Shire reports positive phase II Juvista results

Shire has announced the reporting of positive phase II clinical trial data relating to the administration of Juvista (human recombinant TGF-beta-3) as a treatment for scars resulting from surgery.

These trial results have been announced by Renovo Group, which licensed development and commercialisation rights the compound to Shire for territories worldwide except the European Union in June 2006.

Shire reports that the study met its primary endpoint and showed high statistical significance, exhibiting the clinical efficacy of the microbially derived compound, manufactured by Lonza Biologics.

Following this II trial of Juvista, it has been proposed to use the drug in phase III clinical trials and commercial supply.

Professor Mark Ferguson, chief executive officer of Renovo, said: “This fifth statistically significant trial is very important for Renovo because it is the first time that we have tested Juvista manufactured drug substance at Lonza and the lyophilised product intended for phase III and commercial supply.”

He added that the results confirms earlier findings relating to the l/linear cm of wound margin given a 200ng/100 l/linear optimum dose with a 50-500ng/100 cm broad dosage window.

In August 2007, Shire paid Renovo an initial sum of $75 million (37.4 million pounds) to acquire exclusive marketing rights for Juvista, in addition to an additional equity investment of $50 million for a 6.5 per cent stake in the firm.