Roche has licensed an orally-active form of the somatostatin analogue octreotide from Chiasma that could offer an alternative to injection for patients with the hormonal disorder acromegaly.
The licensing deal – valued at up to $595m – is for Octreolin (oral octreotide acetate), a drug candidate which which is currently in phase III testing for acromegaly and also in development for neuroendocrine tumours.
Acromegaly is a condition associated with excess growth hormone production and overgrowth of the hands, feet, and parts of the face, and is typically treated using large bore intra-muscular needle injections, although it can sometimes be given subcutaneously.
The frequency of the injections varies, but short-acting octreotide requires injections up to four times a day, while long-lasting formulations are given into the buttocks every month.
“Our oral octreotide has the potential to improve the quality of life of acromegaly patients,” says Chiasma.
Under the terms of the agreement, Roche gains exclusive worldwide rights to Octreolin in return for an upfront payment of $65m and up to $530m in milestones, as well as tiered, double-digit sales royalties.
If approved, Octreolin will be manufactured by Roche’s Genentech subsidiary, which will also sell the drug in the US.
Fredric Price, Chiasma’s chief executive, said Roche is “an ideal collaboration partner that has the right development and commercial resources in the areas of endocrinology and oncology to support Octreolin”.
The leading therapy for acromegaly at the moment is Novartis subsidiary Sandoz’ long-acting octreotide product Sandostatin LAR, which had sales of more than $1.5bn in 2012, a rise of 8 per cent year-on-year.
While patents on Sandostatin LAR expired in July 2010 in most world markets, the drug has proved remarkably resistant to generic competition, although it still has protection in the US until 2014.
Meanwhile, Novartis is also developing a new somatostatin analogue called pasireotide for acromegaly, reporting phase III data last year which showed that patients were more likely to achieve full growth hormone control than those on Sandostatin LAR.