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Jan 20, 2010

Novo Nordisk Gains Approval for Type 2 Diabetes Treatment in Japan

  • Novo Nordisk received Japanese regulatory clearance for the type 2 diabetes therapy Victoza® (liraglutide). The drug is indicated as either a monotherapy or along with sylphonylurea. Launch in Japan is expected during the first half of 2010 upon completion of price negotiations.

    Liraglutide is a human glucagon-like peptide-1 (GLP-1) analogue, designed to stimulate the release of insulin from pancreatic beta cells when blood sugar levels are high. European clearance for the drug was granted at the end of June 2009, and regulatory decisions by the FDA and Chinese authorities are pending.  The drug was submitted to FDA during May 2008 and to the Chinese regulatory body in August 2009.

    Liraglutide is also undergoing Phase III testing as a weight-loss treatment in nondiabetic obese individuals.

    Novo Nordisk’s pipeline candidates include the Phase III insulin products, SIBA and SIAC, in development for treating types 1 and 2 diabetes. Semaglutide is a longer-acting human GLP-1 analogue, currently in Phase II trials as a potential once-weekly treatment for type 2 diabetes. The drug utilizes Novo Nordisk's protein acylation technology.

    Additionally, last week Novo Nordisk reported the start of its first Phase I trial with another long-acting oral GLP-1 analogue (NN9924). The drug has been formulated using Emisphere Technologies’ Eligen® platform. Start of the study triggered a $2 million milestone payment to Emisphere. 

    Novo Nordisk’s product portfolio for type 1 and type 2 diabetes candidates includes a range of marketed insulins, modern insulins, and oral antidiabetics. The firm posted total diabetes-care sales of almost DKK 27.9 billion (roughly $5.29 billion) in the first nine months of 2009, up 11% in local currencies from the same period during 2008.

    In the first nine months of 2009, sales of modern insulins, human insulins, and protein-related products reached DKK 25.88 billion (about $4.91 billion), up 11% on the previous year’s figures. Sales of oral antidiabetic products were up 7% to DKK 2.02 billion, or approximately $383.12 million. Novo Nordisk claims to be the global leader in the diabetes market, commanding 51% (by volume) of the total insulin market and 45% of the modern insulin market.

     



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