Chiron Unable to Supply Fluvirin Influenza Virus Vaccine for 2004-2005 Season

EMERYVILLE, Calif. -- Chiron Corporation announced that the UK regulatory body, the Medicines and Healthcare Products Regulatory Agency (MHRA), has today temporarily suspended the companys license to manufacture Fluvirin® influenza virus vaccine in its Liverpool facility, preventing the company from releasing any of the product during the 2004-2005 influenza season.

Chiron has not released any Fluvirin into any territory, and therefore there is no requirement to recall or withdraw any vaccine.

Chiron deeply regrets that we will be unable to meet public health needs this season. We take our responsibility to protect human health very seriously, said Howard Pien, president and CEO of Chiron. Chiron believes in the value of influenza vaccination, and we are committed to taking all necessary actions to ensure an adequate vaccine supply for the 2005-2006 influenza season.

As Chiron conducted its internal quality assurance confirmatory testing in recent weeks,

MHRA, in its capacity as the Liverpool production facilitys local regulatory authority,

reviewed the test data and the manufacturing processes at the facility. As noted in the

companys Sept. 28, 2004, press release, Chiron anticipated that the regulatory

review process would be satisfactorily completed in time to allow release of Fluvirin in

early October. However, MHRA has asserted that Chirons manufacturing process does

not comply with UK Good Manufacturing Practices regulations and has suspended the

companys Liverpool facility license to manufacture influenza vaccine for three months.

Chiron has initiated discussions with the MHRA to determine the appropriate corrective

actions.

As a result of the license suspension, Chiron does not expect to record any sales of

Fluvirin for the 2004-2005 season.

In August, Chiron announced a delay in providing Fluvirin for the 2004-2005 influenza

season. Chiron has communicated regularly with the U.S. Food and Drug Administration

(FDA), which has regulatory oversight for vaccines marketed in the United States, and

U.S. Centers for Disease Control and Prevention (CDC), which makes recommendations

for influenza vaccination through its National Immunization Program (NIP) and the

Advisory Committee on Immunization Practices (ACIP). Chiron has informed the FDA,

CDC and the UK Department of Health of the current situation.

Chiron had previously expected to provide nearly half the U.S. supply for the 2004-2005 influenza season and is discussing potential impact with FDA and CDC. In the United Kingdom, where Fluvirin typically accounts for approximately 20 percent of the influenza vaccine market, Chiron plans to make up a significant proportion of this supply with vaccines that are produced at its other European sites and approved for use in the United Kingdom (but not the United States). Chiron plans to continue to work with the CDC and the U.S. Food and Drug Administrations Center for Biologics Evaluation and Research (CBER) in preparation for the 2005-2006 influenza season.

Our manufacturing and quality staff have worked hard to resolve what we viewed as a

problem limited in scope to a few batches, and we believe our quality assurance

confirmatory testing demonstrates that the Fluvirin doses we anticipated releasing are

safe. While the MHRAs conclusions are unexpected, we respect the regulatory

authoritys judgment, said John Lambert, president of Chiron Vaccines. We apologize

unreservedly to the public and our customers for being unable to meet our commitments

this year.

Source: Chiron Corporation