Friday February 11, 2:09 pm Eastern Time
QLT gets FDA pre-approval for anti-blindness drug
TORONTO, Feb 11 (Reuters) - QLT PhotoTherapeutics Inc. (Toronto:QLT.TO - news)(NasdaqNM:QLTI - news) said on Friday that it had received an approvable letter for its Visudyne treatment for age-related macular degeneration from the U.S. Food and Drug Administration indicating that the agency intends to approve the treatment.
''We are pleased that there are no major outstanding issues raised in the FDA's letter or issues requiring additional clinical trials,'' QLT Chief Executive Julia Levy said in a statement.
''As always we intend to work closely with the agency as it completes its review,'' she said, adding that QLT doesn't anticipate any major delays prior to the approval.
''This is the event the market was looking for...some people were worried that since this was the last day and we hadn't heard yet, maybe they weren't going to get it,'' said Duncan Stewart,
The shares fell as much as C$8.50 to C$92.50 on the Toronto Stock Exchange on Friday morning before being halted, but recovered to C$98 in mid-afternoon to be down C$3 on the day.
Analysts are divided on exactly how large the U.S. market for Visudyne is. However, about 200,000 new cases of AMD are reported there annually, and another 300,000 in the rest of the world.
''I would see $120 for the stock over two or three days here...we believe the market to be half a billion to a billion dollars per year,'' added Stewart.
Visudyne therapy is a two-step treatment for the wet form of age-related macular degeneration, the leading cause of blindness for people over the age of 50 in the western world.
In November the FDA's Ophthalmic Drugs Subcommittee lent support to QLT's Visudyne treatment, urging the FDA to look closely at long-term studies of the treatment, which it had concluded was safe and effective for treating the most severe forms of the disease.
In mid-December Switzerland became the first country to approve the sale of Visudyne, which QLT developed in conjunction with a unit of the Swiss healthcare firm Novartis AG .
The treatment is pending regulatory approvals in Canada, Norway, Iceland, Australia, New Zealand and the European union.
($1=$1.45 Canadian) |
