CIBA Vision and QLT Announce Regulatory Submission
16.08.1999, 16:50
Seeking Approval Of Visudyne Therapy for Wet AMD in the UnitedStates Atlanta, and Vancouver, Canada (PROTEXT) - CIBA VisionCorporation, the eye care unit of Novartis AG, and QLTPhotoTherapeutics Inc. (Nasdaq: QLTI) today announced thesubmission of a New Drug Application (NDA) to the U.S. Food andDrug Administration (FDA) seeking marketing clearance forVisudyne(TM) therapy for the treatment of wet age-related maculardegeneration (AMD), the leading cause of blindness in people overthe age of 50 in the western world. The specific indication requested is for the treatment of AMDin patients with predominantly classic subfoveal choroidalneovascularization, the most aggressive cause of vision lossassociated with the disease and for which Visudyne showed adramatic benefit. The companies have requested a priority reviewwithin a six- month period as there is no current satisfactorytreatment for the majority of patients with wet AMD. Wet AMD is characterized by the formation of abnormal leakyblood vessels (choroidal neovasculature) that grow across thecentral part of the retina, called the macula. The wet formrepresents an estimated 15% of all AMD cases but accounts forapproximately 90% of the severe vision loss associated with thedisease. Currently available treatments are limited ineffectiveness and only applicable for approximately 10% to 20% ofthe 500,000 new cases of wet AMD that develop worldwide everyyear. "On the heels of filing in the European Union last week, thisU.S. submission underscores our commitment to bringing thistreatment as quickly as possible to patients throughout the worldaffected by this deleterious disease," said Dr. Julia Levy,President and Chief Executive Officer of QLT. "There is tremendous demand for more effective treatments formacular degeneration," said Luzi von Bidder, President of CIBAVision's worldwide Ophthalmics Business Unit. "The approval ofVisudyne therapy has the potential to improve the lives of manythousands of people." The submission is based on 12-month data from two 24-monthrandomized, double-masked, placebo-controlled Phase III trialsknown as the TAP (Treatment of AMD with Photodynamic therapy)Investigation. The trials are taking place at 22 centers in NorthAmerica and Europe and have enrolled a total of 609 patients. Atthe 12-month follow-up visit, among the 243 patients in the trialwith predominantly classic lesions, those treated with Visudynetherapy exhibited a large treatment benefit. Specifically, basedon an intent-to- treat analysis, vision was stable (defined as aloss of less than three lines of vision on a standard eye chart)or improved in 67% of these patients treated with Visudynetherapy compared to 39% of patients administered placebo.Accordingly, patients treated with Visudyne therapy were 72% morelikely to retain their vision compared to the placebo group.These results were found to be statistically significant in thispopulation for each of the two studies, as well as for thecombined data (p<0.001). Statistically significant results on the combined datafavoring Visudyne therapy were also obtained for all secondaryendpoints, including contrast sensitivity and lesion growth.Visudyne therapy was more likely to confine the growth of thelesion as well as maintain contrast sensitivity relative topatients receiving placebo. Results also showed that Visudyne therapy was well tolerated,with less than 3% of patients withdrawing from the study due toadverse events. The majority of adverse events occurred insimilar numbers among the treatment and placebo groups. Thoseevents that occurred more often with Visudyne therapy were:reactions at the injection site that occurred in 10% more treatedpatients; transient mild to moderate decreased vision thatoccurred in 2% more treated patients; and self-resolvingphotosensitivity reactions that usually occurred within 24 hourspost-treatment in less than 3% of treated patients. A comprehensive analysis of the data is expected to bepublished in an upcoming issue of a leading ophthalmic peer-reviewed journal. Top-line results were presented at theAssociation for Research in Vision and Ophthalmology meeting inFt. Lauderdale, Florida on May 11, 1999 and at the EuropeanSociety of Ophthalmology symposium in Stockholm on June 28, 1999. About Visudyne therapy Visudyne therapy can be performed in a doctor's office and isrelatively painless to the patient. Visudyne therapy consists oftwo stages. First, Visudyne is injected intravenously into the patient'sarm. It selectively accumulates in the abnormal vessels in theeye. The drug is then activated by shining non-thermal laserlight into the patient's eye. Once activated, Visudyneselectively affects the abnormal blood vessels and correspondingvision loss. Visudyne therapy does not appear to damage normalretina vessels on fluorescein angiography, even after multipletreatments. Background on CIBA Vision and QLT: Visudyne therapy is being co-developed for various ocularconditions by CIBA Vision Corporation and QLT PhotoTherapeuticsInc. Upon commercialization, CIBA Vision will market the productworldwide while QLT will be responsible for manufacturing. Visudyne therapy is protected by a series of U.S. and foreignissued patents which cover the composition of matter,formulations and manufacturing, and the method of use in treatingAMD and other conditions. 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 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. Visudyne(TM) is a trademark of Novartis AG. PHOTOFRIN is a registered trademark of QLT PhotoTherapeuticsInc. Editors Note: The treatment of wet AMD with Visudyne therapy is currentlyinvestigational. Only patients who are currently enrolled inclinical trials sponsored by QLT and CIBA Vision are eligible fortreatment at this time. Patients and practitioners seekingadditional information may view our web site at www.visudyne.comor call the patient/practitioner hotline In North America, 1-800-821-2450. CIBA Vision contacts: Karen Handel or Ann Berry Corporate Communications CIBA Vision Corporation 11460 Johns Creek Parkway Duluth, Georgia USA 30097 Telephone: (USA) (678) 415-4208 Fax: (USA) (678) 415-3592 For more information, you are invited to visit the CIBA Visionweb site at www.cibavision.com or the Visudyne therapy website atwww.visudyne.com. QLT PhotoTherapeutics Inc. contacts: Elayne Wandler or Tamara Hicks Corporate Communications QLT PhotoTherapeutics Inc. 520 West 6th Avenue Vancouver, B.C. Canada V5Z 4H5 Telephone: 1-800-663-5486, (USA) (604)872-7881 Fax: (USA) (604) 873-0816 For more information, you are invited to visit the QLT website at 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 VisudyneO 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:Karen Handel or Ann Berry, Corporate Communications (USA) 678-415-4208, Fax, (USA) 678-415-3592, both of CIBA VisionCorporation, or Elayne Wandler or Tamara Hicks, CorporateCommunications 1-800-663-5486, or 604-872-7881, or Fax, (USA)604-873-0816, both of QLT PhotoTherapeutics Inc. Web site:http://www.qltinc.com Web site: http://www.visudyne.com Website: http://www.cibavision.com
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