Merrion signs “transformational” deal with Novo for oral insulin

Irish oral dosage specialist Merrion Pharmaceuticals is to develop and commercialise Novo Nordisk’s range of insulin analogues as the Danish firm seeks to tighten its grip on the $9bn (€7bn) a year diabetes market.

The deal will apply the company’s generally recognised as safe (GRAS) GIPET solubilisation technology to enhance the bioavailability of Novo’s candidate insulin. Merrion is set to earn $58m when the first product covered by the agreement is successfully commercialised.

In an interview, Merrion CEO John Lynch said that, to his knowledge, no other big pharma company is developing comparable products, which he believes will have significant clinical advantages if the project is completed successfully.

He explained that: “unlike traditional subcutaneous insulins, an oral form of the drug has the potential to selectively target the liver, providing patients with a more effective compliance-friendly treatment.”

Lynch described the Novo deal as “transformational” for Dublin-headquartered Merrion adding that the firm’s “selection by the insulin sector’s major player [Novo currently has a 52 per cent share of global insulin sales] shows that the GIPET technology has massive potential.”

Peter Kurtzhals, senior vice president of Novo’s diabetes research unit, was also positive about the agreement. He said it is “an important part of Novo Nordisk’s strategy within diabetes research.

This feeling was echoed by Frost & Sullivan’s Daniel Ruppar who told in-PharmaTechnologist that the agreement is good news for both firms, particularly Novo as it looks for new products to replace the inhaled insulin candidate that it abandoned earlier this year.

Ruppar added however that the collaboration “won't really get exciting until we see some Phase II proof-of-concept data for their oral product in clinical trials.

The deal is the second that Merrion has signed in recent months following the September agreement with Swiss drugmaker Ferring Pharmaceuticals, under which it is combining its GIPET system with a range of the latter firm’s injectables.

High value oral drugs

In addition to its partnerships with Novo and Ferring, Merrion is actively developing several GIPET-based oral drug products in-house for potentially high value indications. Candidates in the firm’s pipeline include the anticoagulent (MER 102), a prostate cancer medication called acyline, almerol for osteoporosis and orazol for bone cancer patients.

Lynch cited orazol, which is currently being examined in Phase II trials, as among the most exciting. He said that the product, which is similar in nature to $1.3bn a year selling infusion-only products made by drug majors like Novartis, has clear advantages over competitors in terms of ease of administration and its impact on patient quality of life.

Lynch said that Merrion plans to further the development of orazol and its other candidate products through partnering deals that it plans to establish when Phase II development is complete.