Steven Nissen (photo), the Cleveland Clinic's high-profile chief of cardiology, has designed a clinical trial of a new cholesterol medication advanced by Sweden's Karo Bio that he says can dramatically reduce the cost of late-stage research while satisfying the FDA's tough standards for safety and efficacy data in the field.
"What we are trying to do is look for a strategy that allows the company to move forward in a deliberative fashion to develop the data they need without costing half-a-billion dollars," Nissen tells Bloomberg in an interview. "That requires innovative thinking."
The R&D cost is stratospheric because the FDA has raised a high hurdle for developers interested in developing new drugs to prevent heart disease, a lesson Pfizer learned when it was forced to flush a billion dollars in research on torcetrapib. Nissen says his trial design for eprotirome requires fewer people but offers all the insight that regulators are looking for. And instead of a half billion dollars, Nissen says it can be done at the bargain basement price of $300 million.
Bloomberg's story notes that Karo Bio, like a lot of developers with no products on the market, can't afford a half billion dollars, forcing them to seek out Big Pharma companies which can take on that kind of a risk. It's worth noting, though, that the same biotech companies are no more capable of covering a $300 million research tab, leaving them in the same boat as they were before.
One analyst estimates that eprotirome could earn $1.3 billion in annual sales.
- here's the story from Bloomberg