Novo Nordisk makes progress with oral insulin

NEW YORK Wed Nov 11, 2009 1:57pm EST

NEW YORK (Reuters) - Danish drugmaker Novo Nordisk (NOVOb.CO), the world's biggest insulin maker, said on Wednesday it is making progress in developing a tablet form of the drug -- a holy grail of diabetes therapy.

Patients with diabetes who need insulin, a naturally occurring protein that controls blood sugar, must currently inject themselves several times a day. Scientists have tried for years to come up with alternative way of delivering the drug.

Some have tried inhaled insulin, but the dramatic failure of Exubera, an inhaled insulin product made by Pfizer Inc (PFE.N), discouraged the biggest players -- including Novo Nordisk -- from further involvement in the field.

Speaking at the Reuters Health Summit, Lars Sorensen, Novo's chief executive, said development of an oral insulin would be "a potential game-changer" in the diabetes field and said the company could bring a product to the market within six years.

While inhaled insulin has been dogged by concerns it could cause lung damage, the challenge for scientists trying to develop insulin tablets is that insulin degrades quickly in the stomach, meaning only a very small amount reaches the bloodstream. Novo may have found a way around the problem.

"We have seen some interesting leads that makes us believe it might be feasible," Sorensen said. "We have the first product candidates going into human clinical trials as we speak, but it is a very complex issue because proteins need to be changed to be more acid stable."

The development of an oral insulin is part of a broader push by Novo Nordisk to develop next-generation diabetes treatments. The company is also working to develop the first tablet form of its protein-based injectable diabetes drug Victoza, which it believes will be key to keeping it ahead in an increasingly competitive market.

Victoza is one of a class of injectable GLP-1 drugs which encourage the pancreas to produce more insulin. It is on sale in Europe but has yet to win approval in the United States since concerns about potential inflammation of the pancreas and thyroid cancer hover over the class.

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

"It is likely to be a large market if the class survives this regulating scrutiny," Sorensen said.

Diabetes is caused by the body's failure to make insulin, or to respond to it properly. Patients with Type 1 diabetes, who represent a small portion of all diabetics, require a continuous supply of insulin.

Patients with Type II diabetes, often caused by obesity, typically begin by taking a chemically made oral medication such as metformin or Merck & Co Inc's (MRK.N) Januvia, but almost inevitably move to insulin.

Insulin injections have been used since the early 1920s and have gone through several advances. By reducing the concentration of glucose in the blood, insulin can prevent or reduce the long-term complications of diabetes, including damage to the blood vessels, eyes, kidneys and nerves.

An oral insulin would represent the fifth-generation insulin, and be a major technological breakthrough if successful.

(Reporting by Toni Clarke and Ben Hirschler, editing by Matthew Lewis)

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