Antibiotic scientist must push discovery to market
Big pharma not interested in risk and low return of developing new antibiotics
A McMaster University scientist has discovered a compound that attacks a dangerous new class of superbugs, providing a gleam of scientific hope against the spectre of antibiotic resistance.
Disease-causing bacteria share their evolving genes at such a galloping pace that the World Health Organization has warned of an emerging global health security threat, painting a post-apocalyptic image of a world sent back to the pre-antibiotic era, where a routine cut or infection could be deadly.
Against that backdrop, Gerry Wright went looking for a chemical compound that would tackle the fiercest of the emerging threats, an enzyme known as NDM-1, a bacterial cloak of invincibility that the bugs trade with each other.
He found what he was looking for in a lowly soil fungus from a Nova Scotia forest, in a sample stored in a refrigerator in his lab along with thousands of other microbes painstakingly collected from dirt randomly gathered across Canada.
Wright’s discovery was deemed to be significant enough to make the cover of Nature, one of the most prestigious scientific journals in the world, an impressive accomplishment reflecting the importance Nature’s editors attached to the discovery.
Taking the next step
So what is Wright doing now? He is rolling up his sleeves and wading into the drug development business. Otherwise he’s afraid the discovery that made the cover of Nature will never get out of the lab. In other words, Wright must now work on capturing the interest of a drug company.
"The business model of drug companies has changed very significantly," Wright said. "They are more interested in acquiring assets that are very well developed, and they are looking for others to do that work, and so if we don’t do it at this stage then nobody will."
It’s not because he wants to get rich. Wright laughs at the suggestion.
"There are better ways to get rich than working in the antibiotics field. That’s why the drug companies are out of it," he said.
The fact is, there’s not enough money to be made by producing antibiotics, and many drug companies have abandoned the field, even as alarm over antibiotic-resistant bacteria grows.
It’s a situation so serious that the Infectious Disease Society of America put out an urgent call to action in 2010, for 10 new antibiotics by 2020. Halfway to the goal, only three new antibiotics have been approved so far.
There are three major reasons why large pharmaceutical companies have lost interest in antibiotics. First, the science is hard. Most of the easy antibiotics were discovered in the last century, spawning a long line of drugs that are chemical variations on a basic theme.
Secondly, there are many regulatory hurdles, and it costs millions of dollars to conduct the necessary clinical trials.
It’s clear that for logical corporate reasons we have a failure of the drug development pipeline.—Dr. David Patrick
And finally, the blunt truth is that antibiotics don’t sell that well. Unlike drugs for heart disease and other chronic conditions, antibiotics are only taken for a short time. Doctors try not to use newer antibiotics at all, in order to preserve them and protect against antibiotic resistance.
But all antibiotics have a limited lifespan. Eventually, bacteria will evolve ways to fight them off. That means the world has a constant need for new antibiotics, a demand that is not being met by supply.
"It’s clear that for logical corporate reasons we have a failure of the drug development pipeline," said Dr. David Patrick, medical epidemiology lead for antimicrobial resistance at the B.C. Centre for Disease Control. "We need a better model."
Recent U.S. legislation to extend patent protection and speed up the approval process for antibiotics has prompted some activity, but studies suggest there are not nearly enough new antibiotics in development, especially against the alarming Gram negative superbugs.
'Valley of death' trial phase ahead
All of that means it will be up to Wright to push this development through what is known in the drug development business as "the valley of death," the bleak early trial phase where promising lab discoveries often falter and die.
To preserve the value of the discovery, the first thing the researchers did was take out a patent, in the name of McMaster University. Wright said that without patent protection, future investors would not be able to recover their investment, which would be substantial. It costs millions of dollars to put new molecules through all of the clinical trials that are required to convince regulators that a compound is safe and it works.
The next step is to take advantage of U.S. government funding to complete the toxicology and pharmacological studies. The U.S. National Institutes of Health has accepted Wright’s molecule into a special program that will cover the cost of some initial studies and help prepare the discovery for private investment.
"If we can get these studies done, then they’ll be more interested," he said. "If not, then we’ll just start our own drug company."
Despite the discovery’s potential, Wright is realistic. "It could fail in a microsecond. It could have some side-effects that we don’t want and that could ruin it all. But so far it looks pretty good."