This lends credence to the report that they still do not understand the source of the problem....(holding off bottom fishing as a result -- mrk anyone?).
MHRA Notifies Chiron of Continuing Suspension of Liverpool
2004-12-07 22:17 (New York)
License for Influenza Vaccines; Suspension May Be Lifted If Compliance with
License Demonstrated
BIOWIRE2K
EMERYVILLE, Calif.--(BUSINESS WIRE)--Dec. 7, 2004
Chiron Corporation (NASDAQ:CHIR) today announced that it
has received notice from the UK Medicines and Healthcare Products
Regulatory Agency (MHRA) that the MHRA proposes to continue the
suspension of the company's license to manufacture influenza vaccines
in Liverpool for a further period of three months, effective January
4, 2005, at the same time as the expiration of the initial three-month
suspension.
A spokesperson for the UK Department of Health stated that the
extension of the suspension "does not result from any newly identified
safety issues or findings at the Liverpool plant" and called it
"routine regulatory action" that will give Chiron more time to carry
out its remediation plan, which is currently underway. The
spokesperson also stated that the suspension could be lifted at any
time upon satisfactory compliance with the facility's license. The
MHRA has worked closely with the U.S. Food and Drug Administration on
these issues, and the agencies plan to examine progress at the
facility throughout the remediation process.
In order to meet timelines for delivery of FLUVIRIN(R) influenza
virus vaccine for the U.S. market, production must begin no later than
early spring of 2005. The MHRA notice fulfills an agency requirement
to allow Chiron a 28-day period to appeal the notice. Chiron does not
intend to pursue this option.
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.
About Chiron Vaccines
Chiron Vaccines, the world's fifth-largest vaccines business, is
headquartered in Oxford, United Kingdom, and has facilities located
throughout Europe, the United States and Asia. Chiron Vaccines is the
world's second-largest manufacturer of influenza vaccines and has
important meningitis, pediatric and travel vaccine franchises. Chiron
Vaccines is the leading vaccine manufacturer in the United Kingdom,
Germany and Italy. The company's portfolio of products includes
vaccines for influenza, meningitis C, rabies, tick-borne encephalitis,
yellow fever, haemophilus influenzae B (Hib), polio, mumps, measles
and rubella (MMR) and diphtheria, tetanus and pertussis (whooping
cough). |
