The biggest advantage of Zingo is that it has a rapid onset in one to three minutes. The current topical anesthetics take up to 20 minutes to act, which means they usually don't get used in the fast-paced world of health care.
The approval was announced an unheard-of five weeks ahead of its PDUFA date - needless to say, Anesiva doesn't have its commercialization plan ready, and it couldn't comment on when the launch would take place. The company plans to start by targeting hospitals where children have chronic problems that require multiple IV insertions or blood draws.
Anesiva should be able to target that market fairly well, but the bigger question is whether it can expand into the estimated 18 million routine pediatric procedures. The drug device is a little more expensive than a typical drug, and the hospitals may not want to increase costs for routine procedures. Nevertheless, Anesiva is in talks with other companies to develop U.S. partnerships in order to target the 1,200-1,300 hospitals that it can't reach with its own sales force.
Increasing the label indication to include the approximately 400 million adult procedures is just around the corner. Anesiva is conducting a 700-subject phase 3 clinical trial in adults which should complete enrolment in the third quarter. Since most of the data is available immediately after the procedure - "Did it hurt?" "No." - the results of the trial should be back relatively quickly, and a supplementary New Drug Application could be filed by the end of the year.
Approval for Zingo to expand into the larger patient population is no sign that it will be able to make money off the device. Now, granted, I've got veins close enough to the skin that the inexperienced nurse often gets called over to "practice" on me when I'm giving blood, but I just don't think that blood draws hurt that much. Maybe I'm abnormal, but if they offered me lidocaine, I think I'd just laugh at them.
Perhaps the biggest windfall in the Zingo approval is that the drug-delivery technology used in Zingo could be licensed to deliver other drugs such as insulin, Genetech 's (NYSE: DNA) human growth hormone, or Amgen 's (Nasdaq: AMGN) erythropoietin. Now that the device has been proven to work, other companies may become more interested in licensing the technology in order to decrease the pain associated with needle sticks from their drugs.
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Fool contributor Brian Orelli, Ph.D., isn't that tough since he cries every time he stubs his toe. He doesn't own shares of any company mentioned in this article. The Fool's disclosure policy donates blood regularly so that other documents may live.
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