Have you ever allowed yourself what you thought was ample time to drive somewhere, only to be delayed by a construction crew that was repairing the roads? Obviously, things don’t always work out as we plan them. Judging by its latest announcement about its facility ameliorations, Genzyme (Cambridge, MA) must have learned this lesson, too.
In May, the company and the US Food and Drug Administration signed a consent decree that requires Genzyme to correct the well-publicized manufacturing-quality violations at its Allston, Massachusetts, manufacturing plant. The company originally predicted that its remediation would take two to three years to complete. But in a new regulatory filing, Genzyme estimated that the fixes could require as long as four years.
The news seems like yet another embarrassment for the beleaguered biopharmaceutical company. Patients who rely on the company’s specialized enzyme therapies might be understandably dismayed. But maybe we have reason for optimism.
By May of this year, Genzyme was able to produce only enough Cerezyme, its treatment for Gaucher disease, to meet about 50% of patient demand. In a sign that its remediations are proceeding, the company said that patients would be able to receive normal dosing in the fourth quarter of this year. The company also will be able to increase shipments of Fabry-disease therapy Fabrazyme in the fourth quarter.
sanofi-aventis’s (Paris) reported offer to buy Genzyme could benefit that company and its customers alike. Bloomberg reported that sanofi had offered roughly $70 per share, but Genzyme’s shareholders want more than $80 per share. The prospect of winning a better offer from sanofi could induce Genzyme to pursue its facility improvements with extra diligence. Also, market analysts expect sanofi to be sending experts to make sure that manufacturing problems are being resolved, thus supplementing current oversight by FDA and Quantic, a third-party consultant.
Even if Genzyme’s new and longer timetable seems like another black eye for the company, the consent decree and possibility of a merger could mark the beginning of the end of the company’s troubles. With the carrot of a desirable share price and the stick of abundant oversight, Genzyme will likely improve its production operations. Such changes could mean a better future for the company and the availability of high-quality treatments for its patients.