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BioPharm Executive: The New Decade Finally Begins


3/29/2010 4:54:16 PM

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The New Decade Finally Begins

It's been an historic month in American politics, and I'm not just talking about former president Bush wiping his hands clean. on former president Clinton's shirt. It's health care reform, of course! Whatever your political stripes, it was, as our Vice President reminded us, indeed a big f@$&ing deal.

With health care reform comes a major victory for PhRMA and the Biotechnology Industry Organization (BIO) -- a regulatory pathway for follow-on biologics that guarantees 12 years of exclusivity for innovator products. That victory is particularly impressive if you consider that the lengthy exclusivity period was opposed along the way by a very senior committee chairman (Henry Waxman), the Federal Trade Commission, and the White House itself. It's an indication of just how powerful a lobbying force biotechnology, and BIO in particular, have become.

Indeed, the drug industry played reform very well throughout the process, and in the end backed the right horse. The $80 billion in Medicare part D "donut hole" concessions made by PhRMA. should be more than made up in new business and an agreement not to seek price concessions elsewhere. And it puts public attention more squarely on the insurance industry as the recalcitrant bad guys in the process. Sure, it looked shaky for a while, with PhRMA head Billy Tauzin leaving under a question mark and reform itself on the edge of toppling, but right now this is all looking masterfully done.

It's a remarkable cap to a decade that also began with a boom--the peak of the dotcom and genomics bubble, and the completion of the Human Genome Project--but often saw the industry struggling. There are some signs that biotech's star is rising again. We've already seen a nice uptick in the number of novel biologics approved over the past several years, and 2010 is off to a strong start. While we're unlikely to return to a 1990s-style financing environment anytime soon, more success may finally help pry open a financing window that right now still refuses to be either shut or fully open.

This month's digest of news features a number of clinical disappointments (lung cancer, in particular, has been a tough nut to crack, not only for the companies mentioned here but several others, which makes Abraxis' success all the sweeter). This month also includes several significant regulatory victories--new approvals and positive advisory panel opinions. Another IPO limps over the threshold, and Carl Icahn may be turning his attention from Biogen Idec toward Genzyme. - Karl Thiel

Read the BioPharm Executive online newsletter March 2010.

Sign-up for the free monthly subscription to the BioPharm Executive.

More By Karl Thiel



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