0001267602-13-000047.txt : 20131001 0001267602-13-000047.hdr.sgml : 20131001 20131001161541 ACCESSION NUMBER: 0001267602-13-000047 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20130930 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20131001 DATE AS OF CHANGE: 20131001 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ALIMERA SCIENCES INC CENTRAL INDEX KEY: 0001267602 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 000000000 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-34703 FILM NUMBER: 131127106 BUSINESS ADDRESS: STREET 1: 6120 WINDWARD PARKWAY STREET 2: STE 290 CITY: ALPHARETTA STATE: GA ZIP: 30005 BUSINESS PHONE: 6789905740 MAIL ADDRESS: STREET 1: 6120 WINDWARD PARKWAY STREET 2: STE 290 CITY: ALPHARETTA STATE: GA ZIP: 30005 8-K 1 alimera8k.htm 8-K Alimera 8-K Press Release 9-30-13

 
 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549
FORM 8-K
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 30, 2013
ALIMERA SCIENCES, INC.
(Exact name of registrant as specified in its charter)


Delaware
 
001-34703
 
20-0028718
(State or other Jurisdiction of Incorporation)
 
(Commission File Number)
 
(IRS Employer Identification No.)
 
 
 
6120 Windward Parkway
Suite 290
Alpharetta, Georgia
 
30005
(Address of Principal Executive Offices)
 
(Zip Code)
Registrant’s telephone number, including area code: (678) 990-5740


Not Applicable
(Former name or former address if changed since last report.)
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:
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) o 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 30, 2013, Alimera Sciences, Inc. issued a press release announcing that the United Kingdom's National Institute for Health and Care Excellence has recommended ILUVIEN funding for the treatment of pseudophakic eyes in chronic diabetic macular edema patients that are insufficiently responsive to available therapies. A copy of the press release is attached as Exhibit 99.1 hereto and is incorporated by reference herein.




Item 9.01. Financial Statements and Exhibits.
(d)    Exhibits

Exhibit No.
 
Description
99.1
 
Press Release of Alimera Sciences, Inc. dated September 30, 2013



 
SIGNATURE
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.  
 
ALIMERA SCIENCES, INC.
 
 
Dated: October 1, 2013
By:
/s/ RICHARD S. EISWIRTH, JR.
 
Name:
Richard S. Eiswirth, Jr.
 
Title:
Chief Operating Officer and
Chief Financial Officer

EX-99.1 2 alimerapressrelease.htm PRESS RELEASE OF ALIMERA SCIENCES, INC. DATED SEPTEMBER 30, 2013 NICERecommendsILUVIENFinal09302013

Exhibit 99.1

FOR IMMEDIATE RELEASE

For press inquiries:
For investor inquiries:
Katie Brazel, Fleishman-Hillard
John Mills, ICR
for Alimera Sciences
for Alimera Sciences
404-739-0150
310-954-1105
Katie.Brazel@fleishman.com
John.Mills@ICRINC.com


U.K.’S NICE ISSUES FINAL APPRAISAL DETERMINATION RECOMMENDING ALIMERA’S ILUVIEN® FOR CHRONIC DIABETIC MACULAR EDEMA

Recommendation will provide access to funding for a subgroup of chronic DME patients

ATLANTA, September 30, 2013 – Alimera Sciences, Inc. (NASDAQ: ALIM) (Alimera), a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced that in its Final Appraisal Determination, the United Kingdom’s National Institute for Health and Care Excellence (NICE) has recommended ILUVIEN funding for the treatment of pseudophakic eyes in chronic diabetic macular edema (DME) patients that are insufficiently responsive to available therapies.

The final draft guidance reverses the published guidance issued by NICE on January 23, 2013, and takes into consideration a simple patient access scheme submitted by Alimera. In addition, NICE reviewed Alimera’s updated data analysis showing ILUVIEN’s cost effectiveness among a subgroup of chronic DME patients who have an eye that is considered pseudophakic, meaning that the eye has already undergone cataract surgery.

“I am very pleased that my chronic DME patients will soon have access through the National Health Service (NHS) to ILUVIEN as a treatment option,” said Mr. Moin Mohamed, Consultant Ophthalmic Surgeon, Guy's and St Thomas' Hospital NHS Foundation Trust, London. “Vision is precious and a major contributor to a patient’s overall quality of life. This recommendation from NICE gives chronic pseudophakic DME patients, who have exhausted all other treatment options, renewed hope. Ultimately, I would like to see ILUVIEN made available to all people with chronic DME.”

ILUVIEN, a sustained release intravitreal implant, has received marketing authorization in the U.K., Austria, Portugal, Germany, France and Spain, and is pending in Italy. ILUVIEN is currently commercially available in the U.K. and Germany.




“The NICE recommendation is a welcome development for chronic DME patients across England and Wales,” said Mr. Robin Hamilton, Consultant Ophthalmic Surgeon, Moorfields Eye Hospital NHS Foundation Trust, London. “With this determination, these patients will have access through NHS to a long-term, sustained release option for achieving improved visual acuity. ILUVIEN can have a significantly positive impact on their lives.”
“This is excellent news for Alimera, as this positive recommendation from NICE will require the National Health Service (NHS) to make funding available for ILUVIEN in England and Wales. We plan to continue to work with NICE in an effort to broaden access to ILUVIEN to include all chronic DME patients who could benefit from the treatment,” said Dan Myers, Alimera’s president and chief executive officer.
NICE’s final guidance regarding reimbursement of ILUVIEN within the NHS in England and Wales is expected to be published in November 2013.
About ILUVIEN® 

ILUVIEN (190 micrograms intravitreal implant in applicator) is a sustained release intravitreal implant used to treat vision impairment associated with chronic DME considered insufficiently responsive to available therapies. Each ILUVIEN implant provides a therapeutic effect of up to 36 months by delivering sustained sub-microgram levels of fluocinolone acetonide (FAc). ILUVIEN is injected in the back of the patient's eye to a position that takes advantage of the eye's natural fluid dynamics. The applicator employs a 25-gauge needle, which allows for a self-sealing wound. In the FAME™ Study, the most frequently reported adverse drug reactions included cataract development and increased ocular pressure.

About Alimera Sciences, Inc.

Alimera Sciences, Inc., headquartered in Alpharetta, Georgia, is a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals. Alimera’s European operations are conducted from London by its wholly-owned subsidiary, Alimera Sciences Limited.
Forward Looking Statements
This press release contains "forward-looking statements," within the meaning of the Private Securities Litigation Reform Act of 1995, regarding, among other things, the extent of the commercial availability and funding of ILUVIEN in the United Kingdom. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual results to differ materially from those projected in its forward-looking statements. Meaningful factors which could cause actual results to differ include, but are not limited to NICE’s acceptance of the recommendations contained in ACD, uncertainty as to Alimera's ability to commercialize, and market acceptance of, ILUVIEN in the United Kingdom, as well as other factors discussed in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Alimera's Annual Report on Form 10-K for the year ended December



31, 2012 and Quarterly Report on Form 10-Q for the quarter ended June 30, 2013, which are on file with the Securities and Exchange Commission (SEC) and available on the SEC's website at www.sec.gov. In addition to the risks described above and in Alimera's Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the SEC, other unknown or unpredictable factors also could affect Alimera's results. There can be no assurance that the actual results or developments anticipated by Alimera will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Alimera. Therefore, no assurance can be given that the outcomes stated in such forward-looking statements and estimates will be achieved.
All forward-looking statements contained in this press release are expressly qualified by the cautionary statements contained or referred to herein. Alimera cautions investors not to rely too heavily on the forward-looking statements Alimera makes or that are made on its behalf. These forward-looking statements speak only as of the date of this press release (unless another date is indicated). Alimera undertakes no obligation, and specifically declines any obligation, to publicly update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.

# # #



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