ZymoGenetics Announces Completion of Enrollment in Phase 2b Clinical Trial with PEG-Interferon lambda in Hepatitis C

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ZymoGenetics Announces Completion of Enrollment in Phase 2b Clinical Trial with

PEG-Interferon lambda in Hepatitis C

From the PharmaLive.com News Archive - Aug. 25, 2010

SEATTLE--(BUSINESS WIRE)--Aug 25, 2010 - ZymoGenetics, Inc. (NASDAQ:ZGEN) today

announced enrollment has been completed in the Phase 2b clinical trial with

PEG-Interferon lambda and ribavirin in chronic hepatitis C virus (HCV)

infection. ZymoGenetics is investigating PEG-Interferon lambda in collaboration

with Bristol-Myers Squibb Company (NYSE:BMY) for the treatment of HCV infection.

“We're very pleased to have completed the enrollment in the Phase 2b PEG-IFN

lambda clinical trial in less than three months,” said Eleanor L. Ramos, M.D.,

Senior Vice President and Chief Medical Officer of ZymoGenetics. “The rapid

enrollment to this study speaks to the motivation and enthusiasm of the clinical

trial investigators to help address the unmet medical need in hepatitis C and

also to the outstanding execution by our clinical team. We should now be able to

assess the primary endpoint earlier than originally projected, and we look

forward to assessing the data and planning for Phase 3.”

The Phase 2 EMERGE study is an international, randomized multi-center clinical

trial with PEG-Interferon lambda and ribavirin in treatment-naïve patients with

HCV. The Phase 2b study enrolled 570 patients with genotypes 1, 2, 3 and 4

chronic HCV infection. The study is assessing the safety and antiviral efficacy

of three doses of PEG-Interferon lambda (120 mcg, 180 mcg and 240 mcg) compared

to PEGASYS®. Weekly subcutaneous doses of PEG-Interferon lambda or PEGASYS are

being administered for 48 weeks in genotype 1 and 4 patients and for 24 weeks in

genotype 2 and 3 patients. All patients also receive daily ribavirin. The

primary endpoint of the trial is the proportion of patients who achieve

undetectable levels of HCV RNA after 12 weeks of therapy (complete Early

Virological Response). Achievement of Early Virologic Response will also be

assessed by patient IL-28B genotype, which has been shown to be a robust

predictor of treatment success with the combination of interferon-alpha and

ribavirin.

PEG-Interferon lambda

PEG-Interferon lambda (IL-29) is a novel interferon in development for hepatitis

C. The native human interferon lambda proteins are generated by the immune

system in response to viral infection, and signal through a different receptor

than type I interferons, such as interferon alpha. Because this receptor is

present on fewer cell types within the human body, it is hypothesized that

PEG-Interferon lambda may be able to demonstrate an improved safety and

tolerability profile compared to alpha interferons.

About ZymoGenetics

ZymoGenetics is a biopharmaceutical company focused on the development and

commercialization of therapeutic proteins for the treatment of human diseases.

The company has developed and is marketing RECOTHROM® Thrombin, topical

(Recombinant) in the United States. ZymoGenetics has two product candidates in

Phase 2 clinical development: PEG-Interferon lambda, being studied in

collaboration with Bristol-Myers Squibb for treatment of hepatitis C virus (HCV)

infection, and IL-21, being tested as a potential treatment for metastatic

melanoma. In addition, ZymoGenetics has an anti-IL-31 monoclonal antibody in

preclinical development, which it expects to test initially as a treatment for

atopic dermatitis. Several of the product candidates previously identified

through ZymoGenetics' discovery research efforts have been licensed to and are

being developed by third parties, including Merck Serono and Novo Nordisk.

ZymoGenetics is eligible to receive milestone payments and royalties related to

these assets. For further information, visit www.zymogenetics.com.

ZymoGenetics Forward-Looking Statements

This press release contains forward-looking statements, including statements

related to conducting and analyzing the results of clinical trials. Words such

as “believes,” “should” and “could” and similar expressions are intended to

identify forward-looking statements. These forward-looking statements are based

upon ZymoGenetics' current expectations and involve risks and uncertainties.

Actual results and the timing of events could differ materially from those

anticipated in such forward-looking statements as a result of these risks and

uncertainties, which include, without limitation, risks related to ZymoGenetics'

ability to design and conduct clinical trials, the possibility that clinical

trial results may vary between different arms of a clinical trial and the

difficulty of using prior clinical trial results to predict future outcomes, as

well as those other risks detailed in ZymoGenetics' filings with the Securities

and Exchange Commission, including its Annual Report on Form 10-K for the year

ended December 31, 2009 and periodic reports on Form 10-Q and current reports on

Form 8-K. Do not place undue reliance on these forward-looking statements, which

speak only as of the date of this press release. All forward-looking statements

are qualified in their entirety by this cautionary statement, and, except where

required by law, ZymoGenetics undertakes no obligation to revise or update any

forward-looking statements to reflect events or circumstances after the date of

this press release.

PEGASYS® (Peginterferon alfa-2a) is a registered trademark of Hoffman La Roche.

Contact: ZymoGenetics, Inc.

W. Specht 206-442-6592