Healthcare Industry News: fluocinolone acetonide
News Release - November 14, 2012
Alimera Sciences Names European Management TeamATLANTA, Nov. 14, 2012 -- (Healthcare Sales & Marketing Network) -- Alimera Sciences, Inc., (ALIM) (Alimera), a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced the appointment of the management team that will oversee European commercialization of its lead product, ILUVIEN®. Philip Ashman, Ph.D., has been named senior vice president and European managing director, while Eric Teo, MBBS, will serve as vice president and European medical director and Anne-Marie Swift will serve as vice president and European marketing director.
"I am delighted to welcome these talented individuals to Alimera. We believe their broad pharmaceutical experience, and knowledge of the European ophthalmic market, will be integral to achieving our goal of a successful launch of the product in Europe," said Dan Myers, president and chief executive officer, Alimera. "We are confident in this team's ability to drive not only European sales of ILUVIEN in our initial launch markets, but also the development of our long term strategy in Europe."
"ILUVIEN is the first sustained release treatment option for the many patients in Europe suffering from chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies. It is a very exciting time to be joining Alimera Sciences and to have the opportunity to lead the commercial launch of this brand in Europe," said Dr. Ashman. "This is a significant step for the company and the many patients with chronic DME."
Dr. Ashman brings to Alimera more than 20 years of experience in all aspects of pharmaceutical management. During his career, he has held numerous leadership roles, including serving as vice president at Bayer, responsible for setting strategy and early preparations for specialty medicines. He also served at Bayer as Regional Business Unit Head (Europe) in Oncology, responsible for the delivery of oncology sales and profitability targets in Europe, Canada, the Middle East and Africa. Most recently, he has been responsible for leadership of the market access strategy in the U.K. for Bayer, covering numerous therapy areas including ophthalmology. Dr. Ashman holds a doctorate in biochemistry from the University of London: Royal Holloway and Bedford, U.K., and a Bachelor of Science degree in biochemistry from the University College London, U.K.
Following a career as a physician, Eric Teo, MBBS, MBA, FFPM, FRCP, LLM, moved on to the pharmaceutical industry where he has spent more than 11 years in various roles in medical and regulatory affairs, most recently serving as director of global regulatory affairs, health and personal care for Reckitt Benckiser. While there, he established the European medical and regulatory team following the company's acquisition of Boots Healthcare and led several successful European product launches. Dr. Teo trained as a physician at the University of Melbourne, Australia. He is a Fellow of the Royal College of Physicians and Surgeons (Glasgow) and a Fellow of the Faculty of Pharmaceutical Medicine, Royal College of Physicians, U.K. In addition to a postgraduate diploma in medicine, Dr. Teo also holds a MBA from London Business School and a LLM from BPP Law School, London.
Trained as a registered nurse, Anne-Marie Swift has broad experience as a senior market leader in ophthalmic pharmaceuticals. Prior to joining Alimera, Ms. Swift served as European brand director for ophthalmology at Pfizer Limited, focusing on glaucoma and retina treatments. In this role, she managed all aspects of marketing for Xalatan® and Xalacom® across Europe, including development of the medical education programs and key opinion leaders for the brands. Ms. Swift earned a registered general nursing (RGN) degree from St. Helens and Knowsley School of Nursing, Merseyside, a renal and urology specialist nursing degree from Oxford School of Nursing, Oxford, and a Bachelor of Arts in health studies from Oxford Brookes University.
ILUVIEN (190 micrograms fluocinolone acetonide intravitreal implant in applicator) is a sustained release intravitreal implant used to treat patients 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 Alimera's 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 for ILUVIEN conducted by Alimera (collectively known as the FAME Study). 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. Alimera Sciences Limited, a wholly owned subsidiary of Alimera, is headquarters of Alimera's European operations in London. 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 Germany, the UK and France. 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 ability to commercialize, and market acceptance of, ILUVIEN in the EU, 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, 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.
Source: Alimera Sciences
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