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October 18, 2012
08:33 EDTFLMLFlamel announces FDA acceptance of NDA for undisclosed hospital-based product
Flamel Technologies SA announced that the U.S. FDA has accepted the company's New Drug Application, or NDA, for an undisclosed hospital-based product. Flamel has received a Prescription Drug User Fee Act, or PDUFA, date, the target date for the FDA to complete its review of the NDA, of May 31, 2013. For competitive reasons, the Company has decided not to identify the product at this time, but intends to provide additional information at a later date. Flamel believes that the product could have a significant impact on the company's revenue generation and favorably impact its progression to profitability. If approved by the FDA, the product is expected to generate approximately $25M-$35M or more in peak annual revenues, subject to the company being able to market and price the product successfully, of which there can be no assurance.
News For FLML From The Last 14 Days
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November 28, 2014
09:10 EDTFLMLFlamel Technologies sells development and manufacturing facility in France
Flamel Technologies (FLML) announced that it has entered into an agreement to divest its development and manufacturing facility located in Pessac, France, to Recipharm AB. Under the agreement, Recipharm will pay Flamel EUR 10.6M and make an investment of EUR 10.5M in Flamel's stock upon the closing of deal at a purchase price equal to the trailing 20-day average price. This new partnership allows Flamel to retain access to the development and manufacturing capabilities of Pessac and gain the use of any of Recipharm's other facilities for the development or manufacture of their proprietary pipeline if needed. The Pessac facility is not currently used for the production of Flamel finished products and Flamel intends to continue to outsource to third party contract manufacturing companies like Recipharm. Flamel and Recipharm will enter into a 5 year service agreement. Included in the sale of the facility is the royalty contract for Coreg CR with GlaxoSmithKline (GSK). Recipharm has an option to negotiate with Flamel for the European rights to any product that Flamel plans to license for sale in the European market. Recipharm and Flamel have agreed to negotiate a contract with the intention of further enhancing the economic benefits to both companies whereby Recipharm will incorporate Flamel's drug delivery technologies in its contract development business. The closing of the transaction is expected to occur before year end 2014, and there are no material conditions to the closing.

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