Download Overview - ABSORPTION

Top 10 Therapies
Top 10 Drugs
Risk/reward
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Estimated cost for developing a new
drug - $800M to $1.7B (see class web site)
Five Blockbusters of 2006
Drug
Company
Peak Sales
Acomplia
Sanofi-Aventis
$2-5B
Pfizer
$2.25B
Merck
$1-2B
Brisol-Meyers
$1B
Pfizer
$1B
Suppress appetite, smoking
Exubera
Inhalable insulin
Gardasil
HPV, cervical cancer vaccine
Orencia
Arthritis treatment
Sutent
Shrink cancer tumors
http://money.cnn.com/magazines/fortune/fortune_archive/2006/01/23/8366988/index.htm
Acomplia Status
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Sanofi announced that the FDA has set April 26 as the new date
to review Acomplia and give Sanofi a thumbs-up or -down on
marketing it in the U.S. Back in February, the drug received an
approvable letter for its weight-loss indication and was deemed
non-approvable as a treatment to help people stop smoking.
Acomplia was approved in the European Union back in late
June, but the U.S. is where the big money is, especially now
that France and Germany have been enacting new measures
such as higher taxes on drug sales and rules to encourage
doctors to prescribe cheaper prescriptions or generic drugs.
December 11, 2006 http://www.fool.com/News/mft/2006/mft06121118.htm
Exubera Status
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Miller Tabak projected that annual sales will peak at
the range of $250 million to $275 million in 2008, but
added, "That may be too optimistic."
In an Oct. 26 report titled "Inhalable insulin: reality
doesn't live up to the hype," Datamonitor analyst
Daniel Poso projected an Exubera sales peak of about
$200 million by 2015, far short of billion-dollar
blockbuster status.
November 28 2006
http://money.cnn.com/2006/11/28/news/companies/exubera/index.htm
Gardasil Status
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Approved May 2006
Sales of HPV vaccine Gardasil,
garnering $70 million for the quarter
despite being marketed only since June
October 23, 2006 http://www.fool.com/investing/dividendsincome/2006/10/23/merck-mints-money.aspx
Benefits
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Each additional dollar spent on newer
medicines saves $4.44 on
hospitalizations.
New medicines generated 40 percent of
the two-year gain in life expectancy
achieved in 52 countries between 1986
and 2000.
New Drugs 2007
Assignment #1

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What is the reward protection for drug
developers? How does it work?
What is meant by Phase 1, 2, 3? How
does this work?
Risk/reward
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Patent protection – “The term of a new
patent is 20 years from the date on
which the application for the patent was
filed in the United States.”
(http://www.uspto.gov/web/offices/pac/doc/general/)
Road to Approval – Phase 1
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Phase 1 includes the initial introduction of an
investigational new drug into humans. These studies
are usually conducted in healthy volunteer subjects.
These studies are designed to determine the
metabolic and pharmacological actions of the drug in
humans, the side effects associated with increasing
doses, and, if possible, to gain early evidence on
effectiveness. Phase 1 studies also evaluate drug
metabolism, structure-activity relationships, and the
mechanism of action in humans. The total number of
subjects included in Phase 1 studies is generally in
the range of twenty to eighty.
Road to Approval – Phase 2

Phase 2 includes the early controlled clinical
studies conducted to obtain some preliminary
data on the effectiveness of the drug for a
particular indication or indications in patients
with the disease or condition. This phase of
testing also helps determine the common
short-term side effects and risks associated
with the drug. Phase 2 studies usually involve
several hundred people.
Road to Approval – Phase 3
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Phase 3 studies are intended to gather the
additional information about effectiveness and safety
that is needed to evaluate the overall benefit-risk
relationship of the drug. Phase 3 studies also provide
an adequate basis for extrapolating the results to the
general population and transmitting that information
in the physician labeling. Phase 3 studies usually
include several hundred to several thousand people.
http://www.fda.gov/cder/about/smallbiz/faq.htm