Transcript Decision Resources

Macroview Event Report: Abbott’s Humira to become industry’s leading product in 2014
May 2008
May 2008
TITLE:
Abbott’s Humira to become industry’s leading brand in 2014
Use of adalimumab expected to increase for all approved indications
BEHAVIOURAL
 The increased use of
biologics demonstrates the
outstanding unmet need for
efficacious treatments,
despite increased risk of
adverse events
ORGANISATIONAL
 Big Pharma companies,
aggressively seek out
products and programmes
which target areas of unmet
need
FINANCIAL
 Current forecasts reflect a
maturing global ethical drug
market
 Despite the emergence and
success of biologics,
growth of the overall global
ethical drug market is
expected to slow to 4.3% in
2014
 Big Pharma
 Specialty Pharma
 Biotech
Generics
OTC



Anti-infectives
Cardiovascular
CNS
Dermatology
Gastrointestinal
Genitourinary
Metabolism
Musculoskeletal/Pain
Oncology
Ophthalmology
Respiratory
Transplants
Vaccines
Impact areas include:
 All Major Markets
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Macroview Event Report: Abbott’s Humira to become industry’s leading product in 2014
May 2008
Contents
 Summary of Event
 Macro Impact Areas
 Business
 Sector
 Geographic
 Therapeutic
 Appendix
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Macroview Event Report: Abbott’s Humira to become industry’s leading product in 2014
May 2008
Decision Resources Ranks the Top Pharmaceutical Brands

In April 2008, Decision Resources’ Pharmaview group released its most recent edition of Productview Plus

The top 10 leading brands as at end 2007 are:
Molecule
atorvastatin
clopidogrel
salmeterol / fluticasone
epoetin alfa
etanercpet
esomeprazole
infliximab
valsartan
olanzapine
rituximab
Brand
Lipitor
Plavix
Advair
Epogen / Epogin / Procrit /
Enbrel
Nexium
Remicade
Diovan
Zyprexa
Mabthera / Rituxan
Company
Pfizer
BMS / sanofi-aventis
GlaxoSmithKline
Amgen / Chugai / J&J
Amgen / Wyeth
AstraZeneca
J&J / Schering-Plough / Mitsubishi Tanabe
Novartis
Eli Lilly
Roche / Genentech
2007 Sales ($m)
13,630
8,073
7,085
5,839
5,438
5,216
5,169
5,012
4,761
4,664
Source: Decision Resources Productview March 2008

Note that the top three products are traditional, small-molecule products

Five of the of the top ten products set to face intense generic competition during the forecast period
(2007-2014)

Lipitor, Plavix, Nexium, Diovan, and Zyprexa
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Macroview Event Report: Abbott’s Humira to become industry’s leading product in 2014
May 2008
Pharmaview Forecasts Show Biologics Leading the way in 2014

Our forecasts indicate that biologics will comprise 6 of the top 10 products in 2014, accounting for $44.3bn
(and 65.5%) of the combined sales for the top 10 products



Three of the top four molecules are Tumour Necrosis Factor alpha (TNFa) inhibitors***
According to our forecasts, there are several leading players without products in the top 10 - including Pfizer,
AstraZeneca, and Novartis

GlaxoSmithKline scrapes in, thanks to Advair, sales of which are forecast to begin a slow decline starting in
2012 due to the expected launch of only a single generic competitor, Vectura’s VR315

Given it's controlling stake in Genentech and Chugai, Roche consolidates sales of 3 of the top 10 products
in 2014
The top 10 leading molecules in 2014 are as follows:
Molecule
infliximab ***
rituximab
adalimumab ***
etanercpet ***
human papilloma virus vaccine
aripiprazole
bevacizumab
tiotropium
trastuzumab
salmeterol / fluticasone
Brand
Remicade
Mabthera / Rituxan
Humira
Enbrel
Gardasil
Abilify
Avastin
Spiriva
Herceptin
Advair
Company
J&J / Schering-Plough / Mitsubishi Tanabe
Roche / Genentech
Abbott / Eisai
Amgen / Wyeth
Merck & Co
Otsuka
Roche / Genentech
Boehringer Ingelheim
Roche / Genentech
GlaxoSmithKline
2014 Sales ($m)
8,774
8,410
8,332
7,409
6,603
6,242
6,226
5,366
5,178
5,090
Source: Decision Resources Productview March 2008
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Macroview Event Report: Abbott’s Humira to become industry’s leading product in 2014
May 2008
Abbott’s Humira is forecast to become the leading single-company brand

When sales from each molecule are separated by their individual contribution for each company, Abbott’s Humira
emerges as the industry’s leading brand by 2014
Sales of the top 4 products in 2014 by Com pany and TA
Takeda
Amgen
Enbrel
Wyeth
Chugai
Rituxan / MabThera
Genentech
Roche
Eisai
Hum ira
Abbott
Mitsubishi_Tanabe
Schering-Plough
Rem icade
Johnson & Johnson
0
1000
2000
Musculoskeletal/Pain
3000
4000
Gastrointestinal
5000
6000
7000
Dermatology
8000
$m
9000
Oncology
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Source: Decision Resources Productview March 2008
Macroview Event Report: Abbott’s Humira to become industry’s leading product in 2014
May 2008
Humira sales to increase thanks to its recently expanded label


Humira is currently ranked 56th as a
single company brand, due mostly to
its use for the treatment of
rheumatoid arthritis (launched in
2003)
Humira Sales by Therapy Area
Sales of Humira are expected to
grow significantly following recent
approvals for
9000
Gastrointestinal
8000
CAGR 14.8%
Musculoskeletal / Pain

Ankylosing Spondylitis (2006)
7000

Crohn’s disease (2007)
6000

Psoriasis (2007)
A significant portion of Humira’s
usage is currently from patients who
are either intolerant to, or who lose
their response to, infliximab
(Remicade)
$8,069m
Dermatology
sales ($m)

$3,067m
5000
4000
3000
2000
$280m
1000
14
20
13
20
12
20
11
20
10
20
09
20
08
20
07
20
06
20
05
20
In April 2008, Eisai announced that
Humira had received approval in
Japan for the treatment of
rheumatoid arthritis
20

04
0
20
Additional first-line use expected to
help drive future growth
03

Source: Decision Resources Productview March 2008
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Macroview Event Report: Abbott’s Humira to become industry’s leading product in 2014
May 2008
Macro Impact Areas
BUSINESS

Behavioural

The increased use of biologics, especially anti-TNFs, demonstrates the outstanding unmet need for
efficacious treatments for autoimmune inflammatory disorders, despite increased risk of adverse events



Most biologics are immunosuppressive, thus making the patient slightly more susceptible to
opportunistic infection and/or tumours, especially when treatment is combined with other
immunomodulators such as methotrexate or azathioprine
The TNFa inhibitors have demonstrated efficacy at changing the course of rheumatic disease, and as such,
have become an established first line therapy. In other autoimmune diseases, such as Crohn’s disease,
their use is remains restricted to later lines of therapy and as such there remains significant potential for the
growth of these products

At Digestive Disease Week 2008, Abbott released the most recent data from its CHARM study, which
showed that 29% of patients with active Crohn’s disease receiving Humira achieved steroid-free
remission at 12 months

While the percent of patients achieving remission is certainly impressive, there remains a significant
proportion of patients that require additional treatment. That leaves openings for other novel biologics
which can demonstrate efficacy, especially for patients who are non-responsive or intolerant to antiTNFa therapies
Major pharmaceutical companies, especially those set to face significant growth challenges are expected to
boost their business development activities in an effort to gain access to promising products and
programmes, especially biologics
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Macroview Event Report: Abbott’s Humira to become industry’s leading product in 2014
May 2008
Macro Impact Areas
BUSINESS

Organisational

Abbott has sole marketing rights to Humira in all major markets with the exception of Japan, Taiwan, and
Korea

Japanese development and commercial rights were licensed to Eisai in 1999

Commercial rights to many of the top biologics products are shared by multiple companies, especially in
Japan where domestic companies such as Takeda, Eisai, and Mitsubishi Tanabe Pharma have established
commercial operations

The success of biologics, especially for specialty indications, indicates an industry shift away from many
primary care (and highly satisfied) indications such as hyperlipidaemia and GERD

Big Pharma companies, especially those where forecasts do not include any leading brands in 2014, are
expected to aggressively seek out products and programmes which target areas of unmet need
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Macroview Event Report: Abbott’s Humira to become industry’s leading product in 2014
May 2008
Macro Impact Areas
BUSINESS

Current forecasts reflect a maturing
global ethical drug market




1000
10.0%
Sales of leading brands in 2014 fall
well short of Lipitor sales in 2007
900
9.0%
800
8.0%
Combined sales of top 10 brands
for 2007 ($64.9bn) and 2014
($67.6bn) indicate a period of
slower growth
700
7.0%
600
6.0%
500
5.0%
400
4.0%
300
3.0%
200
2.0%
100
1.0%
0
0.0%
Despite the emergence and success of
biologics, growth of the overall global
ethical drug market is expected to slow to
4.3% in 2014
Cost of treatment using biologics remains
very high, thus a need for unequivocal
cost effectiveness data is essential
Year on Year Growth
Financial
Sales ($bn)

2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014
Global Rx market $m
YoY change %
Linear (YoY change %)
Source: Decision Resources Pharmaview March 2008
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Macroview Event Report: Abbott’s Humira to become industry’s leading product in 2014
May 2008
Macro Impact Areas
SECTOR


Big Pharma

Future leading products are likely to be biological treatments for cancer, autoimmune diseases, and other
areas of high unmet need

Many Big Pharma players have shifted away from primary care indications (Roche) or have announced that
such a shift is imminent (BayerSchering, Bristol-Myers Squibb)

We expect many Big Pharma companies without a presence to aggressively pursue products and
programmes which target specialty indications
Specialty / Biotech

A great deal of innovation has come from specialty pharma and biotech companies, most of which have
partnered their novel pipeline programmes with Big Pharma companies
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Macroview Event Report: Abbott’s Humira to become industry’s leading product in 2014
May 2008
Macro Impact Areas
GEOGRAPHIC

Global

Relevant to all geographical markets, but particularly the major markets – USA, Europe, and Japan
THERAPEUTIC

Relevant to all therapy areas; but especially the Musculoskeletal / Pain, Gastrointestinal, and Dermatology sectors
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