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A nonprofit group’s Chagas drug beat out Martin Shkreli’s old rival to FDA OK, valuable PRV

Silvia Gold, Mundo Sano

The FDA has approved a new drug for Chagas disease, but one of Martin Shkreli’s former biotechs — which set its sights on Chagas — isn’t the one benefiting from the marketing OK. And Shkreli’s successors say they now have to switch up their game plan after the rival group snagged the valuable priority review voucher that came with the first OK, blasting their share price.

The nonprofit drug development organization Drugs for Neglected Diseases initiative (DNDi), along with the pharmaceutical company Chemo Group and the nonprofit foundation Mundo Sano set out a year ago to register the drug in areas where its needed, including the US.

Now Chemo Research SL, a unit of the Chemo Group, has won the first ever US OK for the drug — for pediatric patients — along with a priority review voucher that’s likely worth over $100 million.

The nonprofits banded together with the express mission of making the therapy available at cost, plus what they said would be a reasonable margin. They also pledged that half of any money they get from the PRV will be earmarked for Mundo Sano’s nonprofit work. The FDA statement on the approval notes that while Chagas is endemic in Latin America, some 300,000 people have it in the US.

That’s what attracted Martin Shkreli to the drug. After he acquired KaloBios out of bankruptcy, he landed the worldwide rights to a version of the same drug with plans to boost the price — from $50 to $100 in Latin America and free from the CDC — up to then hep C levels, which were $60,000 to $90,000.

Shkreli’s most notorious for his work at Turing, where he bought another old drug and hiked the price more than 5000%.

Shkreli was later charged with fraud — recently convicted on three felony counts — and had to exit KaloBios, which subsequently changed its name to Humanigen $HGEN and barred Shkreli from the premises.

In an SEC post Wednesday morning, though, Humanigen — now run by Cameron Durrant — says the approval for the rival group means they are out of the running on the PRV, raising questions about the future of their work.

As a result of FDA’s actions and with the information currently available, Humanigen, Inc. no longer expects to be eligible to receive a PRV with its own benznidazole candidate for the treatment of Chagas disease. Accordingly, Humanigen is assessing its options in respect of that development program and the company’s monoclonal antibodies, lenzilumab and ifabotuzumab.
That’s not what shareholders wanted to hear. Humanigen’s shares imploded on the news, with the OTC stock dropping 73% and plunging deep into penny stock territory.

According to a spokesperson at DNDi, “one of the first activities in this strategic collaboration was the development of an urgently needed second source of the pediatric dosage form of benznidazole, following disruptions in supply from what at the time was the only existing child-adapted formulation of benznidazole.”

DNDi’s Executive Director Bernard Pécoul had this to say:

Globally, fewer than 1% of the six to eight million people with Chagas disease have access to treatment. In the U.S. only a handful of patients have had access to treatment, thanks to the efforts of leading Chagas clinicians in places like Los Angeles and northern Virginia. It is our hope that patients in the U.S. will now have easier access to benznidazole, and that FDA registration will also catalyze endemic countries in Latin America that have not yet registered the drug to do so.

“The FDA is committed to making available safe and effective therapeutic options to treat tropical diseases,” said Edward Cox, director of the Office of Antimicrobial Products in the FDA’s CDER.

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