Tuesday, September 21, 2010

Why Merck's China Initiative Will Not Be A Cake-Walk

In the course of discussing the vast market opportunity presented to global pharmaceuticals firms by the burgeoning Chinese marketplace this morning, Reuters is absolutely spot on when it details the risks Novartis faces, in trying to gain approval in-country for new treatments and new medicines -- ones not already in widespread use in the West:

. . . .But the quest for the pharmaceutical gold mine that China offers will not be easy.

Firms such as Novartis, with their plans to develop new drugs for China, have to hold "first-in-man" trials, involving new compounds never before tested on people, said Chris Lu, head of drug discovery biology and technologies at China Novartis Institutes for BioMedical Research.

China has set stringent hurdles for such trials.

"We are developing drugs for Chinese patients. If we can't do first-in-man trials in China, then we are ruined. We are working with the SFDA (China's State Food and Drug Administration) to see what we need to do," Lu said. . . .

That gets it just right -- it is a huge opportunity, but daunting barriers to entry still remain. New Merck is absolutely certain to face similar obstacles. That much is sure.

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