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Posted by on Aug 8, 2017 in Ethics, FDA, Infectious diseases, Pharma

US Development (or “Development”) of Benznidazole Reaches a Hitch and It’s All About Money

US Development (or “Development”) of Benznidazole Reaches a Hitch and It’s All About Money

UPDATE: The codevelopment agreement between Savant HWP and Humanigen for the US approval of benznidazole is essentially moot now, as the FDA granted accelerated approval for the treatment for Chagas disease on August 29, 2017 to Chemo Research, S. L. This company worked with 2 nonprofits, the Drugs for Neglected Disease Initiative (DNDi) and Mundo Sano, to bring benznidazole to the US and Latin American markets and is, consequently, the recipient of a coveted Tropical Disease Priority Review Voucher as a result.

As the development of benznidazole chugs along, in an agreement between Savant HWP and Humanigen (formerly Kalobios), a hitch in the agreement of who pays what development costs has reached a fever pitch. The Kalobios Bankruptcy blog has been following the story (unlike the mainstream biotech press).

Humanigen, running light on cash, says Savant owes the company overages in development costs. Savant, on the other hand, says that Humanigen is in default of its milestone payments and wants to terminate the co-development agreement, potentially taking its rights to benznidazole elsewhere. Lurking in the background of the relevant court documents is the notorious Martin Shkreli, newly convicted felon for securities fraud (X3) and originator of the benznidazole deal with Savant.

Shkreli’s idea — in keeping with his extortionist pricing of Turing’s Daraprim (pyrimethamine) — was to “develop” benznidazole on the basis of already-published overseas clinical-trial data (with the addition of a few pharmacokinetic and CMC studies); get quick FDA approval of the drug for Chagas disease; jack up the US price of the drug to similar extortionist levels; and sell a multi-million dollar tropical disease priority review voucher (PRV) that comes with FDA approval.

The CEO of Humanigen, who is not a fan of Shkreli, has since vowed to engage in responsible pricing of benznidazole when it is approved. However, the PRV remains the brass ring for both companies — Savant and Humanigen (although it’s still not clear how the proceeds for the PRV will be split up between the two companies). The not-so-subtle subtext of Humanigen’s plea for a temporary restraining order (TRO) against Savant is that Savant wants to recoup its sole rights to benznidazole and co-develop the drug with someone else who is more than willing to engage in price gouging, once the drug is FDA approved. An easter-egg footnote on page 5 of Humanigen’s TRO brief implies that Shkreli and the CEO of Savant — one Stephen Hurst — may remain in communication.

The Shkreli-Hurst partnership remained intact even after Shkreli was arrested at the end of 2015. In August 2016, Dorsey & Whitney issued a press release, announcing that Shkreli and Hurst had been invited to appear at a September 2016 symposium to discuss their efforts at forging a deal as to benznidazole. The press release stated: “Shkreli and Hurst will discuss how the KaloBios/Savant deal came together, their observations of KaloBios’ bankruptcy process and the impact of the public eye on pricing practices by life sciences companies.” See http://www.businesswire.com/news/home/20160815006183/en/Dorsey-4D-Symposium-Adds-Martin-ShkreliSteve (last accessed on August 4, 2017).

Notably Dorsey & Whitney represent Savant. This could get interesting.

CMC = chemistry, manufacturing, and control.
Rams butting heads in California from https://www.wildlife.ca.gov/Conservation/Mammals/Bighorn-Sheep/Desert/Peninsular/Behavior.
bmartin (1129 Posts)

A native East Tennessean, Barbara Martin is a formerly practicing, board-certified neurologist who received her BS (psychology, summa cum laude) and MD from Duke University before completing her postgraduate training (internship, residency, fellowship) at the Hospital of the University of Pennsylvania in Philadelphia. She has worked in academia, private practice, medical publishing, drug market research, and continuing medical education (CME). For the last 3 years, she has worked in a freelance capacity as a medical writer, analyst, and consultant. Follow Dr. Barbara Martin on and Twitter.