CLINICAL TRIALS
Figure 5: Autoimmune/inflammation trials initiated in the past 12 months by disease
50
By Dr Sylvia Marecki, Citeline’s autoimmune/inflammation
director
In the autoimmune/inflammation therapeutic area, a total of 311
Phase III
industry-sponsored Phase II to Phase III trials were initiated
40
between September 1st, 2007 and August 31st, 2008. Of these,
respiratory indications (asthma, COPD and allergic rhinitis)
Phase II/III
represent approximately 40%, with rheumatology (rheumatoid
arthritis, osteoarthritis, psoriasis, other inflammatory arthritis,
lupus and Sjogren’s syndrome) close behind. Combined, nearly
30
Phase II
75% of trials initiated during this timeframe involved these two
ts
areas. However, unlike the respiratory indications, trial activity in
rheumatology is dominated by activity in rheumatoid arthritis,
and to a lesser extent, psoriasis and osteoarthritis. New trial starts
T
rial star in the remaining indications lagged behind these high-activity
20 indications. For example, among the new trial starts in Crohn’s
disease and ulcerative colitis, only Abbott and Novartis initiated
trials in both indications; all other sponsors initiated single trials in
one of these indications. Likewise, few companies initiated more
than one trial in atopic dermatitis, cystic fibrosis or irritable bowel
10
syndrome. These observations contrast with the large number of
trial starts per drug and per sponsor in respiratory and some
rheumatology indications, suggesting that clinical trial activity will
remain high in respiratory and high-profile rheumatology
indications for the near term. This dearth of trial activity in these
0
lower profile autoimmune/inflammatory indications underscores
y)
osis the opportunity for companies seeking to enter this lucrative
thritis
ome
Asthma
COPD
thritis Lupus thritis
ome
Psoriasis
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s disease
y ar
market.
s syndr
Allergic rhinitis
T
ransplantationOsteoar Cystic f_ibr
ohn’
w
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en’
Ulcerativ
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Atopic dermatitis
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Rheumatoid ar
Anti-ageing (dermatolog
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Other inf_lammator
Source: TrialTrove; accessed September 16th, 2008
Figure 6: Autoimmune/inflammation trials initiated in the past 12 months by company (top 20; Phases II-III)
30
Novartis, independently and through partnerships, leads the pack
Phase III
in terms of new trial starts during this study period, the majority of
which involve respiratory diseases (asthma, COPD and allergic
25
rhinitis). Among the remaining top five companies, development
Phase II/III
is concentrated in respiratory diseases and rheumatology. As a
whole, the top five companies represent approximately 29% of all
new trial starts in autoimmune/inflammatory diseases during this
20
Phase II
timeframe; approximately 59% are accounted for by the top 20
sponsors. Trial starts were fairly balanced between Phase II and
ts
Phase III trials overall, but skewing in either direction hints at the
status of ongoing development programmes. For example,
15 GlaxoSmithKline and Pfizer initiated mainly Phase II trials and
both have several ongoing programmes in mid-stage
T
rial star
development, whereas Abbott initiated mainly Phase III trials
targeting label expansions. Approximately 17% of all initiated
10
trials involve partnerships. Notable partnered programmes
include the GlaxoSmithKline/Theravance Horizon programme
(respiratory), the Novartis/Schering-Plough indacaterol
programme (respiratory), the Roche/Genentech/Biogen-Idec
5
ocrelizumab programme (rheumatology), and the Serono/
ZymoGenetics atacicept programme (rheumatology) [data not
shown]. This concentration of partnerships among the top 20
sponsors suggests that the collaboration strategy may play a
0
larger role in drug development in coming years.
tis
var Meda v
entis
No
Abbott
Pf_izer Roche
UCB
ck & Co
ers Squibb
ck KGaA
ohnson
Galderma
AstraZeneca
Mer
Leo PharmaMer
GlaxoSmithKline
Schering-Plough Astellas Pharma
Sanof_i-ACombinatoRx
J
ohnson & J
Laboratorios LETI
Bristol-My
Boehringer Ingelheim
Source: TrialTrove; accessed September 16th, 2008
82
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