Juvista Licensing Deal
RENOVO GROUP PLC
RENOVO AND SHIRE ENTER LICENSING AGREEMENT TO
DEVELOP AND COMMERCIALISE JUVISTA®
Renovo Group Plc (LSE: RNVO) today announces that it has signed an exclusive licensing agreement with Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) to develop and commercialise Juvista, Renovo’s lead drug for the prevention and reduction of scarring in connection with surgery. Juvista is currently in late phase 2 development with phase 3 trials anticipated to commence in mid 2008.
The agreement covers every country throughout the world except Member States of the European Union (“EU”), the rights to which have been exclusively retained by Renovo. 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 equity investment 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$25 million and on FDA approval, up to US$150 million depending on the characteristics of the approved product labelling
• Contingent on the successful commercialisation of Juvista, Renovo will be eligible for further sales-related milestone payments of up to US$525 million, giving a total deal size of up to US$825 million
• If approved and commercialised Renovo will also receive escalating royalties on Juvista sales
• Renovo will retain responsibility for conducting all future clinical development of Juvista (unless otherwise agreed) in the prevention and reduction of scarring in the skin and Shire will fund all future costs of the studies required to support any filing for regulatory approval in the United States and other territories outside the EU
• Renovo will retain the rights to and fund all future costs of the studies required to support any filing for regulatory approval for Juvista in the Member States of the EU
• Both parties shall have the right to reference and use, at no cost, 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 TGFβ3) is a novel biopharmaceutical investigational drug and when injected at the time of surgery has been shown in clinical trials to markedly 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 has been administered to over 1,500 human subjects and has reported statistical and clinical significance in four phase 2 efficacy trials.
This is a potential multi-billion dollar market which includes a large proportion of cash payers. Consumer research shows that 85% of patients would self pay for the reduction or prevention of scarring. Recognizing the changing dynamics of the US health reimbursement and pricing policies, Shire is actively managing the economic risk profile of its overall product portfolio by seeking an entry to the private pay market.
Renovo estimates that the U.S. total market could potentially be worth $4.1 billion with 42 million patients undergoing surgery each year. Surgeons have a high concern for scarring in 46% of total patient procedures. 90% of surgeons stated their intention to use a preventative drug (Source: Mattson Jack Group). The majority of patients discuss their concerns regarding scarring with their surgeon prior to surgery and 44% are unhappy with their scar following surgery. 87% of patients wanted their scars to be less noticeable (source: Adelphi International Research consumer study).
Current patient options are limited to treatment of existing formed scars, not the prevention of scarring and comprise OTC (over the counter) products or off-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 leading specialty company with a track record of successfully commercialising specialist pharmaceutical products in new therapeutic areas and an infrastructure which will enable us to maximise Juvista’s potential.
“We believe that the two companies will make excellent partners. As the world experts in this field Renovo will continue to be responsible for developing Juvista, giving the clinical programme continuity and focus. Shire will provide us with their expert opinion, guidance, and regulatory expertise in successfully getting products to the market.
“In addition, and as we’ve previously promised our shareholders, this deal also means that we will have the potential to participate in the direct sales of Juvista as we have retained the rights to its commercialisation in the European Union.”
Matthew Emmens, Shire’s CEO, said:
“This is a novel biopharmaceutical drug candidate that we believe could become a leader in the market for prevention and treatment of scarring, a market served by specialist physicians – as are all of Shire’s markets. Shire’s strength in commercialization of specialty products combined with proven experience of building new specialty markets where patient need is high, through the introduction of novel treatments, makes us the ideal partner for Renovo in the development of JUVISTA.
“We are excited by the potential market opportunity and the profile of this drug candidate, which fits well with our specialty biopharmaceutical focus. Market research shows that surgeons and patients have a high concern for scarring and 90% of surgeons would use a preventative treatment if available. Renovo estimates that the U.S. total market could potentially be worth approximately $4 billion. We look forward to the continued development of Juvista.”
For further information:
Professor Mark Ferguson, Chief Executive Officer
+44 (0) 161 606 7222
Simon Bielecki, Head of Communications
+44 (0) 7810 157649
+44 (0) 161 606 7328
Tim Anderson/Lisa Baderoon/Mary-Jane Johnson
+44 (0) 20 7466 5000
Renovo is a biopharmaceutical product company and is the world leader in scar prevention and reduction research and the development of drugs to prevent and reduce scarring. The Company has a highly skilled management team with over 30 years of research experience in the field of scarring and significant pharmaceutical industry expertise.
Scarring can result from acute injury in, or surgery to, the skin, blood vessels, eyes, nerves, internal organs, tendons and ligaments. These are high value markets of significant unmet medical need.
Renovo has a portfolio of drugs which exploit different novel mechanisms of action to prevent and reduce scarring at multiple body sites and to accelerate healing. Juvista, Renovo’s lead drug for the prevention and reduction of scarring in the skin has been safely administered to over 1,500 human subjects and has reported statistical and clinical significance in four Phase 2 efficacy trials. Zesteem®, Renovo’s drug for the acceleration of wound healing in the skin, commenced Phase 3 clinical trials in December 2006. Juvidex™ and Prevascar™, Renovo’s other two drugs in Phase 2 clinical development for the prevention and reduction of scarring, are also planned for additional indications in the prevention and reduction of scarring following injury or surgery to the cornea and nerves, respectively.
Renovo aims to be first to the market with a pharmaceutical drug in the US and Europe to prevent and reduce scarring and current demand is inadequately met.
According to external research, the potential commercial market for prevention and reduction of scarring in the skin is worth, in the order of, $4 billion per annum in the US alone.
Juvista®, Zesteem®, Juvidex™ and Prevascar™ are all trademarks of Renovo Group Plc.
About Shire plc
Shire’s strategic goal is to become the leading specialty biopharmaceutical company that focuses on meeting the needs of the specialist physician. Shire focuses its business on attention deficit and hyperactivity disorder (ADHD), human genetic therapies (HGT), gastrointestinal (GI) and renal diseases. The structure is sufficiently flexible to allow Shire to target new therapeutic areas to the extent opportunities arise through acquisitions. Shire believes that a carefully selected portfolio of products with a strategically aligned and relatively small-scale sales force will deliver strong results.
Shire’s focused strategy is to develop and market products for specialty physicians. Shire’s in-licensing, merger and acquisition efforts are focused on products in niche markets with strong intellectual property protection either in the US or Europe.
For further information on Shire, please visit the Company’s website: www.shire.com