|By PR Newswire||
|November 29, 2012 07:02 PM EST||
ATLANTA, Nov. 29, 2012 /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today announced that the United Kingdom's National Institute for Health and Clinical Excellence (NICE) has issued final draft guidance indicating that ILUVIEN is not recommended for the treatment of chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies. While the Appraisal Committee acknowledged the clinical effectiveness of ILUVIEN® in the treatment of vision impairment associated with chronic DME considered insufficiently responsive to available therapies, it noted that cost-effectiveness thresholds for the product have not yet been met.
In response to the final draft guidance, Alimera is now developing a Patient Access Scheme (PAS) to address the Appraisal Committee's cost concerns that pose a barrier to access for people in the United Kingdom with chronic DME who might benefit from ILUVIEN. The goal of the PAS will be to determine the appropriate pricing for ILUVIEN in order to ensure that treatment decisions are based on patient need, rather than cost.
Andrew Lotery, Professor of Ophthalmology, University of Southampton, said, "I am very pleased that NICE has recognized that ILUVIEN is clinically effective for chronic diabetic macular oedema. I am hopeful that this sustained-release therapy will become available to the thousands of people affected with diabetes in the United Kingdom."
The International Diabetes Federation estimates that more than 3 million people are currently living with diabetes in the U.K., nearly 200,000 of whom, according to Alimera's estimates, suffer with vision loss from DME.
"In recognition of the ongoing process with NICE, we have immediately begun to develop a Patient Access Scheme which, if accepted, will make ILUVIEN available to all chronic DME patients in the United Kingdom considered insufficiently responsive to available therapies," said Dan Myers, president and chief executive officer, Alimera.
ILUVIEN (190 micrograms fluocinolone acetonide intravitreal implant in applicator) is a sustained release intravitreal implant used to treat 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 (FAc). 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 Study, the most frequently reported adverse drug reactions included cataract operation, cataract and increased ocular pressure.
In July 2010, Alimera submitted a Marketing Authorization Application (MAA) to seven European countries via the Decentralized Procedure (DCP) with the Medicines and Healthcare products Regulatory Agency of the U.K. (MHRA) serving as the Reference Member State (RMS). The MAA included data from two Phase 3 pivotal clinical trials (collectively known as the FAME™ Study) for ILUVIEN conducted by Alimera. The trials involved 956 patients in sites across the United States, Canada, Europe and India to assess the efficacy and safety of ILUVIEN for the treatment of DME. At the end of the DCP, a consensus was reached by the RMS and the other six countries that the MAA for ILUVIEN was approvable. To date, five of the seven countries, Austria, the United Kingdom, Portugal, France and Germany have granted national licenses for ILUVIEN. ILUVIEN has not been approved by the United States Food and Drug Administration.
About Alimera Sciences, Inc.
Alimera Sciences, Inc., based in Alpharetta, Georgia, is a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals. Presently Alimera is focused on diseases affecting the back of the eye, or retina. Its primary product, ILUVIEN, is an intravitreal implant containing fluocinolone acetonide (FAc), a non-proprietary corticosteroid with demonstrated efficacy in the treatment of ocular disease.
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 commercial plans for ILUVIEN in the United Kingdom. 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, NICE's acceptance of the Patient Access Scheme, uncertainty as to Alimera's ability to commercialize, and market acceptance of ILUVIEN in the United Kingdom, and 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, 2011 and Quarterly Report on Form 10-Q for the quarter ended September 30, 2012, 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.
For press inquiries:
Katie Brazel, Fleishman-Hillard
for Alimera Sciences
For investor inquiries:
John Mills, ICR
for Alimera Sciences
SOURCE Alimera Sciences, Inc.
The WebRTC Meetup, where WebRTC enthusiasts exchange ideas, is being held on Wednesday, June 10, from 7 pm – 9 pm at the 4th WebRTC Summit, June 9-11, 2015, at the Javits Center in New York City, NY. The WebRTC Meetup is being hosted by the New York WebRTC Developer Group. WebRTC is the future of browser-to-browser communications, and continues to make inroads into the traditional, difficult, plug-in web communications world. The 4th WebRTC Summit continues our tradition of delivering the late...
Jun. 3, 2015 01:30 PM EDT Reads: 198
SYS-CON Events announced today that O'Reilly Media has been named “Media Sponsor” of SYS-CON's 16th International Cloud Expo®, which will take place on June 9–11, 2015, at the Javits Center in New York City, NY. O'Reilly Media spreads the knowledge of innovators through its books, online services, magazines, and conferences. Since 1978, O'Reilly Media has been a chronicler and catalyst of cutting-edge development, homing in on the technology trends that really matter and spurring their adoption...
Jun. 3, 2015 01:30 PM EDT Reads: 1,261
The basic integration architecture, as defined by ESBs, hasn’t changed for more than a decade. Most cloud integration providers still rely on an ESB architecture and their proprietary connectors. As a result, enterprise integration projects suffer from constraints of availability and reliability of these connectors that are not re-usable across other integration vendors. However, the rapid adoption of APIs and almost ubiquitous availability of APIs amongst most SaaS and Cloud applications are ra...
Jun. 3, 2015 01:30 PM EDT Reads: 845
ProfitBricks has an early preview of its new Docker hosting platform. The ProfitBricks Docker platform enables its customers to build fully-portable applications within the ProfitBricks cloud. Unlike other Docker platforms, ProfitBricks’ Docker provides developers and system administrators with a platform with dedicated resources that autoscales the Docker hosts. Early access customers will be able to utilize up to 2,500 CPU core hours as part of ProfitBricks’ early access Docker preview.
Jun. 3, 2015 01:30 PM EDT Reads: 409
The 17th International Cloud Expo has announced that its Call for Papers is open. 17th International Cloud Expo, to be held November 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA, brings together Cloud Computing, APM, APIs, Microservices, Security, Big Data, Internet of Things, DevOps and WebRTC to one location. With cloud computing driving a higher percentage of enterprise IT budgets every year, it becomes increasingly important to plant your flag in this fast-expanding bu...
Jun. 3, 2015 01:15 PM EDT Reads: 4,469
The 4th International Internet of @ThingsExpo, co-located with the 17th International Cloud Expo - to be held November 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA - announces that its Call for Papers is open. The Internet of Things (IoT) is the biggest idea since the creation of the Worldwide Web more than 20 years ago.
Jun. 3, 2015 01:15 PM EDT Reads: 2,043
SYS-CON Events announced today that SUSE, a pioneer in open source software, will exhibit at SYS-CON's DevOps Summit 2015 New York, which will take place June 9-11, 2015, at the Javits Center in New York City, NY. SUSE provides reliable, interoperable Linux, cloud infrastructure and storage solutions that give enterprises greater control and flexibility. More than 20 years of engineering excellence, exceptional service and an unrivaled partner ecosystem power the products and support that help ...
Jun. 3, 2015 01:15 PM EDT Reads: 1,285
It’s no news that microservices are one of the top trends, if not the top trend, in application architectures today. Take large monolithic applications which are brittle and difficult to change and break them into smaller manageable pieces to provide flexibility in deployment models, facilitating agile release and development to meet today’s rapidly shifting digital businesses. Unfortunately, with this change, application and infrastructure management is more complex due to size and technology c...
Jun. 3, 2015 01:15 PM EDT Reads: 168
IBM has acquired Blue Box Group, Inc., a managed private cloud provider built on OpenStack. Customers benefit from the ability to more easily deploy workloads across hybrid cloud environments. Financial details were not disclosed. Enterprises are seeking ways to embrace all types of cloud to address a wide range of workloads. Today's announcement reinforces IBM's commitment to deliver flexible cloud computing models that make it easier for customers to move to data and applications across cloud...
Jun. 3, 2015 01:15 PM EDT Reads: 515
"Cloud consumption is something we envision at Solgenia. That is trying to let the cloud spread to the user as a consumption, as utility computing. We want to allow the people to just pay for what they use, not a subscription model," explained Ermanno Bonifazi, CEO & Founder of Solgenia, in this SYS-CON.tv interview at Cloud Expo, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
Jun. 3, 2015 01:00 PM EDT Reads: 3,766
Platform as a Service vendors in public cloud are mostly focused on the platform for Java, PHP, Python, Ruby and other programming languages. But what about C/C++ and COBOL apps, which continue to be mission-critical for enterprises? Do you bring such apps to the cloud? If so, what are the options for transitioning to cloud? Or would you rather leave such apps on-premises, possibly in a private cloud, and only worry about integrating these applications with new applications in the cloud?
Jun. 3, 2015 01:00 PM EDT Reads: 183
SYS-CON Events announced today that BMC will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. BMC delivers software solutions that help IT transform digital enterprises for the ultimate competitive business advantage. BMC has worked with thousands of leading companies to create and deliver powerful IT management services. From mainframe to cloud to mobile, BMC pairs high-speed digital innovation with robust...
Jun. 3, 2015 12:45 PM EDT Reads: 1,476
Imagine a world where targeting, attribution, and analytics are just as intrinsic to the physical world as they currently are to display advertising. Advances in technologies and changes in consumer behavior have opened the door to a whole new category of personalized marketing experience based on direct interactions with products. The products themselves now have a voice. What will they say? Who will control it? And what does it take for brands to win in this new world? In his session at @Thi...
Jun. 3, 2015 12:45 PM EDT Reads: 1,017
DevOps Summit, taking place Nov 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with 17th Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. The widespread success of cloud computing is driving the DevOps revolution in enterprise IT. Now as never before, development teams must communicate and collaborate in a dynamic, 24/7/365 environment. There is no time to wait for long developmen...
Jun. 3, 2015 12:30 PM EDT Reads: 2,440
17th Cloud Expo, taking place Nov 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA, will feature technical sessions from a rock star conference faculty and the leading industry players in the world. Cloud computing is now being embraced by a majority of enterprises of all sizes. Yesterday's debate about public vs. private has transformed into the reality of hybrid cloud: a recent survey shows that 74% of enterprises have a hybrid cloud strategy. Meanwhile, 94% of enterprises a...
Jun. 3, 2015 12:30 PM EDT Reads: 2,437