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News Release - February 6, 2017
Alimera Sciences Announces the Reimbursement of ILUVIEN(R) in ItalyATLANTA, Feb. 06, 2017 -- (Healthcare Sales & Marketing Network) -- Alimera Sciences, Inc. (ALIM) (Alimera), a leader in research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced that its subsidiary, Alimera Sciences Limited, received the pricing and reimbursement decree for ILUVIEN® from Agenzia Italiana del Farmaco (AIFA) on January 11, 2017. The decree, published February 2, 2017 in the Gazzetta Ufficiale della Repubblica Italiana, the official journal of record of the Italian government, changed the reimbursement status of ILUVIEN from Class C, in which the patient covers the cost of the treatment, to Class H, with a restriction to patients with an artificial lens implanted. This means that in Italy, ILUVIEN will be hospital-administered and should be fully reimbursed for those patients who have previously undergone cataract surgery. In Europe, ILUVIEN is a sustained release intravitreal implant for the treatment of vision impairment associated with chronic diabetic macular edema (DME).
“With this decree we have reached a major milestone. We now have our first price set in Southern Europe, and have a clear path to a new revenue stream with our distributor, Societa Industria Farmaceutica Italiana (SIFI),” said Dan Myers, Alimera’s chief executive officer. “We believe ILUVIEN is the only therapy that treats DME consistently every day due to its continuous microdosing for up to three years, and we are pleased with this outcome.”
ILUVIEN will be distributed throughout Italy, San Marino and Vatican City by SIFI. Under the terms of the five-year agreement signed in August 2015, SIFI is handling all promotion, marketing and commercial activities in those geographies for ILUVIEN, and was responsible for the successful pursuit of the Class H designation.
“At SIFI, we strive to offer Italian ophthalmologists and their patients a full range of products to address their eye care needs,” said Fabrizio Chines, executive chairman of SIFI SpA. “ILUVIEN is a wonderful complement to our existing portfolio. We believe ILUVIEN is the most advanced technology for sustained drug release with continuous microdosing providing a physician the only therapy to treat the disease consistently every day. It represents a real innovation in DME treatment both for physicians and patients because providing a consistent daily dose makes patient compliance and adherence to therapy easier, reduces the risks of multiple intravitreal injections, and thus we believe provides a clear improvement in the patient’s quality of life.”
ILUVIEN (fluocinolone acetonide intravitreal implant) 0.19 mg is a sustained release intravitreal implant indicated in the EU to treat vision impairment associated with chronic DME considered insufficiently responsive to available therapies. Each ILUVIEN implant with its continuous microdosing is designed to release submicrogram levels of fluocinolone acetonide, a corticosteroid, for 36 months, enabling the physician to treat the disease consistently every day.
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. The Wisconsin Epidemiologic Study of Diabetic Retinopathy found that over a 10-year period approximately 19% of people with diabetes included in the study were diagnosed with DME. All people with type 1 or type 2 diabetes are at risk of developing DME.
About Alimera Sciences, Inc.
Alimera, founded in June 2003, is a pharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals. Alimera is presently focused on diseases affecting the back of the eye, or retina, because these diseases are not well treated with current therapies and will affect millions of people in our aging populations. Alimera’s commitment to retina specialists and their patients is manifest in Alimera’s product and development portfolio designed to treat early- and late-stage diseases. For more information, please visit www.alimerasciences.com.
SIFI is the leading Italian ophthalmic company, focused on eye care since 1935. SIFI designs, manufactures and markets innovative pharmaceutical specialty products, surgical and medical devices. Headquartered in Catania, Sicily, SIFI operates directly in Italy, Romania and Mexico with a staff of over 370 people worldwide. Since June 2015 SIFI is backed by 21 Investimenti, the private equity firm founded by Alessandro Benetton and leader in the Italian mid-market, to support the company's international expansion and portfolio development strategy. For more information, please visit www.sifigroup.com.
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 status of patient reimbursement for ILUVIEN in Italy and Alimera’s expectations regarding the receipt of revenue from the sale of ILUVIEN by its distributor in Italy. 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 sufficiency of insurance reimbursement by the Italian authorities, SIFI’s ability to timely launch ILUVIEN in 2017 in Italy in a meaningful way and to provide adequate promotion, marketing and commercial support for ILUVIEN, and the degree to which physicians and hospitals in Italy accept ILUVIEN for administration to their DME patients, 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, 2015 and Quarterly Report on Form 10-Q for the quarter ended September 30, 2016, which are on file with the Securities and Exchange Commission (SEC) and available on the SEC’s website at www.sec.gov. Additional factors may also be set forth in those sections of Alimera's Annual Report on Form 10-K for the year ended December 31, 2016, to be filed with the SEC in the first quarter of 2017. 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.
Source: Alimera Sciences
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