Form 8-K

ZYMOGENETICS, INC.

Date: December 11, 2009

/s/ JAMES A. JOHNSON

James A. Johnson

Executive Vice President, Chief Financial Officer and Secretary

-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, VFgZd4KvAy7hqDimnt2nEn1JFsKsOY7gZovnVRwa4oPms9Uu+D7GiT871GVnUxx9 AjbvND/Fv00eko9aBpG69w== 0001193125-09-251681.txt : 20091214 0001193125-09-251681.hdr.sgml : 20091214 20091211190654 ACCESSION NUMBER: 0001193125-09-251681 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 1 CONFORMED PERIOD OF REPORT: 20091211 ITEM INFORMATION: Other Events FILED AS OF DATE: 20091214 DATE AS OF CHANGE: 20091211 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ZYMOGENETICS INC CENTRAL INDEX KEY: 0001129425 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 911144498 STATE OF INCORPORATION: WA FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-33489 FILM NUMBER: 091237353 BUSINESS ADDRESS: STREET 1: 1201 EASTLAKE AVENUE E CITY: SEATTLE STATE: WA ZIP: 98102 BUSINESS PHONE: 206-442-6600 MAIL ADDRESS: STREET 1: 1201 EASTLAKE AVENUE E CITY: SEATTLE STATE: WA ZIP: 98102 8-K 1 d8k.htm FORM 8-K Form 8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8–K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

December 11, 2009

Date of Report (Date of earliest event reported)

ZYMOGENETICS, INC.

(Exact name of registrant as specified in its charter)

Washington

000-33489

91-1144498

(State or other jurisdiction

of incorporation)

(Commission File Number)

(I.R.S. Employer

Identification No.)


1201 Eastlake Avenue East Seattle, Washington		98102-3702
(Address of principal executive offices)		(Zip Code)

(206) 442-6600

(Registrant’s telephone number, including area code)

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2.):

¨	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

¨	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

¨	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

¨	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Item 8.01

Other Events.

On December 11, 2009, Bayer notified the European Medicines Evaluation Agency (EMEA) of Bayer’s decision to voluntarily withdraw the Marketing Authorization Application (MAA) for RECOTHROM^®, recombinant human thrombin, in Europe, in response to indications from the regulatory authorities that approval would not be forthcoming without additional clinical trial data. ZymoGenetics, Inc. licensed all rights to RECOTHROM outside the United States to Bayer in 2007.

It is the view of the Committee for Medicinal Products for Human Use (CHMP) that the data provided were not sufficient for approval because Bayer’s submission did not meet CHMP’s fibrin sealant guideline. The MAA was filed by Bayer in August 2008 based on data from ZymoGenetics’ Phase 3 clinical trial, which was conducted in the United States prior to the Bayer license transaction and which used a comparator, bovine thrombin, that is not available in Europe. Bayer proceeded with the approval application based on data from the United States trial after consulting with regulatory authorities in certain key member countries. Although RECOTHROM is not a fibrin sealant, it now appears that an additional clinical trial complying with the CHMP fibrin sealant guideline will be required to support approval in Europe.

This current report on Form 8-K 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 uncertainties that are difficult to predict. For example, ZymoGenetics has licensed the rights to develop and commercialize RECOTHROM in territories outside the United States to Bayer Schering Pharma AG, Germany. Consequently, we have limited ability to influence the development and commercialization of RECOTHROM outside the United States, in particular, ZymoGenetics has no assurance RECOTHROM will be approved in Europe or in other territories. In addition, the forward-looking statements in this press release are subject to the other risks detailed in the company’s Annual Report on Form 10-K for the year ended December 31, 2008, Quarterly Report on Form 10-Q for the quarter ended September 30, 2009 and from time to time in other reports filed by ZymoGenetics with the U.S. Securities and Exchange Commission. 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.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

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