JOSEPH COOK JR. - AMYLIN PHARMACEUTICALS INC (AMLN)
CEO Interview - published 02/18/2002

DOCUMENT # NAZ255

JOSEPH C. COOK, JR., has been Chairman of the Board and Chief Executive
Officer of Amylin Pharmaceuticals, Inc., since March 1998. Prior to
that, he had served as a Board member of, and a consultant to, the
company from 1994. Mr. Cook serves as a member of the Board of Directors
of Boehringer Ingelheim Corporation US. Mr. Cook is a Founder and serves
as Chairman of the Board of Microbia, Inc., a privately held
biotechnology company. Mr. Cook is also a founder of Clinical Products,
Ltd., Life Science Advisors, LLC, Cambrian Associates, LLC, and Mountain
Ventures, Inc. Mr. Cook also serves on the Boards of the American
Diabetes Research Foundation, the Advisory Board of the College of
Engineering, University of Tennessee and the Board of Trustees for
Louisville Presbyterian Theological Seminary. Mr. Cook retired as a
Group Vice President of Eli Lilly & Company in 1993 after more than 28
years of service. Mr. Cook received a BS in Engineering from the
University of  Tennessee.

Sector: PHARMACEUTICALS

TWST: Could we start out with a brief overview of the history and
evolution of Amylin Pharmaceuticals?

Mr. Cook: Amylin Pharmaceuticals is a company devoted to developing
products for people with diabetes and other metabolic disorders. The
company was founded in 1987, starting out with a focus on research and
development. Today that history has evolved to include those original
functions plus clinical operations, commercialization, product
development and a broad support team. We find that we are at a point
that is very unique in this industry as Amylin Pharmaceuticals is the
only company with exclusive rights to two, first-in-class, late-stage
product candidates for diabetes. That includes not only biotech
companies, but large pharmaceutical companies as well.

TWST: Could you expound on these particular compounds?

Mr. Cook: Both of our late stage product candidates deserve a fair
amount of discussion. There is also a third product candidate, which
I'll mention as a part of this. The first product is SYMLIN, an
injectable compound being evaluated as a potential treatment for people
with diabetes who use insulin. SYMLIN is our trade name for pramlintide
acetate. Pramlintide is a synthetic analog of human amylin, a normally
occurring hormone known to be deficient in people with diabetes.
Diabetes is a disease characterized by the body's inability to maintain
adequate blood glucose control. The medical hypothesis behind SYMLIN is
to replace a missing, or deficient hormone, and thereby improve control
of blood glucose. To date we have studied SYMLIN in over 4,500 people
with diabetes who use insulin. Our studies have shown that when SYMLIN
is added to insulin therapy, we see improved glucose control with a
lower utilization of insulin compared to those on insulin alone. Perhaps
equally important, the subjects in these trials who used SYMLIN had much
better weight management. On average, SYMLIN subjects who began the
study overweight, lost weight during the trial, while those on insulin
alone tended to gain weight. In October of last year, we were very
pleased to receive an Action Letter from the FDA declaring SYMLIN
approvable as a drug, subject to the satisfactory completion of some
additional clinical work. This additional work is largely focused on how
to safely introduce this medicine into a patient's existing therapy of
using insulin. Our goal is to have the studies finished and submitted in
the form of an NDA amendment by the end of this year. If SYMLIN is
approved by the Agency in their normal cycle of time following the
submission of the amendment, we would be looking to begin
commercialization in the US market in the first half of 2003. That's a
really exciting and important point because many biotech companies work
a long time and sometimes never get the opportunity to even plan for
commercialization. But with the approvable letter now, and with the
additional work reasonably well defined, we are optimistic and excited
about our future opportunities here.

TWST: Would SYMLIN_ be used in conjunction with some existing
treatments?

Mr. Cook: Yes, our submission is for SYMLIN to be used as an adjunct to
insulin. But, to answer that question properly, we need to go into a
little more detail about the two different types of diabetes.  The
condition called Type 1 diabetes, which used to be referred to as
juvenile onset diabetes, is characterized by an autoimmune reaction in
which the body essentially kills off the beta cells in the pancreas.
These are the cells that produce insulin. So in a fairly short period of
time, when people are diagnosed with Type 1 diabetes, their body stops
producing insulin. They have to take insulin injections for the rest of
their lives or they will die. That observation was made in 1922. But, it
was not until 1987 that a researcher at Oxford University was able to
show that there is a second hormone produced by the same beta cells that
is also missing in the condition of Type 1 diabetes. That hormone is
called amylin, and was adopted as the name of our company. For the Type
1 patient who has been taking insulin all along, we believe SYMLIN
should be used in addition to the insulin as an adjunct therapy. The
second group of patients that SYMLIN would be targeted for is the Type 2
patient. This is a more complex disease, though the end result again is
that patients aren't producing or utilizing enough insulin and amylin to
maintain adequate glucose control. Type 2 diabetes is typically
associated with obesity, and the course of therapy begins with diet and
exercise and progresses to oral agents. Eventually, many of these
patients wind up with inadequate glucose control using oral agents and
progress to take injections of insulin. So, we believe SYMLIN would also
be used for the group of Type 2 patients who use insulin. In summary,
SYMLIN is targeted for people with diabetes who currently use insulin.
There are over 4.5 million people in the United States who use insulin
each day to control their diabetes. So you can see there is a very large
market that we hope to be able to address with SYMLIN.

TWST: You mentioned two products. What is the second?

Mr. Cook: Our second product candidate, currently in Phase III clinical
trials, is AC2993. This is a very exciting compound targeted for the
treatment of Type 2 diabetes. The initial focus of our clinical program
for this product is the group of patients with diabetes who have not yet
progressed to insulin. This product candidate has a very unique set of
properties. We've demonstrated in clinical trials that AC2993 is active
in the presence of undesired high blood glucose but is quiescent as the
glucose approaches normal ' a highly desirable performance criterion for
a diabetes drug. This means that the risk of AC2993 pushing a patient's
glucose too low is greatly reduced. In fact, in clinical trials to date,
no severe hypoglycemia has been reported with the doses we believe to be
the target doses.  Two other aspects of this drug candidate that are
very exciting are its potency and its biological half-life. The target
doses that we are studying in our Phase III trials are 5 micrograms and
10 micrograms, twice a day. That's a very small quantity of drug. And
the biological half-life is over five hours. These parameters create an
opportunity for us to look at alternative means of delivery including
sustained release forms.

TWST: As you look ahead the next several years down the road, are there
any other specific trends that you see emerging within the patient
population you address, that you'd want to stay on top of, to help steer
Amylin's focus, whether it be delivery systems or some other factor?

Mr. Cook: With an agent like AC2993 that works only in the presence of
high glucose and is very potent, there is the potential for more
convenient ways of delivery. That brings me to our third product
candidate, AC2993 LAR. LAR stands for long-acting release. It's the same
molecule as AC2993, but this product is encapsulated in a biodegradeable
matrix of small microspheres that are injected subcutaneously. The goal
of the AC2993 LAR program is to be able to provide drug product that
will supply a sustained level of AC2993 for over 30 days. The
possibility of a once-a-month injection that would be on board to reduce
the glucose when it is high but that would be inactive when the glucose
approaches normal is a very exciting opportunity.  AC2993, the first
product form, which is a twice-a-day injection, has now entered Phase
III testing. The first of three pivotal studies was initiated in
December of last year and the second study started in January. We plan
to initiate the remaining pivotal trial later in the first quarter of
this year, and plan to report results from the first trial in the early
part of 2003. So to summarize our development status: our first product,
SYMLIN, has passed the FDA's first level of review and the Agency has
granted us approvable status. We have begun additional clinical trials
on SYMLIN and plan to submit an amendment to the SYMLIN NDA later this
year; AC2993 has started Phase III testing, and our third product
candidate, AC2993 LAR, is planned to enter Phase II trials during the
first half of this year.

TWST: Do you have the balance sheet and cash to make sure that you can
take these products from this stage to the next?

Mr. Cook: As you may know, we recently sold 10.5 million shares of
common stock in a secondary offering at $8.00 per share. As of today,
the underwriters have a 30-day option to purchase from us up to 1.575
million additional shares, which we hope they will exercise. In
addition, we are very encouraged by the level of partnering interest
being shown by large pharmaceutical companies. Also on the asset side, I
would point out that we have an extensive set of experience here at
Amylin. We have 220 employees but collectively we have over 2,000 person
years of experience in the pharmaceutical and biotech industry. In fact,
from a senior leadership standpoint, our top six executives have over
140 years of relevant experience combined. That's an average of
approximately 25 years a person. So we are an experienced group, which
is one of the reasons we believe we have a unique opportunity going
forward.

TWST: As you look ahead over the next couple of years, especially when
SYMLIN gets released to the market, what do you expect in the first year
or two, as far as sales are concerned?

Mr. Cook: We haven't made a public sales forecast. Sales forecasts are
largely driven by the label claims granted by the FDA and we do not know
that at this time. But if one looks at the patient populations we aim to
serve, there are 4.5 million people in the United States currently using
insulin. Capturing even a very small percentage of that market could
make SYMLIN a pretty interesting product. Current therapies in that
marketplace average, as a price per day of therapy, somewhere around
$4.50 a day. While this is not our forecast, some analysts and others
have suggested that the product opportunity for SYMLIN is in excess of
$500 million at maturity.

TWST: What would be the cost difference between using SYMLIN and not
using SYMLIN?

Mr. Cook: We don't view SYMLIN as a replacement for any existing
therapy. We actually view it as an additive to existing therapies. The
reason that's important is that existing diabetes therapies are not
currently getting the job done. The data are, unfortunately, rather
dramatic. The most recent data that we have show that 74% of the people
who take insulin have glucose readings above the maximum threshold
guideline set by the American Diabetes Association. That just tells us
that we aren't able to get it done with insulin alone. So instead of
viewing this as a cost replacement, what we're going to be able to
offer, if SYMLIN is approved, is a benefit over and above what is
currently available with insulin alone. We believe that added value will
have a profound impact on the management of blood glucose and
consequently long-term consequences of this disease.

TWST: Assuming the approval process finishes without a hitch, what
foreseeable risk could be somewhat of a hurdle to Amylin down the road?

Mr. Cook: One of the risks we always have, as a small company, is how to
get our product to market. I mentioned we have over 150 years of
experience among the senior leadership, and many of us have been
involved with pharmaceutical sales and marketing before. But, as a
company, we've never done this. We have decided, however, that we
believe we can market SYMLIN with our own sales force. Our reasoning
behind this decision is that a fairly concentrated number of physicians
write a large portion of the insulin prescriptions. These physicians
would be the physicians who we would target for SYMLIN with our sales
activities. The numbers are as follows: approximately 20,000 physicians
write about 50% of the insulin prescriptions in the US. These 20,000
physicians are very concentrated in major metropolitan areas, as you
might suspect. We believe we can adequately launch and support SYMLIN
from a sales and marketing standpoint with a field force of less than
150 people. That size is feasible for a small company but it's
nonetheless a risk. That's why we have paid particular attention to
recruit top-level management team members and executives who have done
this before, so that they can bring their direct experience to that
process. There are no guarantees in the drug development game, which is
part of the reason drugs are so difficult to develop, take so long to
develop and cost so much. But, we are extremely encouraged by the FDA's
decision to issue an approvable letter for SYMLIN, because we believe
that reduces some of the risk associated with the regulatory approval
process.  I would say that these two areas probably characterize the
biggest risks that we face today.

TWST: As CEO, where do you see yourself focusing most of your attention
these days?

Mr. Cook: A big part of my attention is now focused on developing a
broader platform to support the diabetes franchise that we are building.
We believe we have a chance to become a key player in the diabetes and
metabolic disease marketplace. In order to do that, we need to focus on
adding new technologies and product opportunities into our pipeline. We
now know how to conduct clinical trials. We now know how to develop
product candidates, move them through the process rapidly and
efficiently. We believe that this combination of experience in the
diabetes space is not often found in small companies. Many of the large
pharmaceutical companies do but very few biotech companies actually have
this capability. So I would say that part of my attention will be
focused on how best to build the strategy map for the company going
forward. Another key part of my attention will be focused on what could
be the most appropriate manner to consider an alliance or a strategic
partnership to properly develop our products on a global basis.
Obviously, as a small biotech company, we don't have a presence in
Japan, and our presence in Europe is very limited. It's our intention to
try and form a strategic alliance with one or more large pharmaceutical
companies that would help us develop these products more fully and
quickly in these markets.

TWST: What would you want a long-term investor who is looking at your
financial report to focus on primarily?

Mr. Cook: I think the best thing that a long-term investor can focus on
is what I mentioned at the beginning of this interview. Amylin
Pharmaceuticals is the only company with exclusive rights to two late-
stage, first-in-class agents for diabetes, and a third compound headed
for Phase II this year. The upside value for these product candidates,
if they're approved, is substantial. I would look at this as a long-term
investment, which, while having embedded in it all the risk associated
with drug development, also has the potential for great rewards that can
come about if we are successful. This risk/reward profile is potentially
attractive to some investors.

TWST: Do you feel that Amylin's stock is fairly valued?

Mr. Cook: Given the way in which we define value in the marketplace: an
equal number of willing buyers and sellers to trade at this price, you'd
have to say our stock is fairly valued. But from my standpoint, I view
the stock as still having substantial potential. I believe that this is
a value transfer that will be paid out over time and that could be
rather significant.

TWST: Do you feel that there is any particular misperception about
Amylin?

Mr. Cook: The nature of drug development is always a difficult and
challenging path and I think a lot of investors have been on the
sidelines, waiting for the path forward to become more clear. I believe,
now that we have the approvable letter from the FDA for SYMLIN and we've
started Phase III with our second compound, AC2993, that some of these
risks have been reduced and the picture is much clearer now. The
misperceptions investors may have had in the past will begin to
dissipate once they understand the company. As people read the articles
and write-ups on the company, such as this interview, I believe they'll
gain a much better appreciation for the opportunities that are here.

TWST: What other top two or three reasons would you give a long-term
investor to buy today?

Mr. Cook: I think the most important thing to look at is the market that
a company is aiming to serve. Is it a growing or a declining market? The
focus of our development programs right now is on diabetes. The Centers
for Disease Control and Prevention estimate that there are approximately
16 million people in the United States with diabetes, and,
unfortunately, it has been estimated that this population is growing at
up to 6% per year which is 4 times the US population growth rate of 1.3%
a year. In the US we spend approximately 15% of our healthcare dollars
on the 5% to 6% of the US population that currently has diabetes. Of our
Medicare dollars, 25% are spent on people with diabetes. This market is
also poorly served: 60% of all patients with diabetes today are not well
controlled, according to the American Diabetes Association. We are
uniquely positioned with two late stage products in a rapidly growing
market with major unmet needs. The second thing a potential investor
would want to look at is: how much of the value of their compounds does
a company hold rights to? We have exclusive rights at this point in time
to all of the product candidates I've discussed today. That's an
enormous asset. And a third consideration: Are the product candidates of
this company really, truly innovative, first-in-class? Are they going to
make a difference? I hope I laid out in my earlier discussion with you,
reasons why both SYMLIN and AC2993 could make a real difference in the
treatment of diabetes.  So in summary, we are focused on a large and
growing target market that is currently underserved. We have exclusive
rights to product candidates. And we have innovative compounds that
could make a difference in the market.  The last thing I think an
investor should look at is: does the company have a competent management
team and Board to pull it off? With over 200 years of experience in the
pharmaceutical and biotechnology industry we are better equipped to
tackle the challenges we face. We consider it a privilege to be able to
serve in the healthcare industry. We are very focused on this. We know
that patients with diabetes and other metabolic disorders are calling
for more help. We view our opportunity to serve them as unique and to be
able to do so with the potential of economic rewards is a motivating
construct.

TWST: Thank you. (AAM)

JOSEPH C. COOK, JR.
 Chairman & CEO
 Amylin Pharmaceuticals, Inc.
 9373 Towne Center Drive
 San Diego, CA 92121
 (858) 552-2200
 (858) 552-2212 - FAX
 www.amylin.com
 e-mail: ir@amylin.com

Each Executive who is the featured subject of a TWST Interview is
offered the opportunity to include a Corporate Profile or other
highlight material to be provided and sponsored by and for the company.
This Interview with Joseph C. Cook, Jr., Chairman & CEO of Amylin
Pharmaceuticals, Inc., is accompanied by a Corporate Profile containing
corporate information.

This interview contains forward-looking statements about the company,
which involve risks and uncertainties. The company's actual results
could differ materially from those forward-looking statements discussed
in this interview, due to a number of risks and uncertainties, including
risks and uncertainties in the FDA's review of NDAs generally, risks and
uncertainties in FDA and European Regulatory Authority requirements for
SYMLIN approval, including risks and uncertainties that approval by
those authorities, if any, may be withheld, delayed and/or limited by
indications, risks and uncertainties regarding the drug discovery and
development process, uncertainties regarding the company's ongoing
clinical studies of its drug candidates and the ability of the company
to commercialize its drug candidates, whether through sales,
distribution, marketing and/or corporate partnering agreements, on terms
acceptable to the company or otherwise. Additional risks and
uncertainties are described more fully in the company's most recently
filed SEC documents, such as its Annual Report on Form 10-K for the
fiscal year ended December 31, 2000, and its recently filed registration
statement on Form S-3 (File No. #333-75066) under the heading 'Risk
Factors,' and its Quarterly Reports on Form 10-Q.

Copyright 2001 The Wall Street Transcript Corporation
All Rights Reserved


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