Vanda Pharmaceuticals wins drug approval, stock soars - Washington Business Journal:

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No doubt an understandable response tothe FDA’a unforeseeable turnaround this week to greenlighft Vanda’s lead drug, iloperidone, as a marketable schizophrenia treatmenf — less than nine months after the agencyh rejected it as being The news sent Vanda’s stock leaping by 626 percent in tradinf Thursday and revived a future that, before 5:30 p.m. was thought doomed by analystsand investors, one of whom launchedf a public campaign to liquidate the company.
And now, after shrinking in half and cutting back on most spendinygsince then, the 24-person company said it’s draftinyg a strategy to start hiring again, perhaps some of the employeed it had let go during this ordeal, and sellint its first drug in an estimated $15 billion market. “We’re evaluating all the plans,” Polymeropoulod said. “This includes hiring new people.” He’s short on details, thoughu a permanent chief financial officer and chief commerciao officer would seemlikely — both were let go in a rounr of layoffs in December and have since founc other jobs.
Polymeropoulos has said all options are on the including partnering up with another company to help it sell which it will marketas Fanapt. But he said Vanda has the capacityh to market the drug onits own, with a smallk sales force targeting the 5,0009 psychiatrists who are responsiblse for 60 percent of the country’s antipsychotixc prescriptions. Vanda now owes Swiss pharmaceutical , wherde Polymeropoulos previously worked and from wherre he first licensed the rights tothe drug, $12 millioj for making it to this approval milestone. As of the end of last the companyhad $46.
5 million in cash and Polymeropoulos said he knew he was working against general consensusz regarding the chances for iloperidone’s approval. But he place his bet on additional data the companh had collected during the previouss clinical trials that he said thecompanyt didn’t initially think the FDA needed results that showed that iloperidons worked as well as other riva drugs on the market, namely Risperdal sold by , Geodonh sold by and Haldol, created by And then Vanda waited. Even when the second decision day was set forMay 6, no news came the entirse day on Wednesday. It wasn’t until after 5 p.m.
that surrounded by a few executives and chairmaand co-founder Argeris Karabelas in the conference room, receivec the agency’s e-mail. And then the FDA whippes out its press release on iloperidone minutes before the company could send outits own, causing the executivex to dash up and down its hallwayws to tell employees before they read their fate online. The nighft of July 28, when Vanda received the first rejectiob letter fromthe FDA, a psychiatrist himself, said he spen t the night writing “an elaborate draft” of the response lettee he’d send to the agency askinvg for another chance at approval.
On Wednesdauy evening, when share prices already started soaring tonew 52-weeik highs in after-hours Polymeropoulos went to the nearby bar with colleagues for a celebrator drink. And that night, he