Novo Nordisk and Neose Announce Completion of Initial Phase 1 Clinical Trial of NN7128 (Long-Acting Factor VIIa)COPENHAGEN, Denmark & HORSHAM, Pa.--(BUSINESS WIRE)--Jun 2, 2008 - 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(R) 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," said S0ren Bj0rn, 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.
About Novo Nordisk A/S
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 hemostasis management, growth hormone therapy and hormone replacement therapy. Novo Nordisk manufactures and markets pharmaceutical products and services that make a substantial 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 Nordisk's 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.
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 hemostasis compounds Factor VIIa, Factor VIII, and Factor IX, target markets with aggregate 2006 sales of approximately $8 billion. For more information, please visit www.neose.com.
Neose "Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995: Statements in this press release regarding our business that are not historical facts are "forward-looking statements" that involve risks and uncertainties, including without limitation the risk that none of the collaborations will continue or will be successful, the risk that clinical trials for Factor VIIa will not be successful, and the risk that GlycoPEGylated versions of Factors VIIa, VIII and IX will not be successfully developed or commercialized. For a discussion of these risks and uncertainties, any of which could cause our actual results to differ from those contained in the forward-looking statement, see the sections of Neose's Annual Report on Form 10-K for the year ended December 31, 2007, entitled "Risk Factors" and "Special Note Regarding Forward-Looking Statements" and discussions of potential risks and uncertainties in Neose's subsequent filings with the SEC.
Neose Technologies, Inc.
A. Brian Davis
Sr. Vice President and Chief Financial Officer
Novo Nordisk A/S
Mike Rulis, (+45) 4442 3573
Outside North America:
Mads Veggerby Lausten, (+45) 4443 7919
Hans Rommer, (+45) 4442 4765
In North America:
Christian Qvist Frandsen, (+1) 609-919-7937
Posted: June 2008