In February 2013, Roche entered an agreement to develop and commercialise an oral form of the peptide octreotide, paying New York and Israel-based firm Chiasma $65m (€45m) up front, with future milestones potentially worth up to $530m more.
However, Roche has struck a blow to the drug, currently in Phase III trials, and cancelled its agreement, removing the Oral Octreotide acetate (OOA) drug - previously known as Octreolin – from its pipeline.
“Recently Roche / Genentech made a decision to no longer continue its work to commercialize oral octreotide acetate (OOA),” Chiasma’s CEO Roni Mamluk told this publication. “Chiasma was surprised by this decision, especially in light of positive Phase III data presented recently at the international ICE/ENDO conference.”
Roche itself told Outsourcing-Pharma.com the decision was based on several factors including the available phase III data and feedback from regulatory authorities. "This has been a tough decision and is disappointing news, as Roche had hoped to eventually offer people with acromegaly an approved alternative to the injections that are standard treatment for this life-long disease," said spokesman Štěpán Kráčala.
Mamluk told us no terms of the commercialisation contract were broken by Roche in its turnaround, and Chiasma is looking to lead the global development and commercialisation of OOA going forward.
Capsugel Contract
In April, Roche and Chiasma selected Capsugel to scale-up production of the drug from its site in Livingston, Scotland, acquired when Capsugel bought Encap Drug Delivery in 2013.
Roche’s pull-out will not affect the scale-up contract, Mamluk told us, and Chiasma will continue to work with Capsugel going forward.
This was confirmed by Stephen Brown, Managing Director of Capsugel Dosage Form Solutions' Encap Drug Delivery business who told us: “Our scale-up manufacturing agreement with Chiasma remains in place, and we look forward to continuing to collaborate with them on this project.”
Octreotide is a growth hormone inhibitor used to treat acromegaly. It is only available in an injectable formulation – Sandostatin, marketed by Novartis – but Chiasma is using its Transient Permeability Enhancer (TPE) System to develop an oral form.
The system works by combining excipients to form an oily suspension of solid hydrophilic particles in a hydrophobic medium, which protects peptides, small proteins, and poorly absorbed small molecules within the gastrointestinal environment whilst allowing permeation of the drug molecules through the gut wall.