ATLANTA and MELBOURNE, Australia, April 28, 2014 /PRNewswire/ -- Alimera Sciences, Inc. (NASDAQ: ALIM) (Alimera), a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced that it has signed an exclusive five-year agreement with Specialised Therapeutics Australia (STA) for the distribution in Australia and New Zealand of ILUVIEN®, Alimera's sustained release intravitreal injection for the treatment of diabetic macular edema. Under the terms of this agreement, STA also will handle all regulatory and commercial activities for ILUVIEN in those countries.
The agreement between Alimera and STA will include a milestone payment to Alimera for achievement of a public reimbursement listing and a royalty payment based on net sales that will increase as a specific sales target is met.
"We are very pleased to have entered into this deal with STA for commercialization of ILUVIEN in Australia and New Zealand," said Dan Myers, president and chief executive officer of Alimera. "STA is the only private pharmaceutical company in Australia dedicated to specialty pharma products. Not only do they have a proven track record of successful product launches, but they also consistently top the IMS physician surveys for having the most highly qualified and experienced sales force."
ILUVIEN (190 micrograms intravitreal implant in applicator) is a sustained release intravitreal implant indicated in Europe for the treatment of vision impairment associated with chronic DME considered insufficiently responsive to available therapies. Each ILUVIEN implant provides a therapeutic effect of up to 36 months by delivering sustained sub-microgram levels of fluocinolone acetonide. ILUVIEN is injected in the back of the patient's eye to a position that takes advantage of the eye's natural fluid dynamics. The applicator employs a 25-gauge needle, which allows for a self-sealing wound. In the FAME(TM) Study, the most frequently reported adverse drug reactions included cataract development and increased ocular pressure. ILUVIEN has not been approved for sale in the U.S.
About Alimera Sciences, Inc.
Alimera Sciences, Inc., headquartered in Alpharetta, Georgia, is a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals. Alimera's European operations are conducted from London by its wholly-owned subsidiary, Alimera Sciences Limited. For more information, visit www.alimerasciences.com.
About Specialised Therapeutics Australia Pty Ltd.
Specialised Therapeutics Australia Pty Ltd. (STA) is a biopharmaceutical company dedicated to working with leading pharmaceutical companies worldwide to provide acute care therapies for high unmet medical needs to people living in Australia and New Zealand. The STA therapeutic portfolio and pipeline at present encompasses oncology, hematology, ophthalmology and infectious diseases. STA also has interests in the therapeutic areas of respiratory, dermatology, endocrinology and central nervous system (CNS). Additional information can be found at http://www.specialisedtherapeutics.com.au.
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 potential commercialization of ILUVIEN in Australia and New Zealand. 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 the ability of STA to perform the contracted services, such as obtaining marketing authorization and pricing and reimbursement approval for ILUVIEN in Australia and New Zealand; STA's ability to distribute, promote, market and sell ILUVIEN in Australia and New Zealand; the timing and scope of the marketing authorizations, as well as the level of pricing obtained in Australia; and the timing and success of commercial sales, if any, of ILUVIEN in Australia and New Zealand, 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, 2013, 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.
For press inquiries: For investor inquiries: Katie Brazel, Fleishman Hillard John Mills, ICR for Alimera Sciences for Alimera Sciences 404-739-0150 310-954-1105 Katie.Brazel@fleishman.com John.Mills@ICRINC.com
SOURCE Alimera Sciences, Inc.