At least one more patient has been diagnosed with a rare, and potentially fatal brain infection after taking natalizumab (Tysabri), the hit drug for multiple sclerosis from Biogen Idec and Elan, according to Biogen CEO James Mullen.
There are now 28 confirmed cases of patients with progressive multifocal leukoencephalopathy (PML) as of the last count in mid-December. That’s one more case than I counted in a detailed summary of PML risk that we published on November 19. Mullen made his remarks in front of a group of investors today at a Goldman Sachs conference titled “Healthcare CEOs Unscripted: A View From the Top.”
Mullen talked about the hit drug’s difficult history with PML as part of a wide-ranging and candid conversation with Goldman analyst May-Kin Ho in New York. These were the first public remarks Mullen, 51, has made since the Cambridge, MA-based company (NASDAQ: [[ticker:BIIB]]) announced this week he is stepping down in June as CEO, after a decade at the helm. He offered his thoughts on how to mitigate the risk for multiple sclerosis patients, his reflections on what worked and what didn’t in the 2003 merger with San Diego-based Idec Pharmaceuticals, and how the industry needs to change its ways to keep innovation alive. Here are the highlights that I picked up from the webcast.
On how Biogen Idec plans to keep doctors, patients, and investors informed about PML risk:
Biogen Idec says it plans to offer monthly updates to physicians about the latest statistics on PML cases, and infection rates. It will also staff a hotline for physicians who want to gather detailed, updated information and context from the company’s medical staff. The company plans to lay out the numbers in a more detailed fashion, with rates on incidence of infection, numbers showing how long certain groups of patients have been on the drug, combined with data on how many total patients are receiving treatment. “That’s the best way for people to visualize what’s going on,” Mullen says.
“The whole communications strategy around that has been challenging,” Mullen said. “We’ve gotten lots of feedback. Pretty much whatever we’ve done, someone won’t like it.”
On why he’s leaving the company in June:
Mullen noted that the Tysabri risk-management situation has stabilized during the past year. A new patent that lasts until 2026 has extended the lifespan of pegylated interferon beta (Avonex) which may help it fend off cheaper “follow-on” biologic competitors. And the product pipeline looks encouraging as well, he said.
“There are a lot of good prospects out there for Tysabri, and there aren’t, if you will, a lot of huge, thorny issues to be wrestled to the ground here in the short term. It’s a good time for a transition.”
From a personal perspective, he added: “If you’re going to have a mid-life crisis, you can do one of two or three things, right? Sports cars I’m too big for. Mistresses are not approved at home. Maybe a career change is what’s in order. I decided to go with Number 3. I think it’s a good time, for, you know, a transition. We’ve also got a new chairman with Bill Young. We’ve got some new board members. We’ll have a few more new board members. It’s a good time for people to sort of re-think
