Vanda Pharmaceuticals Inc. followed up its phase III success late last year with the schizophrenia tablet iloperidone by submitting a new drug application to the FDA. The company is using a personalized-medicine approach, partly to ensure the compound's efficacy and partly to quell any potential safety concerns - namely, problems with prolonged QT intervals, a common bugaboo in the class.
The company's stock (NASDAQ:VNDA) closed at $13.40, down 22 cents.
Prolonged QT interval (a wider stretch between the heartbeat's "Q" wave and its "T" wave) is "something the FDA thinks about quite seriously," noted Chip Clark, chief business officer for Rockville, Md.-based Vanda.
Iloperidone's QT prolongation, he said, is "within the boundaries of acceptability by the FDA, and we understand from physicians that it's not clinically relevant to them at these levels." Still, Vanda wanted to "add this layer of certainty of efficacy and/or safety," he said.
Rights to iloperidone, an atypical antipsychotic that binds to dopamine and serotonin receptors, came by way of a 2004 deal. Titan Pharmaceuticals Inc. had partnered the drug with Basel, Switzerland-based Novartis AG - where the core team at Vanda, founded in 2003, originated. Vanda's CEO Mihael Polymeropoulos founded and =an the pharmacogenetics group at Novartis for five years. (See BioWorld Today, June 10, 2004.)
By now, the much-tested compound has undergone =5 trials enrolling more than 3,000 patients. Data on markers are included with the study results in the NDA package.
"We haven't talked about what those genes are yet, only because we had been waiting for the right scientific forums, and we're getting our publications together," Clark said. Officials will be talking more about the discovered markers, and the ongoing search for more, at the American Society of Human genetics annual meeting late next month in San Diego.
"Obviously, the FDA needs to approve the label and claims that may come around genetic markers," Clark said, adding that Vanda is exploring partnerships for the development of a genetic test that could be used with iloperidone.
"For our Phase III trial, we built, with a national lab, a simple blood test," he said. "That itself, or something very much like that, is what we would expect to commercialize."
Also in its pipeline: VEC-162, in Phase III trials for sleep disorders, and =SF-173 for excessive sleepiness, in Phase II trials.
Published September 28, 2007