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BASINGSTOKE, England and PHILADELPHIA, Pennysylvania, March 3 /PRNewswire-FirstCall/ -- Shire plc (LSE: SHP)(NASDAQ: SHPGY), the global specialty biopharmaceutical company, notes that Renovo Group plc, (LSE: RNVO) ("Renovo") has today announced the results of Renovo's latest Phase 2 studies of JUVISTA(R) (human recombinant TGFbeta3) in scar revision surgery (RN1001-319-1009) and in breast augmentation (RN1001-319-1010).
Renovo’s press release can be found on http://www.renovo.com.
The two trials announced by Renovo are part of a broad global Phase 2 clinical program to assess the safety, efficacy, dose and dose frequency of JUVISTA in a variety of surgical procedures.
Shire is at present assessing these latest results with all other results produced to date and plans to discuss these with the US Food and Drug Administration (FDA) in 2008 to determine the regulatory path forward in the United States.
Notes to Editors
Financial terms of the agreement with Renovo
Under the terms of the agreement with Renovo, Shire has the exclusive right to commercialize JUVISTA worldwide, with the exception of EU member states.
As previously announced, Shire will bear the cost of clinical trials designed specifically for obtaining US regulatory approval. Renovo will bear the costs of clinical trials designed specifically for obtaining EU regulatory approval. Shire and Renovo will share equally the costs of conducting global clinical trials that are designed for obtaining both US and EU regulatory approvals.
The financial terms of the agreement are geared to the success of the
development and commercialization of JUVISTA. Shire has paid Renovo US$75
mil
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