Abbott Laboratories 2012 Annual Report Download - page 59

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Abbott 2012 Annual Report
Financial Review
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 prod-
ucts 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 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 2013 and beyond, Abbott’s significant areas of therapeutic focus
will include the following:
Established Pharmaceuticals – Abbott is actively working on 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 the market for many of its
products through registrations across multiple geographies, including
key emerging markets.
Vascular – Ongoing projects in the pipeline include:
• Xience Xpedition, our next-generation drug-eluting stent (DES)
with enhanced deliverability and an expanded size matrix. It utilizes
the Xience PRIME stent, everolimus and biocompatible coating
technology but incorporates new catheter technology for improved
deliverability. Xience Xpedition received U.S. regulatory approval
in December 2012 and is also available in Europe and parts of
Asia and Latin America. Abbott expects to launch the product in
additional markets in 2013.
• 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 January 2013
Abbott initiated the ABSORB III clinical trial which is designed to
enroll approximately 2,250 patients of which the majority will be in
the U.S. The data from this trial will be used to support the U.S.
regulatory filing of Absorb. In 2011 Abbott released five-year data
from its ABSORB clinical trial, which showed efficacy and safety
results consistent with the four-year data. In 2011 after receiving
CE Mark approval for Absorb, Abbott initiated a randomized,
controlled clinical trial to further study the device in an expanded
population in Europe. In 2010, Abbott initiated the ABSORB
EXTEND clinical trial which will enroll up to 1,000 patients with
more complex coronary artery disease.
• MitraClip device for the treatment of mitral regurgitation –
Abbott’s MitraClip system which is on the market in Europe and
in parts of Asia and Latin America is currently under review for
approval by the FDA. An amended filing to the FDA was submitted
in December 2011. A FDA panel is expected to review the filing
in the first half of 2013.
• Coronaryandendovascularcoreproductprojects,includingnew
coronary and endovascular guide wires. The Absolute Pro and
Omnilink Elite stent systems, both for the treatment of iliac artery
disease, a form of peripheral artery disease that affects the lower
extremities, were launched in the U.S. in 2012.
Medical Optics – Abbott is developing a number of new products
for patients undergoing cataract surgery, which are designed to
improve physician efficiency and patient outcomes. Abbott has devel-
oped advanced intraocular lenses (IOLs) that address astigmatism as
well as presbyopia. The Tecnis brand monofocal Toric IOL, which is
sold in Europe, is currently undergoing U.S. regulatory review. A multi-
focal version of the Toric IOL was launched in a number of international
markets in 2012. A preloaded IOL insertion system that is designed to
improve surgeon efficiency is also currently under regulatory review in
the U.S.; the product was launched in Europe in 2012. Abbott is con-
tinuing the development activities required to obtain U.S. approval for
an enhanced version of the Synchrony IOL which is designed to mimic
the eye’s natural ability to change focus and deliver improved vision at
all distances; this product was launched in Europe in late 2012. Abbott
has also developed a new diagnostic instrument and laser treatment
planning software which is designed to improve visual outcomes. After
the receipt of CE Mark approval in November 2011, this instrument
and software were launched in Europe in 2012. A PMA filing for U.S.
regulatory approval of this product was submitted in 2012.