Gilead Sciences is tapping long-term Stanford University researcher Mark Genovese, M.D., to lead its nonalcoholic steatohepatitis (NASH), fibrosis and arthritis pipeline programs.
Genovese has spent more than two decades at Stanford, most recently as the James W. Raitt Professor of Medicine and clinical chief in the division of immunology and rheumatology.
While cancer and, more recently, antivirals have moved to the center of Gilead’s pipeline and focus, the biopharma is still spending billions (and hoping to make billions more) on its inflammation pipeline. Gilead and partner Galapagos are awaiting an FDA decision on their arthritis drug filgotinib, which was filed with the FDA late last year.
This is a major drug for Gilead, which spent $5 billion on a deep pipeline deal with Galapagos last year. Gilead has long had a stake in the late-phase JAK1 inhibitor filgotinib, with recent data readouts showing the med is better than methotrexate alone while suggesting it has an edge over AbbVie’s Humira, the aging blockbuster rheumatoid arthritis incumbent.
Results shared to date suggest Gilead has enough positive evidence to get filgotinib approved. The harder question is whether the evidence is strong enough to get filgotinib a cleaner label than its rivals or otherwise give it an advantage that translates into the hoped-for blockbuster sales.
The safety of filgotinib is a particular source of ongoing uncertainty. Gilead and Galapagos think filgotinib is free from some of the safety problems that blighted Pfizer's Xeljanz and Eli Lilly's Olumiant and hit multiple members of the JAK family.
However, AbbVie’s Rinvoq, which, like filgotinib, is specific to JAK1, received a black box warning when it won FDA approval earlier this year. If approved, this would be the company’s first medicine to treat an inflammatory disease.
Genovese, who is now the company's senior vice president of inflammation, will oversee this drug’s development and has overall responsibility for clinical work of its experimental portfolio of treatments for inflammatory conditions.
This also includes its other big bet in NASH, or fatty liver disease, which has seen hits and a fair few misses with Gilead. This is not unique: Everyone is struggling to get this target right, but it could be worth tens of billions of dollars a year at peak to whichever company does. Those are some big bucks Genovese now has to try and steer through an awkward clinical path.
He will also oversee Gilead’s work in idiopathic pulmonary fibrosis and systemic sclerosis. At Stanford, he established a clinical research program focused on translational medicine in autoimmune diseases and led numerous investigator-initiated studies and international multicenter trials for the treatment of rheumatological diseases, including arthritis. But working at one of the biggest pharmas in the world will be a big step up.
“We are very pleased to welcome Mark to Gilead; he is one of the leading researchers and clinicians in the fields of immunology and rheumatology, and we will benefit tremendously from his expertise as we seek to bring forward new treatments that improve care for patients with rheumatoid arthritis, inflammatory bowel disease and other debilitating conditions,” said Merdad Parsey, M.D., Ph.D., chief medical officer at Gilead.
“The company has set the ambitious goal of introducing 10 transformative medicines over the next decade and I believe that Mark’s appointment will help us significantly advance our work in inflammation.”
“Gilead has a long history of transforming care for people with serious illnesses, such as HIV and viral hepatitis, and I’ve watched as the company has worked over the past several years to add programs, resources and individuals to bring that same scientific rigor and innovation to patients with inflammatory diseases, where doctors and patients are so much in need of better treatment options,” added Genovese.
“In my prior academic role, I had the opportunity to work with Gilead as the company began to grow its work in inflammatory diseases, and I’m excited to join the talented team. I look forward to the progress we will make together to transform care for patients.”