DefinedHealth

Michael C. Rice, MS, MBA

The cardiovascular market with nearly $90 billion in revenues is still the largest therapeutic category, comprising 20% of the overallpharmaceutical market. This dominant position was largely driven by the validation of surrogate risk factors of heart disease suchas hypertension and hyperlipidemia, which facilitated the innovation of cardiopreventative medicines with the ability to affect thesemarkers. These efforts led to multi-billion dollar breakthrough therapies, such as: ACEI, ARBs, Statins, Antithrombotics, ß-Blockersand CCBs, which addressed significant need in the broad market.

Recent and anticipated introduction of generic alternatives and ensuing price erosion is pointing toward a receding cardio preven-tion market. This decline will greatly accelerate in 2011 when generic versions of Lipitor(Pfizer) and Plavix(BMS, s-a) becom eavailable.

Efforts to resuscitate ailing cardiovascular franchises in this critical period of transformation have focused on lifecycle management with reformulations and fixed-dose combinations of existing drug classes to keep brands viable. Truly innovative cardioprotectiveagents with potential to differentiate from a soon to be generic standard of care are sparsely represented in the advanced stage pipeline.

Among the promising agents that exist, success is daunted by complex, expensive and risky clinical routes to market. Predictability of Phase III success based on Phase II proof of concept has been diminished, precedented by numerous failed late-stage pro-grams that have been unable to surmount the hurdle of safety and outcomes evidence achieved with the current inexpensive thera-pies. The paradigm of large outcomes trials to demonstrate safety and efficacy in large patient populations is in question.

New ways to hedge the risk of developing new medicines while serving the needs of significant cohorts of patients are needed. Strategies being explored include pharmacogenetically segmenting the cardiopevention market for those most in need of value-added novel therapies and creating new interventional and regenerative markets. Efforts to genetically segment patient popula-tions can be designed into clinical programs as a risk mitigation strategy; albeit, it has been largely reserved as a means to salvages tumbling broad based programs realizing significant benefits to a niche of a trial population upon subanalysis. Beyond preventative medicine, significant opportunity may exist for interventional and reparative medicine. Although great strides have been madein preventing cardiovascular events in patients identified at risk, there is a void in terms of pharmaceuticals for treating active disease. Among high unmet need areas are acute therapies to stabilize ACS patients, reduce reperfusion injury and restore blood flow to peripheral vasculature. These are areas where there is a poor standard of care with a weak burden of evidence. Additionally, the emerging field of stem cell therapies has the potential to open a new era in cardiovascular medicine by repairing tissue damage that currently leads to permanent deterioration of quality of life and increased mortality.

In this installment of our 8th annual Insight Series, Defined Health will characterize the changing cardiovascular marketplace, and discuss opportunities and barriers to the creation of future value from today’s development pipelines.