It is
widely recognized that Rx-to-OTC switches are the leading method for creating a
new OTC brand. A well established OTC brand may have essentially an unlimited
life expectancy. This provides a powerful strategy for dealing with the dramatic
sales losses that occur when an Rx product goes off patent. Switchability
analysis may be quite useful for developing
strategies for forced switches, as well.
Rx-to-OTC switches may require large, time
consuming clinical trials to gain regulatory approval and there is no guarantee
that an approval will be ever be granted. Therefore,
gaining regulatory approval for a switch must be the cornerstone of the
marketing plan.
Among the major questions for a potential
Rx-to-OTC switch are:
Is this product a candidate for OTC status?
What indications and labeling should be sought for the
proposed switch?
What is the best regulatory strategy to pursue?
What is the OTC potential for the product?
These and many other important questions
can be answered by SDM with our well developed Switchability Analysis.
Switchability Analysis is an in-depth examination of all the key elements of the
switch process from safety assessment to labeling to clinical trial programs.
This process has been developed over the past ten years by SDM to help Rx
and OTC companies plan for the life cycle future of their pharmaceutical product
portfolio.
The process is an interactive one
conducted in conjunction with your staff and SDM consultants. We don’t
re-invent the wheel and build on your hard won knowledge base by adding our
switch expertise to the information mix. The result is an analysis that can
truly help you plan your strategic future.
Labeling is one of the most important factors
in the safe and effective use of an OTC product. Indeed, the ability to label
for safe use by the lay population is the critical identifying characteristic of
an OTC product. Other important labeling issues are:
Adequate self-selection/de-selection
Claims
Indications, contraindications
Dosage and administration
Warnings, drug interactions
Communication of indications, warnings & dosage
information
Based upon the results of the Safety Analysis
and the Proposed Labeling, SDM will propose a detailed regulatory strategy
Consensus building
Exclusivity analysis
FDA tactics: low vs. high risk
The desired labeling to a large extent drives
the clinical research program. Comparative claims which can effectively
distinguish a product from its competitors are also established in the clinical
program.
SDM will carry out an analysis of the current
market for the product as well as the impact of future entrants. Our primary
focus will be on currently marketed Rx products that might be switched to OTC
status. A second focus will be on possible competitive advantages of Hytrin.
A full analysis of the competitive situation
would cover the following elements:
Sale forecasting is accomplished with the
aid of The Delphi Oracle Rx-to-OTC Simulation. This simulation has
undergone a rigorous program of development and is now in its fifth third major
release. The simulation is used in conjunction with the client to forecast the
five year sales potential of OTC drug and any residual Rx product. It can
forecast sales for either an existing category or an entirely new one.
The forecast from the simulation is backed
up by research into the category and the likelihood of additional competitors
entering the marketplace. Explicit estimates of marketing costs required to
support the brand are generated.
Switchability Deliverables
The deliverables will include safety
assessments of the candidate drug, possible superiority claims, regulatory
strategy, a competitive analysis, a sales forecasts and an analysis of certain
key strategic considerations. The sales forecasts will include multiple
scenarios covering a variety of spending levels and competitive situations.
Switchability Uses
Switchability analysis can be used in many
areas of product development to improve decision making.
Evaluate your product portfolio
Prioritize switch efforts
Assess license opportunities
Identify switch candidates in the R&D pipeline
Abandon efforts that have low switch potential
Contact SDM for a free briefing on
Switchability analysis and its application to your program.
