Excellent news out of QLT tonight, here's hoping it continues tomorrow.
In afterhours on NASDAQ, QLTI's last trade so far was at $28.75 up almost $3 from the 4PM close.
Replay of clinical data conference call available at: streetevents.com or 416 626 4100 17863574#
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Favorable Visudyne Clinical Results Announced for Occult AMD and Pathologic Myopia Patients Novartis Ophthalmics, the eye health unit of Novartis AG,and QLT Inc. announced February 7, 2001 top-line results that showed Visudyne(TM) therapy reduces the risk of vision loss in a new population of patients with wet age-related macular degeneration (AMD).
The results were from a multi-center phase IIIb randomized placebo- controlled study, called the VIP (Verteporfin In Photodynamic therapy) trial in which most patients had lesions composed of occult subfoveal choroidal neovascularization (CNV) without classic components. "Occult" and "classic" are terms used to describe different patterns of CNV leakage as seen on fluorescein angiography. Visudyne is currently approved for the treatment of patients with predominantly classic subfoveal CNV caused by AMD, the leading cause of severe vision loss in people over the age of 50. In addition, the results also confirmed the benefits of Visudyne therapy at 24 months in the treatment of CNV due to pathologic myopia, for which regulatory approval is pending in North America and Europe.
"Results from this new study are extremely important because they demonstrate that Visudyne therapy can reduce the risk of moderate to severe vision loss in a large number of patients each year for whom, previously, there was no proven treatment," said Dr. Neil Bressler, retinal specialist and Chair of the Visudyne Study Advisory Group. Dr. Bressler is also the James P. Gills Professor of Ophthalmology at the Wilmer Eye Institute of the Johns Hopkins University School of Medicine in Baltimore, Maryland.
"These results represent a significant milestone in our efforts to expand the use of Visudyne so that most patients with wet AMD can one day benefit from Visudyne therapy," said Dr. Julia Levy, President and Chief Executive Officer of QLT. "We plan to consult with regulatory authorities to determine how best to proceed from a regulatory and clinical standpoint."
"Visudyne has already gained a wide acceptance around the world having received regulatory approval in 31 countries," said Luzi von Bidder, Head of Novartis Ophthalmics. "With respect to this new information, we will work aggressively, to make this therapeutic advance available to this new patient population as quickly as possible."
A complete analysis of the results is currently underway. Further details will be submitted for publication in a peer-reviewed medical journal and presented at the Association for Research in Vision and Ophthalmology (ARVO), to be held April 29 to May 4, 2001, in Fort Lauderdale, Florida.
Study Details - Overall AMD Population:
The following results are based on 339 AMD patients treated at 28 centers throughout North America and Europe over a period of 24 months. Twelve-month results were announced in March 2000.
The entire population included mainly patients with occult CNV without classic components, plus some patients with a component of classic CNV and with vision better than 20/40. At the 24-month examination, 46% of those patients treated with Visudyne therapy lost less than 3 lines of vision, or 15 letters, on a standard eye chart (moderate vision loss) compared to 33% of patients on placebo (p=0.023). The difference of 13% between the treated and placebo group is statistically significant and higher than the 4% difference (p=0.51) seen at 12 months. With respect to severe vision loss, 70% of Visudyne treated patients lost less than 6 lines of vision, or 30 letters, on a standard eye chart versus 53% of patients on placebo, a difference of 17% (p=0.001). Again, this result is higher than the 8% difference (p=0.14) seen at 12 months. At the 24-month time point, Visudyne also showed statistically significant outcomes for other visual acuity endpoints.
The trial also reconfirmed Visudyne's favorable safety profile as no new safety concerns were identified during the second year of treatment. As reported earlier, 4gwof patients experienced a severe vision decrease within 7 days of treatment, which was transient in some of these cases. The most frequently reported adverse events attributed to the treatment were injection site events and visual disturbances. Photosensitivity reactions were infrequent, occurring in only 1% of study patients.
On average, patients treated with Visudyne received five treatments during the 24-month period.
Subgroup Analysis
In those patients with occult CNV without classic components, who comprised approximately 75% of patients enrolled in the study, results were found to be similar to those achieved in the overall population. At 24 months, a difference of 14% was found between the treatment and placebo groups with respect to the avoidance of moderate vision loss (Visudyne 45% vs placebo 31%;p=0.03). Additionally, an 18% difference between treatment groups was found with respect to the avoidance of severe vision loss (Visudyne 71% vs placebo 53%;p=0.004). This compares to differences between treatment groups of 4% (p=0.51) and 10% (p=0.07) seen at 12 months for moderate and severe vision losses, respectively.
While additional subgroup analyses are ongoing, preliminary results suggest that the benefit of Visudyne therapy is greatest in patients presenting with relatively small lesions or lower levels of visual acuity (an approximate Snellen equivalent of less than 20/50 on a standard eye chart). This subgroup comprised about 70% of study patients with occult CNV without classic components. Visudyne therapy may not be beneficial for individual patients presenting with both large lesions ()4 disc areas) and good visual acuity (approximately 20/50 or better).
Additional Study Results About CNV due to Pathologic Myopia
Also reported were two-year results from a separate Phase IIIb multi- center randomized placebo-controlled study involving 120 patients with a similar but distinct condition referred to as CNV due to pathologic myopia. In the primary analysis performed at 12 months, it was found that patients showed a definite benefit from Visudyne therapy with respect to the primary endpoint. Specifically, 86% of Visudyne treated patients lost less than three lines of vision, or 15 letters, on a standard eye chart, compared to 67% of patients administered a placebo (p=0.01). The percentage difference dropped over the second year from 19% to 7% in favor of Visudyne (p=0.38). However, the percent of patients who showed an improvement in vision after treatment with Visudyne was much higher than placebo. Forty percent of Visudyne treated patients gained one or more lines of vision versus 13% of those treated with placebo (p=0.003). Furthermore, 12% of patients treated with Visudyne experienced an increase of three or more lines of vision compared to 0% of those on placebo (p=0.03).
"When the results are viewed in their entirety, the 24-month visual acuity data indicate a treatment benefit that is important to patients with CNV due to pathologic myopia," said Dr. Bressler. "Until now, this group of younger patients had very little hope of preserving vision -a devastating proposition given that the vast majority are in the prime of their careers and often have active family lives."
During the two-year period, Visudyne treated patients received an average of five treatments. No new safety concerns were found.
Background Information:
About Age-Related Macular Degeneration (AMD)
AMD is the leading cause of blindness in people over the age of 50 and is caused by a growth of abnormal blood vessels (choroidal neovascularization or CNV) under the central part of the retina or macula. The vessels leak fluid and cause scar tissue that destroys central vision, resulting in a deterioration of sight over a period ranging anywhere from two months to three years. Although the wet form (the form Visudyne is used to treat) represents an estimated 15% of all AMD cases, it accounts for approximately 90% of the severe vision loss associated with the diseases. Worldwide, approximately 500,000 new cases of wet AMD occur each year and this estimate is expected to grow dramatically as the population ages.
About CNV due to Pathologic Myopia
CNV due to pathologic myopia is caused by abnormal blood vessels that grow under the center of the retina as a result of an abnormal elongation of the back of the eye associated with severe near-sightedness or myopia. It generally occurs among people over 30 years of age and can result in a progressive loss of vision for which there were no proven treatments. The worldwide incidence of CNV due to pathologic myopia is estimated to be 50,000 new cases per year, excluding Asia where the incidence may be even greater due to a higher prevalence of pathologic myopia.
About Visudyne therapy
Visudyne therapy is a two-step procedure that can be performed in a doctor's office. First Visudyne is injected intravenously into the patient's arm. A non-thermal laser light is then shone into the patient's eye to activate the drug. Visudyne therapy uses a specially designed laser that produces the low level, non-thermal 689nm light required to activate the drug. These lasers have been developed by two of the world's leading laser companies, Coherent Inc. (Nasdaq: COHR), based in California, and the Carl Zeiss group, based in California. Visudyne therapy has already been approved for commercial use in 31 countries for the treatment of patients with predominantly classic subfoveal CNV caused by AMD, the leading cause of blindness in people over the age of 50. Visudyne is generally well tolerated and has a favorable safety profile. Potential side effects include injection site reactions, headaches, blurring, decreased sharpness and gaps in vision, and, in 1-4% of patients, a substantial decrease in vision with partial recovery in many patients. Patients must follow an appropriate light- protection period as specified in the package insert. People with porphyria should not be treated.
Visudyne therapy is being co-developed for various ocular conditions by Novartis Ophthalmics and QLT Inc. Novartis Ophthalmics markets the product worldwide while QLT is responsible for manufacturing. Visudyne therapy is protected by a series of U.S. and foreign-issued patents on composition of matter, formulations and manufacturing, and the method of use in treating AMD and other conditions. For more information, including full prescribing information, visit www.visudyne.com.
The foregoing press release contains forward-looking statements that can be identified by terminology such as "intends," "expected," "potential," or similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. Such factors include, but are not limited to: risks associated with the commercialization of Visudyne(TM) including patient and physician demand for the treatment; dependence on corporate relationships; manufacturing uncertainties; uncertainty of pricing and reimbursement; uncertainties relating to clinical trials and completion of analysis of the trials discussed in this release and product development; outcome of litigation claims; QLT Inc.'s history of operating losses and uncertainty of future profitability; competition; QLT Inc.'s rapid growth; uncertainty regarding patents and proprietary rights; product liability claims and insurance; no assurance of regulatory approval; government regulation; QLT Inc.'s uncertainty of access to capital; anti- takeover provisions; and volatility of common share price; among others, all as described in QLT Inc.'s Annual Information Form on Form 10-K and recent and forthcoming quarterly reports on Form 10Q, Novartis AG's Form 20-F on file, and other filings with the U.S. Securities and Exchange Commission.
Background on Novartis Ophthalmics and QLT
With worldwide headquarters in Bulach, Switzerland, Novartis Ophthalmics is a global leader in research, development and manufacturing of leading ophthalmic pharmaceuticals that assist
in the treatment of glaucoma, age- related macular degeneration, cataracts, ocular allergies and other diseases and disorders of the eye. Novartis Ophthalmics products are available in more
than 110 different countries. The North American headquarters is based in Atlanta, Georgia. Novartis Ophthalmics has production sites in Switzerland, France and Canada.
Novartis is a world leader in healthcare with core businesses in pharmaceuticals, consumer health, generics, eye-care, and animal health. In 1999, the Group achieved sales of CHF 25.4
billion (USD 16.9 billion) (excluding subsequently divested businesses) and invested approximately CHF 3.6 billion (USD 2.4 billion) in R&D. Headquartered in Basel, Switzerland, Novartis
employs about 66,000 people and operated in over 140 countries around the world. For further information please consult www.novartis.com.
QLT Inc. is a world leader in photodynamic therapy, a field of medicine utilizing light-activated drugs in the treatment of disease. QLT's innovative science has developed and
commercialized breakthrough treatments utilizing this technology for applications in ophthalmology and oncology and is exploring the potential in immune disorders. |
