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PROXY COMMUNICATION STATEMENT AND FORWARD LOOKING STATEMENTS:
Biogen Idec and its directors, executive officers and other members of its management and employees
may be deemed to be participants in the solicitation of proxies from the stockholders of Biogen
Idec in connection with the companys 2009 annual meeting of stockholders. Information concerning
the interests of participants in the solicitation of proxies will be included in any proxy
statement filed by Biogen Idec in connection with the companys 2009 annual meeting of
stockholders. In addition, Biogen Idec files annual, quarterly and special reports with the
Securities and Exchange Commission (the SEC). The proxy statements and other reports, when
available, can be obtained free of charge at the SECs web site at www.sec.gov or from Biogen Idec
at www.biogenidec.com. Biogen Idec stockholders are advised to read carefully any proxy statement
filed in connection with the companys 2009 annual meeting of stockholders when it becomes
available before making any voting or investment decision. The companys proxy statement will also
be available for free by writing to Biogen Idec Inc., 14 Cambridge Center, and Cambridge, MA 02142.
In addition, copies of the proxy materials may be requested from our proxy solicitor, Innisfree M&A
Incorporated, by toll-free telephone at (877) 750-5836 or by e-mail at email@example.com.
This presentation includes forward-looking statements about estimates of the market potential for
our product candidates, our expected filings with regulatory agencies, the anticipated development
and timing of programs in our clinical pipeline. Each forward-looking statement is subject to
risks and uncertainties that could cause actual results to differ materially from those that we
express or imply, including the uncertainty of success in commercializing our products, the
occurrence of adverse safety events with our products, competitive pressures, our dependence on
collaborations over which we may not always have full control, our ability to attract and retain
qualified personnel, our ability to protect our intellectual property rights and the cost of doing
so, product liability claims, and the other risks and uncertainties that are described in Item 1.A.
Risk Factors in our annual report on Form 10-K and in other reports we file with the SEC.
RESEARCH AND DEVELOPMENT DAY
Cecil B. Pickett, PhD
Biogen Idec President, Research & Development
Good afternoon, everyone, and thank you very much for attending our R&D Day. I hope you get a sense
today of our pipeline, our overall pipeline. One of the messages that I really would like for you
to take home is that there is something more about Biogen Idec than just TYSABRI. And I think you
should see that as we go through the pipeline today.
What I thought I would do is just to make some general comments. After being here now two and a
half years, some general comments about the strengths of the R&D organization. Id like to talk a
little bit about the strategy that weve implemented over the past few years to build our pipeline.
And then talk a little bit about some data readouts were anticipating, and also some comments
about the late-stage pipleine.
I think, as I look at Biogen Idec and the R&D organization, I think we clearly have a world-class
biotherapeutic discovery and development organization. If you look at our ability to do cell
engineering or protein engineering to generate innovative antibodies or proteins, its second to
none in the industry. We have a very focused drug discovery and development organization. We focus
primarily in Neurology, Immunology, Oncology and Cardiology, and youll hear about these
therapeutic areas from the presenters after me.
Theres a very strong link here at Biogen Idec between the discovery organization, between clinical
development and between the business units, so theres always I think an eye on the patient and
physician as we think about developing innovative new therapies. I think for any organization, this
organization has a proven track record of discovering and developing innovative molecules, starting
with AVONEX, discovery of RITUXAN and then more recently with the development of TYSABRI. And then
finally, I think its fair to say again, we are second to none in having extensive biologic
The R&D strategy that weve implemented over the past few years is to focus on novel therapeutics
to address areas of high, unmet medical need. We have built our pipeline both through our
discovery, research engine as well as in-licensing opportunities. We because of the strong
biology at Biogen Idec, many of our molecules are first-in-class molecules in a therapeutic area,
but we also have focused on best-in-class molecules where theres an opportunity either to improve
efficacy or safety in a specific class and in a specific therapeutic area.
As Ive said, were experts in biologics, but over the last few years, weve also built some
expertise in small-molecule drug discovery and development because, as you know, it turns out that
some of the targets that you want to intervene with are not on the surface of cells. They tend to
be intracellular, and you need small-molecule approaches to do that. And I think having many years
of experience in small-molecule development, that with our targeted, specific targeted approaches,
we can be competitive with any organization.
So, the idea behind selecting targets, we select targets based on biology and based on the
pathophysiology of disease, and once we do that, we rapidly try to get in humans to test the
feasibility of whether or not the candidate that we recommend for development is suitable for
further development. We then rapidly perform scientifically rigorous proof-of-concept experiments
where we can determine, based on data that we generate, a go/no-go decision, and then we execute
our Phase 3 registration programs with a global clinical operations infrastructure.
The strategy that weve implemented at Biogen Idec has worked. 20 programs are currently in
preclinical. We have 5 programs in first-in-human studies, 13 programs at the proof-of-concept
stage and 7 programs either in registration or in filing, and youll hear about some of these
programs during the course of the presentation today.
Our late-stage pipeline has grown considerably over the past couple of years. In the first half of
08, we had five programs in our development, our registration pipeline. Ive listed these here for
you. When we exit 2009, I anticipate that we will have nine programs in registration programs.
These will include additions that we added in the second half of 08 of ADENTRI, our adenosine 1a
receptor antagonist, an IV formulation, youll hear from Evan Beckman about that program, a
PEGylated form of Interferon Beta, Al Sandrock will update you on the advances were making with
this PEGylated form. Lixivaptan in heart failure, vasopressin-2 receptor antagonists, again Evan
Beckman will update you on that. And in the breakout session, youll hear about Daclizumab from
Mike Panzara, antibody to the IL-2 receptor.
So again, I think weve had significant growth in our registration programs. We have a broad
pipeline, and importantly, we have a diverse pipeline at the registration stage, so we are not
dependent in a single therapeutic area.
This has recently been validated by Moodys, who went through 12 companies Ive listed on this
slide and rated the quality of their late-stage pipeline, and it turns out that Biogen Idec is the
lead in terms of the quality of the late-stage pipeline. We also were in the first third in terms
of pipeline diversity, again a comment I made previously, important to have a diverse, late-stage
pipeline so youre not totally dependent on a single therapeutic area.
Weve had a number of data readouts over the past 2 years. As in any R&D organization, and Ive
been doing this now for 30-plus years, there is always positive readouts and theres always going
to be negative readouts. Im not going to go through these on this slide.
I want to draw your attention to 2, Heat shock protein 90 inhibitor where weve had positive
interim data in a Phase 2a study in gastrointestinal stromal tumors. In the breakout session,
youll hear about this program and in BIIB with BIIB14, our adenosine 2a receptor antagonist for
the treatment of Parkinsons disease, weve also had positive data readout in an early-stage
clinical program. And youll hear about this program from Gilmore ONeill again in the breakout
Very interesting molecule, I think many of you are aware there have been no new therapies for the
treatment of Parkinsons disease probably in the last four decades since the Merck Labs actually
discovered and developed SINEMET, so this offers a real opportunity to Parkinsons patients. We
have a number of potential data readouts in 2009 and 2010. Ive listed them here. I wont go over
in detail these. Youll hear about some of these programs during the course of the day.
A criteria thats a metric that should be used for innovation in any R&D organization are patent
filings and publications. Ive shown on this slide, youll see our recent patent filings, those
applications filed and those applications issued over the past three years and the total number of
Biogen Idec patents.
Youll also see, in 2008 alone, we had 89 peer review publications in a variety of different
therapeutic areas. All of these publications, any one youre interested in, you have access to. You
can actually print them out outside, so if any as you go through and look at the publications,
if theres any specific one you want, you can simply print out outside.
So in summary, my view of this organization and and I think what youll see today is that we
have outstanding people at all levels in the R&D organization, and this is really the foundation of
any R&D organization is the quality of the people that you have.
We have a robust pipeline with important compounds at all stages of development. The registration
programs presented have presented a challenge to us, and to meet that challenge, one of the
things that weve done over the past two years is build our global clinical operations
infrastructure. Weve had an annual increase in headcount of about 26% to build that infrastructure
to execute these late-stage programs.
We are we now have a presence in 19 countries, on-the-ground presence, but by the end of 2009 in
19 countries, because as you know, clinical trials have become more difficult and effect to
effectively do, and you consequently need the ability to really work in a global manner to
execute these studies.
And last year was able to recruit in an individual from the Merck Research Labs whos here, Jorge
Guerra, who was their Clinical Trial who was the head of their Clinical Trial Management within
the Merck Labs. And Jorge brings more than 20 years of experience to clinical trials, has been a
great addition for us as we operationalize many of these registration programs.
We have world-class expertise, as I said, in discovery and development of biologics and we have
built some small-molecule expertise in targeted areas. And I think as youll go through the day,
our focus for the next several months and year is to focus on executing our clinical trials, to
continue to develop compounds and registration programs that Ive indicated and to move our earlier
programs rapidly to proof of concept.
Cecil B. Pickett, PhD
Biogen Idec President, Research & Development
Okay, I think we should probably start. I just have a slide. There are three slides in sort of my
deck here. Im just going to cover the first slide for you.
I hope you liked the interactive breakout session. We decided to do it that way this year and
hopefully you could hear from our scientific staff and get a little deeper insights into the
programs. I heard from I got some feedback that you had wished that we would not have done so
many programs. We actually pared the number down quite considerably. Youre only looking in that
program probably with a third, maybe to a half of the total pipeline, so youre really just getting
a snippet of the pipeline. And we concentrated hard on which programs we were going to show you. So
again, hopefully you got something out of that.
The only point I want to make, one more time, this is a company with more than just Tysabri. Youre
going to hear about Tysabri, but its a company with more than Tysabri. I think we have a robust
late, early and discovery pipeline. Weve significantly improved it over the past three years.
Thereve been more than 20 programs that weve added to the clinical pipeline since the start of
2007. Weve also been very active at in-licensing. More than 10 molecules were assessed via
business development strategy that we implemented. We have 60 clinical trials ongoing. This is
and this represents more than a fourfold increase in patients enrolled in clinical trials today
versus 2007 and 15 indications in these therapeutic areas.
I think weve shown you we have seven programs currently in registration studies and filing and 20
programs that are in Phase II or beyond. And we have more than actually 35 preclinical and
discovery research programs that are ongoing in the laboratory. So again, I just want to make a
point, I think we have a robust pipeline, both late, early and the discovery stage and its a
company thats a lot more than just Tysabri, Tysabri, Tysabri.