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The main goal that the FDA has required other drugmakers to achieve is improvement in the distance patients can walk in six minutes. Aires is still trying to figure out whether it needs to give its drug three times a day (not very practical for patients) or whether it can be given once a day, Johnson says. The drug is given through a nebulizer that can fit in a purse or small bag. It takes one or two minutes to administer, she says.
No one else is competing directly with an inhalable drug like this for pulmonary arterial hypertension, although Clinton, NJ-based Ikaria has an inhalable nitric oxide that’s FDA approved for premature infants with “Blue Baby” syndrome. Other companies, like United Therapeutics, Novartis, and Bayer are testing different kinds of medicines, which are further along in development. Johnson isn’t forecasting when her company’s drug might be able to run the gamut of trials needed to reach the marketplace, but when it does, she says it should be able to capture sales that run into the range of “several hundred millions” of dollars.
Johnson has said very little publicly about the company until now, partly because she wanted to make sure she had secured the technology license from the NIH lab of Mark Gladwin, who is now at the University of Pittsburgh Medical Center. “I’m not one of those people who believes you should hype up your company,” Johnson says. “We had to line up some data first in human beings,” she says.