UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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FORM 8-K
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CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): February 11, 2016
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FLAMEL TECHNOLOGIES S.A.
(Exact name of registrant as specified in its charter)
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Republic of France
(State or Other Jurisdiction of Incorporation) |
000-28508
(Commission File Number) |
98-0639540
(I.R.S. Employer
Identification No.) |
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Parc Club du Moulin à Vent
33, avenue du Docteur Georges Levy 69200 Vénissieux France (Address of Principal Executive Offices)
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Not Applicable
(Zip Code)
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Registrant's telephone number, including area code: 011 +33 472 78 34 34
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
£ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
£ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
£ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
£ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 8.01 Other Events.
On February 11, 2016, the registrant issued a press release, a copy of which is furnished as Exhibit 99.1 to this current report and is incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
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99.1
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Press release of Flamel Technologies S.A. dated February 11, 2016
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
FLAMEL TECHNOLOGIES S.A.
By: /s/ Phillandas T. Thompson
Phillandas T. Thompson
Senior Vice President, General Counsel and Corporate Secretary
Date: February 11, 2016
Exhibit Index
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99.1
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Exhibit 99.1
Flamel Technologies to Present at RBC Capital Markets' 2016 Global Healthcare Conference
Lyon, France – February 11, 2016 - Flamel Technologies (NASDAQ: FLML) today announced that the
Company will be presenting at the RBC Capital Markets' Global Healthcare Conference to be held in New York City February 23 – 24, 2016. Michael Anderson, Chief Executive Officer of Flamel, is scheduled to present on Tuesday, February 23rd at 9:30 a.m. Eastern Time.
Mr. Anderson's presentation will be webcast live and can be accessed by visiting the Investor section of the Company's website at http://www.flamel.com/investors. A replay of the presentation will also be available and archived on the website following the event.
About Flamel Technologies:
Flamel Technologies SA (NASDAQ: FLML) is a specialty pharmaceutical company utilizing its core competencies in formulation development and drug delivery to develop safer and more efficacious pharmaceutical products, addressing unmet medical needs and/or reducing overall healthcare costs. Flamel currently markets two previously Unapproved Marketed Drugs ("UMDs") in the United States, Bloxiverz® (neostigmine methylsulfate injection) and Vazculep® (phenylephrine hydrochloride injection), and in September 2015 announced that the NDA for its third UMD filing was accepted by the FDA and assigned a PDUFA date of April 30, 2016. The Company also develops products utilizing its proprietary drug delivery platforms, Micropump® (oral sustained release microparticles platform), along with its tangent technologies, LiquiTime® (a Micropump-derivative platform for liquid oral products) and Trigger Lock™ (a Micropump-derivative platform for abuse-resistant opioids). Additionally, the Company has developed a long acting injectable platform, Medusa™, a hydrogel depot technology, particularly suited to the development of subcutaneously administered formulations. Current applications of Flamel's drug delivery products include sodium oxybate (Micropump®), extended-release of liquid medicines such as ibuprofen and guaifenesin (LiquiTime®, through a license arrangement with Elan Pharma International Limited for the U.S. Over-the-Counter market) and a current study of the delivery of exenatide utilizing the Medusa™ technology. In February 2016, Flamel acquired FSC Pediatrics, a Charlotte, North Carolina-based company that markets three pediatric pharmaceutical products Cefaclor for oral suspension, indicated for infection, Karbinal™ ER, indicated for allergic rhinitis and AcipHex® Sprinkle™ (rabeprazole sodium) indicated for the treatment of gastroesophageal disease (GERD). FSC also received 510(k) clearance from the FDA in October 2015 for Flexichamber ™, a collapsible holding chamber for used in the administration of aerosolized medication using pressurized Metered Dose Inhalers (pMDIs) for the treatment of asthma. The Company is headquartered in Lyon, France and has operations in St. Louis, Missouri, USA, Charlotte, North Carolina, USA, and Dublin, Ireland. Additional information may be found at www.flamel.com.
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Contact:
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Michael S. Anderson
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Chief Executive Officer
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Phone: (636) 449-1830
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E-mail: anderson@flamel.com
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Michael F. Kanan
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Chief Financial Officer
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Phone: (636) 449-1449
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E-mail: kanan@flamel.com
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Investor Relations
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Stephanie Carrington
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ICR Inc.
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Phone: (646) 277-1282
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Email: stephanie.carrington@icrinc.com
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Lauren Stival
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ICR Inc.
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Phone: (646) 277-1287
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Email: lauren.stival@icrinc.com
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