John, No sweat. I just didn't want you to waste any effort looking for a program on CNBC which is going to be on CBC's Cable channel.
Nice coverage in today's NationalPost.
canoe.ca
Saturday, January 9, 1999
QLT PhotoTherapeutics eyes a blockbuster
A new drug to treat a disease of the retina may bring this biotech company into billion-dollar sales territory
By JOHN GREENWOOD
The Financial Post
Nearly two decades after the biotechnology industry was born, only a handful of companies have succeeded in fulfilling their early dreams of fabulous wealth. Vancouver-based drug developer QLT PhotoTherapeutics Inc. appears set to join that exclusive group.
Early last week QLT released results of clinical trials of its most promising drug, a potentially breakthrough treatment for something called age related macular degeneration, a leading and largely untreatable cause of blindness worldwide.
To a layman, the findings were hardly dramatic. According to the company, of the 609 patients in the study, 61.4% of those on the drug, called Visudyne, experience stabilization or improved vision, compared to 45.9% of patients given a placebo. Furthermore, the company extrapolated, patients on Visudyne were 34% more likely to retain their vision than patients taking the placebo.
Nonetheless, industry analysts and the medical community were overjoyed, describing the event in terms rarely heard in this country. "Certainly Visudyne is being tossed around as a potential blockbuster, the numbers are there," said Michael Lorimer, an analyst at ScotiaMcleod Inc. (A blockbuster in industry parlance is a drug with more than $1-billion in annual sales.) "This is a huge success story," said Ezra Lwowski, a normally low-key analyst at Yorkton Securities Inc.
On Tuesday, when results were announced, QLT's share price shot up 25%, and unlike other biotech companies whose shares soar on the strength of positive news and then settle back, QLT has kept on climbing. Yesterday it closed in Toronto at a record high of $47, up a whopping 37% since Monday's close. Investors apparently believe there's more good news to come.
One reason for the optimism is that QLT is likely to be the first company to come out with an effective therapy for what is a devastating disease that has stubbornly resisted attempts to find a cure. AMD is a disease of the elderly; most sufferers are in their sixties and seventies. It starts off as a thinning of one of the layers of the retina. That phase is called dry AMD. Eventually, about 10% to 15% of those cases develop into what's called wet AMD, where the bottom retinal layer becomes so atrophied it cracks, allowing the growth of abnormal blood vessels. Within five years (usually less) nearly all people who develop the wet form of the disease are legally blind.
Most of the time "there is really nothing you can do," says Patricia Harvey, a doctor at The Toronto Hospital and a leading retinal specialist who took part in the Visudyne trial. "We provide them with visual aids like magnifiers and software programs that allow them to read text on a computer screen, but that doesn't change visual acuity, it just helps them to use what they've got a little better."
QLT's drug is good only against the wet form of the disease. But that's still a potentially huge market with about 500,000 new cases worldwide every year, 200,000 of them in North America, according to the company. Even though it appears Visudyne is effective in a fraction of cases, it represents the only option available.
So if the drug is approved, analysts expect a high proportion of suffers to try the therapy. (At least in rich countries; neither the company nor its licensee CIBA Vision have released pricing information, but analysts speculate that a full treatment regimen will cost about $5,000 US.)
Visudyne, which is derived from pigs' blood, is part of a new generation of photodynamic, or light-activated drugs, that are injected into the patient and then migrate to the afflicted part of the body. In this case, within about 15 minutes, the drug collects in the cells of the abnormal blood vessels in the retina. The patient then undergoes a 90-second procedure in the ophthalmologist's office with a laser. Activated by the light, the Visudyne produces oxygen singlet, a toxin that rapidly kills the cells in the abnormal blood vessel. Only harmful tissue is killed and there is no scarring.
The drug is at least a year away from market approval, but some analysts are already predicting that it will have a major impact with sales in the hundreds of millions of dollars, perhaps even topping $1-billion, a year. At the other, more conservative end of the spectrum are those like Yorkton's Mr. Lwowski, who's calling for sales of $330-million (US) three years out.
Visudyne appears likely to live up to its billing. First, it has virtually no competitors. Though some AMD cases can be treated by thermal laser, Visudyne appears to be the only safe treatment candidate applicable to nearly all cases of wet AMD.
Second, the trial results may be a lot better than they appear. Observers say that while people with AMD do sometimes experience episodes where the disease appears to go into remission, they never last. If the trials tracked patients over five years instead of just 12 months, the disease would have taken its natural course in the patients receiving the placebo. Still, even QLT doesn't know how many times patients must be treated before the disease is halted, or even whether the halts are permanent.
Julia Levy, the company's president and chief executive, is confident that won't be a problem. "We have been saying for the past six months that this has huge breakthrough potential," she says.
Observers agree that sales will take time to ramp up, as doctors acquire the laser machines and become comfortable with the technology. At about $40,000 (US) each, the lasers are expensive pieces of equipment, but if the drug is approved a sufficient number of doctors is expected to make the investment.
With QLT poised to hit the big time, Dr. Levy is feeling proud -- and more than a little amused, given the drug that is causing all this fuss was only recently given the auspicious name Visudyne. Back in the '80s, when Dr. Levy and a colleague discovered it, it was simply called "Green Stuff."
QLT was founded in 1981 at the dawn of the biotechnology revolution by a group of scientists from the University of British Columbia who were frustrated at the lack of government funding available for their projects. By starting a company, they hoped to solve the problem themselves. "It wasn't at all focused, as a lot of [biotech] companies at the time weren't," she recalls.
But they did have some good ideas. In the mid-'80s, QLT attracted the attention of New Jersey-based drugs giant American Cyanamid (now a subsidiary of American Home Products Corp.), which agreed to inject $19-million into the company. It used part of the money to acquire the rights to Photofrin, another photodynamic drug being developed as a treatment for cancer. It was further along in development than Visudyne and therefore would allow the company to generate revenue much sooner than by simply relying on Visudyne.
Though it still has promise, Photofrin never quite lived up to early expectations. When Health Canada approved it in 1993 for the treatment of bladder cancer, it became the first photodynamic drug to make it onto the market anywhere in the world.
Photofrin was later okayed in the U.S., Europe, and Japan, for lung cancer and oesophageal cancer. But approvals came fitfully (it was only in December that the FDA gave QLT the go-ahead to market the drug for early stage lung cancer). And doctors haven't exactly been beating down the door at QLT to get at supplies. In 1997, total sales of Photofrin amounted to just $4.8-million.
In QLT's defence, observers say Photofrin (also made from pigs' blood) was a first-generation product. Plus it's a radically new way of treating cancer, requiring oncologists to learn new techniques and to take chances. That's a lot to ask, especially when there are plenty of traditional alternative treatments around.
But the company isn't giving up hope. Phase 3 trials for Photofrin as a treatment for Barretts oesophagus are expected to wind up later this year and more approvals are expected.
Among investors and industry analysts, however, the attention is focused on Visudyne. For once, a biotechnology product appears set to achieve one of the key goals of the biotech industry, to provide a remedy for a major disease.
Of the thousands of biotech drugs being developed in North America, only about 100 have actually made it onto the market. Of that group, only a handful have achieved blockbuster status. So far, Laval, Que.-based BioChem Pharma Inc. is the only Canadian biotech to achieve success on that scale.
Last year, BioChem's AIDS drug 3TC had sales of about $980-million -- more than all other Canadian biotech companies combined.
Now for the first time, it seems BioChem Pharma is about to see some real competition.
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