Afinitor - Novartis

Afinitor (everolimus)
Launch Date: March 2009
First Full-Year Sales (2010): $243 million
First-Half 2013: $611 million
Analyst Estimate for 2018: $3.487 billion

Novartis ($NVS) knows how to grow cancer drugs, and that expertise has been on full display with Afinitor. Since its original approval back in 2009, the drug has posted big sales increases every year. The company racked up $243 million in sales in 2010 and then more than tripled it--to $749 million--last year. By the end of the first half of this year the treatment, also known as everolimus, was already well on its way to breaking the billion-dollar blockbuster barrier.

Novartis likes to break into one disease category and expand with follow-on approvals. First approved for kidney cancers, Afinitor went on to rack up indications in pancreatic cancer, rare childhood brain tumors, and benign tumors caused by tuberous sclerosis. And last year Afinitor became the first mTOR inhibitor to gain an approval for breast cancer--an indication that could, some analysts felt, be worth up to $1.5 billion in additional sales. Meanwhile, under the brand names Zortress and Certican, it won FDA approval to prevent organ rejection in transplant patients.

But it hasn't all been clear sailing. Just weeks ago investigators reported that Afinitor was no better than a placebo in improving survival rates among liver cancer patients. That key trial failure followed a setback at NICE, which refused to clear the breast cancer indication.

Novartis doesn't let setbacks roil its development strategies, though. There are studies underway for gastrointestinal and lung tumors, HER2-positive breast cancer, lymphoma and tuberous sclerosis complex. Those trials will deliver new data and new marketing possibilities through 2015.

Analysts' peak sales projections have been settling in around the $2 billion to $3 billion mark, with Bank Vontobel analyst Andrew Weiss at one point pegging the top at an ambitious $3.5 billion.

It's worth noting that everolimus sales under the Certican and Zortress brand names add more heft to the drug's sales. In the transplant world, everolimus brought in an additional $210 million last year. Together with its Afinitor numbers, that's blockbuster territory--$1.07 billion.

For more:
Afinitor's breast cancer OK could add $1.5B to Novartis sales
Novartis discount fails to persuade NICE on Afinitor in breast cancer
Novartis' ambitions for Afinitor suffer on liver-cancer failure
Novartis nabs another FDA-approved indication for everolimus

-- Tracy Staton (email | Twitter)

Afinitor - Novartis