Roche Holding Ltd (RHHBY)

[SAE]

FDA: Roche Unit Didn't Follow Procedures Designed To Prevent Drug Contamination

Food and Drug Administration inspectors said Roche Holding AG's (RHHBY, ROG.VX) Genentech unit didn't follow proper procedures designed to prevent contamination of drugs such as Avastin.

The FDA released an inspection report Friday dated Sept. 27 involving a plant in Alameda, Calif., that makes the cancer drug Avastin. Parts of the report were blacked out. However, much of the report discussed problems related to caps used to cover the Avastin vials and the capping process.

The report said the company found particles in some Avastin vials, which were sent for analysis. The company also found a problem with disintegrating gaskets. But the FDA said the company didn't compare the particles in the Avastin vials with the disintegrating gasket material "in order to rule out potential...contamination of this lot." The FDA said the vials in question were quarantined and it doesn't appear any of the product was released. It wasn't clear from the FDA's inspection report if the two problems were related.

Genentech couldn't immediately comment on the inspection report. Such reports list observations found during FDA inspections but they don't represent a determination about whether a manufacturer has violated FDA manufacturing rules.

In the report, the FDA said the Avastin caps are made by a contract manufacturer. The caps are shipped inside folded, non-sealed plastic bags inside a cardboard box. FDA said there are no data or controls to assure that the manner in which the caps are shipped doesn't affect "cap integrity" or prevent contamination.

There also appeared to be a separate problem with an oil leak in a machine that caps the Avastin vials. The company stopped production to fix the problem, but the FDA said it wasn't documented that the problem was fixed before production was resumed. The agency also said the company's report about the problem didn't state what happened to the Avastin vials that were on the manufacturing line during the shutdown and repair period.

Avastin is one of Roche's top-selling products, and is approved to treat certain types of lung, brain, kidney, colon and breast cancers, although sales have slipped in the U.S. Roche is fighting to keep the FDA from revoking the approval for breast cancer after clinical studies called into question the product's effectiveness for that type of cancer.

-By Jennifer Corbett Dooren, Dow Jones Newswires, 202-862-9294; [e-mail]

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