ATLANTA, Dec. 15, 2015 /PRNewswire/ -- Alimera Sciences, Inc. ALIM (Alimera), a pharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced that its subsidiary, Alimera Sciences B.V., has signed an agreement with MEAgate International FZLLC (MEAgate), headquartered in the United Arab Emirates (UAE), to distribute ILUVIEN® throughout much of the Middle East. The countries included in the agreement are Bahrain, Egypt, Iraq, Jordan, Kuwait, Lebanon, Oman, Qatar, Saudi Arabia, UAE, and Yemen, where an estimated 16 million people today are living with diabetes.
MEAgate is led by a seasoned management team with more than 35 years of pharmaceutical and medical device experience in the Middle East including tenure with Merck, Medtronic and GE Healthcare. In addition to the management team's experience, the board of directors is comprised of individuals with extensive pharmaceutical distribution experience throughout the Middle East.
Under the terms of the agreement, MEAgate will open a scientific office for Alimera in the Middle East to support regulatory, medical affairs, and sales and marketing operations. In addition to its administrative and regulatory support personnel, MEAgate will initially have a team of five Medical Science Liaisons, with two in Saudi Arabia, two in Egypt and one in the Gulf Cooperation Council countries, to support Named Patient Sales, which are expected to begin in Saudi Arabia, Egypt, UAE and Lebanon in 2016. Named Patient Sales is an early access program where health authorities allow selected institutions to provide globally approved innovative medications to their patients while the products are still in the process of approval and full registration. MEAgate will assist Alimera in registering ILUVIEN in all countries included in the agreement.
"The Middle East market holds great opportunity with a population that exceeds 200 million people, a high rate of diabetes and developing healthcare systems," said Dream Samir, Partner and CEO of MEAgate. "We believe ILUVIEN will be a welcome addition for those with diabetic macular edema in the region. MEAgate will ensure high scientific and compliant standards while managing a network of carefully chosen country distributors for Alimera."
"MEAgate is an excellent partner for Alimera to increase the availability of ILUVIEN," said Dan Myers, president and CEO, Alimera. "Their management team knows how to navigate the variable economic and healthcare systems across countries in the region, which should provide us with a terrific opportunity to make ILUVIEN a market leader in the Middle East."
About ILUVIEN®
ILUVIEN (fluocinolone acetonide intravitreal implant) 0.19 mg is a sustained release intravitreal implant approved in the U.S. to treat diabetic macular edema (DME) in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure. Each ILUVIEN implant is designed to release submicrogram levels of fluocinolone acetonide (FAc), a corticosteroid, for 36 months.
Corticosteroids have a history of effective use in treating ocular disease inflammation. ILUVIEN is injected in the back of the patient's eye with an applicator that employs a 25-gauge needle, which allows for a self-sealing wound. In the FAME™ Study, a phase 3 clinical study of ILUVIEN, the primary endpoint of improvement in vision of 15 letters or more was demonstrated at 24 months and the most frequently reported adverse drug reactions included cataract development and increased ocular pressure.
About Diabetic Macular Edema (DME)
DME, the primary cause of vision loss associated with diabetic retinopathy, is a disease affecting the macula, the part of the retina responsible for central vision. When the blood vessel leakage associated with diabetic retinopathy results in swelling of the macula, the condition is called DME. The onset of DME is painless and may go unreported by the patient until it manifests with the blurring of central vision or acute vision loss. The severity of this blurring may range from mild to profound loss of vision. According to the International Diabetes Foundation's Diabetes Atlas Sixth Edition, Update 2014, the comparative prevalence of diabetes in the countries covered by the agreement with MEAgate ranges from 8% to 24% of the population.
About MEAgate International FZ LCC
The management team of MEAgate are seasoned pharmaceutical and life sciences executives with over 35 years combined experience in selling pharmaceuticals and medical devices in much of the Middle East. They have developed a Middle East hub to address the needs of small to medium innovative companies, and become the partner of choice that ensures highest scientific and compliant standards while managing – on behalf of the company – a network of carefully chosen country distributors. Teams are centrally selected, hired and trained, ensuring that the same high standards are applied across the region.
About Alimera Sciences, Inc.
Alimera Sciences, Inc., headquartered in Alpharetta, Georgia, is a pharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals. Alimera's European operations are conducted by its subsidiary, Alimera Sciences Limited, based in the United Kingdom.
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 prevalence of diabetes in the countries in the Middle East covered by the agreement with MEAgate, Alimera's expectations regarding the commencement of Named Patient Sales and the countries in which they will occur, Alimera's ability to register ILUVIEN in the countries listed in the Middle East, and the desirability of ILUVIEN to patients in the Middle East. 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, the estimated number of diabetics in the countries covered by the agreement with MEAgate, that physicians in the Middle East will accept ILUVIEN for use with their DME patients, that ILUVIEN will be accepted by various institutions in the countries covered by the agreement on a Named Patient Sales basis, that the governments of the countries covered by the agreement will allow ILUVIEN to be registered for sale and that the process of registration will not take extensive time and expense, 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, 2014 and Quarterly Report on Form 10-Q for the quarter ended September 30, 2015, 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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SOURCE Alimera Sciences, Inc.
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