The Quest to End Tuberculosis: 14 Memorable Moments in Innovation

Paul Janssen, the founder of Janssen Pharmaceuticals, part of the Johnson & Johnson family of companies, is born in Turnhout, Belgium.

When Janssen was a child, his 4-year-old sister died of tuberculous meningitis. The loss affected him so deeply that it drove him to pursue a career in medicine—and find a new treatment for tuberculosis.

The antibiotic, which was discovered by a researcher in the U.S., is part of a class of drugs called aminoglycoside antibiotics. It is the first effective treatment for TB and works by killing the bacteria that cause the disease.

A novel and potent antibiotic called rifampin is discovered in Italy, which helps cut treatment time from 18–24 months to 6–9 months, when used in concert with other drugs.

In this decade, rates of MDR-TB—which can develop if a treatment is misprescribed, or if a patient does not successfully complete treatment—start to soar.

“We’ve seen an increase in drug-resistant tuberculosis for two reasons," explains Koen Andries, Koen Andries,Distinguished Research Fellow, Janssen, Belgium Distinguished Research Fellow, Janssen, Belgium. "The first is patients stopping medication too early, or not taking all the pills as prescribed, since regimens can be complicated. The second is doctors not prescribing medications correctly.”

Andries and his team find that a compound discovered two years earlier is able to kill off tuberculosis bacteria by blocking a specific enzyme. Janssen researchers use this knowledge to create a new anti-tuberculosis treatment.

One year later, the team publishes a study in the medical journal Science showing that the drug successfully treats MDR-TB in mice.

The treatment has a setback, following a disappointing initial Phase 2 clinical trial.

“We tested it for seven days in about 70 patients with pulmonary tuberculosis, but the drug didn’t work,” recalls Anil Koul, Ph.D. Anil Koul, Ph.D.,Senior Scientific Director and Fellow, Janssen, Belgium, Senior Scientific Director and Fellow, Janssen, Belgium.

But researchers like Andries fought to keep it on the playing table.

“It turns out the drug simply needed more time to become active in the human body—a month, as opposed to a week in mice,” Andries explains.

The first medicine for TB in more than 40 years with a novel mechanism of action receives accelerated approval from the U.S. Food & Drug Administration, due in large part to results from a Phase 2 clinical trial.

After 24 weeks of treatment, almost 79% of patients in the group treated with the drug tested negative for TB, compared with only 58% among those not receiving the treatment.

The following year, the World Health Organization releases guidelines recommending the use of the drug, in combination drug therapy, for people with MDR-TB when an adequate regimen cannot otherwise be used because of resistance or intolerance to other drugs.

Johnson & Johnson announces a collaboration with the International Union Against Tuberculosis and Lung Disease to include the company's treatment in the STREAM study, a multicenter international trial to evaluate the medicine in patients with MDR-TB. Final study results are expected as early as 2023.

The company signs an agreement with USAID and JSC Pharmstandard to donate 30,000 six-month courses of the treatment over the next four years to be used for MDR-TB treatment worldwide.

Since then, Johnson & Johnson has signed on to provide 30,000 more courses—bringing the company's total donation to 60,000 treatments.

"We are currently tracking our efforts in reaching patients in such high-TB-burden countries as China, India and South Africa through what we call the four A's—availability, affordability, adoption and appropriate use," Ionescu explains. "We ensure the latter through our adverse event reporting and medical education."

The company garners the prestigious recognition for its TB work. The International Prix Galien Award—named for Galen, the forefather of modern medicine and pharmacology—honors important drugs and research achievements.

“It’s a testament to our company’s perseverance, and our commitment to ensuring medical care for some of the world’s most neglected populations,” Parys says.

Johnson & Johnson and global health nonprofit PATH form a unique partnership in Vietnam called Breath for Life.

The collaboration combines the support of PATH, the National TB Control Program (NTP), the Nghe An Provincial Health Department (PHD) and the Nghe An Provincial Tuberculosis and Lung Disease Hospital (PTLH) to help improve the detection, diagnosis and management of TB in Nghe An, an area in Vietnam with a very high burden of TB.

Johnson & Johnson announces a collaboration with India’s Institute of Microbial Technology (IMTech) that's focused on discovering new treatments for TB.

The hope: pairing IMTech’s world-class expertise in microbial technology with the TB expertise of Janssen scientists will lead to safer, more effective oral treatments and multidrug regimens for MDR-TB.

“Most drug regimens now require taking 10 to 12 pills a day for two years, and a daily injection for six months,” Koul explains. “This can be difficult for even the most compliant user, so our ultimate goal is to develop a much safer and shorter treatment regimen, and possibly one day even combine several drugs into a single potent pill.”

On September 26, the United Nations holds its first-ever high-level meeting on TB at its headquarters in New York City to help drive progress toward defeating the disease. The theme: "United to end tuberculosis: an urgent global response to a global epidemic."

Johnson & Johnson attends the meeting, which brings together heads of state to commit to accelerated action to end TB by 2030.

In the lead-up to the event, Johnson & Johnson also hosts the TB Innovation Summit, in conjunction with the Stop TB Partnership, the UN Foundation, the Global Fund to Fight AIDS, Tuberculosis and Malaria, and the World Economic Forum—and announces a 10-year initiative in support of ending the TB pandemic.

For its part, Johnson & Johnson is also hard at work on a lofty research effort. “Our scientists are investigating a way to treat all tuberculosis patients—whether they have a multidrug resistant strain or not—with the same, single-pill regimen," Parys says.

Part of Johnson & Johnson’s 10-year commitment to help end TB includes investing in critical innovation work. In July, the company launches the international RESPIRI-TB research consortium, in partnership with Europe’s Innovative Medicines Initiative and nine research institutions, which is aimed at discovering and developing new TB antibiotics.

The following month, the FDA grants approval for Janssen’s MDR-TB medication as part of combination therapy for eligible adolescent patients, marking an important step in addressing the needs of all MDR-TB patients.

The FDA also approves a novel medicine developed by the TB Alliance as part of a three-drug combination regimen—which contains Janssen’s medication—for the treatment of extensively drug-resistant TB and treatment nonresponsive or intolerant MDR-TB. This offers a simpler, shorter treatment option for patients who have historically faced lengthy treatment regimens.

This story was updated September 2019