Israel-based Entera is developing technology to enable oral delivery of peptides, proteins and other large molecules. The technology has attracted the interest of Amgen, which entered into an alliance with Entera worth up to $270m (€245m) in milestones late last year.
Part of the appeal of Entera’s technology is that it will result in more convenient dosage forms for patients – instead of receiving drugs via injections, patients will swallow an oral dosage form.
Entera thinks its dosage forms can beat injectable biologics in other regards, too. Having spent the past few years making Entera’s processes compliant with good manufacturing practices (GMPs), Phillip Schwartz, the company’s president of R&D, told investors on a recent third quarter results conference call that production efficiency is another differentiator.
Schwartz said, “[Adopting GMPs] facilitated greater efficiency in production, higher yields, decreased time and a substantial decrease in the cost of goods for both excipients and, ultimately, the final drug tablet. We expect that these cost advantages will be among the critical parts of our ability to offer patients less costly and more convenient alternatives.”
Entera relies on contract manufacturing organizations (CMOs) for supplies of active pharmaceutical ingredients (APIs) and drug candidates, and expects to continue to do so as it moves therapies into tests in humans and, if they get that far, onto the market as commercial products.
However, the nature of Entera’s products means the reliance on CMOs comes with some risks, as the company noted in a filing with the US Securities and Exchange Commission.
Entera wrote, “Contract manufacturers may not have sufficient expertise to manufacture a dry oral formulation with a large molecule API, in which case we may have to establish our own commercial manufacturing capabilities, which could be expensive and delay launch of product candidates.”
The concern reflects the novelty of oral formulations of large molecule APIs. The idea is starting to gain traction, though, with Novo Nordisk recently winning approval of an oral GLP-1 agonist that uses the same absorption enhancer as candidates in Entera’s pipeline.
Entera CEO Adam Gridley told investors the approval validates the technology, which may simplify the path to market for other oral formulations of large molecules and lead to a “substantial” rise in the number of detailed talks the company is holding with potential partners.