By Andy Georgiades
Of DOW JONES NEWSWIRES
TORONTO (Dow Jones)--Rumors that QLT Inc. (QLTI) may be required to conduct
a second clinical trial before it can significantly expand the label of its
flagship drug took a bite out of the company's stock price Thursday, an
analyst said.
As reported, QLT announced in February that Visudyne, the only treatment
available for wet age-related macular degeneration (AMD), a leading cause of
blindess in the elderly, showed efficacy after 24 months against the "occult"
form of the disease. To date, Visudyne is only approved for the "classic"
form.
Analysts estimated that an expansion into the "occult" form of AMD would
double patient population that Visudyne could address.
At the time of the announcement, QLT's president and chief executive, Julia
Levy, assured investors that the U.S. Food and Drug Administration would
accept the data. But without any updates on talks with the the FDA, investors
may be starting to worry the regulator will ask QLT to perform a second trial.
"People were looking for some color on the timeline on the filing for the
occult indication, and whether or not a second trial would be required,"
Navroze Alphonse, analyst at Leerink Swann & Co., told Dow Jones. "I think
most of Wall St. had estimated that it would not."
Because Visudyne serves an unmet medical need, QLT probably thought it could
bypass a second trial, Alphonse said. "I think you may see some people's
expectations being tapered down a little bit based on that," he said.
But until the company says something, investors will continue to speculate,
he added. "The company hasn't come out and confirmed it or denied it," he
said, and this silence itself could be hurting the stock.
Officials at QLT weren't immediately available for comment.
At the company's annual meeting last month, QLT had little to report about
ongoing discussions with the FDA.
"It would be a considerable delay in the label expansion efforts. Some
people were thinking by 2002 they could have the expansion. Now it wouldn't be
till '04" if the rumors are correct, Alphonse said.
In Toronto Thursday, QLT fell C$6.17, or 14%, to C$36.63, on about 865,100
shares.
Company Web Site: qltinc.com
-Andy Georgiades, Dow Jones Newswires; 416-306-2031 |
