VANCOUVER, British Columbia, Sep 14, 2011 (GlobeNewswire via COMTEX) --
QLT Inc. (Nasdaq:QLTI) (TSX:QLT) today announced the Company's oral synthetic retinoid for retinal diseases, QLT091001, has been granted two Fast Track designations by the U.S. Food and Drug Administration (FDA) for the treatment of Leber Congenital Amaurosis (LCA) due to inherited mutations in LRAT and RPE65 genes and for the treatment of autosomal recessive Retinitis Pigmentosa (RP) due to inherited mutations in LRAT and RPE65 genes.
The FDA's Fast Track is a process designed to facilitate the development and expedite the review of drugs that are intended for the treatment of serious diseases and fill an unmet medical need.
Following the recent completion of the QLT091001 Phase 1b trial in the LCA cohort, the Company continues the ongoing follow-up and initial re-treatment of LCA patients, as well as targeting the completion of subject enrollment in the RP cohort before the end of 2011.
QLT received clearance from the FDA in July 2011 of our Investigational New Drug Application (IND) for QLT091001 allowing the Company to proceed with investigator sites in the U.S. for LCA and RP patients. Also in July, QLT received clearance from the U.K. Medicines and Healthcare Products Regulatory Agency of our Clinical Trial Application (CTA) for QLT091001 allowing the Company to proceed with investigator sites in that jurisdiction for LCA and RP patients.
"QLT091001's Fast Track designation, along with its orphan drug designation, highlights the need for therapeutic options for those patients suffering from inherited retinal diseases," said Bob Butchofsky, President and Chief Executive Officer of QLT Inc. "We are pleased that the FDA recognizes QLT091001 as a potential treatment for LCA and RP and we are now working diligently to advance the development of this compound under the Fast Track process."
The purpose of the FDA's Fast Track process is to get important new drugs to the patient earlier. Once a drug receives Fast Track designation, early and frequent communication with the FDA is encouraged through the drug development and review process, potentially leading to earlier drug approval. In addition, a drug that receives Fast Track designation also qualifies for a Rolling Submission, which means that a company can submit completed sections of its New Drug Application (NDA) for review by the FDA, rather than waiting until the entire application is available before review can commence.
About Synthetic Retinoids
Genetic diseases in the eye such as LCA and RP arise from gene mutations of enzymes or proteins required in the biochemistry of vision. QLT091001 is a replacement for 11-cis-retinal, which is an essential component of the retinoid-rhodopsin cycle and visual function. QLT091001 has received orphan drug designations for the treatment of the LRAT and RPE65 genetic mutations in both LCA and RP by the U.S. Food and Drug Administration. QLT091001 has also received orphan drug designations for the treatment of LCA and RP by the European Medicines Agency.
About Leber Congenital Amaurosis (LCA)
LCA is an inherited degenerative retinal disease characterized by abnormalities such as roving eye movements and sensitivity to light, and manifesting in severe vision loss from birth. Eye examinations of infants with LCA reveal normal appearing retinas. However, a low level of retinal activity, measured by electroretinography, indicates very little visual function. Approximately 1 child out of every 81,000 births will inherit the disease. Mutations in the genes for retinal pigment epithelium protein 65 (RPE65) and lecithin:retinol acyltransferase (LRAT) result in an inadequate production of 11-cis-retinal and occur in approximately 10% of patients with LCA and to a lesser extent in Retinitis Pigmentosa (RP), another inherited retinal dystrophy.
About Retinitis Pigmentosa (RP)
RP is a set of hereditary retinal diseases demonstrating clinical features similar to LCA and characterized by degeneration of rod and cone photoreceptors. By current epidemiological estimates, there are at least 300,000 patients with RP worldwide, of which less than 5% carry the inherited deficiencies of either RPE65 or LRAT.
QLT is an ocular-focused company dedicated to the development and commercialization of innovative ocular products that address the unmet medical needs of patients and clinicians worldwide. We are focused on developing our synthetic retinoid program for the treatment of certain inherited retinal diseases, developing drugs to be delivered in our proprietary punctal plug delivery system, as well as U.S. marketing of the commercial product Visudyneâ (which we co-developed with Novartis) for the treatment of wet age-related macular degeneration. QLT's head office is based in Vancouver, Canada and the Company is publicly traded on NASDAQ (symbol: QLTI) and the Toronto Stock Exchange (symbol: QLT). For more information about the Company's products and developments, please visit our web site at www.qltinc.com.
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Visudyne(R) is a registered trademark of Novartis AG.
Eligard(R) is a registered trademark of Sanofi S.A.
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 in this press release constitute "forward-looking statements" of QLT within the meaning of the Private Securities Litigation Reform Act of 1995 and constitute "forward-looking information" within the meaning of applicable Canadian securities laws. Forward-looking statements include, but are not limited to: statements concerning our clinical development programs and future plans, including plans for our QLT091001 synthetic retinoid program; expected progression of clinical development of these programs and any anticipated timing for development initiatives and receipt of results, including our assumptions related to initiation of new studies, current and future study enrollment and timing to treat and re-treat patients; statements concerning the potential benefits and success of our development programs and product candidates; and statements which contain language such as: "assuming," "plan," "potentially," "prospects," "future," "projects," "believes," "expects" and "outlook." Forward-looking statements are predictions only which involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from those expressed in such statements. Many such risks, uncertainties and other factors are taken into account as part of our assumptions underlying these forward-looking statements and include, among others, the following: the Company's future operating results are uncertain and likely to fluctuate; the risk that sales of Visudyne or Eligardâ may be less than expected (including due to competitive products and pricing); uncertainties relating to the timing and results of the clinical development and commercialization of our products and technologies (including, but not limited to, Visudyne, our punctal plug technology and synthetic retinoid program); assumptions related to continued enrollment trends, efforts and success, and the associated costs of these programs; outcomes for our clinical trials (including our punctal plug technology and our synthetic retinoid program) may not be favorable or may be less favorable than interim results and/or previous trials; there may be varying interpretations of data produced by one or more of our clinical trials; the timing, expense and uncertainty associated with the regulatory approval process for products; risks and uncertainties associated with the safety and effectiveness of our technology; risks and uncertainties related to the scope, validity, and enforceability of our intellectual property rights and the impact of patents and other intellectual property of third parties; and general economic conditions and other factors described in detail in QLT's 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. Forward-looking statements are based on the current expectations of QLT and QLT does not assume any obligation to update such information to reflect later events or developments except as required by law.
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SOURCE: QLT Inc.
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