Abbott Laboratories 2015 Annual Report Download - page 72

FINANCIAL REVIEW
ABBOTT 2015 ANNUAL REPORT
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Medical Optics—Abbott is developing a number of new products
which are designed to enhance surgical eciency and/or improve
visual outcomes for patients undergoing cataract and LASIK
surgery. In 2015, Abbott launched the TECNIS® Monofocal 1-Piece
intraocular lens (IOL) with the TECNIS iTec Preloaded Delivery
System in the U.S. The TECNIS iTec Preloaded Delivery System
isdesigned to provide an additional level of safety and surgical
eciency to the outcomes already provided by the TECNIS®
Monofocal 1-Piece IOL. The TECNIS® Multifocal Low Add prod-
ucts were launched in the U.S. and provide surgeons the ability to
customize treatment based on the patient’s vision needs and life-
style. The WHITESTAR Signature® Pro phacoemulsification
system for removal of cataracts was approved and launched in the
U.S.; this system includes a first of its kind application designed for
iPad® mobile digital devices that gives surgeons the opportunity to
download and analyze data to improve surgical eciency. The
iDESIGN® Advanced WaveScan Studio System was launched in
the U.S. and China; this system provides a high-definition scan of
the eye that can be used to create a personalized LASIK treatment
plan based on the unique “blueprint” of each person’s eyes.
In 2016, Abbott will continue to develop next generation equip-
ment and consumables,including improvements to the LASIK
platform with upgrades to its iDesign system and a new Eximer
Laser, as well as upgrades to the Catalys laser cataract surgery
system. Abbott will seek approval to launch existing products into
new markets to better leverage its product portfolio.
Molecular Diagnostics—Various new molecular in vitro diagnostic
(IVD) products and next generation instrument systems are in
various stages of development and commercialization. Abbott’s
companion diagnostic program includes collaborative eorts with
multiple major pharmaceutical companies.
Core Laboratory Diagnostics—Abbott is working on the development
of next-generation blood screening, hematology, and immu-
nochemistry instrument systems, as well as assays in various areas
including infectious disease, cardiac care, metabolics, oncology,
and automation solutions to increase eciency in laboratories.
Diabetes Care—In 2015, Abbott completed its clinical outcome
trial, Replace, for its FreeStyle Libre Flash Glucose Monitoring
System in people with Type 2 diabetes. The system eliminates the
need for routine finger pricks by reading glucose levels through a
sensor that can be worn on the back of the upper arm for up to
14days. The FreeStyle Libre System also requires no finger pricks
for calibration. In 2014, Abbott received CE Mark in Europe for
the FreeStyle Libre System and in 2015 it also received CE Mark
for an indication for children and young people with diabetes ages
4-17 years old. FreeStyle Libre Pro, which is designed to be used
byhealthcare professionals in a clinic setting, was launched to
patients in India and the PMA for FreeStyle Libre Pro was submit-
ted in the U.S.
Nutrition—Abbott is focusing its research and development spend
on platforms that span the pediatric, adult and performance nutri-
tion areas:gastro intestinal health, brain health, mobility and
metabolism, and user experience platforms. Numerous new prod-
ucts that build on advances in these platforms are currently under
development, including clinical outcome testing, and are expected
to be launched over the coming years.
AREAS OF FOCUS
In 2016 and beyond, Abbott’s significant areas of therapeutic
focuswill include the following:
Established Pharmaceuticals—Abbott focuses on building country
specific portfolios made up of global and local pharmaceutical
brands that best meet the needs of patients in each country. More
than 300 branded generic development projects are active for
oneor several emerging markets. Over the next several years,
Established Pharmaceuticals plans to expand its product portfolio
in its key markets through the development and launch of new
branded generics with the aim to be among the first to market
with a new branded generic for a particular pharmaceutical prod-
uct, further geographic expansion of existing brands, new product
enhancements, and strategic licensing activities. Abbott is also
actively working on the further development of several key brands
such as Creon, Duphaston and Influvac. Depending on the product,
the development activities focus on new data, markets, formula-
tions, combinations or indications.
Vascular—Ongoing projects in the pipeline include:
• Absorb, the world’s first drug eluting bioresorbable vascular
scaold (BVS) device for the treatment of coronary artery dis-
ease that is gradually resorbed into the vessel wall. Absorb GT1
received CE approval and was launched in the second quarter of
2015. Abbott filed for regulatory approval in the U.S. and Japan
in the second quarter of 2015. In 2015, Abbott also released
clinical results which demonstrated similarity to the Xience
metallic drug-eluting stent (DES) at one year through random-
ized non-inferiority studies. Abbott is also actively working on
the development of future generations of BVS technologies.
• MitraClip device for the treatment of mitral regurgitation
(MR).MitraClipis available in the U.S., Europe, parts of Asia,
the Middle East and Latin America for patients who are at
prohibitive risk for mitral valve surgery. Abbott continued
clinical development of theMitraCliptherapy including the
COAPT trial, a prospective, randomized trial in the United
States that will evaluate the impact ofMitraCliptreatment
for an expanded indication. In addition, Abbott continues to
work on the development of next generation systems for the
treatment of MR.
• Supera self-expanding nitinol stent system which was acquired
as part of the acquisition of IDEV Technologies in August 2013.
With its proprietary interwoven wire technology,Superais
designed based on biomimetic principles to mimic the body’s
natural movement. Superais available in the U.S., Europe, and
various countries in Asia, the Middle East and Latin America
for the treatment of blockages in blood vessels due to peripheral
artery disease, with expanded size matrix approved in the U.S.
Abbott is developingSupera’s next generation delivery system.
• Abbott is also developing future versions of metallic DES,
guide wires and balloon delivery catheters. Armada 18, Abbott’s
new peripheral Percutaneous transluminal angioplasty balloon
catheter for the treatment of challenging cases in the superficial
femoral artery and below the knee categories, received CE
approval and was launched in the third quarter of 2015.