The IN VIVO Blog: Surprise! Drug Approvals Increase In 2008
Posted by lindainfo on November 23, 2008
3) Granted GM, Ford and Chrysler can make it through the next year (GMs got roughly $60 billion more in debts than in assets; its burned through $9.7 billion in cash in the first three quarters of 2008 and, with about $16 billion cash remaining, will be flat bust before 2009 is over) the big hope is technology in particular, the electric car (GMs Volt).
Big Pharma has likewise shackled itself to a market primary care — that most of us know in our gut, and IMS can demonstrate with data, is shrinking. Primary-care medicines still make lots of money; SUVs dont. But given the number of new primary-care drugs that have fallen out of the clinic on their own, fallen afoul of regulators, or been yanked off the market or sharply restricted in their use (e.g., Galvus, Zelnorm, Avandia, Pristiq), and the number of drugs that are losing patent protection by 2012, its not got long to thrive. If you call this thriving.
Big Pharmas versions of Detroits nimbler competitors: companies who set themselves up to go after specialist markets Gilead, Genzyme, Celgene, Amgen, Genentech and Biogen Idec (indeed, Gilead and Celgene started out with molecules Big Pharma couldve had). First mistake: Big Pharmas blindness to the value of niche markets (blind because they werent structured to take profitable advantage of them, self-mandated to find drugs that could support primary-care commercial and development organizations rather than new medical needs). Second mistake: unwillingness to adopt a new technology protein therapeutics, a nice parallel to Detroits blindness to hybrid engines.
As for electric engine technology: think biomarkers. As with batteries, the technological hurdles to an effective companion diagnostic are gigantic; so are the regulatory and business challenges. So far, we havent known enough to really make effective therapy-directing diagnostics. But just as electric cars could transform the worldwide car market (and with it, the worldwide political landscapewithout a war), markers could allow drugmakers (or whoever controls the biomarker) an almost incontrovertible argument against recalcitrant payors who, by and large, now determine the success of a drugs launch.
You still hear arguments that Pharmas shouldnt pursue biomarkers because theyll limit markets. You hear even more arguments about the need to continue to focus on primary care. What if we come up with another Januvia, they say? We say: if you come up with another Januvia, great. It aint all that tough to hire a sales force, if and when you need it.
It all sounds a little bit like that other notion were hearing about, even as the car makers beg Congress for a bailout: now that gas prices have tumbled back nearly to where theyd been before things went crazy, maybe the car companies can get by on the old strategy still appealing to some apparently unquenchable American desire to drive cars too big for their own good.
Read more: drug avandia
