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Examples
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Pfizer has a partnership with Neurocrine Biosciences to develop another sleeping pill, indiplon, that is similar to Lunesta.
Either Pfizer Or Schering-Plough Could Acquire Sepracor 2006
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They also sometimes ask companies to run trials of their drug compared to a competitor's drug which the FDA has already approved, as they did with Neurocrine Biosciences, which was asked to run a safety study of their drug indiplon against another FDA approved drug.
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Lunesta, the first sleep aid to be approved by the FDA for long-term use, was released last spring; another insomnia drug, Rozerem, was approved last summer, and Pfizer is hoping to gain approval for its sleep aid indiplon, codeveloped by Neurocrine Biosciences, later this year.
Wake-Up Call 2007
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Meanwhile, regulars recently demanded more data before approving Neurocrine Biosciences' indiplon sleeping pill, prompting partner Pfizer to drop its deal with Neurocrine last week.
Behavioral Therapy 1, Sleeping Pills 0 Robert Langreth 2006
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Shares of Neurocrine Biosciences plunged 25% in late trading after the San Diego-based drugmaker said Pfizer terminated their partnership for sleeping pill indiplon.
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"This result is ours and investors' worst case scenario--it suggests that the key opportunity for indiplon, early refiling with the FDA and approval of both IR [immediate release] and MR [modified release] forms, is a remote possibility."
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But indiplon was recently hit by a Food and Drug Administration setback that could delay its entry to the market until 2008 and reduce its eventual value.
Either Pfizer Or Schering-Plough Could Acquire Sepracor 2006
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Analysts have speculated on whether Pfizer would terminate the partnership ever since federal health regulators delayed a decision on indiplon in May.
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Pfizer opted out of the companies' four-year developmental collaboration on sleeping pill indiplon just a few weeks after the U.S. Food and Drug Administration delayed a decision on the experimental drug.
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Late Thursday, Neurocrine announced the end of its drug development deal with Pfizer on indiplon, an experimental drug similar to Sepracor's Lunesta.
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