Products

Product	Clinical Indication	Phase of Development	Partner	Anticipated Newsflow
Juvista  EU	Prophylactic improvement of skin scar appearance	PhIII in scar revision surgery (1st of 2 efficacy trials for approval)	-	Q4 2010 paediatric formulation trial reports.  H1 2011 1st pivotal EU PhIII trial in scar revision surgery reports
Juvista US	Prophylactic improvement of skin scar appearance	PhII	Shire	Q4 2010 earlobe keloid pilot trial reports
Adaprev	Reduction of adhesions following digital tendon injury	Class III medical device Safety and preliminary performance (1st of 2 trials for approval)	-	H1 2011 trial reports
Prevascar	Reduction of skin scarring	PhII	-	Q2 2010 PhII clinical trial in African subjects commences
Juvidex	Improve skin appearance and promote healing of damaged skin	Cosmetic ingredient Out-license	-	2010 out-license/partner
RN1005	Prevent scarring and enhance tissue regeneration	Preclinical	-	2010 Progress development. TSB grant

Further product specific information can be obtained via the menu options on the left of the screen.

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 studied in an extensive early phase development programme in the EU, involving around 1500 subjects. Efficacy, safety and dose response has been evaluated in statistically powered trials in both normal volunteers and patients, and following scientific advice from EMEA, a phase III programme for the EU has been agreed and initiated. 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 LLC. This agreement was revised in March 2010. Shire has licensed Juvista for USA, Canada and Mexico. Renovo has retained its rights for the rest of the world. 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$705 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.

Prevascar (an intradermal injectable solution of human recombinant Interleukin 10) previously reported a positive exploratory 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 2009 Regenerative Medicine competition.