12 February 2016
Shawn Clackett

To Be or Not To Be Exclusive: The Sutezolid Story

The Lancet
By Jane Andrews
February 2016

I arrived at the Johns Hopkins University campus with a sense of déjà vu; it was my first visit to my alma mater in years. I had travelled to Baltimore for a meeting about the licensing of sutezolid, a much-awaited drug candidate for treatment of Mycobacterium tuberculosis. The research faculty, technology transfer officers, university administration, and advocates at the meeting felt the weight of the responsibility. We knew that licensing a tuberculosis drug candidate could be a historic event. Frustratingly, in the past 40 years the world has added only two new drugs to the arsenal against tuberculosis, the second most deadly infectious disease on the planet. The statistics are infuriating: more than 9 million people developed tuberculosis in 2013, and an estimated 44% of those in countries such as the Philippines, Thailand, and South Korea have resistance to at least one of the second-line agents for tuberculosis treatment.

Horrifically, only one of two people treated for multidrug resistant (MDR) tuberculosis are cured, and the toxic 2-year treatment regimen involves thousands of pills and hundreds of injections. For extensively drug resistant tuberculosis (XDR-TB) the cure rate drops to 20%. With new agents like sutezolid being used in combination with other drugs, we might be on the brink of being able to save more lives with less toxicity. Sutezolid, originally U-100480, began development alongside linezolid in 1996. Even then it showed favourable pharmacokinetic properties, efficacy against drug-resistant strains of tuberculosis, and low toxicity in rat models.  After lying undeveloped for several years in the hands of Pfizer and others, there is a new window of opportunity for the drug. Sequella, a pharmaceutical corporation, acquired the licence for the development and commercialisation of sutezolid from Pfizer in 2011. However, Johns Hopkins University still owns some key pieces of the intellectual property.

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