Abbott Laboratories 2013 Annual Report Download - page 68

ABBOTT 2013 ANNUAL REPORT
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FDA’s Pre-Marketing Approval (PMA) requirements. Other Class
III products, such as those used to screen blood, require the sub-
mission and approval of a Biological License Application (BLA).
In the EU, diagnostic products are also categorized into different
categories and the regulatory process, which is governed by the
European InVitro Diagnostic Medical Device Directive, depends
upon the category. Certain product categories require review and
approval by an independent company, known as a Notified Body,
before the manufacturer can affix a CE mark to the product to
show compliance with the Directive. Other products only require
a self-certification process.
In the Vascular segment, the research and development process
begins with research on a specific technology that is evaluated
for feasibility and commercial viability. If the research program
passes that hurdle, it moves forward into development. The
development process includes evaluation and selection of a
product design, completion of clinical trials to test the product’s
safety and efficacy, and validation of the manufacturing process
to demonstrate its repeatability and ability to consistently meet
pre-determined specifications.
Similar to the diagnostic products discussed above, in the U.S.,
vascular products are classified as Class I, II, or III. Most of
Abbott’s vascular products are classified as Class II devices that
follow the 510(k) regulatory process or Class III devices that are
subject to the PMA process.
In the EU, vascular products are also categorized into different
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 requirements vary across different 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
objective of proving product superiority.
In the Nutritional segment, the research and development process
generally focuses on identifying and developing ingredients and
products that address the nutritional needs of particular popula-
tions (e.g., infants, athletes) or patients (e.g., people with diabetes).
Depending upon the country and/or region, if claims regarding a
product’s efficacy will be made, clinical studies typically must be
conducted. Most other product development, such as a product
form change from liquid to powder, generally does not necessitate
clinical studies.
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 2014 and beyond, Abbott’s significant areas of therapeutic
focus will include the following:
Established Pharmaceuticals — Abbott is actively working on
development plans for about 20 - 30 key brands. Depending on
the product, the development activities focus on new data,
markets, formulations, combinations, or indications. Abbott
focuses on building country-specific portfolios made up of global
and local pharmaceutical brands that best meet each local market’s
needs. Over the next several years, Established Pharmaceuticals
will work to expand its product portfolio in its key markets through
further geographic expansion of existing brands, new product
enhancements, and strategic licensing activities.
Vascular — Ongoing projects in the pipeline include:
• XIENCE Xpedition, our latest drug-eluting stent (DES) with
enhanced deliverability and an expanded size matrix. It utilizes
the XIENCE PRIME stent, everolimus and biocompatible coat-
ing technology but incorporates new catheter technology for
improved deliverability. XIENCE Xpedition received U.S. regula-
tory approval in December 2012 and is also available in Europe
and parts of Asia and Latin America. In 2013, Abbott continued
to expand DES size offerings. XIENCE Xpedition 48 received
CE regulatory approval in May 2013, making it the longest
length DES among major brands. XIENCE Xpedition 2.0 mm
diameter received CE regulatory approval in December 2013,
making it the smallest diameter DES among major brands.
• Absorb, the world’s first drug eluting bioresorbable vascular
scaffold (BVS) device for the treatment of coronary artery
disease that is gradually resorbed into the vessel wall. In 2013,
Abbott made significant progress in enrolling patients in clinical
trials for regulatory approval in the United States and China,
and completed enrollment in trials in Japan in December 2013.
• MitraClip device for the treatment of mitral regurgitation (MR).
In October 2013, MitraClip received U.S. regulatory approval
for patients with significant symptomatic degenerative MR who
are at prohibitive risk for mitral valve surgery. MitraClip is also
available in Europe, parts of Asia, the Middle East and Latin
America. Abbott expects to seek product approval in additional
markets in 2014. In addition, Abbott will continue clinical
development of the MitraClip therapy including the COAPT
trial, a landmark, prospective, randomized trial in the United
States that will evaluate the impact of MitraClip treatment on
the progression of heart failure.
FINANCIAL REVIEW