Big Pharma betting billions in high-stakes hunt for the next Lipitor

Lipitor and Plavix combined pumped $20 billion into Pfizer ($PFE) and Bristol-Myers Squibb ($BMY) last year. And now that the generic rivals have come along, that money is disappearing like a Texas river in a bad drought. 

In the wrap-up of the European Society of Cardiology meeting in Munich, Reuters' Ben Hirschler assessed the field in search of the next potential Lipitors in the pipeline--megablockbusters that will cost hundreds of millions of dollars to test in huge clinical trials--and came up with three big fields. Each of them has big caveats to consider.

There's Merck's ($MRK) anacetrapib, a CETP inhibitor that promises to boost "good" HDL and represents the last of three big programs. Roche ($RHHBY) tried the same thing though with dalcetrapib--before it blew up--and Pfizer threw in the towel on torcetrapib long ago. There's also some deep-seated skepticism about the whole approach, in which Eli Lilly ($LLY) has also been engaged.

"I think we are a long way from showing that raising HDL really works. I've haven't seen anything that convinces me that we have a winner yet," the University of Minnesota's Russell Luepker told Hirschler, a veteran reporter in biopharma. 

Then there are the PCSK9 inhibitors, one of the new darlings in heart research which promise to dramatically lower bad cholesterol in ways that statins can't. Sanofi ($SNY) and Regeneron ($REGN) are recruiting 22,000 patients for their pivotal program involving 10 trials. Investigators journeyed to Munich to make the case for REGN727/SAR236553, a treatment that dramatically lowered bad cholesterol at the top dose. After 12 weeks of treatment, the drug cut LDL by up to 72% at the 150 mg dose. 

"Within a short period of time you get LDL levels down very, very significantly," study lead Michael Koren told FierceBiotech last week.

Roche isn't far behind with its own PCSK9 treatment--the closely guarded RG7652 program at Genentech--as Amgen ($AMGN), Pfizer and other contenders wade into this field. While the Reuters story doesn't mention it, there are also a number of analysts ready to pooh-pooh the notion of megablockbuster returns in a broad market now dominated by generics. But billions will be wagered to prove the skeptics are wrong. 

Finally there's GlaxoSmithKline ($GSK), which enrolled 27,000 people for its work on darapladib, even though mid-stage studies indicated some potential trouble ahead. GSK wound up buying Human Genome Sciences for $3 billion, with darapladib--which regulates Lp-PLA2--figuring into the financial equation.

The reason why these drugs cost so much to develop has a lot to do with the FDA's high bar on safety. Tens of thousands of patients have to be treated over a prolonged period of time to offer regulators a clean bill of health. If any of these trials can't deliver solid efficacy combined with a clean bill of health on safety, they'll be tanked in a heartbeat.  

- here's the article from Reuters

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