For Exelixis Inc., there was a lot riding on Cabometyx. The launch of the drug marked a new opportunity for success after several lean years at the oncology-focused biotechnology company.
South San Francisco-based Exelixis in April 2016 obtained U.S. Food and Drug Administration approval for Cabometyx, a therapy for patients with an advanced form of kidney cancer whose disease progressed following prior treatment. And it fell to the company’s commercial and compliance lawyers to counsel their business and medical counterparts, most of whom had recently joined Exelixis, about how to be both effective and compliant as they launched the drug in a highly competitive market.
To ensure compliance, the lawyers vetted the company’s go-to-market strategy, materials and resources—from product descriptions to speaker programs to advisory boards. This business-legal partnership culminated with the company’s presence in June 2016 at the annual meeting of the American Society of Clinical Oncology, a prominent conference in the field and the first chance Exelixis had to showcase Cabometyx.
“We can’t do our work effectively unless we have a seat at the table and work closely with our commercial colleagues,” said Bethany Fox, Exelixis’ senior director of commercial legal affairs and compliance. “In order to advise them, I need to know what they’re doing.”
“In our highly regulated industry, the business side needs to understand that legal must be present and around and taking part in team meetings, and legal needs to understand what their plans are,” she added. “It’s really a close partnership.”
The partnership and collaboration with legal and compliance is so strong at Exelixis that over the past year, business executives have grown comfortable coming to the lawyers whenever they have questions or concerns, said Pedro Sandoval, vice president and head of compliance at Exelixis.
“In most companies, compliance is seen as a policing function, but I wanted to make sure that compliance at Exelixis is viewed as a strategic business partner and that our business colleagues understand that we recognize the complexity and challenge of their day-to-day operations,” said Sandoval, adding that compliance’s routine involvement even includes riding along with sales representatives.
In August, Exelixis submitted to the FDA a supplemental new drug application for Cabometyx as a treatment for first-line kidney cancer, or for patients who had not previously been treated for the disease.
“A year ago, we were building the plane as we were flying it,” Sandoval said. “When a drug is launched for a new indication, you have to bring in a whole host of different individuals to cover different activities and functions. When you grow fast, that also creates risk. It is our job to help manage that risk and keep the company doing the right thing.”
Despite how busy the company’s lawyers have been this past year, both Fox and Sandoval said they’re reminded of why they work so hard when patients come to Exelixis to share stories of how the company’s drugs, including Cabometyx, have helped them get well.
“We might work hard, but hearing from the patients who have benefited from Cabometyx brings our efforts full circle and makes the job worthwhile,” Fox said.