By Alan Sverdlik
The FDA approved QLT Inc.¿s Visudyne ocular therapy for use in a younger, sparser patient population, a development that keeps the photodynamics pioneer on track for $1 billion in Visudyne sales by 2005, company officials and analysts said.
The procedure can now be used to treat the form of class subfoveal choroidal neovascularization (CNV) that occurs in people 30 and older. The drug was approved in the U.S. in April 2000 for wet age-related macular degeneration, another form of CNV.
¿These are patients who are still in the work place, who are still raising a family and still have many years ahead of them,¿ said Elayne Wandler, QLT¿s director of corporate communications. ¿They face a progressive loss of vision, and it¿s devastating.¿
Mark Schoenebaum, a biotechnology analyst with CIBC World Markets, said the regulatory approval would ¿accelerate Visudyne sales for the rest of the year¿ and help the product reach CIBC¿s US$158 million U.S. sales target for 2001, up from US$65.5 million for the part of 2000 it was on the market. Sales outside the U.S. are projected to be $86 million this year, up from $33 million last year.
Considering that ¿the competition is pretty immature and there¿s such a potentially large market, you could see sales in the billion-dollar range in 2005 to 2007,¿ he said.
There are two basic categories of CNV.
Last year, the FDA approved Visudyne for CNV patients with wet age-related macular degeneration, or AMD, a condition seen in those aged 50 and older. There are approximately 500,000 such cases every year worldwide, Wandler said. The second category is CNV caused by pathologic myopia, or severe nearsightedness, and ocular histoplasmosis syndrome. About 50,000 cases in that category are reported every year in people between 30 and 50, the target group of QLT¿s new approval.
QLT, of Vancouver, British Columbia, developed Visudyne, a two-step procedure that can be performed at a doctor¿s office, in collaboration with Atlanta-based Novartis Ophthalmics, the eye health unit of Novartis AG, that began in 1995. Under the terms of the partnership, Novartis paid 60 percent of Visudyne¿s development fees to QLT¿s 40 percent, with the partners sharing any profits equally.
Between April 2000 and April 2001, Visudyne¿s sales were US$150 million, Wandler said. In the second quarter of this year, sales were $56 million, a 120 percent increase over the same period in 2000, she said.
Wandler said Visudyne could generate $1 billion in sales by 2005 if it can overcome the clinical hurdles ahead. One of those hurdles, she said, is a trial scheduled for the fourth quarter. In that study, QLT will test Visudyne¿s efficacy in treating occult AMD, which is characterized by fluid that seeps out of the eye. About 200,000 cases of occult AMD are reported every year, she said. Predominantly classic AMD, of which there are 125,000 cases every year, occurs when fluid ¿gushes out, like a geyser.¿
Minimally classic AMD¿s leakage, with 175,000 cases annually, is not as severe as the predominantly classic strain, nor as mild as occult.
Schoenebaum said the trial of the occult indication would be a repeat, or confirmatory, trial of one already conducted by QLT in which Visudyne met the primary endpoint of ¿visual acuity.¿ He said the FDA, being extra careful, wanted another trial because of the large potential size of the market.
¿Millions of people have lost their vision from this disease,¿ Wandler said. ¿We can¿t go back and help them. What we can do is stabilize levels of vision in people¿ with the various indications.
Visudyne is injected intravenously into a patient¿s arm. A nonthermal 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, nonthermal 689 nm light required to activate the drug.
QLT¿s trademark technology, which it uses in many of its treatments, is known as photodynamic therapy, which uses light to activate drugs.
The company¿s pipeline also includes photodynamic therapy with verteporfin for non-melanoma skin cancer, and tariquidar (formerly XR9576), which was licensed in last week from Xenova Group plc, for non-small-cell lung cancer. Both are headed into Phase III trials next year, Wandler said.
The company reported net income of $12.56 million, or 19 cents a share, for the six-month period that ended June 30. Net income for the second quarter was $4.3 million, or 6 cents a share.
QLT¿s stock (NASDAQ:QLTI), closed Thursday at $21.29, up 36 cents.