-----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, LcCpTTfXpCbmiwmnyE/urnBhIFFQ8uasZxyB3sbr3FlFnft/Xg4peBb+U6bkosp7 7yZhuXOOrAvyARuyKis2QQ== 0001104659-03-011781.txt : 20030605 0001104659-03-011781.hdr.sgml : 20030605 20030605143453 ACCESSION NUMBER: 0001104659-03-011781 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 20030604 ITEM INFORMATION: Other events ITEM INFORMATION: Financial statements and exhibits FILED AS OF DATE: 20030605 FILER: COMPANY DATA: COMPANY CONFORMED NAME: CERUS CORP CENTRAL INDEX KEY: 0001020214 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 680262011 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-21937 FILM NUMBER: 03733940 BUSINESS ADDRESS: STREET 1: 2411 STANWELL DR CITY: CONCORD STATE: CA ZIP: 94520 BUSINESS PHONE: 9252886000 MAIL ADDRESS: STREET 1: 2525 STANWELL DRIVE STREET 2: STE 300 CITY: CONCORD STATE: CA ZIP: 94520 FORMER COMPANY: FORMER CONFORMED NAME: CERUS TECHNOLOGIES INC DATE OF NAME CHANGE: 19960731 8-K 1 j1819_8k.htm 8-K

 

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

 

Date of Report (Date of earliest event reported):  June 4, 2003

 

CERUS CORPORATION

(Exact name of registrant as specified in its charter)

 

 

 

 

 

Delaware

 

0-21937

 

68-0262011

(State of jurisdiction)

 

(Commission File No.)

 

(IRS Employer Identification No.)

 

 

 

 

 

2411 Stanwell Drive
Concord, California 94520

(Address of principal executive offices and zip code)

 

 

 

 

 

Registrant’s telephone number, including area code: (925) 288-6000

 

 



 

Item 5.  Other Events.

 

On June 4, 2003, Cerus Corporation (the “Company”) and Baxter International, Inc. (“Baxter”) announced that the Company and Baxter reached agreement with the U.S. Food and Drug Administration on steps for regulatory approval for their pathogen inactivation system for platelets.  A copy of the Company’s press release is attached as Exhibit 99.1 hereto and is incorporated herein by reference.

 

Item 7.  Exhibits.

 

Exhibit
Number

 

Description of Exhibit

99.1

 

Press Release, dated June 4, 2003, entitled “Baxter and Cerus Reach Agreement With FDA On Steps To Gain Regulatory Approval For Innovative Pathogen Inactivation System.”

 

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SIGNATURE

 

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.

 

 

 

CERUS CORPORATION

 

 

 

 

 

 

 

 

Dated:

June 4, 2003

By:

   /s/  Gregory W. Schafer

 

 

 

 

Gregory W. Schafer

 

 

 

Vice President, Finance and
Chief Financial Officer

 

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Index to Exhibits

 

Exhibit
Number

 

Description of Exhibit

99.1

 

Press Release, dated June 4, 2003, entitled “Baxter and Cerus Reach Agreement With FDA On Steps To Gain Regulatory Approval For Innovative Pathogen Inactivation System.”

 

4


EX-99.1 3 j1819_ex99d1.htm EX-99.1

Exhibit 99.1

 

 

 

For Cerus

 

For Baxter

Media and Investor Relations:

 

Media:

Sylvia Wheeler, (925) 288-6061

 

Tanya Tyska, (847) 270-4918, North America

Lisa Luttinger, (925) 288-6036

 

Jed Weiner, (847) 270-3928, North America

 

 

Patty O’Hayer, 32 2 650 1924, Europe

 

 

 

 

 

Investor Relations:

 

 

Neville Jeharajah, (847) 948-2875

 

 

Mary Kay Ladone, (847) 948-3371

 

BAXTER AND CERUS REACH AGREEMENT WITH FDA

ON STEPS TO GAIN REGULATORY APPROVAL

FOR INNOVATIVE PATHOGEN INACTIVATION SYSTEM

 

DEERFIELD, ILL. and CONCORD, CALIF., June 4, 2003—Subsidiaries of Baxter International Inc. (NYSE: BAX) and Cerus Corporation (Nasdaq: CERS) announced today that the companies reached agreement with the U.S. Food and Drug Administration (FDA) on steps for regulatory approval for their pathogen inactivation system for platelets.

 

Baxter and Cerus have been in ongoing discussions with the FDA throughout the submission of their modular application for their pathogen inactivation system for platelets.  The steps that have been agreed upon include conducting a supplemental platelet transfusion study and performing additional analysis of the U.S. Phase III clinical trial data.  The clinical trial will be carried out using the commercial set and will provide additional data to address FDA questions related to platelet performance in the U.S. Phase III clinical trial.  This commercial set has previously undergone successful European clinical testing and is now commercially available in Europe.

 

“We are pleased to have reached this agreement, and with these two additional steps we now have a clear path to complete the regulatory submission process,” said Stephen T. Isaacs, president and chief executive officer of Cerus.  “Our resolve is strong to make the blood supply as safe as possible and we are committed to moving expeditiously to bring this innovative technology to the marketplace.”

 

-more-

 



 

 

Greg Young, corporate vice president and president of Baxter’s Transfusion Therapies business said,  “We continue to work collaboratively with the FDA throughout this process, and accept the responsibility that comes with being leaders looking to bring an innovative critical care therapy to the marketplace.  Baxter and Cerus are dedicated to taking all necessary steps required by the FDA to definitively demonstrate that our pathogen inactivation system will offer an additional layer of safety to the nation’s blood supply.”

 

The two companies expect to complete the additional steps in the next 15-18 months with regulatory submission to follow shortly thereafter.

 

Baxter and Cerus’ pathogen inactivation system is being developed to potentially protect patients by reducing the risk of transfusion-transmitted diseases.  The system is designed to go a step beyond current blood safety measures, which test for certain infectious diseases, by inactivating a broad spectrum of pathogens, including viruses, bacteria, parasites and potentially harmful donor white blood cells in blood components intended for transfusion.  For platelets, the system uses a light-activated compound that is designed to target and inactivate pathogens containing DNA and RNA, such as HIV and hepatitis B and C, and to render them harmless by preventing them from replicating.

 

In 2002 the companies received regulatory approval in Europe for the technology, known as the INTERCEPT Blood System for platelets.  The INTERCEPT Blood System is the only pathogen inactivation system that is approved and available for use in Europe with platelets. Patients undergoing chemotherapy, heart bypass surgery and other procedures that require platelet transfusions are expected to benefit from this technology.

 

Cerus and Baxter are conducting clinical trials of their pathogen inactivation system for use with plasma and red blood cells for transfusion, making their system the only pathogen inactivation technology currently being developed for use with all primary blood components.

 

Baxter International Inc. assists health-care professionals and their patients with treatment of complex medical conditions, including cancer, hemophilia, immune disorders, kidney disease

 

2



 

and trauma. The company applies its expertise in medical devices, pharmaceuticals and biotechnology to make a meaningful difference in patients’ lives. For more information about Baxter, please visit www.baxter.com.

 

Cerus Corporation is developing medical systems and therapeutics to provide safer and more effective options to patients. The company is developing products based on its proprietary Helinx® technology for controlling biological replication. Cerus’ most advanced programs are focused on systems to enhance the safety of the world’s blood supply. The INTERCEPT Blood System, which is being developed in collaboration with subsidiaries of Baxter International Inc. is based on the company’s Helinx technology.  The Concord, California-based company also is pursuing therapeutic applications of Helinx technology to treat and prevent serious diseases.

 

Helinx is a U.S. registered trademark of Cerus Corporation.

Baxter and INTERCEPT Blood are trademarks of Baxter International Inc.

 

Statements in this news release regarding regulatory filings, product development and commercial potential are forward-looking statements that involve risks and uncertainties.  Actual results could differ materially from the above forward-looking statements as a result of certain factors, including the risks and uncertainty of the timing and results of clinical trials and other development activities, actions by regulatory authorities at any stage of the development and commercialization process, additional financing activities, manufacturing, market acceptance of any products, competitive conditions and other factors discussed in the companies’ most recent filings with the Securities and Exchange Commission.

 

# # #

 

3


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