GTC Biotherapeutics (fka GTCB)

[DewDiligence]

Novo Nordisk, Neose Announce Completion of Phase-1 Trial of NN7128 (Long-Acting FVIIa)

[Details such as the half-life and the safety profile are being kept under wraps until the data can be presented at an unspecified scientific conference. NN7138 is one of two attempts by NVO to deal with life after NovoSeven patent expiration in 2011 –– the other is a fast-acting FVIIa analog called NN1731, which is in phase-2.]

;http://biz.yahoo.com/bw/080602/20080602005164.html

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Monday June 2, 8:00 am ET

COPENHAGEN, Denmark & HORSHAM, Pa.--(BUSINESS WIRE)--Novo Nordisk A/S (NYSE: NVO ) and Neose Technologies, Inc. (Nasdaq GM: NTEC ) today announced that Novo Nordisk has completed the initial Phase 1 clinical trial with NN7128 (GlycoPEGylated Factor VIIa), a long-acting version of NovoSeven® Coagulation Factor FVIIa (Recombinant) administered intravenously. The trial assessed the safety and pharmacokinetics of NN7128 in 30 healthy subjects.

In the trial a significant prolongation of the half-life of NN7128 was observed. Furthermore, single doses of NN7128 were well tolerated with no serious adverse events. [Stay tuned for details.]

“We are pleased to report the successful completion of this Phase 1 study and to have demonstrated a prolonged half-life of NN7128,” said Søren Bjørn, Corporate Vice President, Biopharm Research at Novo Nordisk. “As we continue our analysis of the data collected in this study, we look forward to presenting the full results at upcoming scientific and medical meetings.”

“We are encouraged by the safety and pharmacokinetic profile that NN7128 has demonstrated in this Phase 1 study,” said George J. Vergis, Ph.D., Neose President and Chief Executive Officer. “We look forward to continued progress in the clinical development of this compound.”

About Coagulation Factor VIIa

Recombinant Factor VIIa is used in the treatment of bleeding episodes and for the prevention of bleeding during surgery or invasive procedures in patients with congenital hemophilia with inhibitors to coagulation factors VIII or IX. The worldwide market for hemophilia with inhibitors was more than 1 billion USD in 2007, with Novo Nordisk’s recombinant Factor VIIa dominating this market.
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