The company: Roche
Worldwide sales: $6.751 billion
First approved for treating colon cancer a decade ago, Avastin is one of those special drugs for which doctors continue to find more uses, allowing Roche ($RHHBY) to continue to nab new approvals and new revenues along the way. Last year the FDA approved it as a second-line treatment, with chemotherapy, for patients with metastatic colorectal cancer, while Japan approved it for a first-line use in brain cancer, to name two. Roche currently has it in half a dozen trials for different treatment options.
The drug saw a 13% jump in sales last year, in part because of continued uptake in use against ovarian cancer in Europe. It was approved in 2011 for treating women with newly diagnosed, advanced ovarian cancer and less than a year later for treating recurrent, platinum-sensitive ovarian cancer.
That is not to say the drug has had a completely unfettered path to success. In 2010, the FDA retracted its approval for treating breast cancer and the European Medicines Agency restricted its use to one type of chemotherapy after trial data raised questions about its effectiveness. It has run into government drug price police in some countries, like the U.K. But it has been so effective that even there is it the most prescribed medicine in the country, paid for out of a special fund because doctors demand access.
Its versatility has created some issues recently. The Italian Competition Authority fined Roche and Novartis a total of €182.5 million ($253 million), claiming the marketing partners had blocked distribution of Avastin in favor of the more expensive Lucentis for treating wet age-related macular degeneration. They said it cost the government health system an extra €45 million ($62 million) in 2012. The drugs work similarly to restrict blood vessel growth so many doctors use Avastin off-label to treat the condition because it costs a fraction of what Lucentis does. The companies deny any wrongdoing, but Italian prosecutors and French anticompetition regulators have now jumped in to investigate.
Avastin's widespread use and big price tag also has attracted biosimilar makers. It is among the Roche drugs that Amgen ($AMGN) hopes to copy. But its patent in the U.S. doesn't expire until 2019, giving it time to rack up new uses and more sales for years.
Avastin scores first-line brain-cancer use in Japan
Will U.K. watchdogs change their minds on Avastin in ovarian cancer?
Roche's Avastin gets another indication approval
FDA, EMA move against Avastin for breast cancer
Novartis and Roche now have France eyeing competition issues
-- Eric Palmer (email | Twitter)