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Brill Pharma S.L. to also serve as agent in price negotiations with the Spanish Ministry of Health
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 agreement with Brill Pharma S. L. (Brill Pharma), Barcelona, Spain, for distribution of ILUVIEN® in the Kingdom of Spain, Alimera's sustained release intravitreal injection for the treatment of diabetic macular edema.
Under the terms of this agreement, Brill Pharma will handle promotion, marketing and commercial activities in Spain for ILUVIEN. In addition, Brill will negotiate with the Spanish Ministry of Health on the appropriate confidential net price for reimbursement of ILUVIEN within the Spanish National Health System, as well as on the public price.
"As a continuous microdosing treatment that lasts for up to three years, ILUVIEN can make a major difference to patients with DME in Spain," said Dan Myers, President and Chief Executive Officer of Alimera. "With the help of Brill Pharma's experienced team, we expect to reach Spanish patients and their physicians with a truly innovative product that can consistently treat their disease every day and markedly improve their quality of life."
"Spain has a strong tradition in the use of corticosteroids being one of the largest markets in Europe. The introduction of ILUVIEN will represent a substantial improvement in the long term management of the pathology and the quality of life of a significant number of patients. Brill Pharma will be the first pharmaceutical company with Spanish capital, marketing an innovative intravitreal product in diabetic macular edema," said Dr. Jordi Martinez Rotllan, Chief Executive Officer of Brill Pharma.
ILUVIEN (fluocinolone acetonide intravitreal implant) 0.19 mg is a sustained release intravitreal implant indicated in the E.U. 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.
About Brill Pharma S. L.
Brill Pharma, the Spanish subsidiary of Bristol Laboratories U.K., is based in Barcelona, Spain and was established in September 2012. It markets innovative products in ophthalmology, is already ranked fourth in this specific segment of the Spanish pharma market and was recently recognized as the fastest growing Spanish pharma company in its segment. The company employs more than 60 medical representatives covering Spain. For further details, please visit www.brillpharma.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, that Alimera believes it will reach Spanish patients and physicians with Brill Pharma's team. 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, Brill Pharma's ability to launch ILUVIEN in 2017 in Spain, Brill Pharma's ability to successfully negotiate a price for ILUVIEN with the Spanish Ministry of Health, Brill Pharma's ability to provide adequate promotion, marketing and commercial support for ILUVIEN, physician's in Spain will acceptance ILUVIEN for use with their DME patients, and ILUVIEN acceptance by various institutions in the Spain, 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, 2016, which is 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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