Nano-Drug's Dirty Little Secret
ETC Group's September 2006 report on nanomedicine, Nanotech Rx, requires some updating. After all, it's nearly 30 days old. Our report mentions the nano-drug Abraxane, and it acknowledges that approval of the cancer drug was a watershed event for the nanotech industry. But important details are emerging. On October 1 the
New York Times featured a blockbuster exposé of nano-enabled Abraxane written by Alex Berenson.
When the US Food & Drug Administration (FDA) gave regulatory approval to nanotech drug Abraxane in January 2005 it was hailed as "a giant leap for nano." Abraxane is a nano-formulated drug to treat late-stage breast cancer developed by American Pharmaceutical Partners - which morphed into Abraxis BioScience earlier this year. The company's stock soared after Abraxane received FDA approval, and it made the company's chairman (who owns over 80% of the company's stock) a multi-billionaire.
But the nano cancer drug is not-so-new, at least in some respects. Abraxane is a nano-formulated version of Taxol - the cancer drug derived from the bark of the Yew tree and patented by Bristol-Myers Squibb. When the patent on taxol expired in 2000, a generic version - paclitaxel - became available at about $150 a dose. Abraxane is distinct because it's formulated at the nano-scale and encased within an albumin-coated "shell." Because the albumin coating is a naturally occurring protein, patients have fewer allergic reactions, an adverse (and often severe) side-effect of paclitaxel (taxol). The company charges $4,200 a dose for Abraxane - 28 times the cost of generic Taxol.
But the exposé by Alex Berenson reveals that Abraxane and other new Taxol-like formulations have not actually extended patients' lives any longer than Taxol. And, according to several cancer drug specialists interviewed by Berenson, Abraxane is not a new class of drug with significant advantages over older, cheaper medicines. Dr. Ramaswamy Govindan told the New York Times, "In general, the novel formulations so far have not stood out as distinctly superior."
Industry analysts predict that Abraxane's annual sales could reach $1 billion by 2010.
This scenario underscores one of the points we make in Nanotech Rx: Nanotech-enabled drugs will play a role in securing and extending exclusive monopoly patents on new versions of existing drug compounds and older, under-performing drugs. In the words of NanoMarkets research firm, reformulation of drugs at the nano-scale "may increase profitability, expand a firm's intellectual property estate, and discourage competition during a drug's most valuable years."
Like so much of Big Pharma these days, new, nano-formulated drugs may have very little to do with innovation, and everything to do with patents, profits and corporate greed.