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Regorafenib – Top 10 Late-Stage Cancer Drugs – 2012

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Developer: Bayer HealthCare
Partner: Onyx Pharmaceuticals
Key date: Filings for approval in colon cancer slated for 2012

Bayer has banked on regorafenib to be one of the future standouts in its portfolio of cancer medicines, with CEO Marijn Dekkers eyeing the program to yield blockbuster returns on the company's R&D investment. This year the German drugmaker has turned in positive data from a pair of Phase III trials of the multi-kinase inhibitor to support its bid to market the experimental drug for multiple types of cancers.

The two recent batches of late-stage trial data have put Bayer on track to seek approval of regorafenib for gastrointestinal stromal and colorectal cancers. In the Phase III CORRECT trial involving patients with aggressive colorectal tumors, the drug helped boost overall survival 29%, and patients on the drug had median overall survival of 6.4 months compared with 5 months in patients taking a placebo. The company provided an encore in late March, announcing preliminary data from its late-stage GRID trial, which achieved its main goal with gastrointestinal stromal cancer patients on regorafenib living longer without their cancer worsening than those in the control group.

Bayer has said it will take a shot at approval of the drug for the colorectal cancer indication later this year and will make a bid for approval in gastrointestinal stromal tumors as well. Onyx Pharmaceuticals ($ONXX) would get to share in the sales if regorafenib, which closely resembles Bayer and Onyx's Nexavar, finds its way onto the market. Onyx, of course, grabbed a 20% royalty on potential sales of regorafenib in its deal with Bayer that settled the dispute over whether Bayer researchers had crafted regorafenib as an analog of Nexavar without paying Onyx.

Onyx pocketed $160 million upfront from Bayer in the partnership deal. Yet that chunk of change could be just a fraction of what Dekkers envisions regorafenib bringing in in annual sales, which his company expects will eventually top more than $1 billion in yearly revenue via uses for multiple types of tumors.

Clarification: This item was updated to make clear that Bayer also owns Nexavar. It wasn't our intention to say that only Onyx had title to the blockbuster drug.