Abbott Laboratories 2014 Annual Report Download - page 72

FINANCIAL REVIEW
ABBOTT 2014 ANNUAL REPORT
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Vascular—Ongoing projects in the pipeline include:
• XIENCE Alpine, our newest drug-eluting stent (DES), received
US FDA approval in September 2014 and is the only DES with
an indication for chronic total occlusions (CTOs). XIENCE
Alpine was also approved for sale in Europe, Japan and parts
of Latin America in 2014.
• Absorb, the world’s first drug eluting bioresorbable vascular
scaold (BVS) device for the treatment of coronary artery
disease that is gradually resorbed into the vessel wall. In 2014,
Abbott completed enrollment of patients in clinical trials for
regulatory approval in the US and China, and enrollment for
trials in Japan was completed in the fourth quarter of 2013.
Abbott initiated a trial with the objective of demonstrating that
Absorb is more cost-eective and provides the patient a higher
quality of life than a permanent, metallic drug eluting stent.
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 with significant
symptomatic degenerative MR 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 on the progression of heart
failure. In addition, Abbott continues to work on the develop-
ment of the next generation system 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 received US FDA approval in March
2014 for treatment of the superficial femoral and proximal
popliteal arteries, which are the main arteries in the thigh that
supply blood to lower extremities. Supera is also available in
Europe, parts of Asia, the Middle East and Latin America for the
treatment of blockages in blood vessels due to peripheral artery
disease (PAD). Abbott continues to work on the development
of Supera ’s size matrix and next generation delivery system.
• Coronary and endovascular guide wires. Abbott’s Versaturn
guide wire received CE regulatory approval in July 2014 and
510(k) clearance in the US in August 2014.
Medical Optics—Abbott is developing a number of new products
which are designed to improve patient outcomes for patients
undergoing cataract and LASIK surgery. In 2014, Abbott launched
the TECNIS® Symfony intraocular lens (IOL) in Europe. TECNIS®
Symfony provides an extended continuous range of high-quality
vision, including distance, intermediate and near vision, with visual
side eects similar to a standard monofocal IOL. A toric version
of TECNIS® Symfony that corrects a patient’s astigmatism was
approved and launched in Europe. In late 2014, Abbott received
approval for two new TECNIS® Multifocal Low Add products in
the US. The new TECNIS® Multifocal IOLs allow the surgeon to
In the EU, vascular products are also categorized into dierent
classes and the regulatory process, which is governed by the
European Medical Device Directive, varies by class. Each product
must bear a CE mark to show compliance with the Directive. Some
products require submission of a design dossier to the appropriate
regulatory authority for review and approval prior to CE marking
of the device. For other products, the company is required to
prepare a technical file which includes testing results and clinical
evaluations but can self-certify its ability to apply the CE mark to
the product. Outside the U.S. and the EU, the regulatory require-
ments vary across dierent countries and regions.
After approval and commercial launch of some vascular products,
post-market trials may be conducted either due to a conditional
requirement of the regulatory market approval or with the objec-
tive of proving product superiority.
In the Nutritional segment, the research and development pro-
cess generally focuses on identifying and developing ingredients
and products that address the nutritional needs of particular
populations (e.g., infants, athletes) or patients (e.g., people with
diabetes). Depending upon the country and/or region, if claims
regarding a product’s ecacy will be made, clinical studies
typically must be conducted.
In the U.S., the FDA requires that it be notified of proposed new
formulations and formulation or packaging changes related to
infant formula products. Prior to the launch of an infant formula
or product packaging change, the company is required to obtain
the FDA’s confirmation that it has no objections to the proposed
product or packaging. For other nutrition products, notification
or pre-approval from the FDA is not required unless the product
includes a new food additive. In some countries, regulatory
approval may be required for certain nutritional products,
including infant formula and medical nutritional products.
AREAS OF FOCUS
In 2015 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 product,
further geographic expansion of existing brands, new product
enhancements, and strategic licensing activities. Abbott is also
actively working on development plans for several key brands such
as Creon, Duphaston and Influvac. Depending on the product, the
development activities focus on new data, markets, formulations,
combinations or indications.