Zaltrap approval a win for Sanofi, even at $400M max

Sanofi ($SNY) got its first green light for Zaltrap, a cancer drug developed with Regeneron ($REGN). It's a second-line approval, in a market already dominated by Roche's ($RHHBY) Avastin and Bristol-Myers Squibb's ($BMY) Erbitux. But it's a step forward after a couple of oncology setbacks--and a first step toward hundreds of millions in sales.

Like Avastin, Zaltrap is an angiogenesis inhibitor, which fights cancer by choking off the blood supply to tumors. It's approved for use in metastatic colorectal cancer, along with a common three-drug chemotherapy regimen known as FOLFIRI, after patients have failed on oxaliplatin-based chemo. That's not an enormous field; analysts expect Zaltrap to max out at $300 million to $400 million in that indication.

The good news for Sanofi is that it will reap the lion's share of those sales over the next few years, under the terms of its partnership with Regeneron. Sanofi gets half of the drug's profits, and Regeneron has to repay half of Sanofi's development costs, RW Baird analyst Christopher Raymond points out. He's expecting Zaltrap sales of $205 million by 2015.

Zaltrap's numbers could go significantly higher if first-line treatment studies pan out. Decision Resources, the market research firm, has said that a first-line indication could push Zaltrap into blockbuster territory. Even farther down the road is the hope for anti-angiogenesis combo therapy. Regeneron R&D chief George Yancopoulos told Reuters that his company and Sanofi are testing two angiogenesis inhibitors that work via different mechanisms, and they could someday be used together with Zaltrap.

But Sanofi knows better than to count on these things. As Reuters notes, Zaltrap has failed studies in prostate cancer, lung cancer and pancreatic cancer. After that, the drug's mere approval is symbolic, analysts note. "Zaltrap isn't likely to be a large medicine for Sanofi, but getting a cancer drug approved is important for them, after a series of setbacks in oncology," Pierre Corby, an Aurel BGC analyst told Bloomberg.

- see the release from FDA
- check out the Reuters news
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