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Optimizing Lifecycle Management: Maximizing commercial lifespan through label expansion and combination products
The need to derive the maximum commercial mileage from all
components of a drug company’s portfolio is clearly evident in
an era of falling returns on investment and higher capital
costs. This report investigates three goals in optimizing
product potential- expanding the drug’s patent protected
lifespan, accessing broader patient populations and launching
line-extensions via fixed dose combinations. The key success
factors in each of these pursuits have been clearly identified,
emerging trends have been presented and the underlying concepts
have been explained to provide a clear understanding of current
industry dynamics. Case studies on popular products have been
used to illustrate these concepts in the real world. An in-depth
analysis of drug approval data provides context for the issues
discussed. This information is juxtaposed with historic sales
data to explore the correlation between the strategies employed
and revenue potential.
This report explains the basics of drug lifecycle and
investigates three goals in optimizing product potential-
expanding the drug’s patent protected lifespan, accessing
broader patient populations and launching line-extensions via
FDCs.
The key success factors in each of these pursuits have been
clearly identified, emerging trends have been presented and the
underlying concepts have been explained to give the reader a
clear understanding of current industry dynamics. Case studies
on popular products have been used to illustrate these concepts
in the real world.
An in-depth analysis of drug approval data provides context for
the issues discussed. This information is juxtaposed with
historic sales data to explore the correlation between the
strategies employed and revenue potential.
Key findings
Drug manufacturers must make the best strategic use of the
patent-protected lifespan of a drug, or else risk losing the
profit incentives they perceived at the start of the project.
(Ch. 1)
In light of the increasing complexity of biopharmaceutical
patenting, the ‘freedom to operate’, i.e. to commercialize the
invention, is coming under increasing scrutiny. (Ch. 2)
The US Congress’ emerging stance on data exclusivity provisions
for biologics will define the length of time a biotechnology
company can keep out generic competition in new indications. The
biotech industry’s stance is that the current provisions do not
provide for enough time to profit from their post-approval R&D
investments. (Ch. 2)
The potential for post-approval label expansion is much greater
for biologics in comparison to small molecule pharmaceutical
drugs. Most biologics on the market today can expect to add
significant revenue streams via new indications, and potentially
extend their commercial lifespan. (Ch 3)
Over 45% of all new indication approvals granted by the FDA
since 1998 belong to drugs that fall in the Genito-urinary
system and Nervous system.
If an FDC is launched close to the loss of exclusivity date of
the constituent brand, it may be interpreted as a marketing
tactic to limit post-LoE revenue losses. If launched early, it
may show intent to cater to a genuine unmet need, or to
legitimately maximize the potential of the parent molecule(s).
(Ch. 4)
Scope of the report
In-depth case studies explore the real-world execution of the
issues and challenges discussed in the report.
Analysis of historic drug approval data provides the reader with
contextual reference points.
Case studies on Vytorin, Advair and BiDil illustrate the
strategies employed by three leading FDC brands.
Brand histories of Yaz, Remicade and Seroquel show how label
expansion is fundamental to successful lifecycle management.
Where applicable, these strategies are discussed with reference
to specific therapeutic areas or geographies.
Issues related to biologics are highlighted to indicate where
they differ from small molecule drugs.
Use this report to
Gain an understanding of legal provision for patent protection
and data exclusivity. Understand their role in the context of
product lifecycle management
Utilize the historical data on NDA approvals to identify trends
and build assumptions into competitive landscape forecasts.
Understand the stance of key stakeholders and implications of
off-label drug usage.
Understand the role of FDCs in optimizing the commercial
potential of a product asset, and the main challenges in their
commercialization
Juxtapose historic sales performance with the timing of
indication expansion and FDC based strategies to assess the
success or failure
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