Key Developments: Flamel Technologies SA (FLML.W)
4.77USD
13 May 2013
$0.11 (+2.36%)
$4.66
$4.77
$4.77
$4.77
100
6
$5.49
$3.08
Latest Key Developments (Source: Significant Developments)
Judge Dismisses 2007 Class Action Case Against Flamel Technologies SA
Flamel Technologies SA announced that Judge Robert Sweet of the United States District Court for the Southern District of New York issued a summary judgment on March 8, 2013 dismissing a class action suit against the Company, and its former CEO. The initial class action was filed in 2007 and, during the six year period, had two different plaintiffs. The case, Billhofer v. Flamel Technologies, et al., alleged claims arising under the Securities Exchange Act of 1934 based on certain public statements by the Company concerning, among other things, Coreg CR. The Company previously stated that it intended to vigorously defend itself in the action. In dismissing the case, Judge Sweet's opinion states that as there is no genuine issue of fact and no reasonable jury could find in the lead plaintiff's favor on his claim, the motion for summary judgment is granted. Full Article
Flamel Technologies SA Announces $15 Million Debt Financing To Advance R&D Efforts
Flamel Technologies SA announced that it has completed a USD$15 million debt financing with Deerfield Management, a current Flamel shareholder. This financing will allow the Company to continue its investment in R&D projects going forward. The interest rate on the debt is 12.5% and the debt must be repaid over four years, with the initial payment of principal and accrued interest due in 18 months. Deerfield Management will also receive a 1.75% royalty on net sales of products resulting from the R&D projects of the former Eclat Pharmaceuticals, subject to required regulatory approvals and sales of these products. Full Article
Flamel Technologies SA Announces FDA Acceptance Of New Drug Application
Flamel Technologies SA announced that the U.S. Food and Drug Administration (FDA) has accepted the Company's New Drug Application (NDA) for an undisclosed hospital-based product. Flamel has received a Prescription Drug User Fee Act (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 $25 million to $35 million 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. Full Article
Flamel Technologies S.A. To Acquire Éclat Pharmaceuticals; Names Mike Anderson As CEO
Flamel Technologies S.A. announced that it has agreed to acquire Éclat Pharmaceuticals, a St. Louis, Missouri-based special pharmaceutical company focused on developing and commercializing niche brands and generic products. Éclat Pharmaceuticals is a wholly owned subsidiary of an affiliate of Deerfield Capital L.P., which together with its other affiliates is the Company's largest shareholder. Under the terms of the acquisition, a newly formed US subsidiary of Flamel has issued a $12 million senior note to Éclat Holdings, LLC, the former owner of Éclat, that is guaranteed by Flamel and its subsidiaries and secured by the equity interests and assets of Éclat. The note is payable over six years only if certain contingencies tied to the approval and net sales of certain Éclat products are satisfied. The note accrues interest at an annual rate of 7.5%, payable in kind, until satisfaction of certain of the foregoing contingencies. Flamel also will pay Éclat Holdings an earnout payment of 20% of the gross profit generated by the Éclat launch products. Steve Willard, Flamel's current Chief Executive Officer, has resigned as CEO, and Mike Anderson, Éclat's Chief Executive Officer, has become Chief Executive Officer of Flamel Technologies. Mr. Willard will remain a Director of Flamel and an employee of a US subsidiary of Flamel. Full Article
Flamel Technologies S.A. Announces Multi-Year Supply Agreement With GlaxoSmithKline For Coreg CR Microparticles
Flamel Technologies S.A. announced that it has entered into a multi-year supply agreement with GlaxoSmithKline plc for the production of Coreg CR microparticles. Flamel Technologies is the sole supplier of Coreg CR microparticles for GSK. Under the agreement, Flamel will receive guaranteed minimum payments to supply Coreg CR microparticles over a period of several years. The agreement defines the manufacturing relationship between the two companies following the expiration of the previous supply agreement on December 31, 2010. Pursuant to the agreement, Flamel received a payment of EUR1.3 Million during the third quarter and anticipates a further EUR1.3 Million payment to be paid in the next ten days, as well as the higher margin on all product produced by Flamel since January 1, 2011. Full Article
Eagle Pharmaceuticals, Inc. And Flamel Technologies S.A. Announces Eagle To License Medusa Technology For Extended-Release Of Tigecycline
Eagle Pharmaceuticals, Inc. and Flamel Technologies SA announced that the two companies have entered into a license and development agreement for the development of a Medusa-based hydrogel depot formulation of the small molecule antibiotic, tigecycline. Following the promising results generated in the frame of an initial feasibility study established between Flamel and Eagle Pharmaceuticals, Eagle Pharmaceuticals has decided to exercise its option to pursue its partnership with Flamel. Under the terms of the license and development agreement, Flamel will receive upfront, milestone and double-digit royalty payments. Additionally, Flamel is entitled to receive a percentage of any sub-licensing revenues received by Eagle Pharmaceuticals. All development expenses are the sole responsibility of Eagle Pharmaceuticals. Full Article
Flamel Technologies S.A. and Digna Biotech Announce Multiple Product Development Agreement
Flamel Technologies S.A. and Digna Biotech SL today announced that the two companies have entered into a joint development agreement for the pre-clinical and clinical development of multiple products. The agreement has been structured to leverage Digna’s groundbreaking research, preclinical and clinical development efforts, and Flamel’s formulation expertise in creating safer, more efficacious products using its innovative proprietary drug delivery platforms, Medusa® and Micropump®. Flamel will be primarily responsible for the formulation and manufacturing process development and Digna will be primarily responsible for the preclinical and clinical development. The three initial Digna products that have been identified for development under the agreement are P144, P17, and Methylthiadenosine (MTA). All of these molecules have shown significant activity in preclinical studies involving multiple indications with high unmet medical need. Both companies expect that the achievement of clinical proof of concept data under the joint development agreement will result in significant additional value creation for the parties. Full Article
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