Novo Nordisk begins phase 1 study with rFXIII in cardiac surgery (18 Oct 2005)
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Milestone payment earned by ZymoGenetics
Copenhagen and Seattle, 18 October 2005 – Novo Nordisk A/S and ZymoGenetics, Inc (Nasdaq: ZGEN) today announced that the first patient has been dosed in a phase 1 study with rFXIII (recombinant coagulation factor XIII) in patients undergoing cardiac surgery. The purpose of the study is primarily to investigate the safety of a range of rFXIII doses in patients being treated at major hospital institutions in North America and Europe.
In late 2004, Novo Nordisk A/S obtained a worldwide exclusive licence to rFXIII under ZymoGenetics’ patent rights and know-how. The phase 1 study in cardiac surgery is the first of several rFXIII studies planned by Novo Nordisk. Upon initiation of the study, ZymoGenetics earned an undisclosed milestone payment under the licence agreement.
Novo Nordisk has significant expertise in the field of bleeding and coagulation disorders that is now being applied to the development of rFactor XIII.
About recombinant coagulation factor XIII (rFactor XIII)
Coagulation factor XIII plays an important role in the maintenance of haemostasis through cross-linking of fibrin and other coagulation molecules. Factor XIII is the terminal enzyme in the clotting cascade and is responsible for stabilising blood clots. Its primary function is to crosslink individual fibrin molecules into a strong fibrin mesh. Individuals with congenital factor XIII deficiency have a high risk of bleeding into the brain and in soft tissues. Clinical experience related to use of plasma-derived factor XIII shows significant potential for factor XIII therapy in a variety of indications.
About Novo Nordisk
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 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 21,200 full-time employees in 78 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 novonordisk.com.
The above sections contain forward-looking statements as the term is defined in the US Private Securities Litigation Reform Act of 1995. Forward-looking statements provide current expectations or forecasts of events such as new product introductions, product approvals and financial performance. Such forward-looking statements are subject to risks, uncertainties and inaccurate assumptions. This may cause actual results to differ materially from expectations. Factors that may affect future results include interest rate and currency exchange rate fluctuations, delay or failure of development projects, production problems, unexpected contract breaches or terminations, government-mandated or market-driven price decreases for Novo Nordisk's products, introduction of competing products, Novo Nordisk's ability to successfully market both new and existing products, exposure to product liability and other lawsuits, changes in reimbursement rules and governmental laws and related interpretation thereof, and unexpected growth in costs and expenses. Risks and uncertainties are further described in reports filed by Novo Nordisk with the US Securities and Exchange Commission (SEC) including the company's Form 20-F, which was filed on 21 February 2005. Please also refer to the section 'Risk Management' in the Annual Report 2004. Novo Nordisk is under no duty to update any of the forward-looking statements or to conform such statements to actual results, unless required by law.
ZymoGenetics is a biopharmaceutical company focused on the discovery, development and commercialisation of therapeutic proteins for the prevention or treatment of human diseases. The company is developing a diverse pipeline of potential proprietary product candidates that are moving into and through clinical development. These span a wide array of clinical opportunities that include bleeding, autoimmune diseases and cancer. ZymoGenetics intends to commercialise these product candidates through internal development, collaborations with partners and out-licensing of patents from its extensive patent portfolio. For further information, visit zymogenetics.com.
This press release contains ‘forward-looking statements’ within the meaning of the Private Securities Litigation Reform Act 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 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 for the year ended 31 December 2004. Except as required by law, ZymoGenetics undertakes no obligation to update any forward-looking or other statements in this press release, whether as a result of new information, future events or otherwise.
For further information please contact:
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John Calhoun, MD, MBA
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Susan W Specht, MBA
Corporate Communications Manager
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