Elan Drug Technologies is celebrating 40 years of leadership in drug delivery and innovation. In 2010, they achieved several major milestones including helping partners receive FDA approval for new drugs and expanding their technology research. Looking ahead, they expect additional approval milestones and advancements in clinical trials. Elan also formally launched a new manufacturing services business to provide scale-up and commercial manufacturing. They hope to sign new deals and continue helping clients deliver clinically meaningful benefits to patients through proprietary drug delivery technologies.

1. November 2010 Newsletter
40 Years of Drug Delivery Leadership and Innovation
“Delivering Clinically
Meaningful Benefits to
Clients and Patients”
A Message from Shane Cooke, EVP & Head, Elan Drug Technologies
Dear Colleague,
Since our newsletter this past spring, it has been an interesting number of months for us at Elan Drug Technologies. I’m
pleased to say that we have achieved many major milestones in 2010 – adding to the dozens of products we have helped
reach the market, expanding our alliances and extending our technology research. As we continue to grow our business and
our technological offerings, we of course would be glad to hear from you with any feedback or queries on current activities or
interest in discussing potential collaborations or projects.
This year our partner Acorda Therapeutics Inc. received US FDA approval for Ampyra® (dalfampridine extended release
tablets) which has demonstrated strong performance in the initial stages of its launch. We are particularly proud of the Ampyra®
performance as it was initially developed in-house using one of our proprietary oral controlled release technologies – the
MXDAS® technology. Ampyra® is indicated as a treatment to improve walking in patients with multiple sclerosis (MS); this
was demonstrated by an increase in walking speed. The product, which was sub-licensed by Acorda to Biogen Idec Inc., for
all territories worldwide ex-US, has been filed in the EU and Canada. We hope to see further approvals in Europe and other
territories.
In 2011, another partner Janssen-Cilag International NV is expecting to receive approval for paliperidone palmitate in the
European Union. Paliperidone palmitate, which was launched in 2009 by Janssen, in the US, as INVEGA® SUSTENNA®, the first
once monthly atypical antipsychotic injectable treatment for patients with schizophrenia and uses our NanoCrystal® technology
and was filed with the European Union regulatory authorities in December 2009.
To bolster efforts in our scale-up and manufacturing services offerings, we formally launched our Manufacturing Services
business at this year’s CPhI meeting in Paris. Our new offering has received
very positive feedback and we hope to sign a number of scale-up and
manufacturing deals in the next six months.
Calendar of Events
Additional development milestones we are looking forward to in 2011 include:
• Advancement of our novel controlled release formulation of hydrocodone
Please come see us at one of the following upcoming
without acetaminophen, ZX002, for moderate to severe pain, through conferences and events
Phase 3 trials. Licensed to Zogenix in the US, this product is available
for licensing in other territories. We look forward to ZX002 progressing AAPS Annual Meeting and Exposition / FIP2010
successfully through clinical trials and its manufacture at our DEA approved World Congress
site in Gainesville, Georgia, US. (New Orleans, Louisiana, Nov. 14-18, 2010)
• Successful licensing of our non-narcotic IV, post-op pain product, which Visit us at Booth 2409 or request a meeting with us.
was developed in-house using our NanoCrystal® technology, to a
commercial partner. This year we reported strong Phase 2 results for this BIO-Europe 2010
(Munich, Germany, Nov. 15-17, 2010)
compound. The product is now Phase 3-ready and available for
Request a meeting with us.
licensing worldwide.
JP Morgan Healthcare Conference
Please be sure to look for Elan Drug Technologies at the AAPS Annual (San Francisco, California, Jan. 10-13, 2011)
Meeting/FIP Pharmaceutical Sciences World Congress taking place Request a meeting with us.
November 14-18 in New Orleans, at the BIO-Europe meeting being held
November 15-17 in Munich and at other upcoming events. We look forward Drug Delivery Partnerships Meeting
to speaking with you and discussing how our extensive experience and (Miami, Florida, Jan. 26-29, 2011)
proprietary delivery technologies can help you deliver new and innovative Visit us at Booth 201/203 or request a meeting with us.
products that provide clinically meaningful benefits to patients.

2. What’s New at Elan Drug Technologies Why Work with Elan Drug Technologies
Upcoming: Elan Drug Technologies to Sponsor Key Industry Webinars in 2011 World’s Leading Drug Delivery Company
• 40 years of innovation and expertise in drug delivery
EDT will sponsor a series of webinars in 2011 – watch out for announcements and sign up to • 2.5 million patients benefit daily from drugs
receive our updates to keep informed. incorporating our technologies
• Successful collaborations with many of world’s leading
pharma companies
Manufacturing Updates: Elan Drug • Most successful drug delivery company in the US in
Technologies Announces New recent times – 12 products launched since 2001
Manufacturing Services and Publishes • Over $20 billion in market sales generated for
Manufacturing Services Brochure our licensees
Most Robust Drug Delivery Portfolio in
At the CPhI annual meeting in Paris this the Industry
past October, EDT officially launched its
Manufacturing Services business – • More than 35 products launched in 100+ countries
• 14 products in clinical development
a new initiative that provides scale-up and
• NanoCrystal® technology– 5 licensed products
commercial scale manufacturing of solid launched with over $1.9B annual in-market sales
oral dosage forms. This new service offers • Oral Controlled Release Platform – delayed release,
a significant advantage in outsourcing, including a broad range of services and expertise extended release, pulsatile release, chrono-timed
delivery; all commercially launched
integrated in one company based in the US and Europe. Building on 40+ years experience
• 1,900+ patents/patent applications
in drug delivery, EDT provides pharmaceutical clients with process design and development
expertise, process improvements as well as improved production methods in scale-up 40 years experience and expertise in Scale-up &
and commercial manufacturing. Our outstanding quality compliance, together with our Manufacture
excellent track record in product optimisation, have made us the supplier of choice for an
• Extensive product development, scale-up and
impressive number of pharmaceutical organisations, including seven of the world’s leading manufacturing capabilities in the US and EU
pharmaceutical companies. • 2.5 billion solid oral dosages can be manufactured
annually
• 250,000 sq. ft. dedicated cGMP manufacturing
Read the launch announcement, visit our website or view our newly published Manufacturing
facilities
Services Brochure which highlights our range of services and offerings in scale-up and • Fully compliant FDA/EMA/JMHLW GMP facilities
manufacturing. • International expertise, manufacturing and exporting
to 96 countries including India and China.
Elan Drug Technologies Publishes a Review of its Business Highlights for 2009
Want to Keep in Touch?
Since our last newsletter, we have published our business review document, which highlights
our achievements for 2009 – a year in which we met or exceeded all our financial targets
Please visit our website, www.elandrugtechnologies.
and generated over $275 million in revenues from over two dozen marketed products. We
com, to sign up for our alert system which provides
continued to be cash positive in 2009, generating $138 million in cash flow. updates on events and news announcements as they
happen.
Elan Drug Technologies Welcomes Two New VPs to the Team
Contact Us
Johannes Roebers, Ph.D. joined Elan Drug Technologies as Senior Vice President and Head
of R&D in October 2010. Dr. Roebers joined Elan Corp as Senior Vice President, Head of
Biologic Strategy, Planning and Operations, in July 2007. Roebers previously worked at Dr. Sarah Carty, Director Business Development,
Europe and ROW
Genentech Inc. and has held positions with Biogen Idec, IDEC, Bayer AG and Bayer Corp. in
+353 1 709 4068
Leverkusen, Germany, Canada and the US. He received his Diplom-Ingenieur in mechanical sarah.carty@elan.com
engineering from RWTH Aachen in Aachen, Germany and his Ph.D. in chemical engineering
from Clemson University in Clemson, South Carolina. Dr. Scott Jenkins, Director Business Development, USA
+1 610 313 7045
scott.jenkins@elan.com
Philip Pratten joined the EDT team as Vice President of Manufacturing Services Operations.
Pratten previously worked at Catalent Pharma Solutions and has held positions with Cardinal
Health, GlaxoWellcome and the Wellcome Foundation. He has almost 30 years of broad
based experience in the pharma industry and graduated with a degree in biophysical
science from North East London Polytechnic (now University of East London).
Products Available for Licensing
As key projects are progressing through development, a number of out-licensing product opportunities are available. These include:
• Megesterol acetate liquid for cachexia, all territories ex-US, which has completed Phase 3 studies in Europe
• Morphine once daily for severe chronic pain, all territories ex-North America, which is filed with regulatory authorities in Europe
• Hydrocodone twice daily novel controlled release formulation, for moderate to severe pain in all territories ex-US, which is in Phase 3 trials in the US
• Non-narcotic IV once daily formulation for post-op acute pain, all worldwide rights, has completed Phase 2 studies.
If you are interested in any of these or other opportunities, please contact us or for more information visit us here.
www.elandrugtechnologies.com general email: edtbusdev@elan.com