To: Ian@SI who wrote (1125 ) 12/15/2000 10:18:37 AM From: Julian Read Replies (1) | Respond to of 1321 NOVARTIS SAYS VISUDYNE WINS EU PANEL BACKING FOR NEW USE (The following is a reformatted version of a press release issued by Novartis AG and received via fax. The release was confirmed by the sender.) CPMP recommends approval in Europe for Visudyne therapy in the treatment of pathologic myopia Basel/BĀlach/Vancouver, Canada, Dec. 15 -- Novartis Ophthalmics (previously the ophthalmic business unit of CIBA Vision) and QLT Photo Therapeutics Inc. announced today that the Committee for Proprietary Medicinal Products (CPMP) of the European Medicines Evaluation Agency (EMEA) has adopted a positive opinion on Visudyne (verteporfin) for the treatment of patients with choroidal neovascularization (CNV) caused by pathologic myopia (PM) - a serious eye disorder with a worldwide incidence rate of 50'000 new cases every year. The European Commission is expected to make a final decision regarding the expanded indication of the application in the next few months. If approved by the Commission, Visudyne therapy for pathologic myopia will be available throughout the EU, and it is anticipated that the Norwegian and Icelandic authorities will grant corresponding national authorizations. Visudyne is already commercially available in 30 countries for use in age-related macular degeneration (AMD) patients with CNV. CNV is a growth of abnormal blood vessels under the central part of the retina, or macula. These vessels leak fluid and cause scar tissue that destroys central vision, resulting in a deterioration of sight. "This recommendation by the CPMP is excellent news", said Luzi von Bidder, worldwide Head of the Novartis Ophthalmics Business Unit. "We are now one step closer in making this important treatment for pathologic myopia commercially available throughout Europe". Dr. Julia Levy, President and Chief Executive Officer of QLT, said: "We are extremely pleased by this decision from the Committee and look forward to helping the many thousands of people around the world who have this serious ocular condition", CNV due to pathologic myopia (PM) CNV due to pathologic myopia is caused by abnormal blood vessels that grow under the center of the retina as a result of an abnormal elongation of the back of the eye associated with severe near-sightedness or myopia. It generally occurs among people over 30 years of age and can result in a progressive loss of vision; there is no approved treatment for the majority of patients. The worldwide incidence of CNV due to pathologic myopia is estimated to be 50'000 new cases per year, excluding Asia where the incidence may he even greater due to a higher prevalence of pathologic myopia. About AMD and Visudyne therapy 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. A non-thermal laser light is then shone into the patient's eye to activate the drug. Visudyne therapy uses a specially designed laser that produces the low level, non-thermal 689nm light required to activate the drug. These lasers have been developed by two of the world's leading laser companies, Coherent Inc. (NASDAQ:COHR), and Zeiss based in Germany. Novartis Ophthalmics markets the product worldwide, while QLT is responsible for manufacturing. Visudyne therapy is protected by a series of US and foreign-patents on composition of matter, formulations and manufacturing, and the method of use in treating AMD and other conditions. Contacts: Novartis Ophthalmics Non-US: Sabine Ciccotosto Telephone: +41 1 864 15 69 Fax: +41 1 862 08 10 Novartis Ohthalmics North -America: Jan McClure Telephone: (678) 415-3646 Fax: (678) 415-3592 QLT Inc. Corporate Communications contacts: Ian Harper or Tamara Hicks Telphone: (604) 707-7571 Fax: (604) 873-0816 (jfa) LO -END- -0- (CRL) Dec/15/2000 10:18 GMT