QLT reiterates confidence in Visudyne's potential
VANCOUVER, Aug. 30 /PRNewswire-FirstCall/ -- QLT (Nachrichten) (NASDAQ: QLTI; TSX: QLT) reiterated its confidence in Visudyne(R)'s potential in the treatment of age-related macular degeneration (AMD). The company also reiterated its 2004 guidance of Visudyne sales of US$430 to $455 million and its post-integration guidance for the combined QLT-Atrix company of a cash EPS compound annual growth rate of 20-25%. This statement is made following the U.S. Food and Drug Administration (FDA) advisory panel for the anti-VEGF aptamer which was held on Friday, August 27th. At this panel, Phase II/III results were presented for the anti-VEGF aptamer, confirming QLT's earlier view of the top- line aptamer data, that those data appear to provide no advantage over Visudyne therapy for patients with AMD, the leading cause of blindness in patients over 50. In the United States, Visudyne is reimbursed by the Centers for Medicare and Medicaid Services (CMS) for certain patients with all three forms of wet AMD, predominantly classic, occult and minimally classic.
"While there are no head-to-head comparative clinical trials of Visudyne vs. the anti-VEGF aptamer, the data presented at the panel did not appear to provide any advantage over Visudyne and requires nine repeated intravitreal injections yearly, directly into the eye," said Paul Hastings, President and Chief Executive Officer of QLT Inc. "Given the discrepancies in efficacy across all subtypes that was evident in the FDA briefing document, we believe that retinal specialists who now for the first time have access to this more detailed data, will take this into consideration in their treatment decisions."
QLT will hold an analyst and investor conference call to discuss the outcome of the FDA advisory panel meeting on August 31, 2004, at 8:30a.m. ET. The call will be broadcast live via the Internet at www.qltinc.com/. A replay of the call will be available via the Internet and also via telephone at 416-695-5800, access code 3094357. Visudyne therapy is developed and commercialized through the alliance of QLT and the Ophthalmics Business Unit of Novartis Pharma AG.
Visudyne 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. Once activated, Visudyne affects abnormal blood vessels, resulting in a cessation of growth of blood vessels in the eye and a stabilization of the corresponding vision loss. Visudyne therapy does not appear to damage normal retinal vessels.
Visudyne is the only drug approved for the treatment of some forms of wet AMD, the leading cause of blindness in people over the age of 50, and has been used in more than 250,000 patients worldwide. Visudyne is commercially available in more than 72 countries for the treatment of predominantly classic subfoveal CNV and in over 40 countries for occult subfoveal CNV caused by AMD. It is also approved in more than 56 countries, including the EU, U.S. and Canada, for the treatment of subfoveal CNV due to pathologic myopia (severe near-sightedness). In some countries Visudyne is also approved for presumed ocular histoplasmosis or other macular diseases.
QLT is a global pharmaceutical company specializing in the discovery, development and commercialization of innovative therapies to treat cancer, eye diseases, and dermatological and urological conditions. Combining expertise in ophthalmology, oncology and photodynamic therapy, QLT has commercialized two products to date, including Visudyne therapy which is one of the most successfully launched ophthalmology products. For more information, visit our web site at www.qltinc.com/.
QLT Inc.: Therese Hayes/Tamara Hicks Telephone: 604-707-7000 or 1-800-663-5486 Fax: 604-707-7001 Visudyne(R) is a registered trademark of Novartis AG
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."
In connection with QLT's proposed merger with Atrix Laboratories, Inc., QLT has filed with the SEC a registration statement on Form S-4, containing a joint proxy statement/prospectus and other relevant materials. INVESTORS AND SECURITY HOLDERS OF QLT AND ATRIX ARE URGED TO READ THE PRELIMINARY JOINT PROXY STATEMENT/PROSPECTUS REGARDING THE TRANSACTION AND THE DEFINITIVE JOINT PROXY STATEMENT/PROSPECTUS, WHEN IT BECOMES AVAILABLE, AS WELL AS OTHER RELEVANT MATERIALS BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT QLT, ATRIX AND THE TRANSACTION. The preliminary joint proxy statement/prospectus on file with the SEC and the definitive joint proxy statement/prospectus and other relevant materials (when they become available), and any other documents filed by QLT or Atrix with the SEC, may be obtained free of charge at the SEC's web site at www.sec.gov/. The definitive joint proxy statement/prospectus and other relevant materials (when they become available) will be mailed to stockholders of QLT and Atrix in advance of the special meetings to consider the transaction. In addition, investors and security holders may obtain free copies of the documents (when they are available) filed with the SEC by QLT by directing a request to: QLT Inc., Attn: Investor Relations, 887 Great Northern Way, Vancouver, BC, Canada, V5T 4T5. Investors and security holders may obtain free copies of the documents filed with the SEC by Atrix by contacting Atrix Laboratories, Inc., Attn: Investor Relations, 2579 Midpoint Drive, Fort Collins, CO, 80525.
QLT, Atrix and their respective executive officers and directors may be deemed to be participants in the solicitation of proxies from the stockholders of QLT and Atrix in favor of the transaction. Information about the executive officers and directors of QLT and their ownership of QLT common shares is set forth in the proxy statement for QLT's 2004 Annual Meeting of Shareholders, which was filed with the SEC as Exhibit 99.1 to Form 10-K/A on April 28, 2004. Information about the executive officers and directors of Atrix and their ownership of Atrix common stock is set forth in the proxy statement for Atrix's 2004 Annual Meeting of Stockholders, which was filed with the SEC on April 5, 2004. Investors and security holders may obtain more detailed information regarding the direct and indirect interests of QLT, Atrix and their respective executive officers and directors in the transaction by reading the definitive joint proxy statement/prospectus regarding the transaction when it becomes available.
Certain statements in this press release constitute "forward looking statements" of QLT within the meaning of the Private Securities Litigation Reform Act of 1995, which involve known and unknown risks, uncertainties and other factors that may cause our actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. Forward looking statements include, but are not limited to, anticipated levels of 2004 sales of Visudyne(R), those with respect to our expectation that the acquisition of Atrix will close, estimates of the post-integration guidance for the combined QLT-Atrix company of a cash EPS compound annual growth rate, those with respect to our interpretation of the released anti-VEGF (Macugen) data, and in particular our conclusion that the Phase II/III Macugen results provide no advantage over Visudyne therapy for patients with AMD, our predictions or comments as to the safety and efficacy of Macugen, and our predictions of the effect that the data now available on Macugen may have on treatment decisions made by retinal specialists. These statements are only predictions and actual events or results may differ materially. Factors that could cause such actual events or results expressed or implied by such forward looking statements to differ materially from any future results expressed or implied by such statements include, but are not limited to: data not available to us concerning Macugen may lead us to different conclusions or cause our expectations to change, our competitive position may change in the future, the risk that future sales of Visudyne may be less than expected, our future operating results are uncertain and likely to fluctuate, currency fluctuations in our primary markets may impact our financial results, uncertainty of and timing of pricing and reimbursement may limit the future sales of Visudyne, the risk that the proposed merger with of Atrix will not be successfully completed or that the businesses will not be successfully integrated, the risk that, if the merger proceeds, risk factors relating to the business or products of Atrix will impact the combined company's results, our clinical development programs may not be successful or regulatory approvals not obtained in the United States and other factors described in detail in QLT's Annual Information Form 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 our current expectations and QLT is not obligated to update such information to reflect later events or developments.