JOSEPH COOK, JR. - AMYLIN PHARMACEUTICALS - (AMLN)
CEO Interview - published 02/19/01

DOCUMENT # LAS239

JOSEPH COOK, JR. has been Chairman of the Board and Chief Executive Officer of Amylin Pharmaceuticals, Inc. since March 1998. Prior to such time, he had served as a Board member and a consultant to the company since 1994. Mr. Cook is also a Director of Dura Pharmaceuticals, Inc., a specialty respiratory pharmaceutical and pulmonary drug delivery company, and Nabi, a research- and development-driven biopharmaceutical company that makes and markets products for people with life-threatening conditions. 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 retired as a Group Vice President of Eli Lilly and Company in 1993 after more than 28 years of service. Mr. Cook received a BS in Engineering from the University of Tennessee.

Sector: Drugs - Generic

TWST: Could you start by giving us a summary of your company, Amylin?

Mr. Cook: Amylin was founded in 1987 following the discovery that a second hormone, amylin, is produced by the beta cells in the pancreas. Previously, insulin was seen as the only hormone originating from these cells. Subsequent to that initial finding, Amylin research led to the discovery of a new molecule, SYMLIN™ (pramlintide acetate), an analog of human amylin. In clinical studies, SYMLIN has exhibited actions which compliment those of insulin in maintaining metabolic control. Phase III studies demonstrated statistically significant improvements in blood glucose control without weight gain in people with type 1 or type 2 diabetes using insulin. In early December, we completed the major milestone of submitting a New Drug Application (NDA) for SYMLIN to the Food and Drug Administration (FDA). This NDA summarizes one of the most extensive clinical programs ever conducted in the biotechnology industry. Amylin is utilizing the extensive knowledge of diabetes acquired from the SYMLIN program as we develop a second compound, AC2993 (synthetic exendin-4). AC2993 is now in Phase II clinical studies and is being studied for the treatment of people with type 2 diabetes who have not yet progressed to insulin therapy, but are not achieving target blood glucose levels with their current regimen or oral therapies. In clinical trials to date, the compound has lowered blood glucose in subjects who spanned the spectrum of diabetes severity. One of the more exciting aspects of AC2993 is that its glucose lowering actions appear to be active only during periods of high blood sugar. We recently completed feasibility work on a long-acting release (LAR) version of AC2993, in a collaboration partnership with Alkermes. Alkermes is one of the most accomplished drug delivery development firms in the world, and we are very excited to be working with them on this project. Pending positive results from the ongoing preclinical program, we plan to begin clinical testing in 2001. Amylin has in-licensed a third compound, AC3056. Phase I testing is under way to explore its potential in the prevention of restenosis. We will also be evaluating AC3056 as a potential treatment for atherosclerosis in general. All three of Amylin’s major development programs are focused on disorders associated with the metabolic processes of the human body, principally diabetes and lipid disorders.

TWST: Can you give us a specific agenda for the next 12-24 months? What accomplishments in that time frame would be a success for Amylin?

Mr. Cook: This year has great potential for Amylin Pharmaceuticals. It could be a year of transformation for the company. The Board of Directors’ recent approval of plans to establish an internal sales and marketing function broadens our focus from being a strictly research and development company to a business with the potential to deliver a product all the way to the patients we aim to serve. With the NDA for SYMLIN submitted, Amylin is now in a position to gear up its medical education, clinical study and sales capabilities to capture the commercial and medical potential of the drug, pending its approval by the FDA. These efforts will include the establishment of marketing and sales functions within the company, medical education, phase IIIB clinical trials, coordination of strategic manufacturing partnerships and infrastructure development. We also plan to continue the regulatory submission process for SYMLIN in Europe in early 2001. In addition to our commercial and regulatory activities for SYMLIN, we will also be working hard to progress our other drug candidates in the clinic. Pending positive results from the AC2993 Phase II program, we plan to initiate Phase III testing next year. Our Phase I program for AC3056 has shown good results so far, and we look forward to more data from that program as well. We also hope to advance our fourth development program, AC2993 LAR through the preclinical stage and into Phase I next year. This is the project we’re working on with Alkermes, targeted at a once-a-month dosing regimen of AC2993 for people with type 2 diabetes. Many have said that a product that could be administered once a month would be of extreme benefit to these patients. All in all we have a busy year ahead of us.

TWST: With that agenda apparently very full, give us a frank assessment of your top management team. At this point, do you feel you have the bench strength and the skill sets onboard to meet those opportunities?

Mr. Cook: That’s a very good question. It’s exciting to be involved with a company that has a drug candidate recently submitted to the FDA, with a plan to build its own internal commercial organization and another drug candidate possibly moving into Phase III next year. But that does require a superior management team. We’ve made four additions to our senior management team in the past year and a half that I believe equip us to handle the challenges we face in the coming months. Let me start with Dr. Joann Data, MD and PhD, who joined Amylin in August 1999 as our Senior Vice President of Regulatory Affairs and Quality Assurance. Dr. Data has over 25 years of experience in the drug industry in developing and submitting New Drug Applications to the FDA, and cultivating successful clinical and regulatory relationships. She will be paying close attention to the regulatory process and will be working with the FDA to be sure they have everything they need as they review the SYMLIN application. In December 1999, Dr. Alain Baron, MD, a noted diabetes expert, joined Amylin from the Indiana University School of Medicine where he served as head of the Department of Endocrinology. Dr. Baron is providing clinical leadership for our AC2993 program as it advances through Phase II testing. In March 2000, Mark Foletta came onboard as our CFO. Mark has previous experience as CFO of a publicly traded company. This experience has been with companies which had sales and revenue, an attribute we know will be very valuable as we build our commercial organization. We think it is important to have a senior financial officer who has experience with earnings per share, investor relations, and basic operating procedures. In June, we announced the addition of Julia Brown as Executive Vice President in charge of commercial operations. Julia has over 28 years of experience in sales and marketing in the pharmaceutical industry. More than 20 of those years were with Eli Lilly and Company. During that period of time, she was extensively involved in the sales and marketing of Lilly’s insulin products for diabetes. Her experience will be a great asset to us as we build our sales and marketing organization. With these four people added to our senior management team, along with a number of other recent additions to our overall management group, I believe we are well prepared to face the challenges that face us in the coming months.

TWST: What would you emphasize to help investors better appreciate Amylin’s investment hypothesis, and its medical and commercial potential?

Mr. Cook: If you look at the business models of profitable pharmaceutical companies, you’ll see a relatively straight-forward design. First you’ll see drug innovation. Successful businesses have resources to identify compounds that may have beneficial pharmaceutical effects. The next stage is product development during which a compound is formulated and tested so that it can be safely and effectively studied in the clinic. Clinical studies that follow test the drug candidate in the specific target population. If the studies yield results indicating a drug is effective without undesired side effects or safety issues, successful companies proceed to the next stage of regulatory review. If approved, the company moves on to sales and marketing. What I’d emphasize to investors is that with the upcoming addition of the sales and marketing function, we will have activities in every stage of the business model I just described. In addition to our SYMLIN regulatory and commercial activities, we have AC2993 and AC3056 in the clinic, and AC2993 LAR in product development stage.

TWST: Does the path you’re on require that you stay independent, or are there opportunities, or are there criteria that you use as you assess not only merger and acquisition opportunities for yourself as you move into that financial position, but perhaps alliances stronger than the strategic partnerships that you talked about before? As you get closer to commercialization you become obviously more attractive.

Mr. Cook: To become merged with someone else does not strike me as an essential component of being able to deliver these medicines to the people who need them. Our focus is on the important tasks I outlined earlier. Amylin has the plans and the resources to do this, so execution of these plans is our primary objective. We do, however, examine strategic options which would substantially strengthen our abilities to execute our overall business plan. Our research indicates that less than 25,000 physicians account for 50% of the insulin prescriptions in the US. After careful analysis of the diabetes marketplace, we believe that a small, focused sales force can effectively call on this concentrated group. And with 13 years of research on this compound behind us, we want to be significantly involved in any sales and marketing efforts for SYMLIN. We will, however, be discussing partnering relationships with companies we feel can enhance our sales and marketing activities. This is an important component of our long-range commercialization plan. As a smaller company, it is likely that Amylin will need the strength of a larger partner in selling to the portion of the prescriber base that we cannot call on efficiently, details I know from my experience at Lilly. Outside the US, I expect that we will have partnering relationships for the commercialization of SYMLIN. So we have the resources. I think it would be in the best interest of our shareholders right now for us to concentrate on doing the task at hand, and executing this most efficiently.

TWST: Outside of the US marketplace, the treatment of diabetes is much more aggressive. Has Amylin begun to address these international opportunities?

Mr. Cook: International markets are important to Amylin. Let me start with the most challenging for a small company, and that would be Japan. It would be very costly for Amylin to develop a commercial presence in Japan. It is likely that we will form a partnering relationship or a strategic alliance with a company that already has a physical and commercial presence in Japan. With respect to Europe, it is unlikely that Amylin will establish a full-fledged commercial operation in Europe. However, it is likely that we will play a more meaningful role and a stronger leadership role in Europe than we would in Japan. Europe is characterized by many different countries and the optimal commercial approach varies from country to county. In the US, I think it’s likely that we’ll actually lead the commercial function and actively work with a co-promotion partner.

TWST: Does the pricing mechanism, US domestic versus those in international markets, play into the assessment at all where the US tends to be on a free-market basis?

Mr. Cook: Drug pricing today is an area of interest with a considerable amount of discussion and debate. With respect to products that are used for treatment of advanced disease states like diabetes, pricing is not quite as sensitive. For the most part, these are drugs that will be reimbursed by insurance or by governments. There is some variation of pricing around the world on diabetes products, but in general we expect innovation that helps people with diabetes will be appropriately rewarded. We have not made a decision on pricing yet, and it is unlikely that we will until we have completed the regulatory process.

TWST: Finally, a summary statement for our investor audience. If this was the new road show and you were at that drum roll, what would be that final statement that does convince or compel an investor to buy in?

Mr. Cook: There are 3.7 million people in the US alone using multiple daily doses of insulin to treat their diabetes, and statistics indicate that a high percentage of these people still are not achieving adequate control with the existing therapies. We believe that SYMLIN, if approved, has the potential to help these people. But SYMLIN has also given Amylin the opportunity to demonstrate to the medical and investment communities our capabilities and our commitment to our stated goals. Our task now is to be ready to take SYMLIN to market upon a favorable FDA decision, and we will approach this task with the same dedication that we applied to the preparation of the SYMLIN NDA this year. I’d like to reiterate that we have three other promising development programs under way: AC2993, AC3056 and AC2993 LAR. We hope that the reward for success with SYMLIN will be the opportunity to repeat the process with these other drug candidates.

TWST: What have I overlooked, or what would you normally want to address that we’ve not covered?

Mr. Cook: I think one of the most important things to know about a company is something that can’t be expressed through press releases or SEC filings. We have a dedicated team of people who are aligned and work well together, and who are very focused on doing a quality job. These are very important attributes as we seek to earn the respect of the medical and investment communities as well as the patients we aim to serve. This team has been through a lot, and we are very excited about the privilege we have of advancing these compounds. It’s hard to put in words the level of commitment, flexibility and care that I witnessed during the preparation of the SYMLIN NDA. I just wish that people could see the lights that are still on late in the evening, and the lights that are on early in the morning, because that’s the commitment that people have here. And I think this level of dedication and teamwork oftentimes is the distinguishing attribute of a successful company.

TWST: Thank you.

JOSEPH COOK, JR.
 Chairman and CEO
 Amylin Pharmaceuticals, Inc.
 9373 Towne Centre Drive
 San Diego, CA 92121
 (858) 552-2200
 (858 )552-2211-FAX
 www.amylin.com
 e-mail: investorrelations@amylin.com

Each Executive who is the featured subject of a TWST Interview is offered the opportunity to include an Investors Brief or other highlight material to be provided and sponsored by and for the company.
This interview with Joseph Cook, Jr., Chairman and CEO, Amylin Phamaceuticals, Inc., is accompanied by an Investors Brief 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 discussed in this Interview, due to risks and uncertainties regarding the drug discovery and development process, the results of the Company’s preclinical and clinical studies of its drug candidates, the Company’s ability to coordinate the completion and submission of planned regulatory filings including applications for marketing approvals for 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 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, 1999 under the heading “Risk Factors,” and its subsequently filed Quarterly Reports on Form 10-Q.

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