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Juvista (INN: Avotermin - an intradermal injectable solution of Transforming Growth Factor Beta 3 (TGFβ3)), Renovo's lead drug for the improvement of scar appearance in the skin, has been generally well tolerated by around 1,500 human subjects and has demonstrated statistically significant efficacy data in eight Phase 2 double blind, placebo controlled efficacy trials in patients and volunteers. The first EU Juvista Phase 3 efficacy trial in scar revision surgery is ongoing in ten countries and is on track to report in the first half of 2011.

Renovo announced in June 2007 that it had signed an exclusive licensing agreement with Shire plc to develop and commercialise Juvista, in every country in the world except the European Union, the rights to which have been retained by Renovo. Under the terms of the deal Renovo has already received an upfront payment of US$75 million and an equity investment of US$50 million. Contingent on the successful development and commercialisation of Juvista Renovo will be eligible for further milestone payments of up to US$700 million together with escalating royalties on sales.

Adaprev (an injectable solution of Mannose-6-Phosphate (M-6-P)) is being developed by Renovo as a Class III medical device for the prevention of adhesions (scar tissue) between tendon and tendon sheath, and the improvement of tendon function in patients undergoing surgical repair of flexor tendons in the hand. The first randomised, double-blind, standard care controlled, clinical trial commenced in November 2009 and is due to report in H1 2011. As clinical development programmes for medical devices tend to be simpler compared to pharmaceuticals, with fewer trials and patients, this will provide Renovo with a faster route to market for Adaprev.

Prevascar (an intradermal injectable solution of human recombinant Interleukin 10) previously reported a statistically significant Phase 2 efficacy trial for the reduction of scarring in the skin. Following improvements in the manufacturing of Prevascar drug substance and product, and identification of a clinical cohort who are predicted (on the basis of a non-drug experimental surgery study) to benefit particularly well from Prevascar's modulating effect on the wound inflammatory response, Renovo plans to initiate a new proof of concept clinical trial in skin incisions and excisions in African Ancestral Group volunteers in Q2 2010.

Juvidex (topical application of Mannose-6-Phosphate (M-6-P)) reported statistically significant improvements in pre-specified endpoints of skin appearance and acceleration of healing in a proof of concept clinical trial. Renovo intends to partner Juvidex as a cosmetic ingredient, and is actively seeking a suitable partner to ensure its rapid development and commercialisation.

The development towards the clinic of RN1005, a promising pre-clinical candidate pharmaceutical (discovered by Renovo), targeting the Wnt pathway for reduction of scarring and stimulation of tissue regeneration has been greatly assisted by a financial grant from the Technology Strategy Board (TSB) under its recent Regenerative Medicine competition.

PRODUCTS IN DEVELOPMENT
Juvista - Scar Reduction in skin
Adaprev – Scar reduction in tendons
Prevascar - Reduced Scarring
Juvidex - Improved skin appearance
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