ATLANTA and VANCOUVER, British Columbia (PROTEXT) - CIBA
Vision, the eye care unit of Novartis, and QLT PhotoTherapeutics
Inc. (Nasdaq: QLTI; Toronto) announced today that the Swiss
Regulatory Agency -- Interkantonale Kontrollstelle für Heilmittel
-- has given approval for the marketing of Visudyne (verteporfin)
therapy, for the treatment of the wet form of age-related macular
degeneration (AMD), the leading cause of blindness in people over
the age of 50 in the western world.
Specifically, the agency approved Visudyne for the treatment
of wet AMD in patients with predominantly classic subfoveal
choroidal neovascularization.
Visudyne therapy will be made commercially available in
Switzerland imminently.
The registration application for Visudyne was submitted to the
Swiss regulatory agency on August 18th, 1999. Regulatory
applications are currently pending in the European Union, Canada,
Norway, Iceland, Australia, New Zealand and the US.
"The approval of Visudyne by the Swiss regulatory agency is a
major event for patients suffering from wet AMD," said Luzi von
Bidder, President of CIBA Vision's worldwide Ophthalmic Business
Unit. "At last there is an approved, effective treatment that can
help preserve the vision of many patients suffering from this
terrible, sight threatening condition. We will make Visudyne
available to eye care professionals and their patients across the
country in the coming days.
"We will also use this approval to apply for a free marketing
certificate which will enable us to gain approvals in a number of
other markets around the world," said von Bidder.
Until now, other treatment options are limited to
approximately 15% of the 500,000 patients worldwide that develop
wet AMD every year. Medical experts estimate that between 40-60%
of all wet AMD cases will develop predominantly classic lesions
as the disease progresses.
"This is a monumental day for QLT and CIBA Vision," said Dr.
Julia Levy, President and Chief Executive Officer of QLT. "We are
proud to have been able to transform our discovery of Visudyne
into a significant vision saving treatment. Today's achievement
is a testament to the strong partnership and successful research
collaboration between QLT, CIBA Vision and Novartis."
About AMD and Visudyne therapy
Wet AMD typically destroys central vision, which is necessary
for daily tasks such as reading, driving, and recognizing faces.
The condition is characterized by the formation of abnormal blood
vessels (choroidal neovasculature or CNV) that grow across the
central part of the retina, called the macula. These vessels leak
fluid and eventually cause scar tissue, which destroys central
vision in as little as 2 months to 3 years.
Visudyne is being co-developed for ocular conditions by CIBA
Vision Corporation, the eye care unit of Novartis AG, and QLT
PhotoTherapeutics Inc. Upon commercialization, CIBA Vision will
market the product worldwide while QLT will be responsible for
manufacturing Visudyne.
Visudyne therapy can be performed in a doctor's office as a
two-step procedure. First, Visudyne is injected intravenously
into the patient's arm. Then the drug is activated by shining
non-thermal laser light into the patient's eye.
Visudyne therapy involves the use of a specifically designed
laser that produces the low level, non-thermal 689 nm light
required to activate the drug. These lasers have been developed
by two of the world's leading laser companies, Coherent Inc.
(Nasdaq: COHR), based in California, and the Carl Zeiss Group,
based in Germany.
Additional clinical trials are being conducted to determine
the effectiveness of Visudyne therapy in patients with an earlier
stage of AMD who were originally excluded from the TAP
Investigation as well as patients with a similar but distinct
condition of abnormal blood vessels associated with progressive
near-sightedness known as pathologic myopia.
Visudyne therapy is protected by a series of U.S. and foreign
issued patents that cover the composition of matter, formulations
and manufacturing, and the method of use in treating AMD and
other conditions.
Background on CIBA Vision and QLT
With worldwide headquarters in Atlanta, Georgia, USA, CIBA
Vision is a global leader in research, development and
manufacturing of optical and ophthalmic products and services,
including contact lenses, lens care products and ophthalmic
pharmaceuticals. CIBA Vision products are available in more than
70 countries. For more information, you are invited to visit the
CIBA Vision website at
http://www.cibavision.com .
CIBA Vision is the eye care unit of Novartis AG, a world
leader in Life Sciences with core businesses in Healthcare,
Agribusiness and Consumer Health (Nutrition and Self-Medication).
In 1998, Novartis Group sales were CHF 31.7 billion, of which CHF
17.5 billion were in Healthcare, CHF 8.4 billion in Agribusiness
and CHF 5.8 billion in Consumer Health. The group annually
invests more than CHF 3.7 billion in R&D. Headquartered in Basel,
Switzerland, Novartis employs about 82,000 people and operates in
over 100 countries around the world.
QLT PhotoTherapeutics Inc. is a world leader in the
development and commercialization of proprietary pharmaceutical
products for use in photodynamic therapy, an emerging field of
medicine utilizing light-activated drugs in the treatment of
disease. QLT's innovative science has advanced photodynamic
therapy beyond applications in cancer towards potential
breakthrough treatments in ophthalmology and autoimmune disease.
In addition to Visudyne therapy, QLT's portfolio of products
include PHOTOFRIN(R) (porfimer sodium), the world's only approved
photodynamic therapy drug, used in the treatment of various
cancers throughout North America, Japan and Europe. For more
information, you are invited to visit QLT's web site at
http://www.qltinc.com .
Visudyne(TM) is a trademark of Novartis AG.
PHOTOFRIN(R) is a registered trademark of QLT
PhotoTherapeutics Inc.
For more information, you are invited to visit the CIBA Vision
web site at
http://www.cibavision.com or the Visudyne therapy
website at
http://www.visudyne.com .
For more information, you are invited to visit the QLT web
site at
http://www.qltinc.com .
QLT PhotoTherapeutics Inc. is listed on The Nasdaq Stock
Market under the trading symbol "QLTI" and on The Toronto Stock
Exchange under the trading symbol "QLT".
The foregoing information contains forward-looking statements
which involve known and unknown risks, uncertainties and other
factors which may cause the actual results to be materially
different from any future results, performance, or achievements
expressed or implied by such statements. Such factors include:
risks associated with the commercialization of Visudyne(TM)
therapy; dependence on corporate relationships; manufacturing
uncertainties; uncertainty of pricing and reimbursement;
uncertainties relating to clinical trials and product
development; the Company's history of operating losses and
uncertainty of future profitability; competition; rapid growth;
uncertainty regarding patents and proprietary rights; product
liability claims and insurance; no assurance of regulatory
approval; government regulation; uncertainty of access to
capital; anti-takeover provisions; and volatility of common share
price; among others, all as described in the Company's Annual
Information Form on Form 10-K. ots Original Text Service: CIBA
Vision Corporation Internet:
http://www.newsaktuell.de Contact:
Pierre Billardon or Gerald Werner, Telephone: 01 864 1615, 01 864
1561, or fax, 01 862 1219, both of CIBA Vision Switzerland, or
Karen Handel or Ann Berry of CIBA Vision Corporate
Communications, 11460 Johns Creek Parkway, Duluth, Georgia USA
30097, 678-415-4208, or fax, 678-415-3592, or Elayne Wandler or
Tamara Hicks, Corporate Communications and Investor Relations of
QLT PhotoTherapeutics Inc., 520 West 6th Avenue, Vancouver, BC
Canada V5Z 4H5, 800-663-5486 or 604-872-7881, or fax, 604-873-
0816 Web site:
http://www.visudyne.com Web site:
http://www.qltinc.com Web site:
http://www.cibavision.com
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