Marketwired Issues Correction on Earlier Flamel Tech Release

Flamel Technologies (NASDAQ: FLML)today announced that its First-in-Man (FIM) clinical study in healthyvolunteers using its proprietary Micropump(R) technology applied tosodium oxybate has identified formulations that demonstrate thepotential to eliminate the second nighttime dose for patientssuffering from narcolepsy. The current dosing regimen for thestandard of care, Xyrem(R) (sodium oxybate), in the United States istwo equal, divided doses: the first dose at bedtime and the seconddose 2.5 to 4 hours later. The elimination of the second dose fornarcolepsy patients would not only provide more convenience, but mayimprove the benefit sodium oxybate provides as there will be nodisruption to nighttime sleep. The potential for additional benefits,including improved safety, will be studied.The trial was designed as a 16 subject four-way crossover evaluatingthree different formulations of Micropump sodium oxybate and Xyrem ata nightly dose of 4.5g (two doses of 2.25g for Xyrem) with anextension phase at 6g for successful Micropump formulations. Eachsubject consumed a standard meal two hours prior to dosing. Subjectswere instructed to maintain a consistent meal time and dosingschedule throughout the study. When a subject took Xyrem they wereinstructed to take the second dose 4 hours after the first dose. Twosubjects dropped out of the study prior to the completion of the 4.5gdosing portion for reasons unrelated to drug. The key data for the 14evaluable subjects at 4.5g are:-- Onset of action similar to Xyrem-- Cmax lower than Xyrem-- Mean blood concentration (ug/ml) at hours 7 and 8 similar to XyremFor the extension phase of the study, two formulations were movedforward for dosing at 6g. Thirteen subjects were evaluable as onesubject dropped out for a reason unrelated to drug. The profiles forboth formulations were consistent with expectations.The current study will continue to treat subjects at higher doses.Given these results, Flamel plans to begin a new clinical studybefore the end of 2014 in a larger number of subjects furtherevaluating its formulations as well as certain pharmacodynamicendpoints. This study is not expected to be a registration study.Flamel plans to meet with regulatory authorities prior to embarkingupon registration studies which are expected to begin prior to theend of 2015.Flamel's Micropump technology is protected by intellectual propertythrough at least 2025 in the United States. Micropump is a provendrug delivery platform for the oral delivery of small molecules.Narcolepsy is a sleep disorder involving irregular patterns in RapidEye Movement (REM) sleep and significant disruptions of the normalsleep/wake cycle. People with narcolepsy experience excessive daytimesleepiness, sleep attacks, cataplexy, sleep paralysis, hallucinationsand disrupted nighttime sleep.Xyrem(R) is sold in the United States by Jazz Pharmaceuticals plc, inCanada by Valeant Canada Limited (via license from Jazz) and intwenty-two EU countries and Mexico by UCB Pharma Limited (via licensefrom Jazz).A conference call to discuss these results and other updates isscheduled for 8:45 AM Eastern Daylight Time on April 7, 2014. Aquestion and answer period will follow management's prepared remarks.To participate in the conference call, investors are invited to dial888-857-6930 (U.S.) or 719-457-2615 (international). The conferenceID number is 9695267. The conference call webcast may be accessed atwww.flamel.com. A replay of the webcast will be archived on Flamel'swebsite for 90 days following the call.