FDA On-Site Inspection of Chiron's FLUVIRIN(R) Influenza Virus Vaccine Facility Underway; Full cGMP Inspection Process Expected
July 15 2005 - 8:00AM
Business Wire
Chiron Corporation (NASDAQ:CHIR) today announced that the U.S. Food
and Drug Administration (FDA) is currently conducting a full cGMP
(current Good Manufacturing Practices) inspection of Chiron's
Liverpool facility, which manufactures FLUVIRIN(R) influenza virus
vaccine. Following the on-site inspection, Chiron expects to
respond to any observations noted by the FDA. Chiron expects that
the FDA will then assess Chiron's response in conjunction with the
agency's findings. Chiron will communicate the outcome of the full
inspection once this process has concluded and the FDA has issued
formal results, which may occur several weeks after the on-site
inspection has ended. Chiron currently expects to produce 18 to 26
million doses of FLUVIRIN vaccine for the 2005-2006 influenza
season, with the vast majority of the supply going to the U.S.
market. This dose range assumes that Chiron is successful in its
remediation efforts; that the company encounters no further adverse
manufacturing or regulatory developments; and that the major
factors that determine production, including volumes, yields and
timing, develop as anticipated. In addition to the facility
inspection, Chiron will need to receive supplemental approvals for
changes in its product from the Medicines and Healthcare products
Regulatory Agency (MHRA) and FDA because of variations to its
manufacturing process. The Center for Biologics Evaluation and
Research (CBER), a division of the FDA, validates and releases
FLUVIRIN vaccine for the U.S. market. About Chiron Chiron delivers
innovative and valuable products to protect human health by
advancing pioneering science across the landscape of biotechnology.
The company works to deliver on the limitless promise of science
and make a positive difference in people's lives. For more
information, please visit www.chiron.com. This news release
contains forward-looking statements, including statements regarding
supply of FLUVIRIN(R) influenza virus vaccine that Chiron expects
to deliver to the U.S. market in future influenza seasons, sales
and earnings expectations, and improvements to manufacturing
facilities, that involve risks and uncertainties and are subject to
change. A discussion of the company's operations and financial
condition, including factors that may affect its business and
future prospects that could cause actual results and developments
to differ materially from those expressed or implied by
forward-looking statements, is contained in documents the company
has filed with the SEC, including the Form 10-K for the year ended
December 31, 2004, and the Form 10-Q for the quarter ended March
31, 2005, and will be contained in all subsequent periodic filings
made with the SEC. These documents identify important factors that
could cause the company's actual performance to differ from current
expectations, including, among others, additional adverse
developments resulting from the suspension of Chiron's UK license
to manufacture FLUVIRIN vaccine from October 5, 2004, through March
2, 2005, the announcement of such suspension and the litigation and
investigations relating to those matters, regulatory review and
approvals, manufacturing capabilities, intellectual property
protections and defenses, litigation, stock-price and interest-rate
volatility, marketing effectiveness, and the severity of the
2005-2006 influenza season. In particular, there can be no
assurance that additional issues with respect to FLUVIRIN vaccine
or Chiron's manufacturing generally will not arise in the future or
that Chiron will successfully address matters raised in a warning
letter from the FDA with respect to its FLUVIRIN vaccine
manufacturing facility or resume sale of FLUVIRIN vaccine for the
2005-2006 influenza season. In addition, the company may face
additional competition in the influenza market in the future and
challenges in distribution arrangements as a result of recent
influenza vaccine developments. In addition, the company may engage
in business opportunities, the successful completion of which is
subject to certain risks, including approval by Novartis AG,
shareholder and regulatory approvals, and the integration of
operations. Chiron does not undertake an obligation to update the
forward-looking information the company is giving today. NOTE:
FLUVIRIN is a trademark of Chiron Corporation.
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