20th Jun 2007 07:02
Renovo Group Plc20 June 2007 For immediate release 20 June 2007 A briefing for analysts and investors on this agreement and Renovo's interimresults for the six months ended 31 March 2007 will be held at 9.30 am today atthe offices of Buchanan Communications, 45 Moorfields, London, EC2Y 9AE. Simultaneous to the meeting, there will be a live audio web cast of thepresentation. To connect to the web cast facility, please go to the Company'swebsite www.renovo.com approximately 5 minutes (09:25 am) before the start ofthe briefing. In addition there will be a conference call for audience participation in thepresentation Q&A session. Dial-in details for the Renovo Plc conference callare as follows: Participant dial in number: +44 (0)20 7138 0817, ConfirmationCode: 4315755 RENOVO GROUP PLC RENOVO AND SHIRE ENTER LICENSING AGREEMENT TO DEVELOP AND COMMERCIALISE JUVISTA(R) Renovo Group Plc (LSE: RNVO) today announces that it has signed an exclusivelicensing agreement with Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) todevelop and commercialise Juvista, Renovo's lead drug for the prevention andreduction of scarring in connection with surgery. Juvista is currently in latephase 2 development with phase 3 trials anticipated to commence in mid 2008. The agreement covers every country throughout the world except Member States ofthe European Union ("EU"), the rights to which have been exclusively retained byRenovo. Under its terms: • Renovo will receive an initial payment of US$125 million,consisting of a US$75 million upfront payment and US$50 million equityinvestment in Renovo Group Plc at a price of £2.00 per share, equating to 6.7%of the total outstanding shares in the Company immediately after the issue • On acceptance of filing with the FDA, Shire will pay Renovo US$25million and on FDA approval, up to US$150 million depending on thecharacteristics of the approved product labelling • Contingent on the successful commercialisation of Juvista, Renovowill be eligible for further sales-related milestone payments of up to US$525million, giving a total deal size of up to US$825 million • If approved and commercialised Renovo will also receive escalatingroyalties on Juvista sales • Renovo will retain responsibility for conducting all futureclinical development of Juvista (unless otherwise agreed) in the prevention andreduction of scarring in the skin and Shire will fund all future costs of thestudies required to support any filing for regulatory approval in the UnitedStates and other territories outside the EU • Renovo will retain the rights to and fund all future costs of thestudies required to support any filing for regulatory approval for Juvista inthe Member States of the EU • Both parties shall have the right to reference and use, at nocost, any data or regulatory filings made by each other The agreement is subject to Hart Scott-Rodino clearance in the US Juvista - meeting a high unmet market need Juvista (human TGFbeta3) is a novel biopharmaceutical investigational drugand when injected at the time of surgery has been shown in clinical trials tomarkedly improve subsequent scar appearance in the skin. Plastic surgeons and dermatologists have particularly high interest in Juvista,which is also anticipated to gain widespread use by all surgeons. Juvista hasbeen administered to over 1,500 human subjects and has reported statistical andclinical significance in four phase 2 efficacy trials. This is a potential multi-billion dollar market which includes a largeproportion of cash payers. Consumer research shows that 85% of patients wouldself pay for the reduction or prevention of scarring. Recognizing the changingdynamics of the US health reimbursement and pricing policies, Shire is activelymanaging the economic risk profile of its overall product portfolio by seekingan entry to the private pay market. Renovo estimates that the U.S. total market could potentially be worth $4.1billion with 42 million patients undergoing surgery each year. Surgeons have ahigh concern for scarring in 46% of total patient procedures. 90% of surgeonsstated their intention to use a preventative drug (Source: Mattson Jack Group).The majority of patients discuss their concerns regarding scarring with theirsurgeon prior to surgery and 44% are unhappy with their scar following surgery.87% of patients wanted their scars to be less noticeable (source: AdelphiInternational Research consumer study). Current patient options are limited to treatment of existing formed scars, notthe prevention of scarring and comprise OTC (over the counter) products oroff-label prescribed steroid injections. Professor Mark W J Ferguson, Renovo's CEO, said: "We are delighted to have partnered Juvista with Shire, which is a leadingspecialty company with a track record of successfully commercialising specialistpharmaceutical products in new therapeutic areas and an infrastructure whichwill enable us to maximise Juvista's potential. "We believe that the two companies will make excellent partners. As the worldexperts in this field Renovo will continue to be responsible for developingJuvista, giving the clinical programme continuity and focus. Shire will provideus with their expert opinion, guidance, and regulatory expertise in successfullygetting products to the market. "In addition, and as we've previously promised our shareholders, this deal alsomeans that we will have the potential to participate in the direct sales ofJuvista as we have retained the rights to its commercialisation in the EuropeanUnion." Matthew Emmens, Shire's CEO said: "This is a novel biopharmaceutical drug candidate that we believe could become aleader in the market for prevention and treatment of scarring, a market servedby specialist physicians - as are all of Shire's markets. Shire's strength incommercialization of specialty products combined with proven experience ofbuilding new specialty markets where patient need is high, through theintroduction of novel treatments, makes us the ideal partner for Renovo in thedevelopment of JUVISTA. "We are excited by the potential market opportunity and the profile of this drugcandidate, which fits well with our specialty biopharmaceutical focus. Marketresearch shows that surgeons and patients have a high concern for scarring and90% of surgeons would use a preventative treatment if available. Renovoestimates that the U.S. total market could potentially be worth approximately $4billion. We look forward to the continued development of Juvista." For further information: RenovoProfessor Mark Ferguson, Chief Executive Officer +44 (0) 161 606 7222Simon Bielecki, Head of Communications +44 (0) 7810 157649 +44 (0) 161 606 7328 Buchanan CommunicationsTim Anderson/Lisa Baderoon/Mary-Jane Johnson +44 (0) 20 7466 5000 About Renovo Renovo is a biopharmaceutical product company and is the world leader in scarprevention and reduction research and the development of drugs to prevent andreduce scarring. The Company has a highly skilled management team with over 30years of research experience in the field of scarring and significantpharmaceutical industry expertise. Scarring can result from acute injury in, or surgery to, the skin, bloodvessels, eyes, nerves, internal organs, tendons and ligaments. These are highvalue markets of significant unmet medical need. Renovo has a portfolio of drugs which exploit different novel mechanisms ofaction to prevent and reduce scarring at multiple body sites and to acceleratehealing. Juvista, Renovo's lead drug for the prevention and reduction ofscarring in the skin has been safely administered to over 1,500 human subjectsand has reported statistical and clinical significance in four Phase 2 efficacytrials. Zesteem(R), Renovo's drug for the acceleration of wound healing in theskin, commenced Phase 3 clinical trials in December 2006. Juvidex(TM) andPrevascar(TM), Renovo's other two drugs in Phase 2 clinical development for theprevention and reduction of scarring, are also planned for additionalindications in the prevention and reduction of scarring following injury orsurgery to the cornea and nerves, respectively. Renovo aims to be first to the market with a pharmaceutical drug in the US andEurope to prevent and reduce scarring and current demand is inadequately met. According to external research, the potential commercial market for preventionand reduction of scarring in the skin is worth, in the order of, $4 billion perannum in the US alone. Juvista(R), Zesteem(R), Juvidex(TM) and Prevascar(TM) are all trademarks of RenovoGroup Plc. About Shire plc Shire's strategic goal is to become the leading specialty biopharmaceuticalcompany that focuses on meeting the needs of the specialist physician. Shirefocuses its business on attention deficit and hyperactivity disorder (ADHD),human genetic therapies (HGT), gastrointestinal (GI) and renal diseases. Thestructure is sufficiently flexible to allow Shire to target new therapeuticareas to the extent opportunities arise through acquisitions. Shire believesthat a carefully selected portfolio of products with a strategically aligned andrelatively small-scale sales force will deliver strong results. Shire's focused strategy is to develop and market products for specialtyphysicians. Shire's in-licensing, merger and acquisition efforts are focused onproducts in niche markets with strong intellectual property protection either inthe US or Europe. For further information on Shire, please visit the Company's website:www.shire.com This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
Shire