本帖最后由 凤凰涅盘 于 2011-11-15 21:19 编辑
http://www.qltinc.com/newsCenter/pressReleases.htm#
QLT is currently conducting a Phase 1b clinical proof-of-concept study of QLT091001, a synthetic retinoid therapy for 11-cis-retinal, a key biochemical component of the visual cycle, in patients with Leber Congenital Amaurosis (LCA) and Retinitis Pigmentosa (RP). QLT is also developing a proprietary punctal plug technology for the delivery of drugs topically to the eye through controlled sustained release to the tear film. We are currently targeting the treatment of glaucoma with this system.
“We are pleased to announce that we have now achieved a retention rate of 81% at 4 weeks in 27 eyes with our new proprietary upper punctal plugs. We will continue to study the longer-term retention rate of the new upper plugs, and refine the current design if needed to support our clinical development goal of commencing Phase III activities in 2013,” said Bob Butchofsky, President and Chief Executive Officer of QLT. “In our synthetic retinoid program, we have also been recently encouraged by positive feedback from the European Medicines Agency in discussions regarding our pivotal trial plans for LCA in 2012."
QLT091001 orphan drug program for the treatment of Leber Congenital Amaurosis and Retinitis Pigmentosa
On October 21, 2011, we presented results for the full cohort of 14 LCA subjects and updated longer-term visual function data on previously reported subjects at the 2011 American Academy of Ophthalmology annual meeting. We continue to monitor and analyze LCA patient follow up data and will be initiating retreatment in subjects as needed.
In RP, we are expecting to complete enrollment of up to 14 patients in the RP cohort by year end and report data from these patients in the first quarter of 2012.
We have received clearance from the FDA for our Investigational New Drug Application (IND) and also clearance from regulatory agencies in the U.K., the Netherlands, and Germany allowing us to proceed in our synthetic retinoid studies with seven investigator sites.
Punctal Plug Drug Delivery System
Ongoing device-only development work, initiated following the positive Glau 11 trial results, with our new proprietary upper punctal plug showed a retention rate of 81% at one month in 27 eyes. Further study of the longer-term handling, comfort and retention of the new upper plug, as well as other plug iterations, is underway. In our Phase II Glau 11 clinical study, we used a slightly modified, commercially available plug in the upper puncta, which achieved a 45% retention rate after four weeks of treatment (consistent with retention rates of commercially available plugs).
R&D plans include commencing further Phase II trials in glaucoma by Q1 2012 that will evaluate single versus double plug approaches as well as duration of sustained release. If these trials are successful, then we would expect to commence Phase III clinical development activities in 2013.
On August 29, 2011, we announced positive results from our Phase II clinical study on the safety and efficacy of L-PPDS (Glau 11). The trial featured simultaneous placement of latanoprost-eluting punctal plugs in both the upper and lower puncta for delivery of a daily drug load with a goal of enabling comparable clinical outcomes to that of daily administered Xalatan® eye drops. After 4 weeks of L-PPDS treatment, the mean intraocular pressure (IOP) reduction from baseline was 5.7 mmHg and 60% of subjects at 4 weeks showed an IOP reduction of 5 mmHg or greater
Guidance Update
We expect worldwide Visudyne sales and contingent consideration earnings for 2011 will be near the high-end of the original guidance ranges.
We are now expecting annual U.S. Visudyne sales to be in the range of $20 million to $22 million, compared with the original annual guidance of $23 million to $26 million. Visudyne sales in the U.S. through nine months were $15.6 million.
Cost of Sales expense guidance is now being increased to $10 million to $11 million compared with the original annual guidance of $8 million to $10 million.
The key guidance ranges for the full year 2011 are as follows :
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Share Repurchase Program Update
During the third quarter, the Company repurchased approximately 629,000 shares under its normal course issuer bid program at an average price of $7.15 per share, for a total cost of approximately $4.5 million. In total, since this program commenced on December 16, 2010, the Company has repurchased approximately 2.2 million shares at an average price of $7.02 per share, for a total cost of $15.4 million. In aggregate since the Company began repurchasing shares in 2005, it has purchased almost 46 million shares at a cost of approximately $247 million.
Recent Corporate Announcements
On September 14, 2011, QLT announced the Company's oral synthetic retinoid for retinal diseases, QLT091001, has been granted two Fast Track designations by the FDA for the treatment of LCA due to inherited mutations in LRAT and RPE65 genes and for the treatment of autosomal recessive RP due to inherited mutations in LRAT and RPE65 genes.
On August 29, 2011, QLT announced results in its Phase II clinical study on the efficacy and safety of L-PPDS in subjects with ocular hypertension and open-angle glaucoma. Highlights:
First reported demonstration of a clinically significant, prolonged (4 weeks) reduction in intraocular pressure (IOP) in glaucoma with an extraocular, minimally-invasive sustained release ophthalmic drug delivery system
After 4 weeks of L-PPDS treatment, the mean IOP reduction from baseline was 5.7 mmHg
60% of subjects at 4 weeks showed an IOP reduction of 5 mmHg or greater
Retention of QLT's proprietary punctal plug placed in the lower punctum was 95% at 4 weeks
Passive Foreign Investment Company
The Company believes that it qualified as a Passive Foreign Investment Company (PFIC) for 2009 and 2010, and that it may qualify as a PFIC in 2011, which could have adverse tax consequences for U.S. shareholders. Please refer to our Annual Report on Form 10-K for additional information.
Conference Call Information
QLT Inc. will hold an investor conference call to discuss third quarter 2011 results on Thursday, November 3, 2011 at 8:30 a.m. ET (5:30 a.m. PT). The call will be broadcast live via the Internet at www.qltinc.com. To participate on the call, please dial 1-800-319-4610 (North America) or 604-638-5340 (International) before 8:30 a.m. ET. A replay of the call will be available via the Internet and also via telephone at 1-800-319-6413 (North America) or 604-638-9010 (International), access code 7157, followed by the “#” sign.
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About QLT
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 our proprietary punctal plug delivery system, as well as U.S. marketing of the commercial product Visudyne® (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® is a registered trademark of Novartis AG.
Eligard® is a registered trademark of Sanofi-aventis Corp.
Xalatan® is a registered trademark of Pfizer Health AB.
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."
A full explanation of how QLT determines and recognizes revenue resulting from Visudyne sales is contained in the financial statements contained in the periodic reports on Forms 10-Q and 10-K, under the heading “Significant Accounting Policies – Revenue Recognition.” Visudyne sales are product sales in the U.S. by our wholly-owned U.S. subsidiary, QLT Ophthalmics, Inc., and product sales outside the U.S. by Novartis under its agreement with QLT. |
