Novo Nordisk A/S (NYSE:NVO) and Neose Technologies, Inc. (Nasdaq GM: NTEC) 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.
"We are pleased to report the successful completion of this phase 1 study and to have demonstrated a prolonged half-life of NN7128,â said Søren Bjørn, corporate vice president, Biopharmaceuticals Research Unit at Novo Nordisk. âAs 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, PhD, 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 haemophilia with inhibitors to coagulation factors VIII or IX. The worldwide market for haemophilia with inhibitors was more than 1 billion US dollars in 2007, with Novo Nordiskâs recombinant factor VIIa dominating this market.
About Neose Technologies, Inc.
Neose Technologies, Inc. is a clinical-stage biopharmaceutical company focused on the development of next-generation therapeutic proteins that are competitive with best-in-class protein drugs currently on the market. The lead candidates in its pipeline, GlycoPEG-GCSF for chemotherapy-induced neutropenia, and the GlycoPEGylated haemostasis compounds factor VIIa, factor VIII and factor IX, target markets with aggregate 2006 sales of approximately 8 billion US dollars. For more information, please visit www.neose.com.
About Novo Nordisk
Novo Nordisk is a healthcare company and a world leader in diabetes care. In addition, Novo Nordisk has a leading position within areas such as haemostasis management, growth hormone therapy and hormone replacement therapy. Novo Nordisk manufactures and markets pharmaceutical products and services that make a significant difference to patients, the medical profession and society. With headquarters in Denmark, Novo Nordisk employs approximately 26,300 employees in 80 countries, and markets its products in 179 countries. Novo Nordiskâs B shares are listed on the stock exchanges in Copenhagen and London. Its ADRs are listed on the New York Stock Exchange under the symbol 'NVO'. For more information, visit www.novonordisk.com.