Projected 2018 sales: $1.555 billion
2012 sales: $1.236 billion
Kidney cancer drug Sutent has seen its fair share of ups and downs. First, it struggled to get past the U.K.'s National Institute for Health and Care Excellence (NICE); in 2008, it was rejected along with fellow kidney cancer drugs Avastin from Roche ($RHHBY), Nexavar from Bayer and Torisel from Wyeth. Pfizer ($PFE) eventually managed to sneak past the cost-effectiveness gatekeeper by offering to pay for the first cycle of treatment, which weeds out those patients who don't respond to the drug. And then it scored a victory in 2009 when NICE once again rejected its three competitors.
Then there have been the failed trials in the push to expand Sutent's market. Pfizer hit hard times with the drug in the second half of 2010, particularly, with Sutent striking out in prostate cancer and lung cancer trials. In April of that year, Sutent also failed a liver cancer trial, and prior to that it had failed a late-stage study in breast cancer patients as well.
But in addition to kidney cancer, Sutent has proven effective for gastrointestinal stromal tumors and a rare type of pancreatic cancer. And this February, through DNA sequencing, researchers from the Dana-Farber Cancer Institute and elsewhere uncovered a potential new use. A subset of lung cancer samples showed mutations that could be targeted with Sutent.
Recently, Pfizer has been dealing with IP woes that have plagued other Big Pharma players in India. Last October, the Indian Patent Office yanked Pfizer's patent for Sutent, which had already been opposed by Indian drugmakers Cipla and Natco Pharma. Two months later, India's Supreme Court ordered the patent office to reconsider, simultaneously lifting the injunction preventing Cipla from putting out a generic. Now, however, India's Intellectual Property Appellate Board may be bailing Pfizer out: In June, it went back on the decision to revoke the Sutent patent, citing a Pfizer affidavit that mistakenly hadn't been passed along to the board for review, which it is now reconsidering.
Indian officials may resurrect Pfizer's Sutent patent