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"We are extremely pleased to report Health Canada's decision to remove theneed for blood monitoring from the Aczone label," said Bob Butchofsky,President and Chief Executive Officer of QLT. "This positive review, alongwith the FDA's recent decision to also remove the need for blood monitoringfrom the Aczone label, validates our regulatory strategy, increases Aczone'scommercial potential, and enhances the product's overall attractiveness topotential acquirers."
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Aczone was originally approved by Health Canada in June 2006 with asimilar label restriction as that required by the US Food and DrugAdministration (FDA). The label called for all patients to undergo G6PDscreening and for those patients with this enzyme deficiency, regular bloodmonitoring was required during Aczone treatment. On March 17, 2008 the Companyannounced that the FDA removed the G6PD screening and monitoring requirementsbased on a Phase IV clinical trial in 56 safety-evaluable G6PD-deficientpatients. During a six-month period, patients were treated with both Aczoneand the Aczone-vehicle (control group) in a cross-over design. Data wasanalyzed by third party clinical experts in dermatology and hematology whoconcluded that no clinically meaningful changes in safety-related parameterswere observed in the trial.
Aczone, a prescription topical medicine for the treatment of acnevulgaris, is the only acne treatment to harness the potential of dapsone in atopical formulation to provide patients with a convenient and effectivetherapy. QLT USA owns worldwide marketing rights to Aczone.
About Aczone(R)
ACZONE is an aqueous topical gel containing 5% dapsone. Combining dapsonein QLT USA's proprietary Solvent Microparticulate (SMP(TM)) gel enablesdapsone to be applied topically and safely. In two randomized double-blind,vehicle-controlled clinical studies in 3,000 acne patients, ACZONE Gelachieved statistically significant percent reduction in the number of acnelesions and better success rate on the Global Acne Assessment Score. The mostcommon adverse events reported from controlled clinical trials includeoiliness/peeling, dryness, and erythema. There were no significant differencesin the adverse event rates between ACZONE Gel and vehicle control treatedpatients.
About QLT
QLT Inc. is a global biopharmaceutical company dedicated to the discovery,development and commercialization of innovative therapies. Our research anddevelopment efforts are focused on pharmaceutical products in the fields ofophthalmology and dermatology. In addition, we utilize three unique technologyplatforms, photodynamic therapy, Atrigel(R) and punctal plugs with drugs, tocreate products such as Visudyne and Eligard(R) and future productopportunities. For more information, visit our web site at www.qltinc.com.
QLT Inc. is listed on the NASDAQ Stock Market under the trading symbol"QLTI" and on The Toronto Stock Exchange under the trading symbol "QLT."
CONTACT: QLT Inc.: Vancouver, Canada: Therese Hayes, Telephone: (604)707-7000, or 1-800-663-5486, Fax: (604) 707-7001; The Trout Group: New York,USA: Brandon Lewis, Telephone: (646) 378-2915; or Marcy Strickler, Telephone:(646) 378-2927Aczone is a registered trademark of QLT USA, Inc. Atrigel is a registered trademark of QLT USA, Inc. Visudyne is a registered trademark of Novartis AG. Eligard is a registered trademark of Sanofi-aventis.
SOURCE QLT Inc.
