28th Apr 2005 07:01
GlaxoSmithKline PLC27 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 thatit has reached agreement on a Consent Decree with the FDA regarding theCompany's Cidra, Puerto Rico, manufacturing site. The Consent Decree provides for an independent expert to review manufacturingprocesses at the site for compliance with FDA Good Manufacturing Practice (GMP)requirements. There is further provision for the Company to provide a report tothe FDA on any deficiencies identified in this review, setting out a correctiveplan and timetable for completion. The Company is fully committed to workingcooperatively with the FDA to address any such issues in a timely fashion. With respect to Paxil CR (paroxetine hydrochloride controlled release) tabletsand Avandamet (rosiglitazone maleate / metformin hydrochloride) tablets,distribution of which was halted in March of this year, GSK believes it hasidentified the source of the manufacturing issues related to both of theseproducts, and has already implemented revisions to those manufacturingprocesses. The Company is now validating those solutions through a third party. Based on the terms of the Consent Decree, the Company can continue tomanufacture products at the site, and expects to begin re-supplying the US andother markets with both Paxil CR and Avandamet in mid-year. No financial penalties have been imposed under the Consent Decree. This ConsentDecree allows for potential future penalties up to a maximum of $10 million ayear if the Company fails to meet the terms of the agreement. The Company isalso required to post a $650 million bond to ensure that product previouslywithheld by the FDA is appropriately destroyed or reconditioned. The Companyanticipates meeting all requirements of the Bond within 90 days following entryof the Decree, after which the Bond will be cancelled. In light of the resolution reached with FDA, the Company confirms that earningsguidance for 2005 is EPS percentage growth (at constant exchange rates) in thelow double-digit range on an IFRS basis. GlaxoSmithKline - one of the world's leading research-based pharmaceutical andhealthcare companies - is committed to improving the quality of human life byenabling people to do more, feel better and live longer. S M BicknellCompany Secretary27th April 2005 Cautionary statement regarding forward-looking statements Under the safe harbor provisions of the US Private Securities Litigation ReformAct of 1995, the Company cautions investors that any forward-looking statementsor projections made by the Company, including those made in this announcement,are subject to risks and uncertainties that may cause actual results to differmaterially from those projected. Factors that may affect the Group's operationsare described under 'Risk Factors' in the Operating and Financial Review andProspects 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 andAvandamet from the US market, citing manufacturing issues affecting a smallnumber of tablets of both medicines. On March 4th, the Company announced thatthe FDA had halted distribution of remaining supplies of both medicines in theUS. Both the Company and the FDA agreed at the time that the manufacturingissues posed no significant safety issue for patients. Appropriate actionfollowed in countries outside of the US in partnership with local regulatorybodies. 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 ExchangeRelated Shares:
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