Not long ago, even a me-too drug could expect pricing freedom through its patent life. Today, we complain about poor R&D productivity, but this dearth of opportunities invites overnight imitators for the handful of successes that the new science has managed to produce.
Hence, patents are necessary but no longer a basis for success. For example, the DPP-4 (dipeptidyl peptidase IV) class of compounds, which holds blockbuster potential for the treatment of diabetes, will have only a few months of exclusivity, as the second one is expected to follow within six to 12 months.
In the hepatitis C category, for years the standard of therapy was interferon (pegylated and nonpegylated) along with ribavirin, which offers modest efficacy at the expense of a high incidence of side effects.
At first, NM283, a polymerase inhibitor from Idenix (www.idenix.com) that showed promising data in combination with the standard of care, seemed likely to steal the show. As of last year, however, the spotlight turned to VX-950, a protease inhibitor from Vertex (www.vpharm.com) that produced some outstanding early data. And now, of course, several other competitors are only another year or two behind Vertex.
The ultimate illustration of this paradigm shift came from Lucentis, which seemed to take the air out of the Macugen launch that had taken place just six months earlier. Early data on Lucentis seemed so superior as to lead clinicians and investors to conclude that Macugens life cycle would be less than two years on the market—a premature end for a compound with patent life until 2016. While this bullish sentiment may have moderated following recent publication of clinical data, it is clear that Macugens potential is smaller than most investors thought at its launch.
The ultimate wrinkle is the unexpected role that off-label use of Avastin is playing in this mix with 20% market share, even though no sound clinical data exist of its efficacy or safety. Simply the potential of a dramatically lower cost of treating AMD has achieved this unprecedented success without any marketing.