Vanda Pharmaceuticals (NASDAQ:VNDA) released its third-quarter financial results last week. Quarterly financial announcements aren't the most exciting for drugmakers without any marketed products, but Vanda set the stage in the third quarter for an eventful 2008.
In late September, Vanda submitted a New Drug Application with the FDA for its lead drug, iloperidone, which has an interesting history bouncing around from one pharma to the next. Vanda acquired the atypical antipsychotic from Novartis (NYSE:NVS).
Assuming that the FDA accepts Vanda's marketing application, a regulatory decision on iloperidone for schizophrenia is expected around August. If all goes according to plan, Vanda has guided for a January 2009 U.S. launch of the drug, but this obviously depends on the FDA and any possible marketing partnerships for the drug.
The January 2009 marketing launch sounds aggressive. As GlaxoSmithKline's (NYSE:GSK) CEO stated a few weeks ago on the company's conference call, four out of five New Drug Applications these days are getting hit with an approvable letter at the FDA, meaning the agency wants the company to provide more information. Considering the tightened regulatory environment at the FDA, investors would be wise to prepare for such a hiccup.
Vanda forecast that it would end 2007 with $85 million to $90 million in cash and investments, which is expected to last a little past the middle of 2008. If there are any delays with iloperidone, this cash position is going to be a vital lifeline for Vanda's pipeline development. More phase 3 results on Vanda's insomnia treatment, VEC-162, are expected by the end of 2008, so even if iloperidone is delayed, Vanda will have another relatively near-term shot on goal.
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