PowerPoint Template

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PowerPoint Template

• www.themegallery.com

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Contents
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What is Protein therapeutics?
It is currently estimated that there are
25,00040,000 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.
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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

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History and Development
2002 and beyond
BIOTECHNOLOGY IMPROVEMENT
19921999
BIOTECHNOLOGY INDUSTRY
19861991
MORE BIOTECHNOLOGY SUCCESSES
Pre-1986
A STAR IS BORN
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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.
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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
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Protein therapeutics replacing a protein that is
deficient or abnormal (Group Ia)
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Protein therapeutics augmenting an existing
pathway (Group Ib)
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Protein therapeutics providing a novel function
or activity (Group Ic)
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Protein therapeutics that interfere with a
molecule or organism (Group II a)
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Protein therapeutics that deliver other compounds
or proteins (Group II b)
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Protein vaccines (Group III )
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Protein diagnostics (Group IV )
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Protein Therapeutics Sales by Category, 2008

• Biologics already account for 12 (gt60bn) of
  total pharmacy sales
• Pharmaceuticals companies have invested heavily
  in production capacity that needs filling
• Acquisitions accelerating

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Biopharmaceuticals coming off patent in U.S. and
Western Europe
Company Brand name Generic name Class 2004 Sales (MUS)
Amgen/JJ/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
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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.
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Thank you for attention!