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This excerpt taken from the ELN 20-F filed Feb 26, 2009. ELAN DRUG
TECHNOLOGIES
Our EDT business is the oldest, independent drug delivery firm
in the industry. As a leader in the business, we have
contributed to over $15 billion of in-market sales for our
clients over our history. An established, profitable specialty
pharmaceutical business unit of Elan, EDT has been applying its
skills and knowledge to enhance the performance of dozens of
drugs that have subsequently been marketed worldwide. Today,
products enabled by EDT technologies are used by millions of
patients each day.
EDT focuses on helping clients bring products to market through
product optimization, new product generation and product rescue.
As experts in life-cycle management we have successfully brought
over 30 drugs to market for clients in over 90 countries
worldwide. We provide a broad range of creative drug
optimization approaches, including formulation development,
scale-up and
manufacturing. Commercialized technologies include those for
poorly water-soluble compounds as well as technology platforms
for customized oral release. Since 2001, our technologies have
been incorporated and subsequently commercialized in
10 products in the United States, making us the most
productive drug delivery company in the industry.
EDT generated $301.6 million in revenue and an operating
profit of $85.8 million in 2008. EDT generates revenue from
two sources: royalties and manufacturing fees from licensed
products, and contract revenues relating to R&D services,
license fees and milestones.
Typically, EDT receives royalties in the single-digit range as
well as manufacturing fees based on cost-plus arrangements where
appropriate. More recently, EDT has brought product concepts to
a later stage of development before out-licensing and as a
result has been able to retain an increasing proportion of
revenue. There are currently 23 products marketed by EDT
licensees, with 10 of these having been launched since 2001. EDT
has a broad pipeline, with 15 products in clinical development,
including three filed, four in Phase 3, three in Phase 2 and
five in Phase 1. These marketed and pipeline products and
EDT’s technologies are protected by an extensive
intellectual property portfolio.
This excerpt taken from the ELN 20-F filed Feb 28, 2008. ELAN DRUG
TECHNOLOGIES
EDT is an established, profitable and growing specialty
pharmaceutical business unit of Elan. For nearly 40 years,
EDT has been applying its skills and knowledge to enhance the
performance of dozens of drugs that have been marketed
worldwide. Today, products enabled by EDT technologies are used
by millions of patients each day.
EDT is focused on using its extensive experience, proprietary
drug delivery technologies and licensing capabilities to develop
innovative products that deliver clinically meaningful benefits
to patients. EDT’s product development capabilities span
formulation development, clinical trial management, analytical
development, clinical trial material manufacturing, product
scale-up,
product registration and commercial manufacturing.
EDT has manufacturing and research facilities in the United
States and Ireland.
EDT generated $295.5 million in revenue in 2007, and an
operating profit of $85.2 million. EDT generates revenue
from two sources: from royalties and manufacturing fees from
licensed products, and from contract revenues relating to
R&D services, license fees and milestones.
Typically, EDT receives royalties in the single digit range as
well as manufacturing fees based on cost plus arrangements where
appropriate. More recently, EDT has brought product concepts to
a later stage of development before out-licensing and as a
result has been able to retain an increasing proportion of the
economics. There are currently 22 products marketed by EDT
licensees, with eight of these having been launched since 2001.
EDT has a broad pipeline, with 17 products in clinical
development, including three filed, four in Phase 3, five in
Phase 2 and five in Phase 1. These marketed and pipeline
products and EDT’s technologies are protected by an
extensive intellectual property portfolio, with approximately
1,700 patents and patent applications.
This excerpt taken from the ELN 20-F filed Feb 28, 2007. ELAN DRUG
TECHNOLOGIES
For more than 37 years, we have been applying our skills
and knowledge to enhance the performance of dozens of drugs that
have been marketed in many countries worldwide. EDT focuses on
product development,
scale-up and
manufacturing to address drug optimization challenges of the
pharmaceutical industry. EDT offers the industry a suite of
proprietary technology-driven solutions. EDT recorded total
revenue of $284.6 million in 2006 (2005:
$261.2 million).
Our
NanoCrystaltm
technology continues to be one of the key platforms that
differentiates EDT. Sales by third parties of products
incorporating NanoCrystal technology continued to grow in
2006. During 2006, we signed a number of development agreements
with third parties, including a license agreement with Abbott
Pharmaceutical PR Ltd. (Abbott) to develop a single fixed-dose
combination of
TriCor®
and
Crestor®
for high cholesterol patients.
This excerpt taken from the ELN 20-F filed Mar 30, 2006. ELAN DRUG
TECHNOLOGIES
EDT focuses on product development,
scale-up and
manufacturing to address drug optimization challenges of the
pharmaceutical industry. EDT offers the industry a suite of
proprietary technology-driven solutions.
Our NanoCrystal technology was integral to the success of
EDT in 2005. Sales by third parties of products incorporating
NanoCrystal technology grew substantially in 2005, and
the fourth NanoCrystal-incorporated product was launched
in the United States. Important announcements for the year
included the signing of a number of development agreements with
third parties, as well as a broad license agreement with Roche.
We also announced that our NanoCrystal technology is
being used by Johnson & Johnson Pharmaceutical Research and
Development in a Phase 3 clinical trial of a long acting
injectable in patients with schizophrenia, and that the Japanese
patent office had granted a key NanoCrystal technology
patent.
Elan’s
Patented and Commercialized NanoCrystal Technology
Elan’s NanoCrystal technology is a drug optimization
technology applicable to poorly water-soluble compounds. It is
covered by more than 130 U.S. and international patents and
patent applications and is part of a suite of technologies that
EDT offers to third-party clients.
Elan’s NanoCrystal technology has offered tangible
patient benefits to a number of compounds. For one product, now
commercialized the technology improved bioavailability by up to
600 percent; for another launched product, it allowed a
four-time reduction in dosage volume; and for others it
eliminated the fed-fasting effects providing clear patient
benefits to particular therapies.
Products developed and now commercialized in the United States
using Elan’s patented NanoCrystal technology include:
We currently have more than 30 products in various stages of
development from feasibility through to Phase 3 projects.
About
NanoCrystal Technology
NanoCrystal technology involves reducing crystalline drug
to particles under 400 nanometers. By reducing particle size,
the exposed surface area of the drug is increased and is then
stabilized to maintain particle size. The drug in nano-form can
be incorporated into common dosage forms, including tablets,
capsules, inhalation devices, and sterile forms for injection,
with the potential for substantial improvements to clinical
performance.
Manufacturing
and Scale-up
Activities
The cohabitation of development and manufacturing capabilities
on the same sites in EDT allows for streamlined
scale-up and
transfer to commercial scale manufacturing activities.
EDT’s principal manufacturing and development facilities
are located in Athlone, Ireland and Gainesville, Georgia, in the
United States. In 2005, we expanded the range of services we
offer clients, with the completion of a sterile fill and finish
facility in our Athlone campus. Our range of services includes
formulation development, analytical development, clinical trial
manufacturing and scale-up, and product registration support.
The Athlone campus, an FDA/EMEA compliant site, now comprises
more than 460,000 square feet under roof, of which
218,000 square feet has dedicated, fully-equipped cGMP
compliant manufacturing capacity.
Table of Contents
Experience,
Expertise and Patented Technology Portfolio
Elan has a proud track record of innovation and expertise in
drug optimization. For more than 35 years, Elan has been
applying its skills and knowledge to enhance the performance of
dozens of drugs that have subsequently been marketed in more
than 40 countries worldwide. Today, more than 2.5 million
patients worldwide use drug products based on or enhanced by our
technologies.
Our NanoCrystal technology was integral to the success of
EDT in 2005. We look forward to more product approvals
incorporating this technology in the next few years and to
growing our business substantially over this period.
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