Shire reports expiration of waiting period for Juvista

Shire has announced that the waiting period for the company’s exclusive license of Juvista (human TGF beta-3) from Revono under the Hart-Scott-Rodino Antitrust Improvement Act of 1976 expired on August 10th 2007.

According to terms of this license, the agreement between the firms then became effective on August 15th 2007, with Shire paying Revono an initial fee of $75 million (37.4 million pounds), with a further equity investment in the firm of $50 million for approximately 6.5 per cent of the firm.

Following from this license agreement, Shire has the exclusive rights to market the compound worldwide – except in the EU.

“Juvista 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,” Shire reports.

Subsequent to the acceptance of a biologics license application by the US Food and Drug Administration, Shire will pay a further $25 million to Renovo, with an additional $50-150 million paid on approval depending on the product labelling.

Royalties to the sum of $525 million will also be paid when specified sales targets are met.

In June 2007, Shire reported that Juvista is currently in late-stage phase II clinical trials, with phase III studies planned for the middle of 2008.