Just one month after naming a new head of corporate development, Gilead is beefing up its top management team again—this time plucking an oncology vet to head up its entrance into the burgeoning market for CAR-T cancer treatments.
Gilead unit Kite, which won FDA approval for the CAR-T drug Yescarta last year, has hired Michael Amoroso as SVP and head of worldwide commercial efforts in cell therapy. He’ll oversee sales and marketing, doctor and patient services, and “market access”—aka payer negotiations—Kite said in a Monday statement.
Underscoring the Yescarta rollout’s importance, Amoroso will report directly to Gilead CEO John Milligan. James Meyers, Gilead’s previous head of worldwide commercial operations, unexpectedly retired in February.
When he jumps into the new job next month, Amoroso will face some tough challenges—including a lag in payer coverage. Gilead rolled out Yescarta to treat lymphoma last October, but pickup was slow, as Medicare and commercial payers stalled on billing procedures for the personalized cell therapy. Gilead didn’t hit the $10 million in sales analysts were expecting for the product last year, and this year the $373,000 treatment has taken in $40 million, making dreams of a blockbuster still a bit elusive. It didn’t help when rival Novartis won FDA approval for its CAR-T, Kymriah, to treat lymphoma in May—and then matched Kite on price.
Gilead is counting on Yescarta to pull the company out of what has been a tough 2018 so far. Hepatitis C blockbusters Sovaldi and Harvoni have been declining for some time, beset by competition and a general shrinking of the patient population. The company surprised investors late last year when it warned that hepatitis C sales for this year would be between $3.5 billion and $4 billion—missing the $5 billion analysts were expecting.
The company could very well be planning another big acquisition to boost its top line and pipeline, given that the executive who spearheaded Gilead’s $11.9 billion acquisition of Kite, Andrew Dickinson, has been entrusted with even more responsibility. Dickinson was promoted to EVP of corporate development and strategy and named to Gilead’s senior leadership team in June. Gilead has $32.9 billion in cash, giving it plenty of resources to pour into another big deal. In fact, Leerink analyst Geoffrey Porges recently named Gilead one of only two companies that could afford to buy a company as large as Biogen or Regeneron. (Amgen is the only other company with that kind of buying power, Porges suggested.)
As for Kite’s new chief of commercial, he brings a deep résumé in oncology to the company. Amoroso previously served as SVP of Eisai’s oncology business group in the U.S. Before that, he worked for Celgene as commercial lead of global marketing for CAR-T programs, where he developed a commercialization strategy for patients with lymphoma and myeloma.
“This experience will help us as we seek to build on our existing portfolio, expand our commercial presence in cell therapy in the United States and around the world, and advance new products to market,” said Milligan in a statement.
There was one recent development that will ease Amoroso’s transition to his new job at Kite: The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) endorsed Yescarta to treat diffuse large B-cell lymphoma (DLBCL) and mediastinal B-cell lymphoma in late June. Gilead will still be in competition with Novartis, which also got the CHMP’s backing, but the endorsement sets Yescarta up for a likely approval from the European Commission. And Gilead is already preparing for a launch there, building out a 117,000-square-foot CAR-T manufacturing facility at a Netherlands airport.