ImmunoGen’s chief commercial officer to step down before drug launch

With less than a month to go before a regulatory decision on its lead asset, clinical-stage biotech ImmunoGen has announced that its senior vice president/chief commercial officer, Kristen Harrington-Smith, will step down.

The company is developing the antibody-drug conjugate mirvetuximab soravtansine in ovarian cancer patients who express high levels of folate receptor alpha (FRα) and are resistant to chemotherapy. The agent is under priority review at the Food and Drug Administration and has a PDUFA date of Nov. 28.

Harrington-Smith is expected to depart Nov. 16 “for personal reasons to pursue a new opportunity closer to home,” ImmunoGen said in a statement this week.

In the company’s third-quarter earnings announcement on Friday, chairman and chief executive Mark Enyedy reassured investors that preparations to launch mirvetuximab this month were complete. The CEO took advantage of a call from analysts on Friday morning to put a more specific point on these activities.

“Our highly experienced field team is fully staffed and committed to customers; our distribution, market access and patient support infrastructure is in place; and we have ready-to-market vials of pharmaceuticals awaiting labeling and packaging,” he said on the call. “We are ready to rapidly deliver mirv’ to patients upon approval.”

About 4,300 doctors treat ovarian cancer in the United States. ImmunoGen plans to initially focus on the roughly 400 physicians who treat about a third of all patients, Enyedy said, before expanding to a broader market.

ImmunoGen estimates that there are 19,500 patients each year in the United States with second- to fourth-line ovarian cancer that can be treated with drugs. About 35% to 40% of them express high levels of FRα and 75% are currently receiving chemotherapy as monotherapy or a treatment regimen without bevacizumab.

“This gives us a market opportunity of approximately 5,200 patients for our planned initial label,” Enyedy said.

Upon approval, the company plans to pursue a label expansion to market mirvetuximab for an additional 1,800 elevated FRα patients, giving it a total opportunity of 7,000 patients in the platinum-resistant setting. Further studies could move the drug into platinum-sensitive diseases, expanding the market to more than 11,000 patients. The MIRASOL trial, scheduled to read in early 2023, is designed to support a conversion from accelerated approval to full approval in the United States.

While Harrington-Smith will play a role in the transition process, Vice President of Market Access Todd Talarico will serve as the interim head of the commercial organization while the search to identify a new permanent commercial leader, ImmunoGen said. .

The company’s statement noted that Harrington-Smith’s departure is “unrelated to the company’s business performance,” including expectations regarding the potential approval of mirvetuximab.

ImmunoGen reported third quarter revenue of $15.4 million, up 14.4% from the prior year quarter. Selling, general and administrative (SG&A) expenses were $33.6 million, an increase of 32.6% over the same quarter last year. This was primarily due to building those commercial capabilities, including hiring staff, in preparation for the potential US launch.

Ovarian cancer is the leading cause of death from gynecological cancers, claiming the lives of approximately 13,000 women each year in the United States, according to the National Institutes of Health.

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