According to NY Times, FDA today announced that they are halting the sales of Iclusig in the US. The serious danger of blood clots had lead to, amputations in some cases, and death in other cases, of individuals taking the drug. These adverse events were serious enough that the FDA decided it could not allow continued marketing of the drug.
This is yet another example of just how challenging and risky drug development remains. Iclusig's approval was heralded as a triumph of the vision of Ariad's founder Harvey Burger, who toiled away for years and persisted in the face of heavy odds to develop Iclusig and get it registered. But signs of trouble began right from the beginning when Iclusig's approval was greeted with a decline in share price of Ariad due to the black box warning in the label. Harvey didn't believe that the adverse events of Iclusig were serious enough to warrant caution, but the street was worried. It seems prescient now that the FDA would require a black box warning in Iclusig's label warning the prescribers of the risk of serious adverse events.
In some ways, Ariad has been a troubled company right from get go. Ariad's earlier entry into the market place was ridaforolimus, which it partnered out to Merck in the hopes of rapid and extensive development. The partnership ran into trouble mid way and Merck took control of the drug's development and commercialization. Unfortunately, the drug was set back significantly when FDA recently turned down the application for an indication in Sarcoma unless Merck conducted additional trials to demonstrate safety.
Ariad had an opportunity to license out the drug to a deeper pocketed partner before the drug was approved and recoup some of the large investments made in the molecule's development. But management decided that they would rather commercialize the drug themselves than give away economic value to some one else. This, unfortunately, meant that the company and its investors were also taking on the risk of something going wrong.
Today Ariad's hopes of a commercializing a drug that would help millions of patients, are in tatters, and so are the hopes of its founder and the investors who believed in him. It will be quite a miracle if the company comes out of this death spiral intact. As I write this, it is difficult not to feel bad for the man who set the vision for the company, the investors who followed him and funded him, the patients who contributed to development of the drug, and those patients who could have benefited from the drug being on the market.
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