Cerezyme patients in the United States whose normal biweekly doses had been restored in January, were temporarily back to once-a-month regimens. Fabrazyme patients faced a one-month delay in receiving already reduced dosages.
“Because we have low inventory, we’ve said that any disruption in our manufacturing will be felt by the [patient] community,’’ said Genzyme spokeswoman Lori Gorski.
The recent moves came after a rocky summer. Sanofi disclosed in July that it would not make a milestone payment to Genzyme investors because the company failed to meet manufacturing targets for the two drugs, made at the Allston Landing plant in Boston.
Around the same time, the French company gave Bill Aitchison, previously head of manufacturing for its Sanofi Pasteur vaccines business, oversight for all of Genzyme’s biologics manufacturing operations. Aitchison replaced Scott Canute, who left the company.
Sanofi’s ability to pull Genzyme out of the production morass it has been stuck in for the past two years will be key to the success of its buyout. The state of Genzyme’s manufacturing recovery was an issue hanging over the merger talks last year, with Sanofi leaders cautioning progress might be slower than their Genzyme counterparts were suggesting.
The potential milestone payment, designed to bridge the parties’ differences over how much Genzyme was worth, put those competing views to the test. Thus far, Sanofi’s skepticism has been borne out. But as Genzyme’s new owner, Sanofi is now saddled with the responsibility to fix the problems at what had been the largest biotechnology company in Massachusetts.
Sanofi can reap substantial benefits from Genzyme if it gets drug-making operations back on track, said Jonathan P. Gertler, senior partner at the Boston consulting firm Back Bay Life Science Advisors. He said Sanofi, with its global reach, can bring more resources to bear on ending the supply constraints than Genzyme could have as a stand-alone company.
