ATLANTA, GEORGIA and MONTREAL, QUEBEC–(Marketwired – Jul 21, 2015) – Alimera Sciences, Inc. (NASDAQ:ALIM) (“Alimera”), a pharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced that it has signed an exclusive agreement with Knight Therapeutics Inc. (TSX:GUD) (“Knight”), a leading Canadian specialty pharmaceutical company, for the distribution in Canada of ILUVIEN®, Alimera’s sustained release intravitreal implant for the treatment of diabetic macular edema. Under the terms of this agreement, Knight will also handle all regulatory and commercial activities for ILUVIEN in Canada. ILUVIEN currently is not approved for sale in Canada.
“We are excited to be working with Knight, whom we believe is well-positioned to assist us in obtaining regulatory approval for ILUVIEN in Canada and subsequently launching the product there,” said Dan Myers, President and CEO of Alimera. “They are adept at introducing innovative products to the Canadian market, and we look forward to developing a successful partnership.”
It is estimated that there are more than two million Canadians who have diabetes, approximately 2.5% of whom suffer from visual impairment due to diabetic macular edema.
“We are pleased to partner with Alimera to bring ILUVIEN to Canada,” said Jonathan Ross Goodman, President and CEO of Knight. “ILUVIEN is a unique product that addresses a clear unmet need for patients suffering from diabetic macular edema, and we are very excited about the prospect of making it available to Canadian patients.”
ILUVIEN (fluocinolone acetonide intravitreal implant) 0.19 mg is a sustained release intravitreal implant approved in the U.S. 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. Each ILUVIEN implant is designed to release submicrogram levels of fluocinolone acetonide (FAc), a corticosteroid, for 36 months.
Corticosteroids have a history of effective use in treating ocular disease inflammation. ILUVIEN is injected in the back of the patient’s eye with an applicator that employs a 25-gauge needle, which allows for a self-sealing wound. In the FAME™ Study, a phase 3 clinical study of ILUVIEN, the primary endpoint of improvement in vision of 15 letters or more was demonstrated at 24 months and the most frequently reported adverse drug reactions included cataract development and increased ocular pressure.
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.
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 regulatory status and availability of ILUVIEN in Canada and assumptions regarding the prevalence of DME in Canada. 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 partner’s ability to obtain regulatory approval for and commercialize ILUVIEN in Canada, 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 and Quarterly Report on Form 10-Q for the quarter ended March 31, 2015, which are 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.
About Knight Therapeutics Inc.
Knight Therapeutics Inc., headquartered in Montreal, Canada, is a specialty pharmaceutical company focused on acquiring or in-licensing innovative pharmaceutical products for the Canadian and select international markets. Knight’s shares trade on TSX under the symbol GUD. For more information about Knight, please visit the company’s web site at www.gud-knight.com or www.sedar.com.
Knight Forward-Looking Statement
This document contains forward-looking statements for Knight and its subsidiaries. These forward looking statements, by their nature, necessarily involve risks and uncertainties that could cause actual results to differ materially from those contemplated by the forward-looking statements. Knight considers the assumptions on which these forward-looking statements are based to be reasonable at the time they were prepared, but cautions the reader that these assumptions regarding future events, many of which are beyond the control of Knight and its subsidiaries, may ultimately prove to be incorrect. Factors and risks, which could cause actual results to differ materially from current expectations are discussed in Knight’s Annual Report and in Knight’s Annual Information Form for the year ended December 31, 2014. Knight disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information or future events, except as required by law.