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Novo Nordisk Starts Clinical Trials of Longer-Acting Factor VIIa Product

Novo Nordisk and Neose Technologies, Inc., have begun a phase I clinical trial of GlycoPEGylated Factor VIIa, a longer-acting version of NovoSeven®, its recombinant factor VIIa product. The trial will assess the safety and pharmacokinetics (what happens to the drug once inside the body) of the new drug in healthy volunteers. The new product is being developed under a license agreement with Neose, which is based in Horsham, PA.

"Novo Nordisk is committed to developing therapies to prevent or reduce bleeding episodes and to improve the quality of life in patients with hemophilia," said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. "We are pleased that our collaboration with Neose has resulted in a long-acting Factor VIIa clinical development candidate that has the potential to contribute to this goal."

NovoSeven® is approved by the U.S. Food and Drug Administration to treat bleeding episodes and prevent bleeding during surgery or other invasive procedures, in people with hemophilia A or B patients who have developed inhibitors to FVIII or FIX. It is also approved to treat bleeding episodes, including during surgery or other invasive procedures, in patients with inherited FVII deficiency.

Source: Pharmaceutical Business Review Online, posted June 18, 2007