Bayer AG used the industry event, inChicago, to showcase its growing oncology pipeline, including Stivarga, which won approval from the Food and Drug Administration a few months later, in September. The drug became Bayer's second oncology product to be approved in theUnited States. In clinical trials, colorectal cancer patients who had previously received available therapies survived 6.4 months when given Stivarga, versus five months with a placebo.
Bayer's hopes for Stivarga extend beyond colorectal cancer: The company also is seeking approval for the use of Stivarga to treat gastrointestinal stromal tumors, or GIST, and it hopes the drug will qualify for other indications as well; Shannon Campbell, vice president and general manager of oncology at Bayer HealthCare, said the company "clearly (has) very high expectations for Stivarga."
Bayer's first cancer drug, the kidney and liver cancer treatment Nexavar, had more than $1 billion in sales last year. If Stivarga is approved for GIST, the drug would have a bigger potential patient population than Nexavar, she said.
Damien Conover, an analyst at Morningstar Financial, said Bayer is right to be optimistic about Stivarga.
"This is a pretty interesting drug," he said. "It's got a different mechanism of action versus some of the other drugs out there, so I think it will definitely help. And it's treating a disease area where, in time, people usually become refractory to treatment — so unfortunately, it's an area where you continue to need new treatments."
Stivarga's significance isn't just related to the drug itself. It also marks a new direction for Bayer, which sees itself as an emerging player in oncology.
"The organization has clearly made a commitment that oncology is an important part of Bayer's pharmaceutical business moving forward,"Campbellsaid, "because we believe the innovation that we have within our discovery and development platform will bring important new therapies to cancer patients."
Pamela Cyrus, vice president and head ofU.S.medical affairs at Bayer, said New Jersey-based employees play a significant role in the clinical development of new cancer drugs, though she said the earliest drug discovery takes place mostly inGermany.
Bayer HealthCare currently is based inWayne, but officials are planning to move those offices to the Whippany section ofHanoveras part of a wider consolidation of Bayer HealthCare's East Coast operations. The move to Whippany is slated to start in the second half of next year, according to spokeswoman Rosemarie Yancosek.
David Finegold, senior vice president of lifelong learning and strategic growth atRutgersUniversity, said Bayer isn't alone in pursuing oncology.
"What we're learning about cancer is there are so many subsets to what we have been calling 'breast cancer' or 'lung cancer,' " Finegold said. "As our knowledge improves, the ability to develop therapies that are much better with fewer side effects is really great."
Bayer is filling its pipeline both through original R&D and through partnerships. Nexavar was the product of a licensing deal with Onyx Therapeutics, aCaliforniacompany. Bayer said it developed Stivarga on its own, though Onyx will receive a portion of the revenue from the drug after settling an Onyx claim that the drug was too similar to Nexavar. The next drug in line is known as radium 223 dicholoride; Bayer plans to file for FDA approval for the treatment of prostate cancer that has spread to the bone by the end of the year.
Another issue Bayer will face is increased concerns about the cost of health care. Stivarga will cost about $9,350 per month. That's in line with competitors, Conover said.
"The bigger question is: Are these things priced correctly?" he said. "And that's a difficult question to answer."
Conover said pharma-economic studies support the pricing, but the drug might still be a difficult sell outside theUnited States, in countries that have government-funded health care systems.
Finegold said that's another reason Bayer's multi-indication strategy for Stivarga makes sense.
"You're not going to invest what these folks do if you thought the only life for this drug was as a therapy of last resort," he said. "You come in with that as your demonstrated outcome, and you can add value as you look for abilities in other indications."
If Bayer proves correct and Stivarga becomes a blockbuster, the company will be two-for-two in its nascent oncology career. If the response out of the ASCO meeting is any indication,Campbellthinks this is just the beginning for Bayer oncology.
"There really are very few even big players in the oncology space that are fortunate to have that much in their near-term portfolio," she said. "So there is a lot of good buzz for Bayer in the oncology space."
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