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.
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.
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.
16. A. M. Watanabe, MD
Executive VP Science &
Technology
Chairman and CEO
R. L. Tobias
VP, Human
Resources
Executive VP,
Finance & CFO
VP & General
Counsel
President
& COO
VP,
Cardiovascular
VP,
Endocrinology
VP,
Cancer
VP, Central
Nervous System
J. Schaus, PhD, Senior
Research Scientist
VP,
Regulatory Affairs
VP,
Development
VP, Medical
(Phases II & III)
CNS Business
Unit
Bianca Sharma,
Project Manager
Eisenstein, MD
VP Technology Core &
Infectious Disease
M. Haslanger, PhD
Executive Director,
Research Technology
And Proteins,
President, Sphinx
Pharmadeuticals
S. Kaldor, PhD, Head of
Combinatorial Chemistry
17. Eli Lilly and Company
-1994 Financial Highlights
(dollars in million)
18. 1994 1993 % Change
Net sales 5,712 5,199 10
R&D expenses 839 755 11
Income from continuing operations 1,185 465 155
Net income 1,286 480 168
Earnings per share
Income from continuing operations 4.10 1.58 159
Net income 4.45 1.63 173
As adjusted
Net income 1,398 1,336 5
Net income per share 4.84 4.54 7
Dividends paid per share 2.5 2.42 3
Capital expenditures 577 634 (9)
Income from continuing operation as
a percent of shares 20.7% 8.9%
Return on assets 11.8% 5.2%
Return on shareholders’ equity 25.9% 10.2%
19. Eli Lilly and Company
-Major Product Sales
(dollars in million)
22. Synthetic Chemistry
Made possible the development of
compounds never before seen in nature,
including more powerful and potent
variations of naturally occurring
compounds
Combinatorial chemistry
Enabled a large collection or “library” of
related chemical compounds to be
quickly generated simultaneously
High-throughput screening
Was aimed at solving problem. Using this
technology high-speed robots would
perform a series of biological tests or
“assay” on all member of a chemical
library virtually simultaneously.
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)
Round Vessel 1 Vessel 2 Vessel 3 Number of
Compounds
1 A B C 3(=31)
2 AD, BD, CD
ADG, BDG, CDG
AEG, BEG, CEG
AE, BE, CE
ADH, BDH, CDH
AEH, BEH, CEH
AF, BF, CF
ADI, BDI, CDI
AEI, BEI, CEI
9(=32)
3 AFG, BFG, CFG AFH, BFH, CFH AFI, BFI, CFI 27(=33)
… … … … …
K … … … (=3K)
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
29. “Migraine”
• was characterized by unilateral pulsating
headaches often severe enough to restrict
physical and mental activity
• afflicted 12 percent of population,
with a 3:1 preponderance in women
30. Imitrex,
• launched in 1992
• was a mildly effective drug that act by
constricting blood vessels
• had an adverse effect on the heart’s vessels
Many scientists felt that the makers of
Imitrex had followed the wrong path by
trying to find a compound that constricted
blood vessels(known as “vasoconstriction”).
31. 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.
