Looks like the FDA review got pushed back a day (appears to be same report you posted -- sorry for the screwed up formatting):
Reuters news report:
FDA Panel to reveiw Eye Disease Treatment Wednesday
By Lisa Richwine
WASHINGTON, Nov. 16 (Reuters) - Federal advisers on
Wednesday are set to review a treatment developed by a unit of Switzerland's Novartis AG NOVZn.S and Canada's QLT PhotoTherapeutics Inc. QLTI.O QLT.TO for a leading cause of blindness in the elderly.
The firms will present data to a U.S. Food and Drug Administration advisory committee on Visudyne, a treatment for age-related macular degeneration (AMD). The committee's support is crucial because the FDA usually follows its panels' advice.
Pharmaceutical industry analysts said Visudyne's approval is considered vital for Canadian biotech firm QLT, which specializes in light-activated therapies. It also could prove important for Novartis, which would split revenues that analysts said would be several hundred million dollars a year.
For QLT, research on Visudyne started a decade ago when
Julia Levy, its president and chief executive officer, began
searching for a treatment for the disease that took sight from her mother and grandfather.
Personal interest aside, QLT and its investors are counting on Visudyne to make the company profitable for the first time, analysts said. QLT already sells another drug, a cancer treatment called Photofrin, but Visudyne is expected to dwarf that product, analysts said.
"It's very important," Nesbitt Burns analyst Christine Charette said of Visudyne. "This drug is QLT."
Visudyne also could bring substantial revenue to Novartis, said Mehta Partners analyst Sergio Traversa. The company has called the drug, developed by its CIBA Vision Corp. unit, one of its key prospects for the next two years.
"For Novartis, it's not so fundamental (as it is for QLT)," Traversa said. "But it's still fundamental. It could have several hundred million (dollars) in peak sales."
AMD is the leading cause of blindness among people over age 50 in the industrialized world. It is caused by the growth of abnormal blood vessels across the central part of the retina that can leak and erode vision.
The companies are seeking approval for Visudyne to treat
the more severe type of the disease, which they said strikes
about 500,000 people worldwide.
The treatment comes in two parts. First, the drug is injected into a patient's arm. Then, the drug is activated by shining a non-thermal laser on the patient's eye.
REUTERS
Rtr 11:05 11-16-99
Copyright 1999, Reuters News Service
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