If one were to list the top cancer drugmakers of all time, it’s fair to say Bayer wouldn’t make the top 10. Despite the German drug giant’s leadership position across the healthcare spectrum—from over-the-counter aspirin to diabetes glucose-testing meters—it has never made much of a splash in cancer. In 2000, Bayer’s (OTCBB: BAYRY) top executives decided to change that by making a major commitment to oncology and boosting its cancer development efforts in a few key sites, including its R&D facility in Montville, NJ.
Judging from Bayer’s showing at the annual meeting of the American Society of Clinical Oncology (ASCO), which ended yesterday in Chicago, that effort is starting to pay off. During the conference, Bayer scientists presented late-stage trial data on two new drugs, one aimed at colon and gastric cancer, the other at prostate cancer that has spread to the bones. Bayer expects to have completed its filings for FDA approval on both by the end of the year.
ASCO was a coming-out party of sorts for Bayer, which currently has just one approved oncology product—sorafenib (Nexavar), a $1-billion-a-year kidney cancer drug it co-developed with San Francisco-based Onyx Pharmaceuticals (NASDAQ: ONXX). In addition to presenting the two late-stage compounds, Bayer unveiled data from three of its earlier-stage cancer drugs. “For years we’ve only had a one-product portfolio [in cancer],” says Alison Ayers-Ptaszek, head of global oncology for Bayer. “This is an exciting expansion.”
The first drug that generated some buzz at ASCO is regorafenib, which the company is testing in colorectal cancer and gastrointestinal stromal tumors (GIST). In colon cancer patients who had failed other therapies, the drug produced a 30 percent improvement in overall survival, says Dirk Laurent, vice president of global clinical development for Bayer’s oncology unit. In the GIST trial, the goal was to improve “progression-free” survival, or the amount of time during which tumors did not grow, in patients that failed the only two available therapies. “With regorafenib, the risk to progress or die was reduced by 73 percent,” Laurent says. “Those are significant results.”
Regorafenib is related to Bayer’s cancer blockbuster, sorafenib, because both are “multi-kinase inhibitors,” meaning they block several enzymes that are key to tumor development. Even though the second-generation molecule was discovered in Bayer’s labs, the company ended up in a dispute with Onyx, which contended the drug should fall into the original licensing agreement. The two companies settled last fall, with Bayer agreeing to give Onyx co-marketing rights in the U.S. and a 20 percent royalty on sales, should the drug make it to market.
Bayer filed to the FDA for approval for the drug in colon cancer, and is preparing to submit the application later this year for approval in GIST, Laurent says.
The second late-stage drug that Bayer presented at ASCO represents a new method for attacking cancer that has spread to the bones. The drug is radium-223 dichloride, and as its name implies, it emits radiation. Radium-223 is a “calcium mimetic,” meaning it acts like calcium in the body by zooming in on newly-formed bone structures. Once it has inhabited the bone, it delivers its radioactive payload. “It works against the tumor cells, in the tumor’s micro-environment,” says Dimitris Voliotis, vice president of global clinical development for Bayer’s oncology unit.
The data Bayer presented at ASCO showed an improvement in overall survival in patients with metastatic prostate cancer of 44 percent. Voliotis says he believes radium-223, which Bayer licensed from Norway-based Algeta, will prove valuable in cancer treatment because of the complications caused by cancer that spreads to bone. “As patients progress they get bone fractures, or spinal cord compressions,” he says. “Some need surgery. We were able to show a significantly prolonged time to the occurrence of these skeletal events.” Bayer will file for approval of the drug in the second half of the year.
Ayers-Ptaszek, who recently joined Bayer from Pfizer, says the company will continue to build its cancer pipeline through a mix of partnerships and internal discovery. “We’re using partnerships to supplement our own research and make sure we have a fully formed portfolio,” she says. She’s quick to add that Bayer is determined to change its one-hit-wonder status in cancer. “We’re committed to oncology and investing heavily. We believe we have the opportunity for a significant growth story in oncology.”