Novo to develop oral insulin

pharmafile | December 22, 2010 | News story | Research and Development Emisphere, Novo Nordisk, diabetes, insulin, oral insulin, type I diabetes 

Novo Nordisk is to develop an oral formulation of insulin with US biotech company Emisphere Technologies.

The New Jersey-based biotech specialises in novel drug delivery methods, and if it can develop a safe and effective oral insulin, the product is certain to be a success.

The deal is by no means the first aimed at developing an oral insulin formulation, which would free type I diabetes patients from daily injections. There are a number of R&D programmes currently focused on oral insulin, including Novo Nordisk’s own collaboration with Merrion Pharma.

Emisphere’s drug delivery technology platform is known as the Eligen Technology, and uses proprietary, synthetic chemical compounds, known as Emisphere delivery agents, sometimes called carriers. The technology makes it possible to deliver a therapeutic molecule without altering its chemical form or biological integrity.

Novo Nordisk will pay $57.5 million in potential product development and sales milestone payments to Emisphere, of which $5 million will be payable upon signing, as well as royalties on sales. Further financial details of the agreement were not made public.

This is the second license agreement between the two companies. The first agreement for the development of oral formulations of GLP-1 receptor agonists was signed in June 2008 with a potential drug currently in a phase I clinical trial.

“This is an encouraging agreement on a promising technology for oral administration of proteins. We are delighted to continue working with Emisphere and their Eligen Technology. It fits very well with Novo Nordisk’s strategy within diabetes research,” said Peter Kurtzhals, senior vice president, Diabetes Research Unit at Novo Nordisk.

This extended partnership with Novo Nordisk is important for Emisphere for several reasons, said Michael Novinski, president and chief executive of Emisphere. “To date, our collaboration with Novo Nordisk has been very productive, and today’s agreement has the potential to offer significant new solutions to millions of people with diabetes worldwide. Finally, it also serves to further validate our Eligen Technology.”

One of the most advanced products in the field is Generex’s Oral-lyn. The insulin is delivered as a spray in an inhaler device, and is currently in phase III trials.

German company Mannkind is also developing an inhalable formulation called Afrezza, but doubts persist about the drug and its similarity with Pfizer’s Exubera. Pfizer’s inhaled insulin launched was in 2006, but withdrawn in 2007 because of poor sales.

Andrew McConaghie

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