Novo Nordisk and Neose Announce Initiation of Phase I Clinical Trial of Long-Acting Factor VIIa.COPENHAGEN, Denmark & HORSHAM, Pa. -- Novo Nordisk A/S (NYSE NYSE See: New York Stock Exchange :NVO NVO no visible oestrus (see no visible estrus). Called also NVE. ) and Neose Technologies, Inc. (NasdaqGM:NTEC NTEC National Tribal Environmental Council NTEC National Transportation Enhancements Clearinghouse NTEC Naval Training Equipment Center NTEC Network Terminal Equipment Center (AT&T) NTEC National Telecommunication Education Committee ) today announced that Novo Nordisk has initiated a Phase I clinical trial Noun 1. phase I clinical trial - a clinical trial on a few persons to determine the safety of a new drug or invasive medical device; for drugs, dosage or toxicity limits should be obtained phase I of GlycoPEGylated Factor VIIa, a long-acting version of NovoSeven[R] Coagulation Factor VIIa coagulation factor VIIa (recombinant) NovoSeven Pharmacologic class: Coagulation factor VIIa Therapeutic class: Antihemophilic agent Pregnancy risk category C Action(Recombinant). The trial will assess the safety and pharmacokinetics of GlycoPEGylated Factor VIIa in healthy volunteers.GlycoPEGylated Factor VIIa is being developed by Novo Nordisk under a license agreement with Neose. The initiation of the Phase I study triggers an undisclosed milestone payment to Neose under the license agreement. "Novo Nordisk is committed to developing therapies to prevent or reduce bleeding episodes and to improve the quality of life in patients with hemophilia. 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," said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. "We are pleased that GlycoPEGylated Factor VIIa has entered clinical development, making it the third GlycoPEGylated therapeutic protein to reach this milestone. Novo Nordisk has proved to be an ideal partner for this development candidate, and we are confident that their clinical expertise will continue to add value to this program," said George J. Vergis, Ph.D., Neose president and chief executive officer." About Coagulation Factor VII coagulation factor VII Factor VII, see there Factor VII/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 recombinant Factor VII was approximately $1 billion in 2006, with Novo Nordisk being the only participant. About Novo Nordisk A/S Novo Nordisk is a healthcare company and a world leader in diabetes care. The company has the broadest diabetes product portfolio in the industry, including the most advanced products within the area of insulin delivery systems. In addition, Novo Nordisk has a leading position within areas such as haemostasis hemostasis, haemostasis the stoppage of bleeding or cessation of the circulation of the blood; stagnation of the blood in a part of the body. Also hemostasia, haemostasia. See also: Blood and Blood Vessels Noun 1. management, growth hormone therapy and hormone replacement therapy Hormone Replacement Therapy Definition Hormone replacement therapy (HRT) is the use of synthetic or natural female hormones to make up for the decline or lack of natural hormones produced in a woman's body. . 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 more than 23,600 employees in 79 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 New York Stock Exchange (NYSE) World's largest marketplace for securities. The exchange began as an informal meeting of 24 men in 1792 on what is now Wall Street in New York City. under the symbol 'NVO'. For more information, visit 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, on its own and through strategic partnerships. The lead candidates in its pipeline, NE-180 for use in the treatment of chemotherapy-induced anemia and anemia associated with chronic renal failure chronic renal failure Chronic kidney failure Nephrology A slow decline in renal function, which may be 2º to chronic HTN, DM, CHF, SLE, or sickle cell anemia and, if extreme, leads to ESRD, mandating kidney dialysis; an abrupt decline in renal function may be and GlycoPEG-GCSF for chemotherapy-induced neutropenia, target markets with aggregate sales in excess of $15 billion. For more information, please visit www.neose.com. Neose "Safe Harbor" Statement under the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and 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 the collaboration will not continue or will not be successful, the risk that the clinical trial will not be successful or that a GlycoPEGylated version of Factor VIIa will not be successfully developed. 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, 2006, 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. |
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