GlaxoSmithKline PLC
27 April 2005
Issued - 27th April 2005, London and Philadelphia (LSE announcement)
GlaxoSmithKline and FDA Reach Agreement on Consent Decree regarding Cidra,
Puerto Rico, Manufacturing Site
GSK Expects to Return Paxil CR and Avandamet to Market in Mid-Year
London and Philadelphia (April 27, 2005) - GlaxoSmithKline today announced that
it has reached agreement on a Consent Decree with the FDA regarding the
Company's Cidra, Puerto Rico, manufacturing site.
The Consent Decree provides for an independent expert to review manufacturing
processes at the site for compliance with FDA Good Manufacturing Practice (GMP)
requirements. There is further provision for the Company to provide a report to
the FDA on any deficiencies identified in this review, setting out a corrective
plan and timetable for completion. The Company is fully committed to working
cooperatively with the FDA to address any such issues in a timely fashion.
With respect to Paxil CR (paroxetine hydrochloride controlled release) tablets
and Avandamet (rosiglitazone maleate / metformin hydrochloride) tablets,
distribution of which was halted in March of this year, GSK believes it has
identified the source of the manufacturing issues related to both of these
products, and has already implemented revisions to those manufacturing
processes. The Company is now validating those solutions through a third party.
Based on the terms of the Consent Decree, the Company can continue to
manufacture products at the site, and expects to begin re-supplying the US and
other markets with both Paxil CR and Avandamet in mid-year.
No financial penalties have been imposed under the Consent Decree. This Consent
Decree allows for potential future penalties up to a maximum of $10 million a
year if the Company fails to meet the terms of the agreement. The Company is
also required to post a $650 million bond to ensure that product previously
withheld by the FDA is appropriately destroyed or reconditioned. The Company
anticipates meeting all requirements of the Bond within 90 days following entry
of the Decree, after which the Bond will be cancelled.
In light of the resolution reached with FDA, the Company confirms that earnings
guidance for 2005 is EPS percentage growth (at constant exchange rates) in the
low double-digit range on an IFRS basis.
GlaxoSmithKline - one of the world's leading research-based pharmaceutical and
healthcare companies - is committed to improving the quality of human life by
enabling people to do more, feel better and live longer.
S M Bicknell
Company Secretary
27th April 2005
Cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the US Private Securities Litigation Reform
Act of 1995, the Company cautions investors that any forward-looking statements
or projections made by the Company, including those made in this announcement,
are subject to risks and uncertainties that may cause actual results to differ
materially from those projected. Factors that may affect the Group's operations
are described under 'Risk Factors' in the Operating and Financial Review and
Prospects in the company's Annual Report on Form 20-F for 2004.
Editor's Note:
On February 9th, GSK voluntarily withdrew selected batches of both Paxil CR and
Avandamet from the US market, citing manufacturing issues affecting a small
number of tablets of both medicines. On March 4th, the Company announced that
the FDA had halted distribution of remaining supplies of both medicines in the
US. Both the Company and the FDA agreed at the time that the manufacturing
issues posed no significant safety issue for patients. Appropriate action
followed in countries outside of the US in partnership with local regulatory
bodies.
Enquiries:
UK Media enquiries: Philip Thomson (020) 8047 5502
David Mawdsley (020) 8047 5502
Chris Hunter-Ward (020) 8047 5502
US Media enquiries: Nancy Pekarek (215) 751 7709
Mary Anne Rhyne (919) 483 2839
Patricia Seif (215) 751 7709
European Analyst/Investor enquiries: Duncan Learmouth (020) 8047 5540
Anita Kidgell (020) 8047 5542
Jen Hill (020) 8047 5543
US Analyst/ Investor enquiries: Frank Murdolo (215) 751 7002
Tom Curry (215) 751 5419
This information is provided by RNS
The company news service from the London Stock Exchange
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