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): October 25, 2004
ONYX PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
Delaware
(State or other jurisdiction of incorporation)
| | | |
0-28298
(Commission File No.) | | 94-3154463
(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
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:
[ ] 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))
TABLE OF CONTENTS
ITEM 8.01 OTHER EVENTS
On October 25, 2004, Onyx Pharmaceuticals, Inc., or Onyx, and Bayer Pharmaceuticals Corporation confirmed plans to pursue registration of BAY 43-9006 for the treatment of patients with advanced kidney cancer utilizing results from the ongoing Phase III trial. It is anticipated that data from the recently completed Phase II Randomized Discontinuation trial will be used in support of the Phase III trial results. BAY 43-9006 is being evaluated by Onyx and Bayer Pharmaceuticals for the treatment of metastatic renal cell carcinoma, or advanced kidney cancer. The press release dated October 25, 2004, titled “Bayer and Onyx Announce Positive Phase II Data in Patients with Advanced Kidney Cancer,” is attached hereto as Exhibit 99.1 and is incorporated by reference herein.
Neither the filing of any press release as an exhibit to this Current Report on Form 8-K nor the inclusion in that press release of a reference to Onyx’s Internet address or Bayer Pharmaceuticals’ Internet address shall, under any circumstances, be deemed to incorporate the information available at such Internet addresses into this Current Report on Form 8-K. The information available at such Internet addresses is not part of this Current Report on Form 8-K or any other report filed by Onyx with the Securities and Exchange Commission.
This Current Report and exhibit incorporated herein contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities and Exchange Act, as amended, regarding the timing, progress and results of the clinical development, regulatory processes and commercialization efforts of BAY43-9006. The forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those referred to in the forward-looking statements. These risks include, but are not limited to, those associated with the timeline for clinical activity, results of pending or future clinical trials, changes in the status of Onyx’s collaborative relationships and Onyx’s expectations or beliefs of the commercial potential of BAY 43-9006. More information about Onyx Pharmaceuticals and these and other risks related to Onyx is detailed in Onyx’s most recent annual report on Form 10-K for the fiscal year ended December 31, 2003 and subsequent quarterly reports on Form 10-Q as filed with the U.S. Securities and Exchange Commission. Onyx cannot guarantee any future results, levels of achievement or performance. Onyx does not undertake an obligation to update forward-looking statements.
ITEM 9.01 FINANCIAL STATEMENTS AND EXHIBITS
(c) Exhibits
| | | |
Exhibit Number | | Description |
| | | |
| 99.1 | | Press Release titled “Bayer and Onyx Announce Positive Phase II Data in Patients with Advanced Kidney Cancer,” dated October 25, 2004. |
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. |
| Dated: October 25, 2004 | | By: | | /s/ Marilyn E. Wortzman
Marilyn E. Wortzman
Vice President, Finance and
Administration |
EXHIBIT INDEX
| | | |
Number | | Description |
| | | |
| 99.1 | | Press Release titled “Bayer and Onyx Announce Positive Phase II Data in Patients with Advanced Kidney Cancer,” dated October 25, 2004. |
