Johnson & Johnson is taking steps to ensure Sirturo, its medicine for people with drug-resistant tuberculosis, is available and properly administered in 130 developing countries across the globe.
The tablet was approved by the U.S. Food and Drug Administration in 2012 as the first new medicine in 40 years to treat the contagious lung infection. It’s recommended by the World Health Organization for use in combination with other drugs to treat those most in danger from the disease. Yet it’s still not approved or affordable in most countries.
J&J agreed to sell the medicine to the Stop TB Partnership as part of a collaboration that will ensure its proper use, said Paul Stoffels, the New Brunswick, New Jersey-based company’s chief scientific officer and worldwide chairman of pharmaceuticals. The deal with the Stichting International Dispensary, which buys medicines on behalf of the WHO, hospitals and governments across the developing world, will ensure the medicine reaches people who need it even in countries where it’s not approved, he said.
“This is one of the most reliable suppliers for tuberculosis drugs and many other medicines to the developing world,” Stoffels said in a telephone interview. “They can, on an exception basis, sort the medicine for people who need it.”
J&J also is pursuing approval of the medicine in many of the countries, though it may take several years to gain clearance. The medicine will be available sooner with tiered pricing in different countries, with the Stop TB Partnership’s global drug facility getting drugs through the Stichting group.
“It will be at significantly lower cost than in the U.S.,” Stoffels said. “We are applying appropriate prices for all these countries so the drug will be accessible to all the people who really need it.”
Tuberculosis, the world’s deadliest infectious disease after AIDS, killed 1.3 million people in 2012, according to the WHO. While TB can be cured with antibiotics, strains that resist the medicines hit about 450,000 people worldwide, the WHO said.
Stoffels said J&J, the world’s biggest seller of health-care products, was worried that Sirturo might be given to some patients as a stand-alone therapy in an effort to cut costs, a move that could spur resistance to the drug. Making it available through the Stop TB Partnership should ensure it is given in combination with other powerful medicines to quell the virus in people who don’t respond to standard therapy.
“This drug is absolutely not intended for widespread use,” he said. “It’s all about getting the right combinations to the right patients in an expedited way so they don’t have to wait for many years. That’s our intention.”