Alimera Sciences Signs Agreement For Exclusive Distributor Of ILUVIEN In France
Published: Aug 30, 2017
ATLANTA, Aug. 29, 2017 (GLOBE NEWSWIRE) -- Alimera Sciences, Inc. (NASDAQ:ALIM) (Alimera), a pharmaceutical company that specializes in the commercialization and development of prescription ophthalmic pharmaceuticals, today announced that Alimera Sciences Limited, its European subsidiary based in the United Kingdom, has signed a distribution agreement with Horus Pharma S.A.S. (Horus). Under the agreement, Horus will serve as Alimera’s exclusive distributor in France for ILUVIEN®, Alimera's sustained release intravitreal injection for the treatment of diabetic macular edema.
Horus will negotiate with the Comité Economique des Produits de Santé, the Union Nationale des Caisses d’Assurance Maladie, the French National Authority for Health and other French regulatory authorities regarding the appropriate public price and confidential net price for reimbursement for ILUVIEN. In addition, Horus will handle promotion, marketing and commercial activities in France for ILUVIEN.
“ILUVIEN’s unique continuous microdosing enables patients to receive treatment consistently every day for up to three years, which we believe can make a major difference to patients with DME in France,” said Dan Myers, Chief Executive Officer of Alimera. “With the knowledge and experience that the Horus team brings in pricing and reimbursement in France, we are optimistic that this partnership will allow French patients suffering from DME access to ILUVIEN.”
“We are extremely pleased and proud to be the exclusive partner of Alimera Sciences for the distribution of ILUVIEN in France, which represents a great treatment opportunity for patients with DME,” said Claude Claret, Managing Director of Horus Pharma. “At Horus Pharma, we have been developing and looking for innovative products in the field of ophthalmology, in order to provide sustainable and affordable solutions for patients. Today’s announcement is the beginning of a process of providing widespread patient access to a unique treatment, in France.”
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 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 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 Horus Pharma S.A.S.
Founded in 2003, Horus Pharma is an independent French laboratory specialized in ophthalmology. Horus Pharma develops, patents and markets products designed to facilitate eye and eyelid healthcare. Horus Pharma operates in most segments related to ophthalmology and develops practical innovations that combine efficacy and safety. Focused on patient safety, our laboratory has developed recognized expertise in the development of preservative-free formulations and product delivery systems. For further details, please visit www.horus-pharma.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, Alimera’s expectations with respect to access to ILUVIEN for French 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, Horus’ ability to launch ILUVIEN in France, Horus’ ability to successfully negotiate a price for ILUVIEN with the French regulatory authorities, Horus’ ability to provide adequate promotion, marketing and commercial support for ILUVIEN, the acceptance by physicians in France of ILUVIEN for use with their DME patients, and the acceptance of ILUVIEN by payers in France, 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 and Quarterly Report on Form 10-Q for the quarter ended June 30, 2017, 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 be set forth in those sections of Alimera’s Quarterly Report on Form 10Q for the quarter ending September 30, 2017, to be filed in the fourth quarter 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.
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