Switzerland Is the First Country to Give Market Approval for Visudyne Therapy for AMD

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

Klíčová slova PROTEXT-QLT PhotoTherapeutics Inc.-CIBA Vision

USA, Kanada, OSN, svět a Arktida (us)


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