CLINICAL TRIALS
Figure 7: Infectious diseases trials initiated in the past 12 months by disease
100
By Karen Currie, Citeline’s infectious diseases director
In the infectious disease therapeutic area, a total of 226
industry-sponsored Phase II to Phase III trials were initiated
Phase III
between September 1st, 2007 and August 31st, 2008. The
80
largest number of new trial starts occurred in vaccines.
Reflective of the expanding global vaccines market, nearly 40%
Phase II/III of all mid- to late-stage trial starts involved the evaluation of a
vaccine (87 of 226 trials initiated). Approximately half of these
ts
60
involved Phase III trials. Leading the way was Wyeth, with its
Phase II extensive development programme for Prevnar 13, a
pneumococcal vaccine which is being evaluated in all age
T
rial star cohorts and across a number of geographical regions. For
Phase II trial starts GlaxoSmithKline was the leader, dominated
40
by its programmes in seasonal and pandemic influenza. New
trial starts in virological diseases (HIV, HCV, HBV) outpaced
those in the bacterial diseases, indicative of the well
acknowledged challenge of identifying new targets to combat
the epidemic of antibiotic resistant infections.
20
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HIV
HCV HBV ection
HPV
V
accines ections
Sepsis
ycosis
ections ections ections
y inf
ychom
Otitis media
On
y tract inf
Bacterial skin inf
Respirator
Urinar Multiple viral inf
Multiple bacterial inf
Source: TrialTrove; accessed September 16th, 2008.
Figure 8: Infectious diseases trials initiated in the past 12 months by company (top 20; Phases II-III)
During the 2007-08 period, the clear leader in infectious disease
Phase III
trial starts was GlaxoSmithKline, whose activities were
40
concentrated in vaccines for influenza, pneumococcal and
meningococcal diseases. A notable exception was the start of
35 Phase II/III
pivotal Phase III trials with eltrombopag for the treatment of
HCV-induced thrombocytopenia. Positioned in second place is
Sanofi, with its strong commitment to global vaccine
30
Phase II
development and highly diversified portfolio of vaccines. All 21
trials initiated were with vaccines, 12 in Phase II and nine in
25
Phase III. A number of Sanofi’s tropical medicine vaccines are
ts
currently in Phase II, including vaccines for dengue fever,
hepatitis A and Japanese encephalitis virus, among others.
20
Novartis began 17 new trials in this period, nine of which were
T
rial star
in Phase III, including two trials in infants evaluating Menveo
15
for the prevention of meningococcal meningitis. Novartis also
launched two Phase II trials of its avian influenza vaccine
acquired from Chiron.
10
5
0
tis
eth
cell
est
Sanof_i
var
y
W
No
ck & Co
ohnson ohnson
Rib-X Roche Arpida F
or
Pf_izer
Innocoll
Baxter
ers Squibb
Inter
Mer
otein Sciences
GlaxoSmithKline
Schering-Plough
Pr
J
ohnson & J
J
ohnson & J
Bristol-My
tex;
Boehringer Ingelheim
V
er
Source: TrialTrove; accessed September 16th, 2008.
www.scripnews.com/supplements Scrip 100
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