, the world's biggest seller of insulin products, said Friday that it expects to resume late-stage clinical testing of its inhaled insulin device during the first quarter.
The Danish company's announcement comes one day after
received approval from the European Union for their inhaled insulin called Exubera. In addition, the Food and Drug Administration may rule today on Exubera.
Novo Nordisk's development of inhaled insulin has proceeded in fits and starts, punctuated with some setbacks. Even if the company's late-stage clinical research and regulatory efforts go smoothly in the future, analysts say a product probably wouldn't reach the market until the end of the decade. Novo Nordisk is using inhalation technology licensed from the U.S. company
Novo Nordisk said improvements on its AERx inhaled insulin project are "almost completed," and that the company "expects to confirm" resumption of clinical trials during the first quarter. "This confirmation will be partly subject to FDA's acceptance of final specifications for the AERx system," the company said.
The announcement accompanied the release of full-year earnings. For the year ended Dec. 31, the company earned $978 million, or $2.97 a share. Net earnings rose 17% and earnings per share rose 20% vs. 2004.
Total sales rose 16% to $5.63 billion in 2005. Sales of diabetes-care products, which account for nearly three-fourths of corporate revenue, rose 17% to $4 billion.
"Novo Nordisk insulin now constitutes more than half of the insulin sold globally, and we expect the strong demand for our strategic products to continue in 2006 despite increased competition," said Lars Rebien Sorensen, president and CEO. In early afternoon trading, Novo Nordisk's stock was down 90 cents, or 1.6%, to $55.84.