A new milestone payment to Renovo of $5m from Shire
A new milestone payment to Renovo of $5m from ShireOther Milestones and Royalty Payments Unchanged
Renovo Obtain Right to License and Sell Outside North America and Mexico
Renovo Group plc (LSE: RNVO), the biopharmaceutical product company developing drugs to reduce scarring, improve wound healing and enhance tissue regeneration, today announces that it has revised its licensing deal with Shire for Juvista® and acquired from Shire the rights to sell and license Juvista in all territories other than the USA, Mexico and Canada.
In 2007 Renovo and Shire signed a licensing agreement giving Shire the rights to sell Juvista throughout the world excluding the EU which Renovo retained. Juvista is currently in its first Phase III trial to support a European Marketing Authorisation.
Renovo and Shire have agreed to simplify the current arrangements to better align both parties interests in making Juvista a successful product.
Key Terms
· The Milestone and Royalty payments for the development and sales of Juvista are unchanged from the original agreement. On acceptance of a BLA filing with the FDA, Shire will pay Renovo US$25m and on approval US$50 - $150m depending on the breadth of the indication on the approved label. Milestones on escalating sales total up to $525m and Renovo receives escalating royalties on Juvista sales
· A new milestone payment to Renovo of $5m from Shire once Shire commences a clinical trial after the first EU Juvista PhIII trial reports (currently on schedule to report H1 2011)
· Renovo is free to commercialise (including licensing) Juvista in all countries of the world (including the EU) except the USA, Canada and Mexico
· Shire retains its Juvista license in the major markets of the USA, Canada and Mexico and acquires the right to sublicense in these territories
· Each party is responsible for its own development costs but future costs can be shared by agreement
· Shire can use the data from Renovo's current EU Phase III trial to support its North American regulatory filings without any cost reimbursement to Renovo
· Renovo and Shire have free access to each other's data to support regulatory filings in their respective territories
· A collaboration committee between Renovo and Shire will be formed to oversee the development programmes
Professor Mark Ferguson, CEO of Renovo Group plc commented: "We are delighted to refine our strong collaboration with Shire on the development and commercialisation of Juvista. Shire retains the rights to the major North American market where they have a significant sales infrastructure. Renovo gains the rights to the rest of the world, and the ability to sublicense in any or all of its territories, providing an opportunity to generate significant additional future revenues. The first EU Phase III trial for Juvista is on track to report in H1 2011".
