QLT Announces FDA Filing and Review of Aczone Labeling Supplement for Removal of Blood Screening Requirement
VANCOUVER, July 23, 2007 /PRNewswire-FirstCall/ - QLT Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing and review QLT USA, Inc.'s labeling supplement (sNDA) for Aczone to request the removal of the glucose-6-phosphate dehydrogenase (G6PD) screening and blood monitoring requirements from its current label. A decision by the FDA on the label revision is expected by the end of March 2008.
"We are pleased to report the FDA acceptance of this filing as it represents another step toward achieving an important milestone for the company. Aczone has the potential to be a key contributor to our growth if this label revision is ultimately approved by the FDA," said Bob Butchofsky, President and Chief Executive Officer of QLT.
The sNDA submitted at the end of May 2007 is primarily based on the Phase IV clinical trial completed in 56 safety-evaluable G6PD-deficient patients (see related press release issued November 7, 2006). This study demonstrated no clinical evidence of hemolytic anemia in this patient population.
The Phase IV clinical trial of Aczone was performed to meet a post-approval commitment requested by the FDA. The purpose of this study was to gather more information about the safety of Aczone, a prescription topical medicine, in treating patients with acne who have G6PD deficiency. During a six-month period, patients were treated with both Aczone and the Aczone-vehicle (control group) in a cross-over design. Data was analyzed by third party clinical experts in dermatology and hematology who concluded that no clinically meaningful changes in safety-related parameters were observed in the trial.
QLT Inc. is a global biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapies. Our research and development efforts are focused on pharmaceutical products in the fields of ophthalmology and dermatology. In addition, we utilize two unique technology platforms, photodynamic therapy and Atrigel(R), to create products such as Visudyne(R) and Eligard(R). For more information, visit our web site at www.qltinc.com.
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.
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."
Certain statements contained in this press release, which are not historical facts, are forward-looking statements, as the term is defined in the Private Securities Litigation Reform Act of 1995. You can identify these forward-looking statements by QLT's use of words such as "expects," "plans," "estimates," "intends," "believes" and similar expressions that do not relate to historical matters. Such forward-looking statements are subject to risks and uncertainties which can cause actual results to differ materially from those currently anticipated due to a number of factors, which include, but are not limited to, the FDA may not approve the labeling revision supplement to remove the Aczone label requirement for blood testing for all patients, or may approve it with other restrictions that are not commercially acceptable, we may not be successful in commercializing Aczone, Aczone may not launch in 2008 and/or become a key contributor to our growth strategy and other factors as described in detail in QLT's Annual Information Form and Annual Report on Form 10-K, quarterly reports on Form 10-Q and other filings with the U.S. Securities and Exchange Commission and Canadian securities regulatory authorities. All forward-looking statements in this press release are made as of today, based upon information known to QLT as of the date hereof. QLT assumes no obligation to update or revise any of its forward-looking statements even if experience or future changes show that indicated results or events will not be realized.
CONTACT: QLT Inc.: Vancouver, Canada, Therese Hayes, Telephone: (604) 707-7000 or 1-800-663-5486, Fax: (604) 707-7001
CONTACT: QLT Inc.: Vancouver, Canada, Therese Hayes, Telephone: (604)707-7000 or 1-800-663-5486, Fax: (604) 707-7001
Ticker Symbol: (Toronto:QLT.),(NASDAQ-NMS:QLTI)
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Posted: July 2007