Genzyme: partly cloudy, chance of regulators

Last Friday--the 13th--the FDA sent Genzyme (GENZ) a complete response letter regarding the company's application to market Pompe disease treatment Lumizyme. Tucked into that letter was a condition: satisfactory resolution of deficiencies at the Allston Landing manufacturing plant prior to approval.

The letter arrived on the same unlucky day that the regulator issued another Genzyme-related letter, this one to healthcare providers warning them to take precautions against metal, rubber and fiber contamination that had been found in five Genzyme products made at that facility. The letter to healthcare workers was a reminder to follow package instructions concerning inspection and filtering of the drug before use, a precaution in light of the contamination finding.

The contamination announcement set off a flurry of press activity leading to a drop in Genzyme shares that approached the lowest level in five years, according to the Wall Street Journal. It was another blow to the company, which has been dealing with financial, regulatory and even threatened legal action following last spring's Vesivirus contamination of the plant, leading to its temporary shutdown. The viral contamination, as reported in our GMP violations report, was preceded by a February warning letter for manufacturing missteps.

In a one-hour conference call Monday, the company remained upbeat. CEO Henri Termeer and management assured investors that the particle contamination--the amount of which is within accepted industry norms and company specs, the company says--was likely the result of aging fill/finish equipment in use at the facility.

The fill/finish operation has since been shut down while the company upgrades equipment. In the meantime, Genzyme said it is farming out the end-stage production activities to contractors and to a newer facility that it runs in Waterford, Ireland, according to a Boston Globe report.

As for the Form-483 deviations report, company managers said during the call that they were aware of the issues and already had a remediation plan, which has been submitted to the FDA. "This has been a complex and unusual process," Termeer said during the call, referring to the Lumizyme application process in conjunction with the facility fix-up. "Not surprising. But unusual."

- here's the WSJ report
- see the Globe report
- read the Genzyme announcement
- listen to the Genzyme conference call