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Gilead discloses manufacturing problems

Gilead has revealed it is suffering manufacturing problems that could delay shipments and regulatory approvals

Gilead Sciences has revealed in a filing with the US Securities and Exchange Commission (SEC) that the company is suffering manufacturing problems that could delay product shipments and hold up regulatory approvals.

The filing discloses that a routine inspection by the US Food and Drug Administration (FDA) earlier this year uncovered violations at Gilead's manufacturing and distribution facility in San Dimas, California, where the company's AmBisome (amphotericin B), Cayston (aztreonam for inhalation solution) and Macugen (pegaptanib sodium injection) therapies are made. 

The inspection, which was conducted during January and February, resulted in the FDA issuing documents to the company related to concerns about the maintenance of aseptic processing conditions in the manufacturing suite for AmBisome; environmental maintenance issues in the San Dimas warehousing facility; batch sampling; and the timeliness of completion of annual product quality reports.

Gilead added that the FDA is apparently considering issuing a Warning Letter related to the concerns, which could make it hard for the company to receive export certificates or regulatory approvals for the related products. "We believe that we have addressed all of the concerns raised by the FDA in its inspection," the company said in the filing. "However, if as a result of a Warning Letter, we are unable to receive export or regulatory approvals for AmBisome or any other products at issue, we may be unable to sell sufficient quantities of these products to meet market demand, which would decrease our revenues and harm our business."

The SEC filing also reveals that Gilead is struggling to acquire certain raw materials that it needs to conduct clinical trials of the products in its pipeline and to manufacture its marketed products.

"In light of the global economic downturn, we have had increased difficulty in purchasing certain of the raw materials used in our manufacturing process," the company said. "If we are unable to purchase sufficient quantities of these materials or find suitable alternate materials in a timely manner, our development efforts for our product candidates may be delayed or our ability to manufacture our products would be limited, which would limit our ability to generate revenues."

11th August 2010

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