Me-too drugs, knockoffs, copycats, retreads—they’re all names for new pharmaceuticals patterned after drugs already proven to work. The number of such labels alone signals the type of passionate commentary surrounding these products.
Critics have charged pharmaceutical companies with churning out these modified drugs to fight common ailments like high cholesterol or heartburn without proving that they perform any better than the first drug to work by the same pathways.
In the climate of resistance to such follow-on products, many pharmaceutical companies are adopting the tactics of innovative biotechnology startups by pursuing novel drug modes of action in a quest for breakthrough treatments, says Arthur Hiller, CEO of the startup SciFluor Life Sciences in Cambridge, MA.
But the drug firms may be sacrificing their best opportunities to improve healthcare and make significant revenues, says Hiller (pictured above). Some of the industry’s biggest success stories have come from important refinements of first-in-class drugs that led to best-in-class drugs, Hiller maintains.
“The most fruitful basis for the discovery of a new drug is to start with an old drug,” says Hiller, whose company is acting on that theory.
Innovations in medicinal chemistry—the art of optimizing a drug’s structure—led to SciFluor’s founding in 2011 by Harvard professor Tobias Ritter and his former student Takeru Furuya, who is now the company’s director of chemistry. SciFluor licensed the methods developed at Harvard for inserting the element fluorine into the structure of an existing drug to reshape its key chemical groups and enhance its value.
SciFluor’s chemists have been tweaking the composition of small molecule drugs by placing atoms of fluorine in strategic spots, such as the site where a drug binds to a target cellular molecule linked to disease. Fluorine, when substituted in for a smaller atom of hydrogen, can improve the “fit” of the drug to the target and thus make it more effective, says Ben Askew, SciFluor’s vice president of research. The binding affinity can increase by 10-fold, he says.
Changing the spatial contours of the drug with fluorine atoms can also prevent the drug from binding with off-target molecules, Askew says. That can prevent the side effects that often come with a medicine that’s not selective enough in its action, he says.
Such molecular tweaking can open a less risky path to valuable new drugs than exploring an exciting new cellular pathway revealed by cutting-edge research, Hiller says. Indeed, researchers have significant advantages when they tinker with drugs already proven to have health benefits, he says. For example, the design of clinical trials and the path toward regulatory approval have already been worked out to a large extent.
The knock on such follow-on drugs is that they’re merely a drug firm’s tactic to prevent a drop in revenues when
