Onyx Pharmaceuticals Provides an Update on BAY 43-9006 - Part 1.

(From Fair Disclosure Wire)

OPERATOR: Good morning. My name is Lynn, and I will be your conference facilitator. At this time, I would like to welcome everyone to the Onyx Pharmaceuticals conference call. All lines have been placed on mute to present any background noise. After the speakers' remarks, there will be a question-and-answer period. (Operator Instructions). Thank you. Ms. Wood, you may begin your conference. JULIE WOOD, VP IR AND CORPORATE COMMUNICATIONS, ONYX PHARMACEUTICALS: Thank you. And let me begin by apologizing for the delay. We had some technical difficulties on the vendor side, and I appreciate your patience. Good morning. As many of you know, I'm Julie Wood, Vice President Investor Relations and Corporate Communications at Onyx Pharmaceuticals. Thank you for joining us today to discuss the top line Phase II trial results, as well as the confirmation that Bayer and Onyx intend to pursue registration, pending data from the ongoing Phase III trial. In the Phase III trial, as well as in the Phase II trial, patients with advanced kidney cancer are receiving BAY 43- 9006, an anticancer agent that we are developing with Bayer Pharmaceuticals Corporation. Please note that this call, being held on October 25th, 2004, is the property of Onyx Pharmaceuticals. Any redistribution, retransmission, or rebroadcast of the call in any form without the express written consent of Onyx is strictly prohibited. After opening remarks by Mr. Hollings Renton, Onyx's CEO, Dr. Leonard Post, the Company's Senior Vice President of R&D, will summarize the conclusions from the Phase II randomized discontinuation trial, specifically regarding the renal patients. He will also discuss the Phase III trial. Following Len's remarks, Hollings will make some closing comments before opening up the call for questions. Dr. Scott Freeman, our Vice President of Clinical Affairs, will also be available during the Q&A period. Please note that we will be making forward-looking statements during this teleconference that could include clinical and commercial projections. Statements that are not historical fact are forward-looking. References to what we expect, believe, intend to do, plan, estimate, or other statements regarding future events or results are intended to identify these statements as forward-looking. Forward-looking statements are inherently subject to risks and uncertainties. For a discussion of these risks and uncertainties, we refer you to our annual report on Form 10-K, filed with the Securities and Exchange Commission on March 15th, 2004, specifically the section entitled additional business risks, as well as to our quarterly report on Form 10-Q. Also note that the forward-looking statements are based on our beliefs and assumptions as of today. These beliefs and assumptions may change as a result of future events or the passage of time, which would cause these forward-looking statements to be outdated and no longer our view. We undertake no duty to update these forward-looking statements. I'd now like to turn the call over to Hollings Renton. HOLLINGS RENTON, CHAIRMAN, PRESIDENT & CEO, ONYX PHARMACEUTICALS: Thank you, Julie. Good morning, and welcome, everyone. We are pleased to be talking with you today about our recent press release, announcing that the Phase II randomized discontinuation study met its primary end point in the renal cancer patients on the study, and confirming plans to pursue regulatory approval based on pending results from the ongoing pivotal Phase III study. Using this creative study design, we were able to meet the original product development goals that Bayer and Onyx established for the Phase II study. First, since BAY 43-9006 is not a classical cytotoxic agent, we wanted to rapidly identify an indication for a Phase III study to prove its full patient benefit. One year ago, we announced the selection of renal cancer as our first Phase III trial, and we were able to start the pivotal Phase III study within about a year of beginning the Phase II trial. Recapping the Phase II results, the 70 percent tumor shrinkage and disease stabilization that we originally reported for the first 50 patients…