Public health advocates call on Johns Hopkins to make TB drug widely available

Public health groups and Johns Hopkins University students are waging a campaign to ensure that a potentially groundbreaking tuberculosis drug developed by Johns Hopkins becomes available to patients in poor nations where the disease is most pervasive.

The groups, including Public Citizen and Medecins Sans Frontieres, are lobbying the university to ensure widespread availability of the drug. Members of student group Universities Allied for Essential Medicines delivered a petition to that effect Thursday to Johns Hopkins President Ronald J. Daniels.

“The majority of people living with TB are living in low- and middle-income countries, and we need to make sure that this is available to those TB patients,” said Rachel Kiddell-Monroe, special adviser to Universities Allied.

In 2013, 9 million people around the world became sick with TB, and there were around 1.5 million TB-related deaths worldwide, according to the Centers for Disease Control and Prevention.

“This drug has the potential to have a huge impact on reducing that number,” Kiddell-Monroe said. “Johns Hopkins has a leadership role to play here.”

The drug developed by Johns Hopkins, sutezolid, showed promise in clinical trials for treating drug-resistant forms of tuberculosis.

Current treatment for drug-resistant TB takes two years, including eight months of daily injections and more than 14,600 pills. It’s expensive, painful and can come with sometimes toxic side effects. Fewer than half those receiving treatment are cured.

The university is working to bring a safe, effective TB therapy to market, Christy Wyskiel, a senior adviser to Daniels, said in a statement.

“We are deeply committed to bringing drugs to market that benefit patients and address major unmet needs,” Wyskiel said, adding that a range of research initiatives is underway through the School of Medicine and the Bloomberg School of Public Health, working with the Center for Tuberculosis Research. “We remain convinced that this is the most rapid and certain path to market for patients for this much needed therapy.”

But how the drug is brought to market is what the public health groups are worried about.

Universities Allied said it believes the university is in the final stages of negotiating an agreement to sell its rights to the drug to a Rockville-based biotech firm called Sequella that licensed pharmaceutical giant Pfizer’s worldwide rights to develop and commercialize sutezolid in 2013.

Johns Hopkins did not confirm that any negotiations were underway.

The organizations, which also include the Treatment Action Group and the Global Tuberculosis Community Advisory Board, want the university to agree only to a nonexclusive licensing agreement with provisions that would keep the drug’s development timely, affordable and accessible.

The situation at Johns Hopkins represents a larger problem, said Pete Maybarduk, global access to medicines director for Public Citizen.

Much of the medical research is conducted at universities, rather than in pharmaceutical company labs, then licensed exclusively to pharmaceutical companies, “which proceed to charge whatever they want, and that leads to people not having access to the drug in low- and middle-income countries,” he said

Pharmaceutical companies often can make more money by selling drugs at high prices to a few patients than at affordable prices to many, Maybarduk said.

Drug companies often defend drug prices by citing the costs of developing and bringing a breakthrough drug to market.

The advocacy groups’ requests of Johns Hopkins were outlined in the petition presented to Daniels on Thursday by two current students and two graduates, both physicians.

Kavitha Kolappa, a psychiatry resident at Massachusetts General Hospital in Boston who graduated from Johns Hopkins’ Medical School, said she emerged from the meeting “impressed with President Daniels’ long-standing commitment to global public health and personal interest in this issue. …

“It’s clear to me he wants to see this drug developed as rapidly as possible and be made as cheaply and affordably as possible.”

But the advocates remain concerned that Johns Hopkins’ technology transfer representatives “seem reluctant to embrace nonexclusivity in the context of these negotiations,” Kolappa said. “This drug needs to be nonexclusively licensed.”

Sequella, a clinical-stage pharmaceutical company that commercializes antibiotics to treat life-threatening infectious diseases, has said it sees a $400 million market for sutezolid in the United States and the European Union.

But drug-resistant TB is even more prevalent in Eastern Europe, Asia and Africa.

Sequella declined to answer questions Thursday but issued a statement from CEO Carol Nacy.

“Sequella is a global health company focused on identifying and developing new drugs to address the growing threat of [multi-drug resistant] TB, our mission for the past 18 years,” Nacy said in the statement. “We are looking forward to developing sutezolid for this indication, and will be working with partners and regulatory authorities to facilitate its expeditious registration and clinical use in patients who desperately need it.”

Kiddell-Monroe said that Sequella holds a primary patent on the drug, giving it rights to develop the base compound and its use as an anti-bacterial. But Johns Hopkins holds a secondary patent on the same compound that gives it the rights to develop the drug in combination with two additional compounds to treat TB. That patent is key, she said, because TB must be treated with a mix of drugs.

Kiddell-Monroe said her group had been meeting with Johns Hopkins officials to encourage it to not sell exclusive rights to the pharmaceutical company “to do whatever they like.” That could mean the drug company only develops and markets the drug for patients who can afford the medicine, neglecting a global need for an effective TB treatment, she said.

The stage of licensing the drug to a pharmaceutical company for distribution is “absolutely critical,” she said. “It is the moment where Hopkins loses control and it goes to a private company.”

lorraine.mirabella@baltsun.com