ATLANTA, Aug. 13, 2015 /PRNewswire/ -- Alimera Sciences, Inc. (NASDAQ: ALIM) (Alimera), a pharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced that Alimera Sciences Limited, its European subsidiary based in London, has signed an exclusive five-year agreement with Societa Industria Farmaceutica Italiana S.p.A. (SIFI), headquartered in Catania, Italy, for distribution of ILUVIEN® in Italy, San Marino and Vatican City. Under the terms of this agreement, SIFI will handle all promotion, marketing and commercial activities in those locations for ILUVIEN, Alimera's sustained release intravitreal injection for the treatment of diabetic macular edema.
"We are very pleased to have entered into this agreement with SIFI for commercialization of ILUVIEN in Italy, San Marino and Vatican City," said Dan Myers, president and chief executive officer of Alimera. "SIFI's long history in Italian ophthalmology, together with its robust portfolio of more than 50 ophthalmic pharmaceutical products, makes it the ideal partner for bringing ILUVIEN to the Italian market."
Under the agreement, which has a term of five years and is automatically renewable for three years, SIFI has the responsibility for pursuing reimbursement of ILUVIEN as an H Class designation. SIFI has a proven track record in obtaining market authorization and reimbursement in Italy for proprietary and licensed ophthalmic pharmaceuticals and medical devices during its 80-year history. Royalty payments will be based on net sales.
"At SIFI, we pride ourselves on providing ophthalmologists with a full range of products to address their patients' eye care needs," said Fabrizio Chines, executive chairman of SIFI SpA. "With the addition of the multiyear ILUVIEN implant, we can now offer the most advanced treatment for diabetic macular edema, which we believe will strategically complement our existing portfolio and leverage our strong relationships with Italian ophthalmologists and eye hospitals."
ILUVIEN (190 micrograms intravitreal implant in applicator) is a sustained release intravitreal implant used to treat patients with diabetic macular edema (DME). Each ILUVIEN implant delivers sustained multiyear 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 two phase 3 clinical trials of ILUVIEN, collectively known as the FAME Study™, the most frequently reported adverse drug reactions included cataract development and increased ocular pressure. For more information, please visit www.iluvien.com.
ILUVIEN® is approved for marketing in Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Ireland, Italy, Luxembourg, the Netherlands, Norway, Poland, Portugal, Spain, Sweden, the United Kingdom, and the United States, and is commercially available in the United States, the United Kingdom, Germany and Portugal.
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 from London by its subsidiary, Alimera Sciences Limited. 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, operates directly in Italy, Romania and Mexico with a staff of over 330 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.
Alimera 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 ability of the parties to obtain reimbursement approvals, successfully commercialize ILUVIEN®, the complementary nature of ILUVIEN to existing products of SIFI, the ability of SIFI to leverage existing relationships and the availability of ILUVIEN® in Italy, San Marino and Vatican City. 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, uncertainty as to Alimera's and its distributor's ability to commercialize, and market acceptance of, ILUVIEN® in Italy., 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, which is 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 Quarterly Report on Form 10-Q for the quarter ended June 30, 2015 and Alimera's Quarterly Report on Form 10-Q for the quarter ended March 31, 2015 filed with the SEC. 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, Inc.