1. Eli Lilly and Company :Drug Development Strategy (A)

2. Introduction to the Pharmaceutical Industry In the mid 1990s

3. By the mid 1990s, annual worldwide pharmaceutical sales were around $250 billion, with roughly 80 percent originating in the industrialized G7 nations. Top Blockbuster drugs targeted diseases of particular concern to industrialized nations.

4. U.S. Pharmaceutical Market by Therapeutic Category (1994)

6. Summary of Drug Development in the USA

8. Under current law, a patent’s term expired 20 years from the time the patent application was field (prior to 1995, patent protection extended 17 years after the patent was issued.) Sales of only a few products could provide exceptional returns. In the mid 1990s, 14 products had annual sale over $1 billion, enabling profit margins of 15-20 percent.

9. Top 20 Prescription Drugs by Worldwide Sales (1994) (dollar in millions)

11. Top 20 Firms Active in the Pharmaceutical Industry (1994) (dollars in millions)

13. Eli Lilly and Company

14. Eli Lilly and Company was found In Indianapolis, Indiana in 1876 by Colonel Eli Lilly. In the mid 1990s, Lilly, operating in 150 countries, was one of the world’s largest pharmaceutical company, with over 25,000 employees and 1994 sales of $5.7 billion.

15. Eli Lilly and Company - Organization Chart

16. Chairman and CEO R. L. Tobias A. M. Watanabe, MD Executive VP Science & Technology VP, Human Resources Executive VP, Finance & CFO VP & General Counsel President & COO VP, Cardiovascular Eisenstein, MD VP Technology Core & Infectious Disease VP, Regulatory Affairs CNS Business Unit VP, Endocrinology VP, Development M. Haslanger, PhD Executive Director, Research Technology And Proteins, President, Sphinx Pharmadeuticals VP, Cancer VP, Medical (Phases II & III) VP, Central Nervous System Bianca Sharma, Project Manager S. Kaldor, PhD, Head of Combinatorial Chemistry J. Schaus, PhD, Senior Research Scientist

21. Innovation in the new Drug Development Process

23. Combinatorial Chemistry At Lilly

24. Combinatorial chemistry is an emerging technology for generating a large collection or “library” of related chemical compounds rapidly, instead of having to make one compound at a time. This allows for creating variations around the backbone of a basic molecular structure.

25. Combinatorial Chemistry (the “Split-and-Mix” Method)

26. Central Nervous System (CNS) Diseases

27. CNS Diseases accounted for roughly 10 percent of all lifetime years lost to disease. E.g. clinical depression, severe insomnia (sleeplessness), and migraine Each of which affected over 10 percent of the population – could take a severe toll on society. For instance, depression might predispose people to suicide

28. Lilly’s Migraine Project

32. By March 1994, out of over 1,000 previously synthesized serotonin-like compounds one particularly good “lead” had been found. In addition, Lilly’s experiments in which lab animals were administered these lead compounds further promise of the “1f” serotonin receptors as treatment targets for migraine without the need for inducing vasoconstriction.

33. Timeline

37. Difficult choices: The Project Team Advisory Committee(PTAC) Meeting

38. The three key business issues for PTAC Presentation

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