Following encouraging results in a positive proof-of-concept Phase II trial earlier this year, Danish drugmaker Novo Nordisk has announced it is initiating a Phase IIIa programmer for an oral formulation of its long-acting glucagon-like peptide-1 (GLP-1) analogue semaglutide.
The compound, aimed at patients with type 2 diabetes, uses the Eligen Carrier Concept technology licenced from Emisphere Technologies to deliver semaglutide orally. The peptide is attached to passive transcellular ‘carriers’ which aid transport across the gastrointestinal tract, allowing the full pharmacological effect of the drug without the need for an injection.
David Kliff, founder and publisher of Diabetic Investor, said this drug could really be a game changer in the diabetes market.
“GLP-1 therapy has many benefits – solid control, low incidence of hypoglycemia, weight loss and preset dosing – the main issue with the therapy has been up until now GLP-1’s had to be injected,” he said.
$2bn spend
And with its oral semaglutide reaching its next development milestone, Novo Nordisk intends to increase its manufacturing capacity across its whole diabetes portfolio saying today it expects to spend as much as $2bn over the next five years to boost its network.
A new production facility for several APIs (active pharmaceutical ingredients) is planned in Clayton, North Carolina, while the firm is also building a new drug-product facility in Måløv, Denmark.
"The decision to expand with two new production facilities is based on the generel increased demand for our diabetes medication," Novo Nordisk spokesperson Katrine Rud von Sperling told this publication. "We have always preferred inhouse production - its a core competence for us. "
Novo Nordisk has been regularly growing its in-house capabilities, and pledged to invest $760m this year alone. In 2014, the firm invested $100m in a Danish purification plant, and snapped up a biomanufacturing facility in West Lebanon, New Hampshire from Olympus Biotech.