Drugs: From Patent to Market is a Long Haul


Recently I was perusing press releases to see if I could find any interesting news items worth reporting. One particular press release did catch my eye. The title was AvidBiotics Granted U.S. Patent for Bactericidal Proteins that Selectively Kill C. Difficile. C. Difficile, or Clostridium difficile…more commonly called C. Diff. for short…. is a bacterium that can cause symptoms ranging from diarrhea to life-threatening inflammation of the colon. I have known people who have suffered with C. Diff., and it is no joking matter. So a treatment for C. Diff. is interesting enough, but an innovation that would kill only C. Diff., without harming other (good) bacteria, might be a real breakthrough. The problem with many antibacterial drugs is that they kill the good bacteria with the bad, or sometimes kill the good and not the bad, which can lead to a hose of digestive problems.

In any event, AvidBiotics Corp., which is a privately held biotechnology company, recently announced that it obtained US Patent No. 8,673,291, entitled “Diffocin and Methods of Use Thereof,” which claims modified R-type bacteriocins from C. difficile that specifically kill C. difficile bacteria. Also covered are methods of manufacturing such bactericidal proteins.

The issued patent covers potent bactericidal proteins that selectively target and kill C. Diff.  The AvidBiotics’ agents, a type of bacteriocin termed a “diffocin,” are designed to selectively attack C. difficile bacteria in the gastrointestinal tract without harm to healthy members of the gut microbiota. In other words, this invention offers a practical means to quickly and precisely kill C. difficile bacteria in the gastrointestinal tract without the negative consequences and side effects associated with many current treatments.

C. difficile infections represent one of the most threatening and rapidly growing hospital… acquired bacterial infections,” said David W. Martin, M.D., Chief Executive Officer of AvidBiotics. “Treatment of these infections with traditional antibiotics kills protective gut bacteria, which then enables a smoldering C. difficile infection to quickly expand in the gut, causing life-threatening diarrhea and colitis.  Even after initial successful treatment with antibiotics, C. difficile infection recurs at a frightening rate, which is one of the reasons treating C. Diff can be so challenging.”

According to Dr. Martin, AvidBiotics expects to file an Investigational New Drug application with the U.S. Food and Drug Administration for its diffocin in 2015.

And therein lies the problem associated with pharmaceuticals from the consumer’s perspective. There is a great deal of time, money and energy devoted to innovating, and then there will be even more time spent navigating the Food and Drug Administration (FDA) process.

And the odds that any particular drug will make it to market and make money are slim. Joe Allen recently explained:

“[F]or every 10,000 compounds about 250 make it to preclinical testing, 5 go on to clinical trials, and one enters the marketplace.  Of these just 20% turn a profit– and they must pay for all those which died in the pipeline.”

See Hunting Bayh-Dole Vampires.

So while the prospects of a cure for C. Diff. are exciting, it will take a while before this innovation will ever make it to the marketplace.


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