It is getting tougher out there to bring novel pharmaceuticals to market -- especially when you aren't working on bringing novel compounds to market to meet unmet medical needs. As this article in FT.com makes clear, it is now fashionable to repurpose drugs to extend their patent life or apply to a new area in an attempt to extend their revenue generating capacity.
Famous examples cited in the article include products like Viagra or Avastin. Viagra was repurposed from its original purpose as a "high blood pressure" treatment when it went on to fame and fortune with the brand new "erectile dysfunction" category. It has since also been introduced (different shape & color) as Revatio for pulmonary arterial hypertension. Avastin of course has been aimed at a whole spectrum of cancers with varying success - especially with the regulators.
The appeal of such drugs of course is there solid IP portfolio which can allow their holders to fund new clinical trials and establish new applications before the patents run out. But not everyone in the market (i.e physicians and consumers) is happy about this strategy in all instances. Biomarin, for example, recently launched a high-priced version of amifampridine phosphate to treat a rare autoimmune disease and received "orphan drug" status in the process. But Britsh physician groups have complaned the drug was formerly available in the pharmacy for a fraction of the cost. A Biomarin spokesman explains the company upgraded quality and spent $30 M bringing it to market.
None of this obviates the fact that pursuing this path as a important strategy gets us further away from discovering and developng novel therapeutics for unmet need - and to that end I think it is a bad trend to continue without concommitant efforts on the side of innovation.
It might do us well to to remember these words in the pharma field:
"I am here for a purpose and that purpose is to grow into a mountain, not to shrink to a grain of sand. Henceforth will I apply ALL my efforts to become the highest mountain of all and I will strain my potential until it cries for mercy."
- - Og Mandino
Posted by Bruce December 25th 2010.