Switzerland Is the First Country to Give Market Approval for Visudyne Therapy for AMD
16.12.1999, 12:58
ATLANTA and VANCOUVER, British Columbia (PROTEXT) - CIBAVision, the eye care unit of Novartis, and QLT PhotoTherapeuticsInc. (Nasdaq: QLTI; Toronto) announced today that the SwissRegulatory 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 maculardegeneration (AMD), the leading cause of blindness in people overthe age of 50 in the western world. Specifically, the agency approved Visudyne for the treatmentof wet AMD in patients with predominantly classic subfovealchoroidal neovascularization. Visudyne therapy will be made commercially available inSwitzerland imminently. The registration application for Visudyne was submitted to theSwiss regulatory agency on August 18th, 1999. Regulatoryapplications 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 amajor event for patients suffering from wet AMD," said Luzi vonBidder, President of CIBA Vision's worldwide Ophthalmic BusinessUnit. "At last there is an approved, effective treatment that canhelp preserve the vision of many patients suffering from thisterrible, sight threatening condition. We will make Visudyneavailable to eye care professionals and their patients across thecountry in the coming days. "We will also use this approval to apply for a free marketingcertificate which will enable us to gain approvals in a number ofother markets around the world," said von Bidder. Until now, other treatment options are limited toapproximately 15% of the 500,000 patients worldwide that developwet AMD every year. Medical experts estimate that between 40-60%of all wet AMD cases will develop predominantly classic lesionsas 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 areproud to have been able to transform our discovery of Visudyneinto a significant vision saving treatment. Today's achievementis a testament to the strong partnership and successful researchcollaboration between QLT, CIBA Vision and Novartis." About AMD and Visudyne therapy Wet AMD typically destroys central vision, which is necessaryfor daily tasks such as reading, driving, and recognizing faces.The condition is characterized by the formation of abnormal bloodvessels (choroidal neovasculature or CNV) that grow across thecentral part of the retina, called the macula. These vessels leakfluid and eventually cause scar tissue, which destroys centralvision in as little as 2 months to 3 years. Visudyne is being co-developed for ocular conditions by CIBAVision Corporation, the eye care unit of Novartis AG, and QLTPhotoTherapeutics Inc. Upon commercialization, CIBA Vision willmarket the product worldwide while QLT will be responsible formanufacturing Visudyne. Visudyne therapy can be performed in a doctor's office as atwo-step procedure. First, Visudyne is injected intravenouslyinto the patient's arm. Then the drug is activated by shiningnon-thermal laser light into the patient's eye. Visudyne therapy involves the use of a specifically designedlaser that produces the low level, non-thermal 689 nm lightrequired to activate the drug. These lasers have been developedby 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 determinethe effectiveness of Visudyne therapy in patients with an earlierstage of AMD who were originally excluded from the TAPInvestigation as well as patients with a similar but distinctcondition of abnormal blood vessels associated with progressivenear-sightedness known as pathologic myopia. Visudyne therapy is protected by a series of U.S. and foreignissued patents that cover the composition of matter, formulationsand manufacturing, and the method of use in treating AMD andother conditions. Background on CIBA Vision and QLT With worldwide headquarters in Atlanta, Georgia, USA, CIBAVision is a global leader in research, development andmanufacturing of optical and ophthalmic products and services,including contact lenses, lens care products and ophthalmicpharmaceuticals. CIBA Vision products are available in more than70 countries. For more information, you are invited to visit theCIBA Vision website at http://www.cibavision.com . CIBA Vision is the eye care unit of Novartis AG, a worldleader 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 CHF17.5 billion were in Healthcare, CHF 8.4 billion in Agribusinessand CHF 5.8 billion in Consumer Health. The group annuallyinvests more than CHF 3.7 billion in R&D. Headquartered in Basel,Switzerland, Novartis employs about 82,000 people and operates inover 100 countries around the world. QLT PhotoTherapeutics Inc. is a world leader in thedevelopment and commercialization of proprietary pharmaceuticalproducts for use in photodynamic therapy, an emerging field ofmedicine utilizing light-activated drugs in the treatment ofdisease. QLT's innovative science has advanced photodynamictherapy beyond applications in cancer towards potentialbreakthrough treatments in ophthalmology and autoimmune disease. In addition to Visudyne therapy, QLT's portfolio of productsinclude PHOTOFRIN(R) (porfimer sodium), the world's only approvedphotodynamic therapy drug, used in the treatment of variouscancers throughout North America, Japan and Europe. For moreinformation, you are invited to visit QLT's web site athttp://www.qltinc.com . Visudyne(TM) is a trademark of Novartis AG. PHOTOFRIN(R) is a registered trademark of QLTPhotoTherapeutics Inc. For more information, you are invited to visit the CIBA Visionweb site at http://www.cibavision.com or the Visudyne therapywebsite at http://www.visudyne.com . For more information, you are invited to visit the QLT website at http://www.qltinc.com . QLT PhotoTherapeutics Inc. is listed on The Nasdaq StockMarket under the trading symbol "QLTI" and on The Toronto StockExchange under the trading symbol "QLT". The foregoing information contains forward-looking statementswhich involve known and unknown risks, uncertainties and otherfactors which may cause the actual results to be materiallydifferent from any future results, performance, or achievementsexpressed or implied by such statements. Such factors include:risks associated with the commercialization of Visudyne(TM)therapy; dependence on corporate relationships; manufacturinguncertainties; uncertainty of pricing and reimbursement;uncertainties relating to clinical trials and productdevelopment; the Company's history of operating losses anduncertainty of future profitability; competition; rapid growth;uncertainty regarding patents and proprietary rights; productliability claims and insurance; no assurance of regulatoryapproval; government regulation; uncertainty of access tocapital; anti-takeover provisions; and volatility of common shareprice; among others, all as described in the Company's AnnualInformation Form on Form 10-K. ots Original Text Service: CIBAVision Corporation Internet: http://www.newsaktuell.de Contact:Pierre Billardon or Gerald Werner, Telephone: 01 864 1615, 01 8641561, or fax, 01 862 1219, both of CIBA Vision Switzerland, orKaren Handel or Ann Berry of CIBA Vision CorporateCommunications, 11460 Johns Creek Parkway, Duluth, Georgia USA30097, 678-415-4208, or fax, 678-415-3592, or Elayne Wandler orTamara Hicks, Corporate Communications and Investor Relations ofQLT PhotoTherapeutics Inc., 520 West 6th Avenue, Vancouver, BCCanada 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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