-----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, RqxQ1qLAEVQdFz4e+YRQ1dSRku3MMRGaO52wc9jgtdaKdocLOuXDMS1IjvRdx3gy 0Om7AbPda5KP//XD72N8EQ== 0000950149-03-001343.txt : 20030612 0000950149-03-001343.hdr.sgml : 20030612 20030612161801 ACCESSION NUMBER: 0000950149-03-001343 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20030611 ITEM INFORMATION: Other events ITEM INFORMATION: Financial statements and exhibits FILED AS OF DATE: 20030612 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ONYX PHARMACEUTICALS INC CENTRAL INDEX KEY: 0001012140 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 943154463 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-28298 FILM NUMBER: 03742356 BUSINESS ADDRESS: STREET 1: 3031 RESEARCH DR STREET 2: BLDG A CITY: RICHMOND STATE: CA ZIP: 94806 BUSINESS PHONE: 5102229700 MAIL ADDRESS: STREET 1: 3031 RESEARCH DRIVE CITY: RICHMOND STATE: CA ZIP: 94806 8-K 1 f90878e8vk.htm FORM 8-K e8vk
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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

Date of Report (Date of earliest event reported): June 11, 2003

ONYX PHARMACEUTICALS, INC.


(Exact name of registrant as specified in its charter)

Delaware


(State or other jurisdiction of incorporation)
     
0-28298   94-3154463

 
(Commission File No.)   (IRS Employer Identification No.)

3031 Research Drive
Richmond, California 94806


(Address of principal executive offices and zip code)

Registrant’s telephone number, including area code: (510) 222-9700

 


ITEM 5. OTHER EVENTS
ITEM 7. FINANCIAL STATEMENTS AND EXHIBITS
SIGNATURES
EXHIBIT INDEX
Exhibit 99.1


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ITEM 5. OTHER EVENTS

     On June 11, 2003, Onyx Pharmaceuticals, Inc. announced that it is further prioritizing the development of BAY 43-9006, a novel small molecule anticancer compound in co-development with Bayer Pharmaceuticals Corporation. In connection with this change in priority, Onyx is restructuring its operations and will discontinue its therapeutic virus program. This restructuring will result in a reduction in force of approximately 50 of Onyx’s employees, most of whom were dedicated to the virus program. Onyx’s remaining scientific and administrative personnel will be focused on furthering the development of BAY 43-9006. The press release issued by Onyx Pharmaceuticals, dated June 11, 2003, titled “Onyx To Focus Exclusively on Small Molecule Cancer Program: BAY 43-9006 Takes Priority as Therapeutic Virus Program is Discontinued,” is attached hereto as Exhibit 99.1.

ITEM 7. FINANCIAL STATEMENTS AND EXHIBITS

(c) Exhibits

     
Exhibit Number   Description

 
99.1   Press Release titled “Onyx To Focus Exclusively on Small Molecule Cancer Program: BAY 43-9006 Takes Priority as Therapeutic Virus Program is Discontinued,” dated June 11, 2003

 


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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.

         
    ONYX PHARMACEUTICALS, INC. (Registrant)
   
Dated: June 12, 2003   By:   /s/ Hollings C. Renton
       
        Hollings C. Renton
Chairman of the Board,
President and Chief Executive Officer
   
Dated: June 12, 2003   By:   /s/ Marilyn E. Wortzman
       
        Marilyn E. Wortzman
Vice President, Finance

 


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EXHIBIT INDEX

     
Number   Description

 
99.1   Press release titled “Onyx To Focus Exclusively on Small Molecule Cancer Program: BAY 43-9006 Takes Priority as Therapeutic Virus Program is Discontinued,” dated June 11, 2003

  EX-99.1 3 f90878exv99w1.txt EXHIBIT 99.1 EXHIBIT 99.1 ONYX TO FOCUS EXCLUSIVELY ON SMALL MOLECULE CANCER PROGRAM BAY 43-9006 TAKES PRIORITY AS THERAPEUTIC VIRUS PROGRAM IS DISCONTINUED RICHMOND, Calif., June 11, 2003 - Onyx Pharmaceuticals, Inc. (Nasdaq:ONXX) today announced that the company is further prioritizing the clinical development of BAY 43-9006, a novel anticancer compound expected to enter Phase III clinical testing later this year. Based on encouraging results to date from Phase I and Phase Ib clinical trials, the company, together with its partner Bayer Pharmaceuticals Corporation, intends to pursue multiple clinical paths with BAY 43-9006. As a result, Onyx will discontinue its therapeutic virus program, resulting in a reduction in force of approximately 50 of the company's employees, most of whom were dedicated to the virus program. Following this reduction in force, Onyx's remaining scientific and administrative personnel will be focused on furthering the development of BAY 43-9006. Onyx expects to record a restructuring charge related to this activity in the third quarter of this year. It is estimated that the company will save approximately $4 million on a quarterly basis. However, these savings are expected to be offset by increased clinical development expenses for BAY 43-9006 as the compound enters Phase III testing. "Though the decision to close our therapeutic virus program was not an easy one, it was an appropriate business action," said Hollings Renton, Onyx's chairman and chief executive officer. "BAY 43-9006 has continued to generate positive data in clinical trials, resulting in some difficult but necessary portfolio management choices." Mr. Renton continued, "Without a corporate partner in the near term to share the investment needed to make meaningful progress in our therapeutic virus program, we cannot continue to fund this program as well as BAY 43-9006. At this point in time, it is important that we apportion our resources in a way that will most directly advance the commercialization of BAY 43-9006." According to the codevelopment collaboration between Onyx and Bayer, Onyx funds 50 percent of the development costs for BAY 43-9006. In return, Onyx will share equally in any profits generated in the United States, where the companies can copromote the product. Everywhere else in the world, except Japan, Onyx's share of any profits will be somewhat less than 50 percent since Bayer has exclusive marketing rights. In Japan, Bayer will fund product development, and Onyx will receive a royalty based on any sales. To date, BAY 43-9006 has been evaluated in hundreds of patients with cancer. Clinical trials include four completed Phase I single agent studies, eight ongoing Phase Ib studies combining BAY 43-9006 with different standard chemotherapies and two ongoing Phase II single agent studies. Final Phase I monotherapy results, along with data from two of the Phase Ib combination studies, were recently reported at the annual meeting of the American Society of Clinical Oncology (ASCO). Onyx and Bayer intend to conduct further clinical testing of BAY 43-9006, including a Phase III study planned for later this year. Cancer is the second leading cause of death in the U.S. Despite its prevalence, many forms of cancer are inadequately treated with conventional approaches. Due to this large unmet medical need, BAY 43-9006 may have significant commercial potential across a number of tumor types -- either as a monotherapy or in tandem with current treatments with chemotherapeutic agents. "Though we are winding down our therapeutic virus program, I have great faith in the ultimate potential of this novel approach. We are leaving open the option of restarting this program, either directly or in combination with outside investigators," said Mr. Renton. "Our employees have made important scientific progress in this area, and I thank them for their numerous contributions." ABOUT ONYX PHARMACEUTICALS Onyx Pharmaceuticals is engaged in the development of novel cancer therapies and has proprietary technologies that target the molecular basis of cancer. The company is developing small molecule drugs, including BAY 43-9006 in codevelopment with Bayer. For more information about Onyx's pipeline and activities, visit the company's website at www.onyx-pharm.com. This news release contains forward-looking statements regarding expectations as to timing and amount of any restructuring charges; cost savings or clinical development expenses; the company's plans as to the development of BAY 43-9006, including further clinical testing and the timing of such clinical trials; the company's expectations or beliefs of the commercial potential of BAY 43-9006; and its plans with respect to strategic alternatives for its therapeutic virus program. These forward-looking statements involve a number of risks and uncertainties that could cause actual events to differ from the company's expectations. These risks are addressed in the company's periodic reports filed with the Securities and Exchange Commission, including but not limited to its Annual Report on Form 10-K filed on March 25, 2003 and its Quarterly Reports on Form 10-Q. -----END PRIVACY-ENHANCED MESSAGE-----