5. Trogarzo

Electromicrograph showing an HIV-infected T cell in blue and yellow
HIV-infected T-cell. (NIAID)

Active ingredient: ibalizumab-uiyk
Disease: Multidrug-resistant HIV-1
Peak sales estimate: Over $1 billion
Approved: March 6, 2018
Company: TaiMed Biologics 

The scoop: Trogarzo represents the first HIV therapy with a new mechanism of action approved in more than a decade. Developed by the Taiwanese firm TaiMed Biologics, the humanized monoclonal antibody blocks the virus from infecting cells by binding to extracellular domain 2 of the CD4+ receptor, a different site than other antiretrovirals. While several drugs in recent years have made HIV a more manageable disease, about 20,000 to 25,000 patients in the U.S. have developed resistance against multiple treatments, according to the company. TaiMed tapped Theratechnologies to market and distribute the drug in North America, with the Canadian pharma paying escalating milestones up to $207 million if Trogarzo tops $1 billion in sales and expands the label. And it has a good chance to make it there, with an orphan designation giving them market exclusivity into 2030, and peak sales expected in 4 to 5 years. Theratechnologies also holds rights to the drug in the EU, Israel, Norway, Russia and Switzerland. Manufacturing will be handled by WuXi Biologics, with a premarket inspection of its Trogarzo facility making the it the first Chinese company to receive an FDA clearance for biological products. — Conor Hale

5. Trogarzo

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