Madison, Wisconsin-based EXACT Sciences stocks climbed as much as 21 percent in premarket trading in response to a deal with Pfizer to co-market Exact’s Cologuard non-invasive colon cancer test. As part of the terms of the deal, the two companies will split marketing expenses and gross profits above an agreed-upon baseline through 2021. The co-marketing deal is expected to start in the fourth quarter of this year. Exact Sciences will keep control of all manufacturing and lab operations.
“This partnership marks a turning point in the fight to end colorectal cancer,” said Kevin Conroy, Exact sciences’ chairman and chief executive officer, in a statement. “Pfizer is joining Exact Sciences’ mission of eradicating colorectal cancer by helping detect the disease at its earliest, most treatable stages. Together we can help reduce the prevalence of colorectal cancer by combining the power of Cologuard and the talented Exact Sciences team with Pfizer’s experience, relationships and resources.”
Colon cancer is cited as the most preventable, but least prevented, type of cancer. It is the second leading cause of cancer death in the U.S., with about 50,000 deaths each year. When diagnosed in Stages I or II, nine out of 10 people survive more than five years. But when it is diagnosed in Stage IV, only one out of 10 people survive more than five years.
Currently, the gold standard of colon cancer detection is the colonoscopy, an invasive procedure that typically requires an unpleasant bowel-cleansing preparation and full, but short-term anesthesia. Although Cologuard was approved by the U.S. Food and Drug Administration (FDA) in August 2014 and is included in the American Cancer Society’s (2018) colorectal cancer screening guidelines and the recommendations of the U.S. Preventive Services Task Force(2016) and National Comprehensive Cancer Network (2016), most physician organizations do not recommend it over colonoscopies.
The Digestive Diseases Center notes, “Colonoscopies are the gold standard in detecting colorectal cancer as well as precancerous lesions through the use of a camera-enabled scope; this has been proven over decades of studies as experienced Gastroenterologists’ cases. This allows a gastroenterologist to clearly view the large bowel and distal part of the small bowel for signs of polyps or cancer lesions. If any are seen, biopsies for further examination can be taken at the same time. In all, colonoscopies can detect about 95 percent of all colorectal cancers and advanced precancerous polyps.”
Cologuard does not have a visual component, but tests DNA from stool samples for the presence of abnormal cancerous or precancerous cells. In studies, it detects 92 percent of colorectal cancers and only about 42 percent of precancerous polyps. There are also concerns with false positive, with about 13 percent of patients receiving false positive results.
On the other hand, since there is a problem with patient compliance—no one happily gets a colonoscopy—Cologuard may get broader usage with an active marketing campaign. In other words, Cologuard is a significantly better option than no colon cancer screening at all.
Exact currently spends about $80 million on marketing Cologuard. Pfizer is expected to invest up to $24 million through 2021. Brian Weinstein of the William Blair investment firm wrote in a note to investors that this was “adding serious firepower” to the sales program. “The quick takeaway is that while Exact is giving up some margin, it is getting a massive infusion of firepower to detail this test to the (general practitioner) community.”
A Product Manager with expertise in pharma marketing and sales operations