Shire has splashed out on the rights to Renovo Group’s Juvista, a novel biopharmaceutical drug in development for the prevention and reduction of scarring from therapeutic or cosmetic surgery.
In return for exclusive development and commercialisation rights outside of the European Union, Shire will make an equity investment in fellow UK firm Renovo of $50 million to get a 6.7% stake as well as hand over $75 million in cash to seal the deal. Furthermore, the filing of a Biologics License Application in the USA for Juvista (human recombinant transforming growth factor beta-3) will trigger a payment of $25 million, followed by $50-$150 million on full approval, with the exact amount dependent on the product’s labelling. Shire will also pay Renovo sales-based royalties and milestone payments of up to $525 million.
In terms of development funding, Shire will bear the cost of any clinical trials for US regulatory approval, while Renovo will retain responsibility for those specifically aimed at EU regulatory clearance. The companies will share equally any costs relating to global studies designed for obtaining both US and EU regulatory approvals.
Juvista is due to enter Phase III testing next year, and has already given an impressive performance in Phase II trials, showing statistical and clinically significant improvements in scarring when injected at the time of surgery, the company said.
According to Renovo, the US market alone could be worth $4 billion, with 42 million patients undergoing surgery each year. And Shire points to consumer research in the USA showing that 85% of patients would “self pay for the reduction or prevention of scarring.” Furthermore, current options are limited to treatment of existing scars and not prevention of scarring, it said, which all adds to the product’s market potential.
“We are excited by the potential market opportunity and the profile of this drug candidate, which fits well with our specialty biopharmaceutical focus, said Matthew Emmens, chief executive of Shire. "Market research shows that surgeons and patients have a high concern for scarring and 90% of surgeons would use a preventative treatment if available," he added.
Shire gets approvable letter for ADHD drug Intuniv
Shire also announced that it has received an approvable letter from the US Food and Drug Administration for Intuniv (guanfacine) extended-release tablets (previously referred to as SPD503 and Connexyn), a nonstimulant selective alpha-2A-receptor agonist, which has been studied in children and adolescents with attention-deficit hyperactivity disorder.
The company noted that unlike some other ADHD treatments, Intuniv, a nonstimulant, is not a controlled substance and does not have a known mechanism for potential abuse or dependence. Getting an approvable letter is “positive news” said chief executive Matthew Emmens, as the information requested by the FDA was not unexpected, and “Shire will be working closely with the agency to address its questions," he added.