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Biotech / Medical : Biotech News

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From: Doc Bones9/25/2008 7:49:13 AM
   of 7143
 
Big Pharma R&D: Things Are Tough All Over

Posted by Scott Hensley
September 24, 2008, 6:23 pm

The woes on Wall Street make the problems in the pharmaceutical sector look almost tame these days.

But that’s not saying much, as we learned when we heard four R&D chiefs shoot the breeze this afternoon. By our calculation, there was more than $20 billion of R&D spending* talking about the high rates of failure in drug research. The execs spoke at Windhover Information’s annual Pharmaceutical Strategic Alliances conference.

windhover.com

Steven Paul (Mr. $3.5 billion at Lilly) said that industrywide only 25% of experimental drugs in phase II make it to phase III. “And that’s bad,” he said, in case anyone wasn’t sure. Attrition in phase III is still lousy at 50%, Paul said. To be clear, he was only talking about stats for novel drugs, or NMEs–not line extensions. Still, the bottom line is that Big Pharma’s business model “won’t work” if these high failure rates continue, he said.

Martin Mackay (Mr. $8.1 billion at Pfizer) seconded Paul’s view, adding that the failure of drugs in phase III is a relatively recent development for Pfizer. Mackay called phase II the “battleground” for big improvements in research productivity. Determining efficacy in those mid-stage studies remains a challenge. To complicate things, internal funding of R&D is coming under pressure. When asked if Pfizer’s spending on research will increase next year, Mackay answered quickly and emphatically: “No.”

Mikael Dolsten (Mr. $3.3 billion at Wyeth) said the smart set will spend more time in phase II on studies that do a better job figuring out how well a drug works before moving it along to phase III or killing it. “How clinically meaningful is the new drug,” is the question to answer, he said. Not an easy one to resolve early on, everybody agreed.

Paul Stoffels (Mr. $5.3 billion at J&J) pointed out that some of the biggest blockbuster drugs have been me-toos that were the second or third try at a drug in a class. (Think Zocor vs. Mevacor.) The research challenges multiply as scientists focus on newer targets that aren’t as well understood as those that led to statins or SSRIs. The market has changed too and tends to reward latecomers to a disease category much less than before.

* R&D figures from 2007

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