FOR IMMEDIATE RELEASE JUNE 15, 2009
VANCOUVER, CANADA— QLT Inc. (NASDAQ: QLTI; TSX: QLT) today announced that 12-month primary analysis results from the Novartis sponsored Phase II MONT BLANC study were presented on June 14, 2009 during the 17th Congress of the European Society of Ophthalmology in Amsterdam, the Netherlands. MONT BLANC is the European study of the Novartis sponsored SUMMIT clinical trial program which investigates the efficacy and safety of combining Visudyne® (Novartis Pharma AG) and Lucentis® (Novartis Pharma AG, Genentech Inc.). SUMMIT also includes the DENALI study in the US and Canada and the EVEREST study in Asia. MONT BLANC is a 24-month randomized, double-masked, multicenter trial in patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration. The purpose of the study is to evaluate whether Visudyne combined with Lucentis is not inferior to Lucentis monotherapy with respect to the mean change from baseline in visual acuity (VA) and to evaluate the proportion of patients with a treatment-free interval of at least three months duration after Month 2. At the Month 12 examination, mean VA in the Visudyne combination therapy group improved 2.5 letters from baseline compared with a 4.4 letter improvement in the Lucentis monotherapy group. In the combination therapy group, 96% of patients had a three-month treatment-free interval, compared with 92% in the Lucentis monotherapy group.
Twelve-month results of the MONT BLANC study show that combining standard-fluence Visudyne with Lucentis 0.5 mg can deliver VA improvements that are non-inferior to a Lucentis monotherapy regimen with three Lucentis loading doses followed by injections on a monthly as-needed basis (non-inferiority margin of 7 letters). There was no significant difference between the combination and monotherapy groups with regard to proportion of patients with a treatment-free interval of at least three months duration after Month 2. There were no unexpected safety findings, and adverse event incidence was similar between treatment groups.
Additional post hoc analysis showed that 85% of patients in the Visudyne combination therapy group, compared with 72% in the Lucentis monotherapy group, had a treatment-free interval of at least four months duration after Month 2. Median time to first retreatment after Month 2 was extended by approximately one month in the combination group (Month 6) versus the monotherapy group (Month 5). Patients in the combination group received, on average, a total of 4.8 Lucentis injections compared with 5.1 in the monotherapy group and a total of 1.7 Visudyne treatments compared with 1.9 sham treatments in the monotherapy group. Results are based on ITT analyses (with LOCF); per-protocol analyses yielded similar results. Overall, only 15 patients discontinued the study before Month 12 (6%).
“MONT BLANC provided the first data within the SUMMIT clinical trial program and showed that patients treated with Visudyne combination therapy had non-inferior visual acuity to patients treated with Lucentis monotherapy,” said Bob Butchofsky, Chief Executive Officer of QLT Inc. “The results from DENALI, which includes a Visudyne reduced fluence group, and EVEREST, which studies combination therapy in polypoidal choroidal vasculopathy, may add to the knowledge about the potential benefits of combining Visudyne and Lucentis.”
About MONT BLANC Phase II Study
The MONT BLANC study is a Phase II, multicenter, randomized, double-masked study comparing standard-fluence Visudyne-Lucentis combination therapy to Lucentis monotherapy in 255 subjects with choroidal neovascularization (CNV) secondary to wet age-related macular degeneration (wet AMD). Subjects were randomly assigned to one of two treatment groups: Standard-fluence Visudyne (600 mW/cm2 for 83 seconds to deliver 50 J/cm2) followed by same day intravitreal Lucentis (0.5 mg), or Lucentis monotherapy (0.5 mg). The Lucentis monotherapy group received sham Visudyne treatment to maintain masking. Standard-fluence Visudyne (or sham) was administered at baseline and then as needed at intervals of at least three months if required based on predefined re-treatment criteria. Lucentis was administered to both treatment groups with three loading doses followed by monthly treatment if required based on predefined re-treatment criteria. Patients were evaluated for VA, anatomical changes and safety at every monthly visit, and the need for retreatment was assessed at monthly visits from Month 3 to Month 11. Re-treatment was based on assessment of central retinal thickness (CRT) (increase of ≥100 µm), presence of subretinal fluid, as assessed by optical coherence tomography (OCT), presence of new subretinal hemorrhage as assessed by ophthalmoscopic examination, presence of CNV leakage as assessed by fluorescein angiography (FA) and decreases in VA of >5 letters as assessed by an Early Treatment Diabetic Retinopathy Study (ETDRS) chart. As needed Lucentis after three loading doses is a standard regimen in Europe, but not in the US, and combination therapy for AMD is not approved for marketing by regulatory agencies. The study duration is 24 months with a planned primary analysis when all subjects completed 12 months of follow-up. At baseline, mean VA letter score was 54 to 55 across treatment groups.
Visudyne therapy is a two-step procedure involving the intravenous administration of the drug into the patient’s arm. A non-thermal laser light is then shone into the patient’s eye to activate the drug. This produces a reaction that closes the abnormal leaky vessels, resulting in a stabilization of the corresponding vision loss.
Visudyne is approved worldwide for the treatment of a form of wet AMD, the leading cause of legal blindness in people over the age of 50, and has been used in more than two million treatments worldwide. Visudyne is commercially available in more than 80 countries for the treatment of predominantly classic subfoveal CNV. In addition, over 60 countries have approved Visudyne to treat one or more other macular neovascular conditions such as minimally classic and occult with no classic AMD lesions, pathologic myopia and presumed ocular histoplasmosis.
Visudyne is generally well tolerated and has a well established safety profile. The most commonly reported side effects include injection site reactions and visual disturbances. In addition, some patients experienced back pain, usually during the infusion. Using the approved light dose of 50J/cm2 between 1% and 5% of patients experienced a substantial decrease in vision in the first 7 days with partial recovery in some patients. Recent studies suggest that halving the light dose/fluence by halving the fluence rate may lower the incidence of visual disturbances with possibly better visual outcomes than the standard light dose used in this study. After treatment, patients should avoid direct sunlight for five days to prevent sunburn. People with porphyria should not be treated with Visudyne.
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 field of ophthalmology. In addition, we utilize three unique technology platforms, photodynamic therapy, Atrigel® and punctal plugs with drugs, to create products such as Visudyne® and Eligard® and future product opportunities. For more information, visit our website at www.qltinc.com.
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Atrigel is a registered trademark of QLT USA, Inc.
Lucentis is a registered trademark of Genentech, Inc.
Visudyne is a registered trademark of Novartis AG.
Eligard is a registered trademark of Sanofi-aventis.
QLT Plug Delivery, Inc. is a wholly-owned subsidiary of QLT Inc.
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: the results of clinical studies may not necessarily result in increased use of Visudyne; our expectations for timing to receive and release further data from clinical studies; any future expectations concerning Visudyne-Lucentis combination therapy; and statements which contain language such as: “assuming,” “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: uncertainties relating to the timing and results of the clinical development and commercialization of our products and technologies (including Visudyne-Lucentis combination therapy and our punctal plug technology) and the associated costs of these programs; the timing, expense and uncertainty associated with the regulatory approval process for products; uncertainties regarding the impact of competitive products and pricing; 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.