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Australian not-for-profit group wins unprecedented FDA approval for blindness drug

Sunday, July 22nd, 2018

London: An Australian company has won unprecedented US approval for a new drug to treat the second most common preventable cause of blindness in the world.

In the process, Medicines Development for Global Health, based in Melbourne, became the first not-for-profit company in the world to register a medicine with the US Food and Drug Administration.

Mark Sullivan, managing director of Medicines Development for Global Health.

Photo: Supplied

The World Health Organisation has been calling for better treatments for river blindness for more than a decade, but because the medicine would be mostly used by those in poverty-stricken countries, there has been no financial incentive for drug companies to develop new treatments. The current treatment is 20 years old.

River blindness is caused by parasitic worms and spread by black flies. It affects the skin and eyes and is prevalent in sub-Saharan Africa.

In a double-win for Medicines Development for Global Health, it has also won a highly sought after voucher designed to financially reward companies that develop drugs for neglected diseases.

Managing director Mark Sullivan said while FDA approval for the company’s drug, moxidectin, was a “momentous achievement” for any pharma company, it was “a particularly rare and exciting event” for those trying to treat neglected diseases.

The FDA gave its approval for the treatment, which is swallowed as a tablet, in June after the application was submitted in October 2017.

Mr Sullivan established the Melbourne-based not-for-profit company in 2005 with the sole purpose of filling the gap left by the big pharmaceutical companies by developing medicines that were based on need for treatment rather than the patients’ ability to afford them.

Medicines Development for Global Health has been working for five years on the development of the drug and is now planning to develop moxidectin as a new treatment for scabies, a common problem in Indigenous communities.

Priority review voucher

The company has also won a priority review voucher under a scheme set up in 2007 to create a financial incentive to reward drug makers willing to spend the time and money developing treatments for the some of the world’s most neglected diseases. The scheme creates a market for making new drugs that the private market was not filling itself.

Under the scheme, a company that wins a voucher gets a fast track through the FDA for consideration of its  next new drug,  even if it’s a treatment that would have a commercial return. This gives it a head-start over its rivals.

Crucially, a company can also on-sell the voucher to a bigger company willing to pay anywhere between $US100 million and $300 million for the right to almost halve the approval time.

Because Medicines Development for Global Health is a not-for-profit, its proceeds from drug sales and the voucher will be reinvested in the company to develop new drugs & medications for other neglected diseases.

“Our plan is to sell the voucher and use the funds to support further development of moxidectin for other neglected diseases but also to expand our portfolio into other medicines and vaccines,” Mr Sullivan said.

Professor David Ridely from Duke University authored the scheme and said Medicines Development for Global Health was a textbook example of how he envisaged the program would work.

“I’m delighted that the voucher program is playing a role in treating patients with river blindness, and one day eliminating the disease,” he said.

Mr Sullivan said the development of moxidectin could not have been possible without a $US13 million co-investment from the Global Health Investment Fund, which is the social impact investment fund initially put together by the Bill and Melinda Gates Foundation.

”We believe moxidectin may play a pivotal role in eventually eradicating river blindness, and look forward to working with MDGH and others in making this happen,” Curt LaBelle, managing partner at the investment fund, said.

Color-enhanced Scanning Electron Micrograph (SEM) of Onchocerca volvulus, image of a female worm with microfilaria. O. volvulus is a nematode that causes onchocerciasis, or “river blindness,” mostly in Africa. Long-term corneal inflammation, or keratitis, leads to thickening of the corneal stroma which ultimately leads to blindness.

The Food and Drug Administration (FDA) has approved moxidectin for the treatment of onchocerciasis (river blindness) due to Onchocerca volvulus in patients ≥12 years of age.

Moxidectin, a macrocyclic lactone, is an anthelmintic drug that selectively binds to the parasite’s glutamate-gated chloride ion channels. It is active against O. volvulus microfilariae but it does not kill adult O. volvulus parasites. The tropical disease spreads from person to person via black flies that breed near rivers in South and Central America, sub-Saharan Africa and Yemen

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He was brought to doctors, who expected to find the soldier in bad shape. But what they also found when they opened him up gave the world a glimpse into just how bad things are in North Korea.

Doctors repairing the unidentified soldier’s digestive tract found dozens of parasites in his intestines. One of the suspected roundworms was nearly a foot long.

“I spent more than 20 years of experience as a surgeon, but I have not found parasites this big in the intestines of South Koreans,” Lee Cook-jong, who leads the team treating the soldier, told the Associated Press.

Authorities have not released the name or rank of the defecting soldier. He has spent his first days in South Korea unconscious, sedated and relying on a breathing machine to stay alive.

But the worms taken from his intestines with tweezers tell a story of the humanitarian and health crisis gripping North Korea even as it expends significant resources in its effort to become a global nuclear power.

Other public spending priorities in North Korea have suffered, as leader Kim Jong Un has built and tested his nuclear arsenal while also trading radioactive barbs with Western leaders.

A Newsweek headline put it more succinctly – and brutally: “North Korea’s Kim Jong Un is starving his people to pay for nuclear weapons.”

According to a report by the United Nations, two of every five people in North Korea are undernourished. Seventy per cent of people require food assistance to survive, including 1.3 million children below the age of five.

And the food they have access to can sicken or kill them. According to The New York Times, many North Koreans who have defected to South Korea have shown up infected with parasites.

That’s partially because North Korea lacks chemical fertiliser, and many farmers rely on human excrement to fertilise fields. As a fertiliser, “night soil” is free and abundant.

But it’s notorious for transmitting parasites like the ones inside the North Korean defector’s stomach.

In a 2014 study, South Korean doctors checked a sample of 17 female defectors from North Korea and found seven of them infected with parasitic worms, according to the BBC. They also had higher rates of other diseases, including hepatitis B and tuberculosis.

Finding worms inside a soldier who once guarded one of the most scrutinised borders in the world is especially telling, a sign that North Korea’s food woes affect military members, who typically have a higher ranking on the food-rationing list. There are even reports that North Korean soldiers have been ordered to steal corn from farmers to stave off hunger.

The soldier’s vital signs were stabilising this weekend, the AP reported, but it was still unclear whether he would recover or wake up.

Until then, the parasites taken from his body were the only things telling a story, as Peter Preiser of Singapore’s Nanyang Technological University told the BBC.

“What they all do is take nutrients away from your body,” the professor told the BBC. “So (even) if most of them might go unnoticed, they all indicate a poor health status.

“To put it simply: People who have parasites are not healthy.”

The Washington Post

www.crimefiles.net

www.foodpassions.net

Henry Sapiecha