Renovo Group (LSE: RNVO) reported another milestone in the development of its Juvista - a drug which reduces scarring by enhancing tissue regeneration – announcing that it had now completed recruitment of patients for the crucial EU Phase III trial.
The Phase III trial, which is on course to report in the first half of 2011, recruited more than 350 patients from 10 countries, including Italy, Spain, France, UK and USA.
In 2007, Renovo signed an $825m licensing agreement with FTSE 100-quoted biopharmaceutical firm Shire Pharmaceuticals to develop and commercialise Juvista in every country in the world, except those in the EU (the rights to which have been retained by Renovo).
Under the 2007 deal, Renovo has already received an upfront payment of USD$75m and an equity investment of USD$50m. Contingent on the successful development and commercialisation of Juvista, Renovo will become eligible for further milestone payments of up to $700m as well as escalating royalties on sales.
The two companies revised terms of the original agreement last month. Shire will retain its right to sell Juvista in the United States, Canada and Mexico, but will no longer maintain the right for other parts of the world outside of the European Union (NYSEARCA:EU). The original financial terms of the agreement have remained intact, with the exception that Shire agreed a new US$5 million milestone payment to Renovo on commencement of a clinical trial by Shire, but after the first EU Phase III trial reports.
The primary endpoint of the Phase III trial is a Clinical Panel assessment of standardised photographs at 12 months after surgery, assessed for scar improvement by the “Global Scar Comparison Scale”, Renovo stated this morning.
“Following the last patient visit at 12 months post surgery, the standardised photographs will be prepared, scored by an independent Clinical Panel and the data analysed, which means that Renovo is on schedule to report the results of this trial in H1 2011, as previously guided.”
Juvista is aimed principally at patients undergoing surgery, or who have very recently undergone surgery, Renovo describes Juvista is a “first-in-class pharmaceutical product candidate” that is aimed at improving the subsequent appearance of surgical scars.
There are approximately 42 million surgical procedures every year in the US, and a further 41.8 million in the European Union, yet there is currently no marketed pharmaceutical in the US or Europe for the prevention and reduction of scarring in skin - hence Renovo believes that there are multi-billion dollar markets in the EU and US for Juvista.
Disclosure: The author holds no positions in the company