ATLANTA, Nov. 14, 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 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.
About ILUVIEN®
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.
For
press inquiries:
Katie
Brazel, Fleishman-Hillard
for
Alimera Sciences
404-739-0150
Katie.Brazel@fleishman.com
|
For investor inquiries:
John Mills, ICR
for Alimera Sciences
310-954-1105
John.Mills@ICRINC.com
|
SOURCE Alimera Sciences, Inc.