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World Autism Awareness 2006 Chiron Withdraws MMR Vaccine from Italian

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http://www.docguide.com/news/content.nsf/news/852571020057CCF685257133

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Chiron Recalls and Withdraws Morupar® MMR Vaccine from Italian and

Developing World Markets

EMERYVILLE, C.A. -- March 16, 2006 -- Chiron Corporation today

announced that it is recalling and withdrawing its measles, mumps and

rubella (MMR) vaccine, Morupar®. Chiron supplied approximately 5

million doses of Morupar vaccine in 2005, providing most of its

production to a limited number of developing countries, largely via

the United Nations Children's Fund (UNICEF) and the Pan American

Health Organization (PAHO), and approximately 450,000 doses to Italy.

The results of routine pharmacovigilance surveillance in Italy

suggest that Morupar vaccine may be associated with a higher reported

rate of adverse events following immunization than other MMR vaccine

products. While recent and historical surveillance data indicate that

adverse events remain rare, Chiron is recalling and withdrawing the

vaccine as a precautionary measure.

Pharmacovigilance results suggest that these adverse events occurred

post-immunization and do not indicate any long-term risk for patients

who have previously received the vaccine. The adverse events on which

the recall and withdrawal are based are within a range of those

commonly associated with vaccines, such as fever, allergic reactions

and swelling of the glands.

Chiron has been in communication with the relevant health authorities

and informed them of its actions in order to enable them to find

replacement supplies of MMR vaccine. Chiron will work closely with

the World Health Organization (WHO) to assist it in conducting a

thorough risk-benefit analysis of Morupar vaccine to determine

whether it is appropriate for a limited quantity of the existing

inventory to remain available for current public health programs such

as those conducted by UNICEF and PAHO.

In 2005, Chiron's sales of Morupar vaccine totaled approximately $10

million. As a result of this recall and withdrawal, as well as other

adjustments identified by Chiron and recorded subsequent to the

company's January 31, 2006, announcement of fourth-quarter and year-

end 2005 financial results, Chiron has revised its 2005 earnings per

share to $1.31 on an adjusted basis and $0.94 on a GAAP basis.

Chiron has written off approximately $6.0 million of Morupar

inventory in 2005 as a result of the withdrawal and has recorded

approximately $1.7 million of product returns reserves in 2005 in

connection with expected returns of 2005 product sales from the

recall. The recall and withdrawal of MORUPAR, which Chiron produces

in Italy, does not affect any of Chiron's other vaccines.

SOURCE: Chiron

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