PowerPoint Template
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Contents
1
Introduction
2
Development
3
Classification
4
Future Direction
What is Protein therapeutics?
It is currently estimated that there are 25,000–40,000 different
genes in the human genome, viewed from the perspective of
disease mechanisms, as disease may result
when any one of these proteins contains
mutations or other abnormalities, so it
gives a tremendous opportunity for
Protein therapeutics to alleviate
these disease.
Why protein therapeutics?
Proteins cannot be mimicked by simple chemical compounds.
There is often less potential for protein therapeutics to interfere
with normal biological processes and cause adverse effects.
It is often well tolerated and are less likely to elicit immune responses.
Provide effective replacement treatment without the need for gene therapy
Time of protein therapeutics may be faster
History and Development
2002 and beyond
1992–1999
1986–1991
Pre-1986
BIOTECHNOLOGY IMPROVEMENT
BIOTECHNOLOGY INDUSTRY
MORE BIOTECHNOLOGY SUCCESSES
A STAR IS BORN
The Evolution of Protein Therapeutics : A Timeline
1953
First accurate model of DNA suggested
1982
Human insulin, created using recombinant DNA technology
1986
Interferon alfa and muromonab-CD3 approved
1993
CBER's Office of Therapeutics Research and Review (OTRR) formed
1997
First whole chimeric antibody, rituximab, and first humanized
antibody, daclizumab, approved
2002
Market for biotechnology products represents approximately $30
billion of $400 billion in yearly worldwide pharmaceutical sales
2006
An inhaled form of insulin (Exubera) approved, expanding protein
products into a new dosage form.
Classification of protein therapeutics
Group I: protein therapeutics with enzymatic or regulatory activity
Group II : protein therapeutics with special targeting activity
Group III : protein vaccines
Group IV : protein diagnostics
Protein therapeutics replacing a protein that is deficient or abnormal (Group Ia)*
Protein therapeutics augmenting an existing pathway (Group Ib)*
Protein therapeutics providing a novel function or activity (Group Ic)
Protein therapeutics that interfere with a molecule or organism (Group II a)*
Protein therapeutics that deliver other compounds or proteins (Group II b)
Protein vaccines (Group III )*
Protein diagnostics (Group IV )
Protein Therapeutics Sales by Category, 2008
• Biologics already account for 12% (>$60bn) of total pharmacy sales
• Pharmaceuticals companies have invested heavily in production capacity that needs filling
• Acquisitions accelerating
Biopharmaceuticals coming off patent in U.S. and Western Europe
Company
Brand name
Generic name
Class
2004 Sales (MUS$)
Amgen/J&J/Sankyo
Epogen/Procrit
Epoietin alfa
Erythropoietin
6,191
Schering-Plough
Intron A
Interferon alfa 2a
Interferon
1,168
Novo Nordisk
Novolin
Insulin
Insulin
2,405
Amgen
Neupogen
Filgrastim
Colony-stimulating factor
1,175
Biogen
Avonex
Interferon beta 1a
Interferon
1,418
Pfizer
Genotropin
Human growth hormone
Growth hormone
1,005
Eli Lilly
Humulin
Insulin
Insulin
998
Genzyme
Cerezyme
Imiglucerase
Other
835
Novo Nordisk
Norditropin
Somatropin
Growth hormone
387
Eli Lilly
Humatrope
Human growth hormone
Growth hormone
385
Genentech
Protropin, Nutropin
Somatropin
Growth hormone
354
Remaining Disadvantages
Protein Therapeutics also have disadvantages that may limit
their more widespread acceptance, include low oral and
transdermal bioavailability, moreover,
injections must be given frequently
because the half-lives of proteins
are short.
Thank you for attention!