UPDATE: Gilead May Get FDA Warning Letter For Calif. Facility
August 09 2010 - 3:06PM
Dow Jones News
Gilead Sciences Inc. (GILD) said it may receive a warning letter
from the Food and Drug Administration after an inspection of its
San Dimas, Calif., manufacturing and distribution facility found a
number of problems.
The routine inspection, in January and February, found
maintenance and procedural problems at the site. Gilead, which is
known for dominating the HIV treatment market, learned in May that
the FDA may issue a warning letter in connection with the findings,
according to a regulatory filing Monday.
The problems come as drug makers have been plagued with
manufacturing issues, causing substantial problems for some major
companies.
A Gilead spokesman declined to comment beyond the information
included in the filing.
Shares of Gilead fell 10 cents to $35.72 in recent trading.
The facility is the only site where Gilead makes fungal
infection treatment AmBisome, sold with Astellas Pharma Inc.
(4503.TO), and Cayston, an inhaled antibiotic used to improve
breathing in certain cystic fibrosis patients that was approved by
the FDA in February.
The company also conducts the final stage of the manufacturing
process for Macugen, an eye-disease treatment sold by Eyetech in
the U.S. and Pfizer Inc. (PFE) overseas.
AmBisome had sales of $300 million last year. Lazard Capital
Markets projects Cayston sales of $105 million next year. Gilead
had total product sales of about $6.5 billion last year.
The San Dimas location is also used to package Gilead's biggest
selling products including Truvada, Atripla, and Viread in their
finished form.
In the inspection, the FDA found problems with the maintaining
of "aseptic processing conditions" in the manufacturing of
AmBisome; maintenance issues in the warehousing facility; problems
with the company's batch sampling; and its completion of annual
product quality reports on time.
In the filing, the company said it believes that it has
"addressed all of the concerns raised by the FDA in its
inspection." But Gilead warned that a warning letter may make it
unable to get "export or regulatory approvals for AmBisome or any
other products at issue," which could lead to a product
shortage.
Production issues have been a problem for several other major
drug makers.
Johnson & Johnson (JNJ) recently shut down a manufacturing
plant because some children's medicines were found to contain
too-strong doses and tiny metallic particles. Genzyme Corp. (GENZ)
had multiple setbacks at its Allston, Mass., facility that caused
shortages of its top-selling drugs, regulatory intervention, and
significantly hurt its business. Both Merck & Co. (MRK) and
GlaxoSmithKline PLC (GSK) have dealt with manufacturing issues
related to their vaccines businesses in recent years.
-By Thomas Gryta, Dow Jones Newswires; 212-416-2169;
thomas.gryta@dowjones.com
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