Prospects for two experimental drugs important to Massachusetts biotechnology companies diverged Monday, with one moving forward and the other facing a delay.
ImmunoGen Inc. of Waltham said its partner, the Genentech division of Swiss drug maker Roche AG, has applied to the Food and Drug Administration for approval of a promising breast cancer drug using ImmunoGen’s technology. If the agency grants accelerated approval for the drug, it could be on the market by early next year.
At the same time, the launch of Lemtrada, a high-profile multiple sclerosis treatment that Genzyme had hoped to make available by early next year, is likely to be postponed. That’s because the FDA asked Genzyme, a unit of France’s Sanofi SA, to change the way it presents clinical data and resubmit an application the Cambridge company filed in June.
The developments underscored the unpredictability of the drug approval process. Shares of ImmunoGen climbed 5.6 percent to $14.62 on the Nasdaq exchange Monday after Genentech disclosed its application for the cancer drug as well as fresh clinical data showing that it improved survival in a trial where some patients were given a treatment now on the market. The findings mean those patients now have the option of taking T-DM1, the experimental drug being developed by Genentech and ImmunoGen.
“This moves us one step closer to seeing our technology used in a commercial application for patients,” said ImmunoGen chief executive Daniel Junius. “It’s a significant step for this company. It makes a statement about our very refined form of targeted therapy.”
ImmunoGen is a pioneer, along with Seattle Genetics Inc., in a new approach to fighting cancer that deploys antibodies to deliver cancer-killing agents specifically to tumor cells. In the case of T-DM1 — which Genentech plans to soon submit to European regulators for approval — ImmunoGen’s technology works with Genentech’s existing breast cancer drug, Herceptin, in a way that is easier for patients to tolerate.
Junius said ImmunoGen has six other therapies in development, some in partnership with drug makers such as Sanofi and Amgen Inc. But the Waltham company, which next year plans to boost its staff by 30 positions to 300, is moving toward proprietary drug development, he said.
Two years ago, after a smaller clinical trial in which T-DM1’s effectiveness wasn’t compared with drugs on the market, ImmunoGen and Genentech suffered a setback when the FDA sent a “refuse to file” letter, meaning it declined to accept an application for accelerated approval.
On Monday, it was Genzyme’s turn to acknowledge that it had received a such a letter from FDA regulators, who asked the Cambridge company to revise its application for Lemtrada to help the agency “better navigate” the massive filing. Shares of Genzyme’s corporate parent, Sanofi, barely budged on the news.
“Everyone’s working very quickly to resubmit,” said Genzyme spokeswoman Erin Walsh. “I can’t say if it’s days or weeks. Everyone’s taking the feedback and working on what needs to be modified.”
Walsh said Genzyme was not asked to conduct additional clinical studies.
Projected revenue from Lemtrada, which will compete with several other multiple sclerosis drugs already being sold, became a major sticking point in 2010 when executives negotiated Sanofi’s takeover of Genzyme. Ultimately, the parties agreed to award Genzyme stockholders a tradeable security, called a contingent value right. Its price will depend on whether Lemtrada is approved by regulators and meets certain sales targets in coming years.
The same drug, sold under the brand name Campath, is currently available in about 50 countries to treat a type of leukemia, but not multiple sclerosis.
Genzyme last week said it was pulling Campath from the market, but making it available for free under a patient access program to about 4,000 people worldwide who take the treatment for up to 12 weeks. Analysts said Genzyme wanted to focus on gaining approval for Lemtrada, which would command a higher price in the marketplace.