Biotech Values

[DewDiligence]

Visudyne reimbursed in Japan:

[Because Japan has socialized medicine, a drug or medical device can’t realistically be launched in Japan until reimbursement is obtained. Although Visudyne was approved for marketing in Japan in October, it only now received reimbursement. Also in today’s news: worldwide Visudyne sales during 1Q04 were slightly in excess of a $400M annual run rate.]

http://biz.yahoo.com/prnews/040423/to208_1.html

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QLT announces reimbursement for Visudyne(R) in Japan for treatment of age-related macular degeneration

VANCOUVER, April 23 /PRNewswire-FirstCall/ - QLT Inc. (NASDAQ: QLTI) announced that Visudyne® (verteporfin), currently the only treatment for some forms of "wet" age-related macular degeneration (AMD), was reimbursed today in Japan. Visudyne was approved by the Japanese Ministry of Health, Labour and Welfare (MHLW) in October 2003 for the "wet" form of AMD with all types of subfoveal choroidal neovascularization (CNV).

"Visudyne therapy is the first approved drug treatment for this devastating condition and we are very pleased to now be in a position to make this therapy available to the Japanese marketplace," said Paul Hastings, President and Chief Executive Officer of QLT Inc. "This is another major milestone in making Visudyne therapy available to improve the lives of so many people on a worldwide basis."

Approval was based on the results of a well-designed 12-month clinical study conducted in Japan, which confirmed the efficacy and safety profile of Visudyne as demonstrated in 3 large randomized controlled trials conducted in the rest of the world. In fact, approximately 3 patients out of 4 participating in this study either maintained or improved their vision as a result of Visudyne therapy. [That’s roughly in Macugen’s league, where 70% of the patients in the phase-3 trials had maintained or improved vision. But it’s not even close to Squalamine’s phase-1/2 results, where *100%* of patients had maintained or improved vision.] Visudyne was evaluated in Japan as a therapeutic drug for the wet form of AMD following its designation as an orphan drug in June 1997.
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