It’s very interesting to read about the story of Zurampic, which is a brand created for the new gout medicine (expected to be a blockbuster drug) – lesinurad by AstraZeneca, a British-Swedish multinational pharmaceutical company.
Lesinurad, original code name RDEA594, is uricosuric drug developed by Ardea Biosciences, Inc. Early clinical researches showed that lesinurad is more effective than probenecid in promoting the urate excretion by the kidneys. When it was in Phase III clinical trials for the treatment for gout, AstraZeneca acquired the company in early 2012 with a definitive merger agreement worth $1.26 billion! Together with this deal, AstraZeneca does not only gain the right to RDEA594, they gain the ownership of RDEA3170, another uricosuric drug which was in Phase I development at the time of merger.
Official press release by AstraZeneca => https://www.astrazeneca.com/media-centre/press-releases/2012/AstraZeneca-to-acquire-Ardea-Biosciences-for-1-billion-23042012.html#
On 22 December 2015, AstraZeneca announced that RDEA594, officially named as lesinurad with the official brand name Zurampic, was approved by FDA (https://www.astrazeneca-us.com/media/press-releases/2015/zurampic-lesinurad-approved-by-us-fda-for-patients-20151222.html#).
Not long after the FDA approval, AstraZeneca announced that they entered into US licensing agreement with Ironwood Pharmaceuticals for lesinurad. Ironwood agreed to pay $265 million and tiered single-digit royalties on Product Sales to AstraZeneca in order to secure the dealership for US market.
There are 2 factors that made Ironwood to dump lesinurad so soon. First, the sales of Zurampic is very disappointing to the company. In 2018 Q2 financial report, Zurampic contributed only $1.1 million out of the total revenue of $81 million. Second reason is that Zurampic fell short of hitting the criteria of three late-stage studies and some FDA’s advisers worried that Zurampic drug’s safety profile did not support an approval. Which means that there’s a risk for Zurampic’s FDA approval to be revoked.
Ironwood had paid $100 million up front, if they were to continue marketing Zurampic, they would have to pay the rest of the milestone payment of $165 million. Well, if I’m the CEO, I would have chopped off the hand before the lost spreads to other hand too.
Now you know what is Zurampic, it’s just a brand name of lesinurad created by the Big Pharma hoping that it would become a blockbuster gout drug. Well, analysts once predicted the peak sales of Zurampic can go as high as $500 million, obviously the sales fell too short away from the analysts’ figure.
Once you know the big deals behind Zurampic, you should naturally understand the reason why it was priced at $396 for one month supply! $396 for a new gout drug, that sound more painful than the gout attacks.
Good-bye Zurampic! and its brother Duzallo too…