 |
Press Releases
|
| Novartis Ophthalmics and QLT File Canadian Submission for Expansion of Visudyne™ Approval |
FOR IMMEDIATE RELEASE SEPTEMBER 10, 2001
ATLANTA, GEORGIA and VANCOUVER, CANADA—Novartis Ophthalmics, the eye health unit of Novartis AG (NYSE: NVS), and QLT Inc. (NASDAQ:QLTI; TSE:QLT) today announced the filing of Visudyne™ (verteporfin for injection) therapy with the Canadian Therapeutics Products Directorate (TPD) for the treatment of a select group of patients with occult subfoveal choroidal neovascularization (CNV) caused by wet age-related macular degeneration (AMD). AMD is the leading cause of blindness in people over the age of 50.
This submission is based on favorable two-year results from a phase III clinical trial showing Visudyne has a significant treatment benefit in AMD patients with occult CNV. The results were published in the May 2001 issue of the peer-reviewed American Journal of Ophthalmology . The submission specifically seeks approval for patients with occult AMD with smaller lesions or lower visual acuity.
“In our efforts to make Visudyne therapy available to all wet AMD patients, today’s filing brings us one step closer to fulfilling that goal as occult CNV represents a significant portion of the total wet AMD market,” said Dr. Julia Levy, president and CEO of QLT.
“We look forward to the agency’s review of this important drug therapy as there is currently no approved treatment for patients suffering from the occult form of this devastating eye disease,” said Dan Myers, president of Novartis Ophthalmics, North America.
Visudyne is commercially available in 50 countries for the treatment of predominantly classic subfoveal CNV caused by AMD. It is also approved in over 20 countries, including the EU, U.S. and Canada, for the treatment of subfoveal CNV due to pathologic myopia (severe near-sightedness). In the U.S., Visudyne has received an additional approval for CNV due to presumed ocular histoplasmosis. Approximately 80,000 patients have undergone Visudyne therapy worldwide. In May, Visudyne was awarded the prestigious Prix Galien for therapeutic innovation in France, Belgium and Portugal.
Occult and classic are terms used to describe different patterns of CNV leakage as seen on fluorescein angiography. Together, the occult and predominantly classic form of the disease account for approximately two-thirds of all wet AMD cases at diagnosis. Annually, it is estimated that 500,000 new patients develop wet AMD worldwide.
As part of the Canadian submission, Novartis Ophthalmics and QLT also filed for approval of Visudyne for presumed ocular histoplasmosis, a condition characterized by CNV resulting from a fungal infection of the retina. The condition is caused by inhaling the fungus Histoplasma capsulatum and can lead to severe, irreversible vision loss. The fungus generally remains in a dormant stage but tends to become more active when a person’s immune system is compromised.
About Visudyne
Visudyne therapy is a two-step procedure that can be performed in a doctor’s office. First, the drug is injected intravenously into the patient’s arm. A non-thermal laser light is then shone into the patient’s eye to activate the drug. Visudyne therapy uses a specially designed laser that produces the low level, non-thermal 689nm light required to activate the drug. Visudyne is generally well tolerated and has an excellent safety profile. Potential side effects include injection site reactions, infusion related pain, back pain, headaches, 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.
The foregoing press release contains forward-looking statements that can be identified by terminology such as “look forward,” “could significantly expand the current market,” “potential,” or similar expressions. 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, patient enrollment, 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; dependence on corporate relationships; volatility of share prices; QLT Inc.’s access to capital; 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 on file, and other filings with the US Securities and Exchange Commission.
Background on Novartis Ophthalmics and QLT
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 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 www.novartisophthalmics.com/us.
Novartis (NYSE: NVS) is a world leader in healthcare with core businesses in pharmaceuticals, consumer health, generics, eye-care, and animal health. In 2000, the Group's ongoing businesses achieved sales of CHF 29.1 billion (USD 17.2 billion) and a net income of CHF 6.5 billion (USD 3.9 billion). The Group invested approximately CHF 4.0 billion (USD 2.4 billion) in R&D. Headquartered in Basel, Switzerland, Novartis employs about 70,000 people and operates in over 140 countries around the world. For further information please consult www.novartis.com.
QLT Inc. (NASDAQ:QLTI; TSE:QLT) is a world leader in photodynamic therapy, a field of medicine utilizing light-activated drugs in the treatment of disease. QLT’s innovative science has led to the development and commercialization of breakthrough treatments utilizing this technology for applications in ophthalmology and oncology and is exploring the potential in other diseases.
Visudyne™ is a trademark of Novartis AG.
- 30 -
Novartis Ophthalmics, North America
Duluth, Georgia, USA
Jan McClure
t 770.905.1020
f 770.905.1510
Novartis Ophthalmics, Worldwide
Bulach, Switzerland
Kathrin Wyss
t +41 1 864 16 19
f +41 1 862 03 86
QLT Inc.
Elayne Wandler or Tamara Hicks
Corporate Communications
t 604.707.7000
f 604.707.7001 |
|
| |
|
|
|
|
|
|
|
|
