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www.fdanews.com/articles/95227-shire-inks-825-million-deal-for-preventative-scarring-treatment

Shire Inks $825 Million Deal for Preventative Scarring Treatment

June 27, 2007

In a deal potentially worth $825 million, Shire agreed to license the worldwide rights, excluding rights in the European Union, of Renovo Group’s preventative scarring treatment Juvista, the companies announced June 20.

UK-based Renovo said the potential U.S. market for the product is worth $4.1 billion with approximately 42 million patients undergoing surgery annually. Under the terms of the agreement, Shire will purchase $50 million in Renovo stock, or approximately 7 percent of the company, and pay the firm $75 million up front once the agreement obtains regulatory clearance, the companies said.

Upon FDA acceptance of the Juvusta biologics license application, Shire will pay the company $25 million. If Juvista is approved, Renovo will receive between $50 million and $150 million depending on the scope of physician labeling. In addition, Renovo is entitled to royalties and milestone payments worth up to $525 million once the product is commercialized.

Shire said that it expects to launch the product in 2011. Phase III clinical trials are expected to commence in mid-2008.