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Genovate BIOTECHNOLOGY CO., LTD.
Jen Chen, PhD, General Manager
Industry
Biotechnology
Computer
Semiconductor
Software
Maturity
Maturing
Middle aged
Middle aged
Technology intense/
Technology intense/ Technology intense/ Technology intense/
R&D critical
R&D critical
R&D critical
R&D critical
Regulation
Heavily regulated Unregulated
Unregulated
Unregulated
Intensive
Moderate
Intensive
Not intensive
Requirements
Opportunity
Product
Development
Very short
Timeline
Source: DRI/McGraw-Hill, Semiconductor Industry Association, American Electronics Association
New Drug Development
z New Drug
New Chemical Entity (NCE), New Indication, New Formulation,
New Route of Administration, New Dosage Form.
z Drug Development
Preclinical
Clinical Studies:
Sales &
Product Approval
Phase 1, 2, 3
Marketing
Discovery
Pilot-Scale
Phase 4 (Post-
Manufacturing
Development
Production
Marketing Studies):
* New Indications
* Performance
Evolution of Pharmaceutical Industry
¾ Cost Containment Pressure
¾ Need for Fast Drug Development
¾ Global Clinical Development
¾ Global Marketing Strategy
¾ Maturation of Biotech Industry
¾ Stringent Regulation
¾ Strategic Alliance
TOP 15 PRESCRIPTION DRUGS BY WORLDWIDE SALES Worldwide Sales
Rank Rank
Brand Name
Chemical
Indication
Atorvastatin calcium
Cholesterol
Atorvastatin calcium
Astellas Pharma
Cholesterol
Simvastatin
Merck & Co.
Cholesterol
Advair/Seretide
Fluticasone propionate +
GlaxoSmithKline
Salmeterol
Amlodipine besylate
Hypertension
Olanzapine
Eli Lilly
Schizophrenia
Esomeprazole magnesium
AstraZeneca
GI disorders
Procrit/Eprex
Epoetin alfa
Johnson & Johnson
Sertraline hydrochloride
Depression
Venlafaxine hydrochloride
Depression
Clopidogrel bisulfate
Bristol-Myers Squibb Thrombotic events
Plavix/Iscover
Clopidogrel bisulfate
Sanofi-Synthelabo
Thrombotic events
Celebrex
Celecoxib
Alendronate sodium
Merck & Co.
Osteoporosis
Diovan and
Valsartan, Valsartan +
Novartis
Hypertension
Co-Diavan
Hydrochlorothiazide
Risperdal
Risperidone
Johnson & Johnson
Schizophrenia
Cozaar and
Losartan potassium,
Merck & Co.
Hypertension
Losartan potassium +
Hydrochlorothiazide
Source: Med Ad News, May 2005
Diagram of Bio-Pharma Industry
Alliance
BIG PHARMA
FORMULATION
REGIONAL LEADER
New Molecular Entities Approved In 2005
No. Product
Indication
Boehringer Ingelheim
HIV infection
GlaxoSmithKline
Leukemia/Lymphoma
Baraclude
Bristol-Myers Squibb
HBV infection
Amlyn/Lilly
Type 2 diabetes
Novartis
Chronic iron overload due to blood transfusions
PrimaPharm
Hypodermoclysis
Hylozyme (marketed by Baxter)
Hypodermoclysis
Increlex
Growth failure in children
Growth failure in children
10 Levemir
Novo Nordisk
Type 1 and Type 2 diabetes
11 Mycamine
Astellas
Candida infections
12 Nevanac
Pain/inflammation associated with cataract surgery
13 Nexavar
Bayer/Onyx
Advanced renal cell carcinoma
14 Revlimid
Transfusion dependent anemia
15 Rozerem
Insomnia
16 Symlin
Type 1 and Type 2 diabetes
17 Tygacil
Intra-abdominal infections and complicated skin and
skin structure infections
18 Vaprisol
Astellas
Euvolemic hyponatremia
Source: The Pink Sheet. January 9, 2006
Biologics Approved in 2005
No. Product
Indication
Sanofi-Aventis
Booster immunization against tetanus, diphtheria and pertussis
Boostrix
GlaxoSmithKline
Booster immunization against tetanus, diphtheria and pertussis
GlaxoSmithKline
Vaccine against influenza virus type A and B
Gammagard Liquid
IV immune globulin for primary immune deficiency
Menactra
Sanofi-Aventis
Vaccine for prevention of invasive meningococcal disease
Naglazyme
BioMarin
IV enzyme replacement therapy for mucopolysaccharidosis VI
Bristol-Myers Squibb
Rheumatoid arthritis
Vaccine against measles, mumps, rubella and varicella
Vaccinia immune
IV immune globulin for abberrant infections
globulin intravenous
(human)
10 Vaccinia immune
IV immune globulin for abberrant infections
globulin intravenous
(human)
Source: The Pink Sheet. January 9, 2006
Top 10 Pharmaceutical Companies
Rank
2006 Market Cap
(in billions)
from 2005
Johnson & Johnson
GlaxoSmithKline
Sanofi Aventis
Novartis
Merck & Co.
AstraZeneca
Abbott Labs
Eli Lilly & Co.
Top 5 Biotech Firms
Rank
2006 Market Cap
(in billions)
from 2005
Genentech
Gilead Sciences
Biogen Idec
Source: S&P Comstock via the Telescan Prosearch Program. Market Cap on
March 1, 2006 and May 9, 2005.
Recent Success of New Drugs
1) Aloxi by Helsinn/MGI
Ö First me-too that has delayed and acute antivomiting effect
2) Cialis by Lilly
Ö First me-too that has long half-life to be claimed as
“Weekend Pill”
3) Factive by LG
Ö First me-too antibiotic approved by Korean FDA
4) Caduet by Pfizer
Ö Combo of Lipitor and Norvasc
5) Niaspan by Kos
Ö Once-a-day formulation of Niacin
Factive® (gemifloxacin) - Fast and ACTIVE
LG Life Sciences, Ltd.
Novelty of invention: Shift of Ciprofloxacin’s 6-member ring “Piperazine” to a 5-member
ring “pyrrolidine” and creates a unique structure “Oxime” to increase activity against G(+)
Clinical Development: 9,402 patients involved in phase 2/3 studies (5,249 received Factive®)
5 Phase 2: STDs, RTI/AECB, LRTI, uncomplicated SSTI, uncomplicated UTI
4 Phase 3: RTI/AECB, RTI/Sinusitis, RTI/Pneumonia,
uncomplicated+complicated UTI
LG company initiated its antibiotic project.
1995-1996
Discovered by LG, the compound completed phase 1 in Europe.
1997.05.12
Strategic alliance with SB (now GSK) for the worldwide development &
commercialization of the compound outside of Korea while LG retained the
option to co-promote the product with SB in certain markets in South East Asia.
Phase 2 completed in the US.
1999.12.15
Phase 3 completed and the NDA filed to the US FDA by SB.
2000.12.15
Not approvable letter granted by the US FDA citing concerns about efficacy and
potential liver damage and drug-related rashes.
2002.04.15
Following its merger with Glaxo, GSK returned the product rights to LG.
Factive® (gemifloxacin) - Fast and ACTIVE
LG Life Sciences, Ltd.
2002.10.22
Licensed to GeneSoft for North America and Europe.
At the request of the US FDA, a further study was performed in 1,011
young adult female patients in order to characterize further a
gemifloxacin-associated rash seen in previous trials.
2002.12.27
New drug approval in Korea.
2003.03.04
GeneSoft presented new data showing no increase in liver enzymes or heart
rhythm problems but a much higher incidence of rash in Factive® patients.
US FDA advisory panel voted 18-0 for approval for the CAP indication
and 15-3 for approval for the AECB indication.
2003.04.04
New drug approval from the US FDA for RTI (CAP & AECB).
Factive® was expected to generate $67M in annual global sales and
royalty revenues for LG.
2003.07.29
US FDA approved Factive® for multi-drug resistant S. pneumoniae
indication.
Similar approvals pending in UK, Canada, Hungary and South Africa.
41.03.12
51.02.09
54.08.26
82.05.03
56.06.30
84.12.12
66.07.02
91.08.26
82.03.17
93.10.18
49.07.22
90.09.27
59.08.25
92.05.12
4.94 0. 89
71.06.16
92.11.05
55.06.30
93.12.13
Challenges in Taiwan Biotech/Pharma Industry
z Taiwan biotech/pharma companies are too small
Ö Need M&A to create Big 3 with individual sales >US$100M
and R&D budget 10%
z Collaboration between industry and academics
Ö Need joint drug discovery and development projects that
focused on competitive program with our strength
z Alliance with US marketing-driven specialty pharmas
Ö Need government’s $$ to invest/establish marketing
network for our products to go abroad

Source: http://www.dls.ym.edu.tw/Biotechnology/(94-2)042506.pdf