Article preview from The RPM Report July 7, 2009
The atypical antipsychotic iloperidone appeared doomed after a “not approvable” letter and its sponsor faced liquidation. Talk about the comeback story of the year: FDA approved the drug May 6 and Vanda is back in business. Here’s the back story on one drug development miracle. Read on...
Article preview from The RPM Report July 7, 2009
Some stories are bigger than others. The seventh atypical antipsychotic approved by FDA wouldn’t appear to be one of those stories, but it is.
Vanda Pharmaceuticals Inc. probably shouldn’t be an ongoing concern today. The company was pushed to the brink with a “not approvable” letter from the Food & Drug Administration in July 2008 for iloperidone (Fanapt).
The letter brought with it a 70% ($65 million) stock price decline, and—coupled with what seemed like definitive statements that the drug simply could not be approved without another large, comparative trial—appeared to spell doom for the small company. Indeed, as May began, the biggest near term event for Vanda appeared to be a proposal by a dissident shareholder to replace the board and liquidate the firm’s remaining assets.
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