Silicon Investor (SI) -- The First Internet Community

STOCKTALK

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor. We ask that you disable ad blocking while on Silicon Investor in the best interests of our community. If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.

Biotech / Medical : QLT PhotoTherapeutics (QLTI) -- Ignore unavailable to you. Want to Upgrade?

To: Ian@SI who wrote (1227)	8/24/2001 6:37:57 AM
From: Andras	Read Replies (1) \| Respond to of 1321

QLT drug gains approval for two more uses Successful FDA testing expands market for Vancouver company's lead product: Visudyne eye treatment..from today's Financial Post VANCOUVER - QLT Inc. announced yesterday its blindness drug has been approved by the U.S. Food and Drug Administration for the treatment of two more eye diseases. Vancouver-based QLT said it received word from the FDA late Wednesday that Visudyne had received approval for the treatment of pathologic myopia and ocular histoplasmosis, of which there are collectively about 60,000 new cases a year in the United States. QLT believes the new approvals could increase the size of the market for Visudyne -- its lead product -- by as much as 40%. "For the first time, patients who would otherwise face progressive loss of vision now have an effective treatment option," said Julia Levy, QLT's chief executive. Vicudyne was launched in the U.S. last year and is being marketed in most of the world by Novartis AG of Switzerland. The drug has been approved in more than 50 countries for the treatment of wet age-related macular degeneration, the leading cause of blindness among the elderly. People with the condition develop abnormal blood vessels in their retinas. Within a few years most go blind. QLT's treatment takes about 20 minutes to administer. After injecting Visudyne into the patient's arm, the doctor uses a laser to "activate" the drug in the abnormal blood vessels of the eye. Before Visudyne's U.S. launch, some analysts predicted it would quickly become a blockbuster with sales close to $1-billion, and QLT's shares jumped as high as $120. But early sales were lower than expected, and shares have since lost more than three-quarters of their value, prompting some shareholders to accuse the company of over promoting itself. Yesterday the stock closed at $33.20, up 80¢. In the second quarter of 2001, QLT said worldwide sales of Visudyne were $86.7-million, up 17% over the first quarter. QLT and Novartis have adopted a strategy of trying to expand the number of approvals for Visudyne as a way to boost sales. So the drug's biggest approval is for the classic form of AMD, of which there are about 125,000 new cases each year, according to the company. Elayne Wandler, a spokeswoman for QLT, said the next big milestone is the approval of Visudyne for what is known as the occult form of AMD, which afflicts an even larger group. There are about 200,000 new cases worldwide every year, according to the company. But in the spring, QLT had a setback: The FDA said it would need to see more test results before it could issue the approval. "They asked us to do a second trial to confirm [our earlier] positive results and that will start in the fourth quarter," Ms. Wandler said. If the all goes well and the regulator is satisfied with the new information, Visudyne could receive approval for occult AMD as early as 2004. "That will double the size of the market," Ms. Wandler said. Meanwhile, QLT and its marketing partner are exploring other areas in which their product could be used. For instance, earlier this year the two companies announced the start early next year of Phase 3 trials of Visudyne for treatment of skin cancer. Ms. Wandler said regulatory approval is key for its blindness drug because most of the market is made up of elderly people. And in the United States -- by far the most important market -- the cost of prescription drugs for people over 65 is covered by the government. But the government plan only covers treatments that have approved by the FDA for specific conditions. In other words, while doctors may legally prescribe Visudyne for conditions for which it has not been specifically approved, the government will not cover the cost. Ms. Wandler said that is a major deterrent for some patients who might benefit from the treatment. Happy investing, andras