggressively in the early phase improves vision outcome and reduces disease progression."
Luzi von Bidder, Head of Novartis Ophthalmics, said, "While Visudyne therapy is the standard of care for treatment of predominantly classic wet AMD, we are continuously working to enhance the therapy with trials such as VER so patients can maintain maximum vision."
QLT’s President and CEO, Paul Hastings, said, "Completing patient enrollment for the VER trial was an important milestone for 2002. If this trial is successful, we will have well-controlled evidence of improved visual acuity benefit in patients with predominantly classic AMD using a new treatment regimen, thereby further strengthening Visudyne’s competitive position."
QLT and Novartis are demonstrating their full commitment to further improve treatment outcomes for Visudyne therapy and maximizing patients’ benefits with a comprehensive clinical trial program comprising several Phase II and III clinical trials involving more than 1000 patients.
About AMD
AMD is caused by a growth of abnormal blood vessels (CNV) under the central part of the retina or macula and occurs in two forms, dry and wet AMD. In the wet form, the vessels leak fluid and blood that lead to the development of scar tissue that destroys the central retina. This results in a deterioration of sight over a period of two months to three 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 hyperfluorescence appears in the late-phase frames of the angiogram.
About Visudyne
Visudyne therapy, the only drug approved for the treatment of some forms of wet AMD, has treated approximately 170,000 patients worldwide. Visudyne is commercially available in 65 countries for the treatment of predominantly classic subfoveal CNV caused by AMD. It is also approved in 44 countries, including the EU, U.S. and Canada, for the treatment of subfoveal CNV due to pathologic myopia (severe near-sightedness). In some countries it is also approved for presumed ocular histoplasmosis and other macular diseases.
Visudyne is generally well tolerated and has an excellent safety profile. Potential side effects include injection site reactions, headaches, back pain, blurring, decreased sharpness and gaps in vision, and in 1-5% of patients a substantial decrease in vision with partial recovery in some patients. People should avoid direct sunlight for five days to avoid sunburn. People with porphyria should not be treated. For more information, visit www.visudyne.com.
Background on QLT and Novartis Ophthalmics
QLT Inc. (NASDAQ: QLTI; TSE:QLT) is a global biopharmaceutical company dedicated to the discovery, development, and commercialisation of innovative therapies to treat cancer, eye diseases and immune disorders. Combining expertise in ophthalmology, oncology and photodynamic therapy, QLT has commercialised two products to date, including Visudyne therapy which is the largest selling ophthalmology product ever launched. For more information, visit our web site at www.qltinc.com.
Novartis Ophthalmics: With world-wide 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 glaucoma, age-related macular degeneration, eye inflammation, 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 has production sites in Switzerland, France and Canada. For more information, visit www.novartisophthalmics.com or http://www.novartisophthalmics.com/us.
Novartis AG (NYSE: NVS) is a world leader in healthcare with core businesses in pharmaceuticals, consumer health, generics, eye-care, and animal 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 www.novartis.com.
Visudyne is a registered trademark of Novartis AG.
- 30 -
QLT Inc.
Vancouver, Canada
Therese Crozier or Tamara Hicks
t 604.707.7000 or 1.800.663.5486
f 604.707.7001
Novartis Ophthalmics, North America
Duluth, Georgia, USA
Jan McClure
t 770.905.1020
f 770.905.1510
Novartis Ophthalmics, World-wide
Bulach, Switzerland
Kathrin Wyss
t +41 1 864 16 19
f +41 1 862 03 86
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 such as "hope to confirm" constitute "forward-looking" statements of QLT and Novartis AG within the meaning of the Private Securities Litigation Reform Act of 1995, which involve known and unknown risks, uncertainties and other factors that may cause our actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. Forward-looking statements include, but are not limited to, those with respect to whether the earlier retreatment regimen in the VER trial will improve the visual outcome for patients with AMD, the anticipated timing of completion of the VER clinical trial and the release of the results of that trial and the ability to optimize the Visudyne commercial opportunities through treatment improvements. These statements are only predictions and actual events or results may differ materially. Factors that could cause such actual events or results expressed or implied by such forward-looking statements to differ materially from any future results expressed or implied by such statements include, but are not limited to: the actual performance of the early retreatment regimen using Visudyne and the timing of the VER trial as actually conducted and any 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, Novartis AG's Form 20-F, and other filings with the US Securities and Exchange Commission and Canadian Securities Regulatory authorities. Forward-looking statements are based on our current expectations and QLT and Novartis AG are not obligated to update such information to reflect later events or developments. |
|
| |
|
|
|
|
|
|
|
|
