It took Canada's National Post 2 days to pick up the story, but they did a reasonable job.
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canoe.ca
For Friday, April 14, 2000
QLT achieves milestone with eye drug in U.S.
Eight years of research
By DREW HASSELBACK
The Financial Post
VANCOUVER - After eight years of research and $200-million worth of development, QLT PhotoTherapeutics Ltd. has received approval to sell its anti-blindness drug Visudyne in the United States, a milestone in obtaining the company's goal of marketing the most successful eye medication in history.
Marketing approval from the U.S. Food and Drug Administration means QLT is now able to sell Visudyne in the United States, where about 180,000 new cases of "wet" age-related macular degeneration or "AMD" are reported each year.
QLT officials said yesterday they believe the company is on track to sell $1-billion worth of Visudyne to patients around the globe within three years.
Julia Levy, QLT's chief executive, got the word late Tuesday that the U.S. regulator was close to making a decision, beginning an agonizing wait by the telephone that finally ended late Wednesday when word of a positive response came from Washington.
"It was the longest day," Ms. Levy said yesterday,
QLT will split half its profits from the drug with marketing partner CIBA Vision, the eye-care unit of Swiss pharmaceutical giant Novartis Inc.
QLT says its share of the profits will be enough to make the Vancouver company profitable by the fourth quarter.
AMD is the leading cause of blindness in people over 50. Until Visudyne came along, opthalmologists had to treat AMD by using lasers to burn through the layers of the retina to treat leaking blood vessels causing the illness. Even then, only 10% of cases were treatable. Visudyne involves injecting dyes into the patients' bloodstreams which are then activated by lights. This doesn't require burning through the retina, and doctors say they now can treat about 40% of patients with AMD.
"It's a treatment breakthrough because no other treatment thus far has been able to kill the tissue that's been deep in the retina without damaging the upper layers," said Patricia Harvey, a retinal specialist in Toronto who has 500 patients on a waiting list to use Visudyne. The drug costs about $2,000 to $2,500 (U.S.) per treatment.
But Canadian sufferers of the disease will have to wait a bit longer before using the new drug. QLT said it does not expect to receive Canadian marketing approval until the second half of the year.
"We're hoping that within the next two or three weeks, Canada will come up with a plan to treat patients," Dr. Harvey said.
QLT was formed in the early 1980s, but didn't begin research on age-related blindness until late 1992. The company began by looking at whether it could close blood vessels in the eyes of rabbits and primates. By December, 1995, the company received FDA approval to begin clinical trials on humans.
"That's really pretty fast. I think it reflects the unmet medical need in this condition," Ms. Levy said. "The awareness is higher."
Clinical trials continued until about a year ago. Last summer, QLT bundled the documentation associated with its test results into 300 thick binders and sent them to the FDA in Washington. Last December, the Swiss government okayed Visudyne. And last February, QLT received a letter from the FDA indicating the drug was "approvable," though not yet formally approved. QLT is still waiting for marketing approvals from European regulators. which is also expected in the second half of the year.
The stock market has anticipated the U.S. approval. QLT's share price has risen 150% since last year. The stock hit a high of $121.30 in January, but fell back after the market for biotechnology stocks weakened. As news of the approval became public, QLT closed yesterday at $87.90 on the Toronto Stock Exchange, up $4.90.
This gives QLT a market cap of $5.75-billion, making it the largest biotech firm in Canada. And Visudyne's billion-dollar potential means that QLT will be only the second Canadian pharmaceutical company to have a blockbuster on its hands. Montreal's Biochem Pharma reported profit of $149-million on revenues of $290.3-million from its share of royalties on the sale of the AIDS drug 3TC.
"We will be one of the top-10 drug companies in the world," said Ken Galbraith, chief financial officer, the man who has been responsible for funding QLT's growth by raising $500-million from capital markets.
Mr. Galbraith, who has been described as a tough negotiator, is also the man that convinced Novartis to market QLT's drug in exchange for 50% of the profits. With annual revenues of about $30-billion a year, Novartis could have been in a position to ask for more.
"We fought to hold on it what we had," he said. "If you're not willing to be tough, you're going to get taken advantage of." |
