ATLANTA, Aug. 13, 2020 (GLOBE NEWSWIRE) -- Alimera Sciences, Inc. (NASDAQ: ALIM) (Alimera), a pharmaceutical company that specializes in the development and commercialization of prescription ophthalmic pharmaceuticals, today announced that its Ireland-based European subsidiary, Alimera Sciences Europe Limited, has signed a distribution agreement with Nordic Prime ApS to serve as Alimera’s distribution partner in Denmark, Finland, Norway and Sweden for ILUVIEN® 190 micrograms intravitreal implant in applicator. ILUVIEN is approved in these territories for the treatment of vision impairment associated with chronic diabetic macular edema considered insufficiently responsive to available therapies and for prevention of relapse in recurrent non-infectious uveitis affecting the posterior segment of the eye.
Under the Agreement, Nordic Prime will engage in hospital tendering activities to secure purchasing agreements of ILUVIEN across the Nordic region and is responsible for shipping of orders and maintaining all back-office support for Nordic customers.
“We continue to advance our strategy of geographically expanding the availability of ILUVIEN into additional countries to increase our global market share and sales,” said Rick Eiswirth, President and Chief Executive Officer of Alimera. “Working with Nordic Prime enables us to supply ILUVIEN to hospitals and physicians in the Nordic region of Europe, where more than 100,000 patients are estimated to suffer from either diabetic macular edema or non-infectious posterior uveitis.”
“We are extremely pleased to be a part of Alimera’s strategic commercial expansion in the Nordic European countries,” said Patricio Aguirre, Managing Director of Nordic Prime. “We believe ILUVIEN’s ability to control the recurrence of debilitating retinal diseases and improve patients’ vision with fewer injections, will provide significant benefits to Nordic physicians and their patients.”
Alimera’s primary product is ILUVIEN (fluocinolone acetonide intravitreal implant) 0.19 mg sustained release intravitreal implant, injected into the back of the eye. With its CONTINUOUS MICRODOSING™ Delivery technology, ILUVIEN is designed to release sub-microgram levels of fluocinolone acetonide, a corticosteroid, for 36 months, to reduce the recurrence of disease, enabling patients to maintain vision longer with fewer injections. ILUVIEN is approved in the U.S., Canada, Kuwait, Lebanon and the U.A.E 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. In 17 European countries, ILUVIEN is indicated for the treatment of vision impairment associated with chronic DME considered insufficiently responsive to available therapies. In March 2019, ILUVIEN received approval in the 17 countries under the Mutual Recognition Procedure for prevention of relapse in recurrent non-infectious uveitis affecting the posterior segment of the eye. The 17 European countries include the U.K., Germany, France, Italy, Spain, Portugal, Ireland, Austria, Belgium, Denmark, Norway, Finland, Sweden, Poland, Czechia, the Netherlands, and Luxembourg. The non-infectious posterior uveitis indication for ILUVIEN was launched in Germany and the U.K. in 3Q 2019. ILUVIEN is not approved for treatment of uveitis in the United States.
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 Non-Infectious Posterior Uveitis (NIPU)
Posterior segment non-infectious uveitis is a chronic, inflammatory disease affecting the posterior segment of the eye, often involving the retina, and is a leading cause of blindness in developed and developing countries. It affects people of all ages, producing swelling and destroying eye tissues, which can lead to severe vision loss and blindness. Patients with NIPU are typically treated with systemic steroids, which are effective, but over time frequently lead to serious side effects, ranging from acne, weight gain, sleep and mood disorders to hypertension and osteoporosis that can limit effective dosing. Patients then often progress to steroid-sparing therapy with systemic immune suppressants or biologics, which also can have severe side effects, including an increased risk of cancer and infection. As a result, there remains a significant need for new therapies with improved efficacy, tolerability, and safety profiles to manage this disease.
About Alimera Sciences, Inc.
Alimera Sciences is a pharmaceutical company that specializes in the commercialization and development 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 affect millions of people in our aging populations. For more information, please visit www.alimerasciences.com.
About Nordic Prime
Nordic Prime is a private owned Danish pharmaceutical distributor, selling to pharmacies and hospitals within the Nordic region. http://www.nordicprime.dk/
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, Alimera’s expectations with respect to access to ILUVIEN for Nordic hospitals and patients. 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, Nordic Prime’s ability to launch ILUVIEN in the Nordic countries, Nordic Prime’s ability to successfully obtain tender business for ILUVIEN, the acceptance by physicians in the Nordic countries of ILUVIEN for use with DME and posterior uveitis 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, 2019 and Quarterly Reports on Form 10-Q for the quarters ended March 31, 2020 and June 30, 2020, which are on file with the Securities and Exchange Commission (SEC) and available on the SEC’s website at www.sec.gov.
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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