BASINGSTOKE, England and PHILADELPHIA, August 15 /PRNewswire-FirstCall/ -- Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ), the global specialty biopharmaceutical company, announces that the waiting period under Hart-Scott-Rodino Antitrust Improvements Act of 1976 with respect to its exclusive license of JUVISTA(R) (human TGF BETA 3) from Renovo Group plc (LSE: RNVO) expired on August 10, 2007. In accordance with its terms, the License Agreement became effective on August 15, 2007.
JUVISTA is a novel biopharmaceutical investigational drug and when injected at the time of surgery has been shown in clinical trials to markedly improve subsequent scar appearance in the skin.
Under the terms of the agreement, Shire has the exclusive right to commercialize JUVISTA worldwide, with the exception of EU member states. Shire's financial obligations under the agreement are geared to JUVISTA's successful development and commercialization. Shire will now pay Renovo US$75 million upfront (expensed during the third quarter as R&D for US GAAP purposes) and in addition, Shire will make an equity investment in Renovo of US$50 million (at a subscription price of GBP2 per share, which represents approximately 6.5% of Renovo's share capital immediately after the issue).
On the FDA's acceptance of filing of JUVISTA's biologics license application, Shire will pay US$25 million and on FDA approval, between US$50 and US$150 million depending on the characteristics of the approved product labelling. Shire will also pay Renovo royalties on sales of JUVISTA and milestone payments of up to US$525 million on the achievement of very significant sales targets.
Notes to Editors
Shire's strategic goal is to become the leading specialty
biopharmaceutical company that focuses on meeting the needs of the
specialist physician. Shire focuses its business on attention deficit and
hyperactivity disorder (ADHD), human genetic therapies (HGT),
|SOURCE Shire PLC|
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