R&D
versions were dropped from competitors’
Table 2: Launched drugs for indications in Table 1
pipelines, at huge cost.
Despite prevailing fears that innovation in
Disease Most common drug target
pharma is suffering, novelty is gaining
HIV infection HIV-1 gag-pol
headway in the pipeline, as can be seen in
pain COX-2 Figure 3. 2007 saw the launch of two new
hormone replacement therapy oestrogen receptor 1
antiretrovirals with completely novel
mechanisms of action – Merck & Co’s
hypertension calcium channel, voltage-dependent,
integrase inhibitor Isentress (raltegravir) and
L type, alpha 1C subunit
Pfizer’s CCR5 antagonist Selzentry
schizophrenia/ Parkinson’s D2 dopamine receptor
(maraviroc) – marking a potentially huge
asthma glucocorticoid receptor, β2 adrenergic receptor
step forward in HIV therapy. The HIV field
previously had only three approved
depression serotonin neurotransmitter transporter
treatment strategies: reverse transcriptase
Source: Pharmaprojects
inhibition, protease inhibition and fusion
inhibition. By forging entirely new paths to
treat HIV based on novel targets, both
Figure 3: Novel drugs by phase of development
Merck and Pfizer have gained access to
80 potentially vast profits by opening up niche
areas of the market. And most importantly,
70
the 38 million patients infected with HIV
worldwide will benefit hugely from the new
drugs, especially those who have developed
60
resistance to, or cannot tolerate, existing
gets
drugs.
50
o
v
en tar
By forging entirely new paths to
40
treat HIV based on novel targets,
tage unpr
30
both Merck and Pfi zer have
c
en
gained access to potentially vast
P
er
20
profi ts by opening up niche areas
of the market
10
0
It is clear that the future of the pharma
Preclinical Phase I/II Phase III PR
industry will depend on key influencing
Source: Pharmaprojects
factors, but whatever shape it takes will
almost certainly be entirely new. Companies
he has used to treat his own condition for and specific symptom sets meant less
as large as Pfizer are rethinking their
the past 15 years, the dopamine agonist blockbuster potential. The Act filled a
business plans, and making dramatic
levodopa, had been around for more than desperate need in targeting untreated
restructuring changes as a result. Such
four decades. He added that, over the patients with chronic and often fatal
streamlining of business practices, including
course of his disease, he had been offered conditions, such as gliomas. Drugs face less
refocusing on therapeutic areas with the
no alternative drug with the possibility of competition in these niche areas, allowing
most potential, may well have a huge
fewer side-effects or greater efficacy in most/all of the potential profits to be
beneficial effect. Add to this the sea of
controlling disease progression, and that he retained by the manufacturer, with the
targets waiting to be taken full advantage of,
could see none on the horizon. added boon of tax reductions and a seven-
and it is clear that anything could happen.
Michael J Fox represents a new year prolonged exclusivity period. The Act
With investors waiting with baited breath
evolutionary pressure influencing drug has proven quite successful; in 2008 alone
for the outcome of all this change, the
development today – that of demand from over 80 drugs have been granted orphan
evolution of the pharma industry has huge
patients, physicians, insurance companies drug status.
potential for exciting innovation, benefiting
and government regulatory bodies. Drugs Patient and physician preference for drugs
patients, shareholders and governments.
for difficult-to-treat and poorly understood can also play a part in their success, as
conditions are now demanded, and highlighted by poor market uptake of
expectations for treating the underlying Pfizer’s inhaled insulin drug Exubera, for
causes, not just symptoms, are higher than example. There were some concerns over
ever. In January 1983, incentives for pharma safety, but a major factor in determining
to develop drugs for unmet diseases came Exubera’s fate was the device’s design –
in the form of the Orphan Drug Act. This patients simply didn’t like it, preferring
piece of US legislation was introduced to modern injectable devices over the bulky Alix Biancardi and Sophie Green are assistant
boost research in rare diseases, where small inhaler. As a result, a potential blockbuster
editors for Pharmaprojects.
patient populations (fewer than 200,000) failed to make an impact, and “me-too”
36
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