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ONYX Pharmaceuticals, Inc. (ONXX)

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Onyx Pharmaceuticals develops small molecule drugs to treat cancer. The company's lead product, Nexavar has been approved by the U.S. and E.U. for the treatment of patients with advanced kidney cancer. Nexavar is developed and marketed in collaboration with Bayer Pharmaceuticals (BAY) of Germany.[1]

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Funds w/ ONXX: 12
Rank: 340 / 351



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Company Analysis

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Company Background

Emeryville, CA based Onyx Pharmaceutical was founded in 1992, by founder Frank McCormick, Ph.D., F.R.S., who is currently Director of the University of California San Francisco Comprehensive Cancer Center and Cancer Research Institute. [1]

The company's current lead product is Nexavar, a small molecule drug to treat various solid tumors. In December 2005, Nexavar was approved by the FDA to treat patients with advanced kidney cancer. Clinical trials are currently underway for Nexavar for treatment of other forms of cancer. And in July 2006, the European Commission granted marketing authorization to Nexavar for the treatment of patients with advanced renal cell carcinoma who have failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy. [2]

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Products

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Nexavar [2]

Nexavar was developed under collaboration with Bayer Pharmaceuticals of Germany. Currently it was approved in the US and EU to treat patients with advanced kidney cancer. The drug achieved over $150 million in its launch year of 2006. [3]

The codevelopment and profit-sharing agreement with Bayer is worldwide except for Japan, where Bayer will fund all development costs for Nexavar, and Onyx will earn a high single-digit royalty on sales. In the U.S., the companies will share sales and marketing responsibilities and split equally any profits that are generated. Outside of the U.S., Bayer will be responsible for all promotional activities. As a result, the profit split will be somewhat less than 50/50. [4]

Nexavar ongoing Clinical Trials as of February 2007.[3]
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Nexavar ongoing Clinical Trials as of February 2007.[3]
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Nexavar Clinical Trial Notable Progresses

Advanced Melanoma Study in combination with carboplatin and paclitaxel [5]

On December 4, 2006, Onyx and Bayer announced that a Phase III trial administering Nexavar® (sorafenib) or placebo tablets in combination with the chemotherapeutic agents carboplatin and paclitaxel in patients with advanced melanoma did not meet its primary endpoint of improving progression-free survival (PFS). The treatment effect was comparable in each arm.

The stock dropped 30.4% to close at 12.18 on December 4, 2006 following the announcement.

Liver Cancer Study[6]

On February 12, 2007, Bayer and Onyx announced that an interim analysis of the companies' pivotal phase 3 trial n patients with advanced hepatocellular carcinoma (HCC), or primary liver cancer showed positive data. An Independent data monitoring committee (DMC) concluded that the trial met its primary endpoint resulting in superior overall survival (OS) in those patients receiving Nexavar® (sorafenib) tablets versus those patients receiving placebo and noted that there was no demonstrated difference in serious adverse event rates between the two treatment arms (Nexavar and placebo). Based on these conclusions, the DMC recommended that the trial be stopped early.

Bayer and Onyx will stop the trial and allow all patients enrolled in this trial access to Nexavar. Given that there are limited approved systemic therapies for this disease, the companies will continue discussions with health authorities worldwide, including the U.S. Food and Drug Administration (FDA) and European health authorities regarding the next steps in filing for approval for the treatment of HCC. Following these discussions, the companies will proceed to file as rapidly as possible. The two companies plan to submit the results from the trial to the American Society of Clinical Oncology (ASCO), for presentation at its annual meeting, June 1-5, 2007.

Following the news, on February 12, 2007 ONXX shares rose sharply to $24.15 or 97% above previous day close.

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PD 332991 [7]

PD 332991, a cyclin-dependent kinase inhibitor, entered clinical testing in September 2004. This compound was developed under collaboration with Pfizer (PFE). Upon the commercialization of this product by Pfizer, Onyx will receive milestone payments and royalties on worldwide sales (exact deal structure was not disclosed).

PD332991 works by modulating the activity of key enzymes that regulate the cell cycle — the process whereby a single cell replicates itself and divides into two identical new cells. Mutations in genes that regulate the cell cycle are present in a majority of human cancers. The research phase of the program ended in August 2001, but Pfizer has continued the clinical development of PD 332991, the most advanced compound in this program.

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Leadership

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News Feed

11/21/08 4:11 pm Coughing Is Bad for Amgen's Health (at Motley Fool)
11/21/08 8:11 am [$$] Oversold Situation Must Still Be Resolved (at RealMoney by TheStreet.com)
11/18/08 6:11 pm Reuters Summit-UPDATE - Amgen tumor-starving drug gets spotlight (at Reuters)
11/13/08 9:11 am ONYX PHARMACEUTICALS INC Financials (EDGAR Online Financials)
11/10/08 12:11 pm BTG Inks $320 Million Pre-clinical Deal With Onyx (at Seeking Alpha)
11/09/08 9:11 am New Star Analyst Rankings for ONYX PHARM INC (StarMine)
11/08/08 7:11 am Onyx licenses British companys cancer drug (at bizjournals.com)
11/07/08 5:11 pm Health Winners & Losers: Luminex (at TheStreet.com)
11/07/08 3:11 pm Onyx -- Still Waiting (at Motley Fool)
11/07/08 1:11 pm Onyx Pharma Healthy with Nexavar (Zacks.com)
More News...
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Risks

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Research Links

ONYX Pharmaceuticals, Inc. Snapshot
ONYX Pharmaceuticals, Inc. Leadership
ONYX Pharmaceuticals, Inc. Fundamentals
ONYX Pharmaceuticals, Inc. Technical Analysis
ONYX Pharmaceuticals, Inc. Message Boards
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Options

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Notes

  1. ↑ 1.0 1.1 "About us" section of compnay website
  2. ↑ 2.0 2.1 Nexavar product page
  3. ↑ 3.0 3.1 Onyx Pharmaceuticals Corporate Presentation by Hollings C. Renton, Chairman and CEO, February 13, 2007. Accessed March 2, 2007.
  4. ↑ Onyx Pharmaceuticals 2005 Annual report
  5. ↑ Phase III Trial of Nexavar in Patients with Advanced Melanoma Does Not Meet Primary Endpoint, company press release, Dec. 4, 2006. Accessed on March 2, 2007
  6. ↑ "Nexavar Shown to Significantly Extend Survival for Patients with Advanced Liver Cancer," Corporate Press release, February 12, 2007. Accessed on March 2, 2007
  7. ↑ Cell Cycle Kinase Inhibitor page from company website.
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