To: tuck who wrote (1225 ) 8/23/2001 5:52:49 PM From: Ian@SI Read Replies (1) | Respond to of 1321 August 23, 2001 QLT Sees New Visudyne Approval Boosting Market 40% By TAMSIN CARLISLE Of THE WALL STREET JOURNAL CALGARY -- QLT Inc. (QLTI) said the U.S. Food and Drug Administration's approval of Visudyne for use in treating progressive vision-loss due to pathologic myopia and presumed ocular histoplasmosis could increase by about 40% the potential market for the drug it jointly developed with Novartis AG (NVS). In an interview, Elayne Wandler, QLT's vice-president of corporate communications, estimated the existing market for Visudyne as a treatment for the predominantly classic form of age-related macular degeneration (AMD) at 125,000 new patients a year . Originally developed to treat AMD, an eye disease that is the leading cause of blindness in people older than 50, Visudyne has received approval in more than 50 countries for treating the predominantly classic, or most serious, form of the disorder. Wandler said that, if QLT and Novartis succeed in their ongoing efforts to win broader regulatory approval for Visudyne's use in treating AMD, this could add a further 200,000 new patients a year to the potential market for Visudyne , more than doubling revenues from the drug. As reported, Visudyne is in phase III clinical trials for the treatment of occult AMD, which is thought to be an earlier stage of AMD than the classic form. Although pathologic myopia and presumed ocular plasmosis each are far less prevalant than AMD, winning regulatory approval for the two new indications is "significant" because most patients suffering from these disorders are between 30 and 50 years old, Wandler said. Among other things, younger patients are likely to seek more repeat treatments for deteriorating vision over their lifetimes than older patients suffering from AMD. Pathologic myopia is characterized by abnormal blood vessels that grow under the center of the retina as a result of an abnormal elongation of the eye associated with severe near-sightedness. Presumed ocular histoplasmosis, found predominantly in the mid-central U.S., is an eye disorder caused by a fungal infection of the retina. Seeking To Broaden Visudyne's Markets Wandler said QLT and Novartis are seeking to broaden Visudyne's market even further by developing the drug as a treatment for diabetic ocular edema, a disorder that causes vision loss in many diabetics. She said Phase I clinical trials of Visudyne to treat this disorder are scheduled to start next year. Diabetic ocular edema, like AMD and pathalogic myopia, is an eye disorder involving abnormal blood vessels that leak fluid, Wandler said. In other steps to build its drug-development pipeline, QLT has recently completed two licensing deals with smaller biotechnology companies for potentially cancer-fighting products that are undergoing clinical trials. With Novartis, it is also developing photodynamic therapy for treating certain forms of skin cancer. In photodynamic therapy, a light-sensitive drug such as Visudyne is first administered by injection, then activated in specific tissues by exposure to laser light. Wandler said QLT is in discussions regarding further licencing deals to develop new drugs, but declined to elaborate. She said QLT plans to develop its own pharmaceutical sales force, in part to help facilitate future deals. Wandler also predicted that QLT will hire a new chief financial officer before the end of this year to succeed Kenneth Galbraith, who left the company last October. She described the market for senior biotechnology executives as "competitive." Company Web site: qltinc.com