Earlier, 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.
Both the parties have agreed to simplify the current arrangements to better align both parties interests in making Juvista a successful product.
Reportedly, 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 is expected to pay Renovo $25m and on approval $50 – $150m depending on the breadth of the indication on the approved label.
Shire is expected to pay a new milestone payment to Renovo of $5m once Shire commences a clinical trial after the first EU Juvista PhIII trial reports (currently on schedule to report H1 2011).
Reportedly, Shire retained its Juvista license in the major markets of the US, Canada and Mexico and acquires the right to sublicense in these territories. Additionally, each party is responsible for its own development costs but future costs can be shared by agreement. Moreover, 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. The companies said that a collaboration committee between Renovo and Shire will be formed to oversee the development programmes
Mark Ferguson, CEO of Renovo Group, said: “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.”