Rx-to-OTC
SWITCH PROJECTS
RECENTLY COMPLETED BY SDM
Worked
with senior management of a emerging OTC company to determine the value of
certain new products developed by the firm.
Further developed an analysis of value based on comparable deals done
in the OTC business. Assisted in
presentations to potential acquiring companies.
Developed
multiple forecasts for three new cough/cold products under development.
Created forecasts for consumer and professional segments of the market.
Developed marketing budgets for forecasts.
Created
a marketing plan for the development of an Rx product in a unique marketing
situation: compounding pharmacies. Strategic
plan including goal setting, brand image development and evaluation of
promotional strategies.
Served
as an Expert Witness in a patent dispute between two leading OTC consumer
companies. Wrote a detailed
expert opinion on the sales and marketing of the two products in the
litigation, gave a full deposition on same, attended other depositions, read
and analyzed other expert reports, testified in Federal Court for a full day
as an Expert.
Client
wanted assistance in evaluating a licensing candidate for cholesterol
reduction based on a novel mechanism of action.
SDM reviewed possible Rx and OTC indications, safety of the drug
compared to statins, sequestrants and niacin.
SDM also looked at switch strategies both near and long term for the
product. SDM also provided sales
potential estimates both Rx and OTC.
SDM
completed a far reaching search for new OTC candidates in the United States,
Europe and Japan. Mixes of
technology and products for the future were also reviewed. Licensing and joint venture opportunities were included in
the mix.
Two
analyses have been completed on products and pipelines of companies that were
merger efforts. SDM examined both
existing and R&D pipelines for switch opportunities with an eye toward
integrated product strategies rather than simple switch candidates.
Reviewed
medical literature, ADRs, poison control data and package insert to establish
that the safety profile of a certain NSAID was at least as good if not
superior to existing OTC compounds.
Managed
entire scientific and clinical program for the development of a unique cold
sore medicine. Developed
submissions for FDA and conducted negotiations with the Agency.
Developed
clinical and regulatory strategy for a combination product.
Worked with CR to review the protocol, study design an outcome measures
for the compound.
Worked
with a client to evaluate the feasibility of creating a new OTC category.
Reviewed issues of self diagnosis, implications of misdiagnosis, safety
of the proposed switch compound as well as potential labeling claims.
Client
desired to know if OTC H2 antagonists had negatively impacted the
prescription market. This was a
prime concern for a switch under consideration by the company.
Management feared that the OTC version of the compound would detract
from Rx profits.
SDM
compiled extensive marketing and regulatory data on the ten most recent
switches completed. Results were
used to benchmark the efforts required to switch certain products in the
company’s pipeline.
Client
desired to introduce a new form for an existing brand but did not want to file
a full NDA. SDM devised a
regulatory strategy which precluded conducting pre-clinical or clinical trials
yet led to an approvable of the new form in less than one year.
An
existing product was about to be challenged by the entrance of an Rx-to-OTC
switch. Working with the client,
SDM simulated the effect of various counter spending strategies.
A sharp increase in couponing was selected so that consumers would have
an supply of the client’s brand on hand at the time of the new switches
introduction.
Developed
forecasts for Rx and OTC nicotine replacement products.
Advised client on product positioning for same.
Evaluated non-nicotine Rx products and developed product forecasts for
these products.
Completed
numerous projects to evaluate the potential for switching compounds from Rx to
OTC status. Categories include
heart burn, cholesterol reduction, men’s health, female health,
cough/cold/allergy.
In
this project, SDM developed a number of scenarios as to what the regulatory
environment in 2005 would look like. We
also provided assessments of the impact of these changes on the OTC and Rx
business lines.
A
major pharmaceutical company wanted to determine what the OTC potential was
for a number of ethical products still in the R&D pipeline.
SDM provided technical analysis of the drugs, epidemiological data for
the diseases, competitive analysis of both marketed drugs and drugs in R&D
as well as OTC forecasts.
SDM
used the Howard Safety Scale to give an assessment of three products that
might be considered for switch. We
also developed forecasts for the switches.
Many
Rx to OTC candidates are not large enough as Rx products to warrant the
attention of the ethical marketing group.
We developed a number of alternative approaches to handling small
switches.
Our
assignment here was to measure the sales impact of promoting OTC products to
professional audiences. We
measured detailing, sampling and professional speaker programs.
SDM
provided forecasts and marketing mix assessments for a pediatric drug that is
in the process of being switched.
SDM
provided support for the launch of a major new Rx to OTC switch.
We developed market forecasts and helped to evaluate promotion spending
levels necessary to achieve the sales forecasts.
We also provided forecasts of the residual Rx product.
A
pharmaceutical company needed help in preparing a preliminary marketing plan
for a potential switch product. SDM
developed a forecast of sales as well as providing input for positioning the
product.
Developed
a strategic vision for an OTC product line, projecting opportunities for
enhanced growth with Rx to OTC switches.
Categories included Antacids, Female Healthcare, Acne and Cough/Cold.
Prioritized
switches based on critical success factors including volume potential,
strategic fit, exclusivity, regulatory/technical success, time to market and
global opportunities.
In
this case, the client was about to be impacted by someone else's switch.
We devised defensive strategies based on the anticipated claims and
spending levels for the competitor.
An
ethical pharmaceutical firm wished to determine which of several possible
advertisements were most effect in eliciting customer response.
SDM analyzed both telephone calls and coupon redemption data to
determine which ad was most effective.
A
major consumer packaged goods company requested assistance in preparing
forecasts for four candidate drugs. SDM
offered expert advice and assistance in generating the forecasts.
A
consumer products company asked SDM to assist in evaluating a possible
licensing opportunity. SDM
determined what the effect of generics on the now off patent Rx product and
produced a series of forecasts for the product's OTC sales.
A
major pharmaceutical company wished to evaluate the feasibility of switching
their prescription anti-ulcer drug to OTC status. We provided data and analyses to arrive at a summary of the
feasibility of switching from prescription to OTC status.
A forecast of the expected sales was also generated.
A
manufacturer of fine chemicals wished to know what the likely demand would be
for the active ingredient in H2 Antagonist anti-ulcer drug if this class of
drugs was switched to OTC status. A
forecast of the market for H2s was generated and used as a basis for
projecting the demand for the ingredient.
Developed
a variety of statistical models which show the effects of various trade
programs such as volume rebates and coop advertising on the sales of an OTC
product. Used results to set new
terms for trade incentive programs.
This
system allows managers and analysts to evaluate potential Rx to OTC switches.
The system can store multiple, independent scenarios and can also be
used to develop launch strategies for new switches.
Inputs included promotional spend and qualitative assessments of the
product attributes.
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