Chiron Announces Favorable Results of FDA Inspection of FLUVIRIN(R) Influenza Virus Vaccine Manufacturing Facility
31 Agosto 2005 - 3:00PM
Business Wire
FLUVIRIN Vaccine Must Receive Supplemental Regulatory Approvals and
Annual Formal Product Release Before Delivery to Customers Chiron
Corporation (Nasdaq:CHIR) today announced that the U.S. Food and
Drug Administration (FDA) has communicated the results of the FDA's
July 2005 GMP (Good Manufacturing Practices) inspection of Chiron's
Liverpool facility, which manufactures FLUVIRIN(R) influenza virus
vaccine. The FDA found Chiron's responses and proposed corrective
actions to the FDA inspection observations, which the FDA issued on
a Form 483 at the close of the nine-day inspection of the Liverpool
facility, to be "generally acceptable." This outcome, coupled with
the conclusion by the UK Medicines and Healthcare products
Regulatory Agency (MHRA) in March 2005 that Chiron could conduct
operations in accordance with GMP, means that Chiron may proceed
with its efforts to return FLUVIRIN vaccine to the U.S. market for
the 2005-2006 influenza season. Production of FLUVIRIN vaccine,
which is currently underway, continues. "The FLUVIRIN remediation
plan called for unprecedented communication and cooperation between
the FDA and the MHRA. Chiron has now achieved a key milestone in
this remediation effort. We are grateful for the direction and
guidance the regulatory agencies have extended to us throughout
this process, and we are proud of the dedication our employees have
demonstrated in working toward this accomplishment," said Howard
Pien, CEO of Chiron. "We remain focused on our objective of
delivering FLUVIRIN vaccine to the U.S. market in support of public
health efforts to prepare for the upcoming influenza season."
Chiron's remediation plan introduced a number of improvements to
FLUVIRIN vaccine facilities, equipment and processes; therefore,
Chiron must receive supplemental approvals from the FDA in response
to filings of these changes before the company can supply FLUVIRIN
vaccine to the U.S. market. In addition, Chiron's ability to
deliver FLUVIRIN vaccine to the U.S. market will depend upon
successful production and final testing of the vaccine, as well as
release of the vaccine by the FDA. Chiron also expects that the
MHRA may again inspect Chiron's Liverpool facility before the
company commences shipment of FLUVIRIN vaccine. The FDA will
evaluate the implementation and effectiveness of Chiron's
corrective actions and assess the company's overall compliance at
the agency's next routine GMP inspection of the facility. 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 in the 2005-2006 influenza season, regulatory
approvals, improvements to manufacturing facilities, product
development initiatives, and product marketing, 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 these 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 June 30, 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, the outcome of clinical
trials, 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 be able
to cover vaccine shortfalls, resume sale of FLUVIRIN vaccine for
the 2005-2006 influenza season, increase sales of existing
products, successfully develop and receive approval to market new
products, or achieve market acceptance for such new products. The
company may face additional competition in the influenza market in
the future and challenges in distribution arrangements as a result
of 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,
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
registered trademark of Chiron.
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