So, John, what are the implications, then, for R&D? Are we talking trials, outcome studies, standard of care…?
John: I think all of that. First of all, no longer will you really run a clinical trial—or should you anyway—against a placebo if there is already a drug to treat the condition that your new drug is for. So, if you have a new drug to treat depression and you run a clinical trial and show that in three or four Phase III trials your drug really had a great impact of lessening the instances of depression compared to a placebo, people will say: “So, what? How does it do against Zoloft or Prozac?” So, I think that most clinical trials will need to have a comparator arm in them to show that your drug is better than existing drugs.
Secondly, probably the more important issue is one of having outcome studies. If you have a drug—and again let’s say the drug’s for heart disease—and it lowers LDL as well as Lipitor or Atorvastatin or maybe a little better, people say: “Well, yeah, but we know that Lipitor, in fact, reduces the incidence of heart attacks or strokes on long-term administration. What does your drug do against long-term administration?” So, in other words, you have to take people who have already had a heart attack and have recovered.
If you give them Lipitor you really reduce the chance of having a second heart attack by about 30% or so. So, what does the new drug do? You have to run a study to show that. This is where things get really expensive, Marc, because these are not six-month studies. They are outcome studies that will run for three, four or five years and include thousands of patients because those are the types of numbers you need to show an effect. And you would run your drug in comparison to a drug like a statin and at the end of this time hopefully your drug will have shown, in fact, a major benefit compared to statin therapy.
These studies can cost hundreds of millions of dollars and I’m not exaggerating. I would say that a four-year study with 15,000 patients looking at cardiovascular outcomes is probably about three or four hundred million dollars in this day and age. And you can run the study and if it doesn’t work, you’re cooked, right? Nobody is going to care about your new drug.
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John LaMattina will be the moderator for the Wall Street State of the Industry Address: Mergers
& Acquisitions in the Industry — Near Term Solution to a Long Term Problem? featuring panelists including Colin Shannon, President, CEO and Director, PRA International; Michael Martorelli,
Director, Fairmount Partners; Eric Coldwell, Managing Director, Robert W. Baird & Co.; and Douglas Tsao, MPH, U.S. Specialty Pharmaceuticals & CROs, Barclays Equity Research. Would you like to join John for this panel at Partnerships in Clinical Trials this coming March 30-April 2, 2014? As a reader of this blog, when you register to join us and mention code XP1900BLOG, you're eligible to save $100 off the current rate!