January 13, 2010 / 9:22 AM / in 10 years

UPDATE 1-Novo starts tests on pill version of Victoza drug

* Phase I study launched for pioneering oral GLP-1 drug

* Part of strategy to stay ahead in competitive market

* Partner Emisphere earns $2 mln from start of UK study

(Adds interview, details on competitors, background)

By Ben Hirschler and Peter Levring

LONDON/COPENHAGEN, Jan 13 (Reuters) - Novo Nordisk (NOVOb.CO), the world’s biggest insulin maker, opened a new front in the fight against diabetes on Wednesday by starting clinical tests on an oral version of its GLP-1 drug Victoza.

The move puts the Danish drugmaker ahead of rivals in the race to develop a pill form of glucagon-like peptide-1 (GLP-1) medicines for controlling blood sugar levels — though analysts remain uncertain about long-term prospects for the drug class.

The launch of the Phase I trial, which will enrol 155 patients in Britain, triggers a $2 million payment to Novo’s partner Emisphere EMIS.OB, whose technology was used in the formulation of the long-acting experimental treatment NN9924. Existing GLP-1s, including Novo’s own Victoza, are protein-based drugs that must be given by injection. Novo believes developing a version that can be taken by mouth will be key to keeping it ahead in an increasingly competitive market.

Making an oral form is far from simple and one of the key hurdles will be to show that the new drug, which is not the same protein as Victoza but it works in the same way, is adequately absorbed in the body.

Results of the Phase I study are expected in 12 months.

“We’ve set out to be first in the market with oral products on GLP-1. No one else has gone into clinical trials, so we believe we can do it,” Peter Kurtzhals, Novo’s head of diabetes research, told Reuters.

Victoza is on sale in Europe but has yet to win approval in the United States, and concerns about potential inflammation of the pancreas and thyroid cancer hover over the drug class.

Eli Lilly (LLY.N) and partner Amylin Pharmaceuticals AMLN.O have the only GLP-1 drug on the market in the United States, while GlaxoSmithKline (GSK.L), Roche ROG.VX and other are developing competing products.

GLPs work by encouraging the pancreas to produce more insulin.

Novo is also working to develop a version of insulin that can be given by mouth rather than injection.

The development of an oral versions of a GLP-1 drug and insulin represent a broad push by Novo Nordisk to develop next-generation treatments for diabetes — a disease which all drug companies view as a major opportunity for future growth.

Editing by Erica Billingham

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