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`Home > Media > Pressreleases > GSK provides update on regulatory fil..
`
`(9 27 September 2009
`
`GSK provides update on
`requlatory filings for
`Zunrisa/Rezonic
`
`GlaxoSmithKline (GSK) has made the difficult
`decision to discontinue the regulatory filings
`for Zunrisa/Rezonic (casopitant), which was
`being developed for chemotherapy-induced
`and post-operative nausea and vomiting.
`Reqgulatory applications were filed in a
`
`number of countries worldwide and GSK is
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`HELSINN EXHIBIT 2077
`Azurity Pharmaceuticals, Inc. v. Helsinn Healthcare S.A.
`Page 1 of 5 [PR2025-00947
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`Page 2 of 5
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`currently communicating with those
`authorities and all study investigators.
`
`Issued: Monday 28 September 2009, London UK
`
`GlaxoSmithKline (GSK) has made the difficult decision to discontinue the reqgulatory filings
`for Zunrisa/Rezonic (casopitant), which was being developed for chemotherapy-induced
`and post-operative nausea and vomiting. Regulatory applications were filed in a number
`of countries worldwide and GSK is currently communicating with those authorities and all
`study investigators.
`
`GSK has made this decision, after requlatory consultation, based on the company's
`assessment that significant further safety data would be required to support the
`registration of casopitant on a worldwide basis, which would take a considerable time to
`produce. Consequently, all on-going requlatory files for casopitant are being withdrawn.
`
`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. For further information please visit
`www.gsk.com
`
`Enquiries:
`
`UK Media enquiries: Philip Thomson (020) 8047 5502
`
`Claire Brough (020) 8047 5502
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`Page 3 of 5
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`US Media enquiries:
`
`European Analyst/Investor enquiries:
`
`Stephen Rea
`
`Alexandra Harrison
`
`Gwenan White
`
`Nancy Pekarek
`
`Mary Anne Rhyne
`
`Kevin Colgan
`
`Lisa Behrens
`
`David Mawdsley
`
`Sally Ferguson
`
`Gary Davies
`
`(020) 8047 5502
`
`(020) 8047 5502
`
`(020) 8047 5502
`
`(919) 483 2839
`
`(919) 483 2839
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`(919) 483 2839
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`(919) 483 2839
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`(020) 8047 5564
`
`(020) 8047 5543
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`(020) 8047 5503
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`Gary Davies (020) 8047 5503
`US Analyst/ Investor enquiries. Tom Curry (215) 751 5419
`Jen Hill Baxter (215) 751 7002
`\ ok
`G S K GSK websites Quick links Get in touch
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`GSK plc. Registered in England and Supplier website Responsibliity Follow us on:
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