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): September 19, 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 September 19, 2016, Flamel Technologies S.A. (the "Company") issued a press release announcing it will host a meeting for investors and analysts on Monday, September 26, 2016. That press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
On September 19, 2016, the Company issued a press release announcing it will present at the Ladenburg Thalmann 2016 Healthcare Conference on Tuesday, September 27, 2016. That press release is attached as Exhibit 99.2 to this Current Report on Form 8-K 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 September 19, 2016
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99.2
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Press release of Flamel Technologies S.A. dated September 19, 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: September 19, 2016
Exhibit Index
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99.1
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Press release of Flamel Technologies S.A. dated September 19, 2016
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99.2
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Press release of Flamel Technologies S.A. dated September 19, 2016
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Exhibit 99.1
Flamel Technologies to Host Investor & Analyst Meeting
Lyon, France – September 19, 2016 – Flamel Technologies (NASDAQ: FLML) today announced it will host a meeting for investors and analysts on Monday, September 26, 2016. The event will take place from 8:00 a.m. – 10:30 a.m. Eastern Time (approximate time) in New York City. Please note, due to limited capacity, attendance at this event is by invitation only.
Senior management and key opinion leaders in the field of sleep medicine will provide the investment community an update on a number of the Company's platform technologies and its upcoming Phase III trial for a once nightly formulation of sodium oxybate for the treatment of narcolepsy.
A live webcast of the presentation and accompanying slides can be accessed on the "Events & Presentations" section of the Company's Investor website at www.flamel.com/investors/upcoming-events/.
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 three previously Unapproved Marketed Drugs ("UMDs") in the United States, Bloxiverz® (neostigmine methylsulfate injection), Vazculep® (phenylephrine hydrochloride injection), and Akovaz™ (ephedrine sulfate injection). 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 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 2014 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 Dublin, Ireland and in St. Louis, Missouri. Additional information may be found at www.flamel.com.
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Contacts:
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Michael F. Kanan
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Chief Financial Officer
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Phone: (636) 449-1844
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E-mail: kanan@flamel.com
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| Lauren Stival | |
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Sr. Director, Investor Relations and Corporate Communications
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| Phone: (636) 449-5866 | |
| Email: stival@flamel.com |
Exhibit 99.2
Flamel Technologies to Present at Ladenburg Thalmann 2016 Healthcare Conference
Lyon, France – September, 19 2016 – Flamel Technologies (NASDAQ: FLML) today announced that management will present at the Ladenburg Thalmann 2016 Healthcare Conference. Michael Anderson, Chief Executive Officer, and Mike Kanan, Chief Financial Officer, are scheduled to present on Tuesday, September 27, 2016 at 3:00 p.m. Eastern Time.
The presentation will be webcast live and can be accessed by visiting the "Events & Presentations" page of the Company's Investor website at http://www.flamel.com/investors. A replay of the webcast will be archived on the website for ninety days 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 three previously Unapproved Marketed Drugs ("UMDs") in the United States, Bloxiverz® (neostigmine methylsulfate injection), Vazculep® (phenylephrine hydrochloride injection), and Akovaz™ (ephedrine sulfate injection). 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 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 2014 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 Dublin, Ireland and in St. Louis, Missouri. Additional information may be found at www.flamel.com.
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Contacts:
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Michael F. Kanan
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Chief Financial Officer
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Phone: (636) 449-1844
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E-mail: kanan@flamel.com
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| Lauren Stival | |
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Sr. Director, Investor Relations and Corporate Communications
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| Phone: (636) 449-5866 | |
| Email: stival@flamel.com |