Medis will enable immediate access of ILUVIEN to patients in Austria, and will manage reimbursement negotiations for ILUVIEN in the Czech Republic
ATLANTA, Sept. 15, 2020 (GLOBE NEWSWIRE) — Alimera Sciences, Inc. (NASDAQ: ALIM) (Alimera), a pharmaceutical company that specializes in the development and commercialization of prescription ophthalmic pharmaceuticals, announces that Alimera Sciences Europe Limited, its Ireland-based European subsidiary, has signed a distribution agreement with Medis Pharmaceutical Company d.o.o. (Medis) for the exclusive sales and distribution of ILUVIEN® in the Czech Republic and Austria. ILUVIEN is Alimera’s sustained release intravitreal injection approved in these countries for both the treatment of vision impairment associated with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies and prevention of relapse in recurrent non-infectious uveitis affecting the posterior segment (NIPU).
Medis will immediately assume responsibility for promotion, marketing and commercial activities in Austria where ILUVIEN is currently reimbursed. Additionally, Medis will commence negotiations in the Czech Republic with the State Institute for Drug Control regarding the appropriate public price and confidential net price for reimbursement of ILUVIEN in advance of the initiation of promotion, marketing and commercial activities.
“This agreement furthers Alimera’s strategic objective to continue increasing the availability of ILUVIEN in additional European countries to treat patients suffering from both DME and NIPU,” said Rick Eiswirth, President and Chief Executive Officer of Alimera. “Medis, with their strong growth and commitment to these markets, makes them a partner of choice, and we are pleased to be working with them as we expand the ILUVIEN franchise globally.”
“We are extremely pleased to partner with Alimera to offer ILUVIEN to our customers in both Austria and the Czech Republic,” added Martina Perharic, Medis’ Chief Executive Officer. “ILUVIEN’s CONTINUOUS MICRODOSINGTM technology enables consistent treatment every day for up to three years to reduce the recurrence of disease, which we believe is highly important to physicians and the patients they serve.”
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™ 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 these same 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, the Czech Republic, 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 Medis d.o.o.
Medis Pharmaceutical Company is a leading independent medical marketing company focused on commercialization of innovative pharmaceutical products, with emphasis on specialty drugs, medical equipment and self-care brands. Medis aims at making the most advanced and effective medical treatments accessible to every patient in the Central and Eastern Europe (CEE) region that represent up to 70 million potential customers. Its fully owned subsidiaries across the CEE region are leveraging its marketing know-how, scientific expertise and product knowledge. It is headquartered in Ljubljana, Slovenia, founded in 1989, and employs more than 350. Learn more about Medis at www.medis.health/en/
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 Medis’ success in managing negotiations for funding in the Czech Republic and promoting ILUVIEN in Austria and the Czech Republic. 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 the Company’s expectations, 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 acceptance of ILUVIEN by payers in the Czech Republic, Medis’ ability to launch ILUVIEN in Austria or the Czech Republic, Medis’ ability to provide adequate promotion, marketing and commercial support for ILUVIEN, the acceptance by physicians in Austria and the Czech Republic of ILUVIEN for use in their DME and NIPU 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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