The concept of a single pill is not new. FDA recently approved Vytorin, a cardiovascular therapy composed of Schering-Plough's
Zetia (ezetimibe) and Merck's Zocor (simvastatin), which reduce cholesterol in different ways. In the HIV area, in which combination
therapies are prevalent, single-pill efforts are now under way, including Gilead's recently approved Truvada, which combines
Emtriva (emtricitabine) and Viread (tenofovir). Gilead is also working with Bristol-Myers Squibb/Merck to combine Sustiva/Stocrin
(efavirenz) with Viread into a single once-daily, fixed-dose HIV pill. Undoubtedly, there is more to come as companies start
to explore the potential of the single-pill approach to both expand and defend their franchises.
One Drug, Many Indications
Of the three new strategies, the treatment platform is the most demanding. It is based on the assumption that various medical
conditions share common denominators and can be treated using the same therapeutic approach. It requires extensive effort
to identify—or at least establish credible, testable hypotheses about—similarities in mechanisms of action that cause different
medical conditions. In the oncology area, for example, it is anticipated that specific platform technologies will be able
to treat many types of cancers. And Allergan's Botox (botulinum toxin), which has shown potential to treat everything from
excessive perspiration to migraines, has been approved for four indications. The scientific challenges to successfully develop
new treatment platforms are significant, but the potential rewards are equally tantalizing. (See "Selecting a Platform.")
The treatment-platform strategy raises its own set of issues. In the past, most companies preferred to test therapeutics one
indication at a time. Such an approach makes sense from the point of view of risk mitigation, but companies that develop treatment
platforms will need to quickly investigate their drug in multiple indications to maximize financial potential. They may need
to investigate several indications in parallel, thus increasing both financial investment and risk.
Second, a robust platform technology that stretches across therapeutic areas could challenge a company's ability to commercialize
it, especially if the platform shows promise in areas in which the company has a weak franchise or none at all. This is a
good problem to have, but to reap the greatest economic benefits, such companies must be willing to license out the indication
that they are unprepared to bring to market. That may be easier said than done.
Until now, the pharmaceutical industry has been largely technology driven—decisions about which R&D efforts to pursue were
based primarily on scientific considerations. Mar-keting has frequently been an afterthought, once there was a product to
sell. The strategies suggested here require a shift to an exploration of medical needs and a greater voice for commercial
input earlier in the R&D process.
All three strategies require greater interaction between R&D and sales/marketing, but the nature and extent of these interactions
differ significantly. The diagnostic-led, market-expansion strategy requires the least interaction. In the extreme, if a product
is already on the market, the commercial team could hire an external diagnostics lab to develop the appropriate diagnostic
test and physician training materials. Preferably, however, the diagnostic development would occur before the product is launched,
which requires sales/marketing and R&D to communicate regarding progress and launch dates.
On the other hand, the single-pill strategy is driven by an assessment of market needs and opportunities. It requires commercial
and R&D units to reach agreement regarding the priority of these projects relative to other opportunities and to allocate
resources accordingly. The therapeutic-platform strategy is the most difficult to conceive and execute, because it requires
full integration of R&D and commercial perspectives at the levels of strategy planning and portfolio management.
An important issue for companies is how to make new product development strategies fit within existing organizational structures.
In most companies, both R&D and sales/marketing are organized along therapeutic area (TA) lines. Many commercial organizations
also have strong product teams that manage products with significant independence. Single-pill and multi-indication blockbusters
don't easily fit within these structures, because they cross indication and TA lines.