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ZymoGenetics and Novo Nordisk Enter into Preclinical Development Alliance for Interleukin 21; Companies to Share Costs and Preclinical Data Leading up to IND Filing.


Business Editors & Health/Medical Writers

BIOWIRE2K

SEATTLE--(BUSINESS WIRE)--Jan. 9, 2003

ZymoGenetics, Inc. (Nasdaq:ZGEN) announced today the Company has signed a collaborative agreement with Novo Nordisk Wikipedia is not the place for advertisement or self-advertising. Novo Nordisk (, NYSE: NVO) manufactures and markets pharmaceutical products and services. Founded in Denmark in 1923, the company has since become a world leader in diabetes care with the broadest  A/S (NYSE NYSE

See: New York Stock Exchange
:NVO NVO

no visible oestrus (see no visible estrus). Called also NVE.
) for the preclinical development of Interleukin interleukin

Any of a class of naturally occurring proteins important in regulation of lymphocyte function. Several known types are recognized as crucial constituents of the body's immune system (see immunity).
 21 (IL-21).

Under terms of the agreement, ZymoGenetics and Novo Nordisk will collaborate on all research and development activities leading up to the filing of an Investigational New Drug application (IND) by ZymoGenetics in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. . Novo Nordisk will reimburse ZymoGenetics for a portion of its costs incurred prior to this agreement, and the two companies will equally share all costs of the program going forward. In total, ZymoGenetics could receive up to $11 million in payment or services under the agreement.

Previously, Novo Nordisk licensed the rights to IL-21 outside North America North America, third largest continent (1990 est. pop. 365,000,000), c.9,400,000 sq mi (24,346,000 sq km), the northern of the two continents of the Western Hemisphere. , however, the two parties were working independently to develop the protein. Under the collaborative agreement, ZymoGenetics will continue to maintain full commercial rights to IL-21 in North America, while Novo Nordisk may use all data, materials and intellectual property generated by the parties in its IL-21 development program outside North America. IL-21 is a protein that stimulates classes of immune cells that are involved in the body's ability to fight malignant or infected cells, and is being developed as a potential therapeutic for the treatment of cancer.

"This agreement marks a significant advance in the IL-21 development program and demonstrates our strategy to enter into collaborative partnerships as a way of leveraging our cash resources," commented Bruce L.A. Carter, Ph.D., President and Chief Executive Officer of ZymoGenetics. "Novo Nordisk's significant investment demonstrates their enthusiasm for the IL-21 project, and their intention to help move the product into the clinic. We are pleased to have expanded our relationship with Novo Nordisk, one of the world's leading developers of therapeutic proteins."

"IL-21 is an example of the high quality product candidates that ZymoGenetics has identified through its bioinformatics-driven discovery efforts," stated Mads Krogsgaard Thomsen, Executive Vice President and Chief Science Officer of Novo Nordisk A/S. "Partnering with ZymoGenetics to share preclinical development efforts should allow Novo Nordisk to advance IL-21 into clinical development outside North America in a more rapid and cost effective manner than if the two companies continued working independently. We are extremely pleased to have expanded our relationship with ZymoGenetics as we jointly work to move IL-21 towards the clinic."

Under the terms of the collaboration, ZymoGenetics and Novo Nordisk will form a joint steering committee to oversee the ongoing preclinical development activities for IL-21. The bulk of the work is expected to be performed by ZymoGenetics, with the IND scheduled to be filed in the first half of 2004. Additionally, the two companies agreed to continue negotiations toward a second agreement that could encompass further non-clinical and clinical development activities through to commercialization of IL-21. Additional details of the collaborative agreement were not disclosed.

About Interleukin 21 (IL-21)

IL-21, a novel protein discovered by ZymoGenetics' scientists, has been shown to activate key classes of immune cells, including cytotoxic T cells cytotoxic T cell
n.
See killer cell.
 and Natural Killer cells natural killer cells,
n.pl lymphocytes that are part of innate immunity that kill foreign substances and abnormal tissues. Decreased number or activi-ty has been linked to a number of diseases, including AIDS, cancer, chronic fatigue syndrome,
, cell types that can destroy malignant or infected cells. In preclinical studies preclinical studies,
n.pl a term used to describe research done before a clinical study. May be laboratory or epidemiologic research.
, IL-21 has been found to be an effective therapy in a number of animal models of cancer.

Based on its mechanism of action and effectiveness in animal models of tumor growth, ZymoGenetics is developing IL-21 for the treatment of cancer. The Company anticipates initiating clinical studies with IL-21 in 2004. Metastatic Metastatic
The term used to describe a secondary cancer, or one that has spread from one area of the body to another.

Mentioned in: Coagulation Disorders


metastatic

pertaining to or of the nature of a metastasis.
 melanoma and renal cell carcinoma renal cell carcinoma
 or hypernephroma

Malignant tumour of the cells that cover and line the kidney. It usually affects persons over age 50 who have vascular disorders of the kidneys. It seldom causes pain, unless it is advanced.
 are the first two indications the Company intends to target.

About ZymoGenetics

ZymoGenetics is a biopharmaceutical company focused on the discovery, development and commercialization of therapeutic proteins for the prevention or treatment of human diseases. Using a product discovery engine, comprising genomics, bioinformatics, protein chemistry and preclinical biology, ZymoGenetics has generated a broad pipeline of proprietary product candidates. ZymoGenetics intends to commercialize these product candidates through internal development, collaborations with biopharmaceutical partners, and out-licensing of its extensive patent portfolio. For further information, visit www.zymogenetics.com.

This press release contains "forward-looking statements" within the meaning of 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. These forward-looking statements are based on the current intent and expectations of the management of ZymoGenetics. These statements are not guarantees of future performance and involve risks and uncertainties that are difficult to predict. ZymoGenetics' actual results and the timing and outcome of events may differ materially from those expressed in or implied by the forward-looking statements because of risks associated with our unproven discovery strategy, preclinical and clinical development, regulatory oversight, intellectual property claims and litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute.

When a person begins a civil lawsuit, the person enters into a process called litigation.
 and other risks detailed in the company's public filings with the Securities and Exchange Commission, including the company's Annual Report on Form 10-K Form 10-K

A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information.


Form 10-K

See 10-K.
 for the year ended December 31, 2001.
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Publication:Business Wire
Geographic Code:1USA
Date:Jan 9, 2003
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