Cephalon Granted Six Months of Pediatric Exclusivity for PROVIGIL(R) Tuesday March 28, 8:00 am ET
FRAZER, Pa., March 28 /PRNewswire-FirstCall/ -- Cephalon, Inc. (Nasdaq: CEPH - News) today announced that the U.S. Food and Drug Administration (FDA) will apply an additional six months of market exclusivity to PROVIGIL® (modafinil) Tablets [C-IV]. The extension attaches to the U.S. patent covering PROVIGIL, such that the associated exclusivity now extends until April 6, 2015.
Specifically, the FDA has confirmed that Cephalon met the terms of a written request to provide data from clinical studies examining the effect of PROVIGIL in pediatric patients. The Food and Drug Administration Modernization Act of 1997 enables the FDA to issue written requests for pediatric studies to companies if the agency determines that information related to the use of an approved drug in pediatric patients may produce health benefits.
Cephalon previously announced its settlement with four generic firms of its patent infringement litigation concerning PROVIGIL. Under the terms of the settlements, Cephalon granted to each of the four defendants a non-exclusive royalty-bearing right to market and sell a generic version of PROVIGIL in the United States, that will now become effective in April 2012 (subject to earlier entry in certain circumstances).
In March, I questioned whether CEPH would bother with Sparlon (#msg-10325200) if push came to shove, and it turns out that they won’t. CEPH can still derive some benefit from off-label sales of Provigil to kids with ADHD.
NEW YORK, Aug 9 (Reuters) - Cephalon Inc. <CEPH> said on Wednesday it would halt development of its experimental attention deficit disorder drug, Sparlon, after U.S. regulators told the biotechnology company the medicine would not be approved, and its shares fell 10 percent.
Cephalon said the U.S. Food and Drug Administration rejected the drug, meant to treat children and adolescents with attention-deficit/hyperactivity disorder, even after the company supplied the agency with new safety data that had been requested.
The company said the FDA decision would have no impact on its previously issued sales and earnings forecasts or its expectations for strong 2007 earnings. But Cephalon shares fell to $57.24 in extended trading on Inet electronic brokerage from their Nasdaq close of $63.95.
Cephalon, which had originally expected to be able to launch Sparlon in the first quarter of 2006, suffered a major setback in March, when an advisory panel to the FDA recommended the drug not be approved due to safety concerns. There was concern a patient in a clinical trial had developed a potentially very dangerous skin rash called Stevens Johnson Syndrome.
Last month, however, Cephalon expressed optimism the drug would win approval based on new safety data it provided the FDA.
"Obviously, we are extremely disappointed and surprised that the agency disagreed with the opinions of our experts, which were based on photographic and other evidence concerning a single suspected case of Stevens Johnson syndrome," Chief Executive Frank Baldino said in a statement.
Cephalon said it plans to fully reserve the $8.6 million of net Sparlon inventory on its balance sheet as of June 30, but the move would not change its reported earnings per share for the first half of the year.
Sparlon contains the same active ingredient as Cephalon's flagship sleep disorder medicine, Provigil. But as the new version was intended for use in children it came under renewed scrutiny by FDA advisors. <<
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