Download NOVARTIS OPHTHALMICS AND QLT ANNOUNCE FDA

MEDIA RELEASE
NOVARTIS OPHTHALMICS AND QLT ANNOUNCE FDA APPROVAL OF
VISUDYNE™ AS THE FIRST DRUG TREATMENT FOR
PATHOLOGIC MYOPIA AND OCULAR HISTOPLASMOSIS
Visudyne improved or stabilized vision in patients with devastating eye conditions
For Immediate Release
August 23, 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
that the United States Food and Drug Administration (FDA) has approved Visudyne™
(verteporfin for injection) therapy for the treatment of predominantly classic subfoveal choroidal
neovascularization (CNV) due to pathologic myopia (severe near-sightedness) and presumed
ocular histoplasmosis. Visudyne is the only drug treatment approved for these devastating eye
conditions.
“The FDA approval is great news,” said Dr. Julia Levy, president and CEO of QLT. “For the
first time, patients who would otherwise face a progressive loss of vision now have an effective
treatment option. The approval also represents another advance in our efforts to combat serious
ocular conditions with Visudyne.”
Dan Myers, president of Novartis Ophthalmics, North America said, “The fact that Visudyne
therapy has demonstrated the ability to stabilize and in some cases improve vision in these
pathologic myopia and presumed ocular histoplasmosis patients is another remarkable success
story for this breakthrough therapy. We’re very pleased to now be able to make Visudyne
available to the tens of thousands of patients who develop these conditions.”
In phase III studies in patients with CNV due to pathologic myopia, Visudyne therapy stabilized
or improved vision (as defined by a loss of less than 8 letters on a standard eye chart) in 72% of
patients versus 44% on placebo at month 12.
In an open label safety study involving 26 patients with ocular histoplasmosis, visual acuity
improved by an average of more than 1 line on a standard eye chart at 12 months (6.7 letters on a
standard eye chart) with 28% of patients experiencing a visual acuity improvement of 3 lines (15
letters) or more. Visual acuity decreased by less than 3 lines of vision in 88% of patients during
the same time period.
Visudyne was approved in April 2000 in the United States and has since been launched in almost
50 countries for the treatment of predominantly classic CNV caused by age-related macular
degeneration (AMD), the leading cause of blindness in people over the age of 50.
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CNV due to Pathologic Myopia
CNV in pathologic myopia is characterized by abnormal blood vessels that grow under the center
of the retina as a result of an abnormal elongation of the eye associated with severe nearsightedness or myopia. It generally occurs among people over 30 years of age and can result in a
progressive, severe loss of vision. The worldwide incidence of CNV due to pathologic myopia is
estimated to be 50,000 new cases per year.
Presumed Ocular Histoplasmosis
In presumed ocular histoplasmosis, CNV develops from the margin of retinal scars in the back of
the eye, which are caused by a fungal infection of the retina. It can lead to severe, irreversible
vision loss. The condition is caused by inhaling the fungus Histoplasma capsulatum which is
found predominantly in the mid-central U.S. 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, headaches, blurring, decreased sharpness and gaps in vision, and in 1-4
% of patients a substantial decrease in vision with partial recovery in many 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
“intends,” “expected,” “potential,” “able to make available” 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; 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 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.
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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 http://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.
For more information, you are invited to visit QLT’s web site at
www.qltinc.com.
Visudyne™ is a trademark of Novartis AG
- 30 Contacts:
Novartis Ophthalmics, North America:
Duluth, Georgia, USA
Jan McClure
Telephone: 770-905-1020
Fax: 770-905-1510
Novartis Ophthalmics, Worldwide:
Bulach, Switzerland
Sabine Ciccotosto
Telephone: +41 1 864 15 69 Fax: +41 1 862 08 10
QLT Inc.:
Vancouver, Canada
Elayne Wandler or Tamara Hicks
Telephone: 604-707-7000 Fax: 604-707-7001
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