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| |  European Committee Recommends Approval Of Visudyne (Verteporfin) For Wet Age-Related Macular Degeneration ATLANTA, GA and VANCOUVER, BC -- April 14, 2000 -- CIBA Vision, the eye care unit of Novartis, and QLT PhotoTherapeutics Inc. announced that The Committee for Proprietary Medicinal Products (CPMP) of the European Medicines Evaluation Agency (EMEA) has recommended the granting of a Marketing Authorisation for Visudyne(TM) (verteporfin) therapy for the treatment of wet age-related macular degeneration (AMD), the leading cause of blindness among people over the age of 50. The committee unanimously concurred that Visudyne therapy is safe and well-tolerated, with minimal adverse events relating to treatment. The Norwegian and Icelandic CPMP members agreed with the recommendation. The EU Commission is expected to make a final decision regarding the approval of the Visudyne application in the next several months. When approved by the EU Commission, Visudyne therapy will be available throughout the EU, and the Norwegian and Icelandic authorities will grant corresponding national authorizations. Visudyne therapy is currently approved and commercially available in the United States and Switzerland, and approved in Malta. Regulatory applications are pending in Canada, Australia, New Zealand, Brazil, Argentina, and India, among others. While regulatory reviews are ongoing, Visudyne is currently being made available under various expanded access programs in more than 25 countries. Currently, only 10 - 15 percent of the estimated 500,000 patients who develop wet AMD worldwide every year are eligible for existing treatments. "Today's endorsement is a major step towards making this much needed treatment commercially available in all markets in Europe," said Luzi von Bidder, President of CIBA Vision's worldwide Ophthalmic Business Unit. "We are excited about this decision especially on the heels of FDA approval," said Dr. Julia Levy, President and Chief Executive Officer of QLT. "Not only does this recommendation have significant implications for QLT and CIBA Vision, but it has the potential to improve the lives of so many people on a worldwide basis." Wet AMD is characterized by the formation of abnormal blood vessels (choroidal neovascularization or CNV) that grow under the central part of the retina, called the macula. These vessels leak fluid and eventually cause scar tissue, which destroys central vision. Visudyne therapy is a two-step procedure that can be performed in a doctor's office. First, Visudyne is injected intravenously into the patient's arm. The drug is then 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. , based in California, and Carl Zeiss, based in Germany. Visudyne is being co-developed for ocular conditions by CIBA Vision Corporation, the eye care unit of Novartis AG, and QLT PhotoTherapeutics Inc. CIBA Vision markets the product worldwide while QLT retains responsibility for manufacturing the product. 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. 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, ophthalmic surgical products and ophthalmic pharmaceuticals. CIBA Vision products are available in more than 70 countries. CIBA Vision is the eye care unit of Novartis AG, a world leader in healthcare with core businesses in pharmaceuticals, consumer health, generics, eye-care, and animal health. In 1999, the Group (including Agribusiness) achieved sales of CHF 32.5 billion and invested more than CHF 4.2 billion in R&D. Headquartered in Basel, Switzerland, Novartis employs about 82,400 people and operates in over 140 countries around the world. The Group recently announced plans to spin off its Crop Protection and Seeds sectors and to merge them with the agrochemicals business of AstraZeneca in the second half of 2000. 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 various cancers towards breakthrough treatments in ophthalmology and autoimmune disease Outside of the United States, Switzerland, and Malta, the treatment of wet AMD with Visudyne therapy is currently investigational. Only patients who are currently enrolled in clinical trials sponsored by QLT and CIBA Vision or under expanded access programs meeting local requirements in certain other countries, are eligible for treatment at this time. Related links: Visudyne, Ciba Vision.
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