Navigation Links
Expiry of Hart-Scott-Rodino Waiting Period for JUVISTA(R) (Human TGF BETA 3)

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), gastrointestinal (GI) and renal diseases. The structure is sufficiently flexible to allow Shire to target new therapeutic areas to the extent opportunities arise through acquisitions. Shire believes that a carefully selected portfolio of products with a strategically aligned and relatively small-scale sales force will deliver strong results.

Shire's focused strategy is to develop and market products for specialty physicians. Shire's in-licensing, merger and acquisition efforts are focused on products in niche markets with strong intellectual property protection either in the US or Europe.

For further information on Shire, please visit the Company's website:


Statements included herein that are not historical facts are forward-looking statements. Such forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, Shire's results could be materially affected. The risks and uncertainties include, but are not limited to, risks associated with: the inherent uncertainty of pharmaceutical research, product development, manufacturing and commercialization; the impact of competitive products, including, but not limited to the impact of those on Shire's Attention Deficit and Hyperactivity Disorder ("ADHD") franchise; patents, including but not limited to, legal challenges relating to Shire's ADHD franchise; government regulation and approval, including but not limited to the expected product approval date of INTUNIV(TM) (guanfacine) extended release (ADHD); Shire's ability to secure new products for commercialization and/or development; Shire's ability to benefit from its acquisition of New River Pharmaceuticals Inc.; the successful development of JUVISTA(R) (human TGF BETA 3) and other risks and uncertainties detailed from time to time in Shire plc's filings with the Securities and Exchange Commission, particularly Shire plc's Annual Report on Form 10-K for the year ended December 31, 2006.


Copyright©2007 PR Newswire.

Related biology technology :

1. Im Still Waiting for the Information Age in Healthcare
Post Your Comments:
(Date:10/12/2017)... ... October 12, 2017 , ... DuPont Pioneer and recently formed ... entered into a multiyear collaboration to identify and characterize novel CRISPR-Cas nucleases. The ... gene editing across all applications. , Under the terms of the agreement, Pioneer ...
(Date:10/12/2017)... ... October 12, 2017 , ... ... with the addition of its newest module, US Hemostats & Sealants. , SmartTRAK’s ... hemostats, absorbable hemostats, fibrin sealants, synthetic sealants and biologic sealants used in surgical ...
(Date:10/12/2017)... ... October 12, 2017 , ... ... first-ever genomics analysis platform specifically designed for life science researchers to analyze ... pioneering researcher Rosalind Franklin, who made a major contribution to the discovery ...
(Date:10/11/2017)... ... October 11, 2017 , ... The ... endogenous context, enabling overexpression experiments and avoiding the use of exogenous expression plasmids. ... is transformative for performing systematic gain-of-function studies. , This complement to loss-of-function ...
Breaking Biology Technology:
(Date:3/30/2017)... The research team of The Hong Kong Polytechnic University (PolyU) ... ground breaking 3D fingerprint minutiae recovery and matching technology, pushing contactless ... use in identification, crime investigation, immigration control, security of access and ... ... A research team led by Dr Ajay Kumar ...
(Date:3/28/2017)... 2017 The report "Video Surveillance ... Servers, Storage Devices), Software (Video Analytics, VMS), and Service ... Forecast to 2022", published by MarketsandMarkets, the market was ... projected to reach USD 75.64 Billion by 2022, at ... base year considered for the study is 2016 and ...
(Date:3/24/2017)... Research and Markets has announced the addition of the ... Forecast to 2025" report to their offering. ... The Global Biometric Vehicle Access System ... over the next decade to reach approximately $1,580 million by 2025. ... forecasts for all the given segments on global as well as ...
Breaking Biology News(10 mins):