UK biotech Renovo saw its share value cut in half in one fell swoop earlier this week after the company announced mixed results from the latest round of Phase II trials of its anti-scarring drug Juvista, which was recently licensed to Shire in certain markets.

Marking the steepest fall in the Manchester-based group’s trading history, Renovo’s stock plummeted 51% to 66 pence on the London Stock Exchange in a knee-jerk reaction to news that Juvista had failed to meet its targets in preventing scarring in breast augmentation surgery.

However, according to Renovo, the failed trial employed a one-dose strategy, while a second Phase II trial of the drug in scar revision, in which Juvista (human recombinant transforming growth factor beta-3) was administered twice, did meet its primary endpoint, leading it to conclude that the drug’s efficacy is greater in higher doses.

“Although it is disappointing that the breast augmentation trial did not meet its primary endpoint, one of the objectives of our Phase II programme was to investigate the most effective dosing strategy for Juvista,” commented Professor Mark Ferguson, Chief Executive Officer of the firm.

“Cumulatively the trials reported to date indicate that twice dosing yields greater efficacy than once dosing, [which] gives us confidence that the large scar reduction market remains accessible with Juvista and our first Phase III trial will start in the second half of 2008,” he added.

According to Renovo, its European Phase III programme will kick off later this year with a trial assessing Juvista’s potential in scar revision, which is performed by plastic surgeons and cosmetic dermatologists for cosmetic enhancement and serious disfiguring scars. Two dose levels of the drug are likely to be evaluated - 200ng and 500ng – and these will be administered twice, at the time of surgery following wound closure and 24 hours later, the group said.

Across the Atlantic
Fellow UK-based company Shire will be keeping a very close eye on the drug’s development, as it recently shelled out for exclusive rights to Juvista, which many analysts believe has multi-billion-dollar potential, outside of the European Union, with an equity investment in Renovo of $50 million for a 6.7% stake and an upfront payment of $75 million.

Under the terms of the groups’ agreement, a US filing of Juvista will trigger a $25 million payment to Renovo, with a subsequent $50-$150 million on approval, depending on the product labelling. Shire will also pay royalties on product sales and milestone payments of up to $525 million on certain sales targets, giving the whole deal a price tag of around $700 million plus royalties.

Shire says it is assessing this latest batch of Phase II results alongside previously reported data, and that it plans to discuss these with the US regulators to determine the regulatory path forward across the pond.

The US market for Juvista could be worth $4 billion alone, with 42 million patients undergoing surgery each year, and Shire has previously cited consumer research in the USA which shows that 85% of patients would self-pay for the reduction or prevention of scarring.”