Note to self: If you're ever pulled over for a speeding ticket, make sure you've got someone from Gilead Sciences' (Nasdaq: GILD ) regulatory department in the car.
Last March, the EU's Committee for Medicinal Products for Human Use said that Gilead's aztreonam lysine, a treatment for bacterial infections in cystic fibrosis patients, wasn't up to snuff. Like its American counterparts, the agency said it wanted to see results from additional trials before approving the drug.
Gilead appealed and, lo and behold, the agency did an about-face and recommended approval for the drug. Well, maybe it was more like a quarter-turn. The recommendation is for a conditional approval contingent on positive results from the ongoing studies. Still, it's better than nothing; at least Gilead would be able to sell the drug in the EU while the trials are occurring.
The therapy is an inhaled version of the active ingredient in Elan's (NYSE: ELN ) Azactam, which was originally developed by Bristol-Myers Squibb (NYSE: BMY ) . When it hits the market, assuming the European Commission signs off on the approval, the drug will compete with Novartis' (NYSE: NVS ) inhaled antibiotic, Tobi, which is also used to treat infections in cystic fibrosis patients.
Drug companies sometimes appeal decisions by regulatory agencies, but it's often a waste of the paper they're written on. For instance, Encysive Pharmaceuticals -- now part of Pfizer (NYSE: PFE ) -- tried to get the Food and Drug Administration to change its mind and approve its pulmonary arterial hypertension drug candidate, Thelin, but came up empty-handed.
Gilead is in the process of expanding from an HIV specialist to a more diversified drug company with therapies for cystic fibrosis and heart diseases. Perhaps it should consider expanding into writing briefs for attorneys appealing to the Supreme Court.
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