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Harsh environment threatens antibacterial development London-
Antibacterial resistence has become so prevalent that in some regions,
sensitivity to some commonly used antibiotics is as low as 40%. Coupled with
increased regulatory scrutiny and the large number of leading products facing
imminent patent expiry, the profit margins of antibacterial producers are also
under threat. This has lead to a significant reduction in R&D investment in
the field, and has contributed to the relative decline in antibacterial return
on investment, according to a new report by independent market analyst
Datamonitor*.
Growing resistance -
a threat? The
development of resistance severely threatens future revenues of leading
antibacterial compounds, most notably the penicillins and macrolides, and has
even led to new practices being introduced by government officials, Datamonitor
Infectious Disease manager John Savopoulos says. "Data from the
PROTEKT study suggests that in some regions, sensitivity to commonly used
antibiotics such as erythromycin is now below 40%." These
low sensitivities have and will continue to have a two-fold impact on relevant
compounds, he says. "First, physicians have started to switch first-line
therapy to compounds with lower resistance, such as fluoroquinolones or newer
macrolides like Zithromax (azithromycin), which has a direct impact on sales
revenue. Second, concerned healthcare authorities and governments have
introduced a number of policies in attempts to reduce unnecessary antibacterial
prescriptions, such as watchful waiting in the community setting." According
to Datamonitor's opinion leader research, these schemes have had varying degrees
of success: "...there
are specific indications in some patients in which it is deemed to be an
appropriate option....its because they present with a clinical syndrome that may
be viral, may be bacterial, has a natural history that 50% of them resolve by
themselves and so it's a low risk situation. Watchful waiting in the setting of
a known pneumococcal pneumonia or a known bacterial sinusitis, don't think
anybody would do that in this country." - US opinion leader. "It
tends to be used inappropriately, infrequently, that is there is greater
opportunity for watchful waiting than we actually take advantage of....either in
the hospital or the community, and this is something that is particularly useful
in the community." - UK opinion leader. While
in medical terms such schemes have clear benefits in terms of reducing
antibacterial use and potentially delaying the onset of resistance, they also
limit product revenues and place greater pressure on antibacterial producers. However,
the development of resistance does create opportunity for novel product
introductions, especially in the hospital setting. This is highlighted by the
large proportion of late-phase clinical trials incorporating patients with
resistant infections (most commonly MRSA). While this may be seen as an
opportunity, the mixed uptake of recent examples, such as Pfizer's Zyvox (linezolid)
and King Pharmaceutical's Synercid (dalfopristin/quinupristin), suggests that
products with efficacy against resistant pathogens may be preserved for
second-line therapy and hold limited long-term potential, Savopoulos says. Regulatory scrutiny
Across
the seven major markets, regulatory scrutiny and responsibilities for
pharmacovigilance are becoming more intense, highlighted by the sharp rise in
regulatory fines and litigation settlements in recent years, Savopoulos says. "Inevitably,
harsher scrutiny increases the costs of developing and marketing antibacterials,
as key players are forced to tighten compliance practices in order to avoid the
implications of regulatory fines and litigation." "In
addition, companies have faced delays in securing product approvals (Ketek and
gemifloxacin in the US), greater pressure to provide comprehensive pediatric
data (recent calls from the UK government) and increased responsibilities for
pharmacovigilance (2000 EU Directive)," he says. In
attempts to reduce regulatory time, a number of companies have gained fast-track
review status in the US, including Cubist's Cubicin and Basilea's BAL5788.
However, this was only achieved through demonstrating efficacy in clinical
trials against problematic resistant pathogens, and such products face
additional challenges once approved. During
2004-2005, five leading antibacterials are expected to experience patent expiry
in the US and EU, leading to a flood of cheaper generic alternatives entering
the antibacterial market. This sudden availability of a range of cheaper
antibacterials is likely to have effects beyond the direct impact on the
respective brands, Savopoulos says. "Datamonitor
believes that during the next two to three years, branded manufacturers will be
forced to review their pricing strategies, lowering list prices or offering
considerable discounts in order to maintain competitivity with the increasing
number of generic products." The
continuing increase in the number of leading products exposed to generic
competition, greater regulatory scrutiny and growing resistance have all placed
greater pressure on antibacterial profit margins. This explains, in part, the
lack of significant activity in the current antibacterial pipeline. As such,
Datamonitor predicts that, by 2014, pipeline compounds will only account for
10.9% of total antibacterial revenue across the major markets. Ends Notes
to editors Related
research *Commercial Insight: Antibacterials - Regulations, Resistance &
Generics To order these reports contact peter.barfoot@bioportfolio.com or telephone +44 1300 321501 or +1 415 680 2472 and a representative will get back to you. You can also order on line at: http://www.bioportfolio.com/cgi-bin/acatalog/search.html
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