Onyx Pharmaceuticals

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Onyx Pharmaceuticals Incorporated
HeadquartersSouth San Francisco California U.S.
Key people
N. Anthony (Tony) Coles (CEO)
ProductsSorafenib (Nexavar)
Number of employees

Onyx Pharmaceuticals Inc. is a biopharmaceutical company headquartered in South San Francisco, California. The company develops and markets medicines for the treatment of cancer. Onyx was founded in 1992 by Kevin J. Kinsella and Frank McCormick Ph.D., FRS.[1] In 2009, the company acquired Proteolix, Inc., a private biotechnology company. In January 2012, the company was named "the top biotechnology takeover target in 2012" through an industry survey.[2] Onyx CEO Tony Coles had said that Onyx liked its prospects as an independent company and was focused on bringing new therapies to patients.[3] However, at the end of August 2013, Amgen announced it was acquiring Onyx in an agreed $10.4 billion deal.[4]

Other backers of Onyx were Avalon Ventures, Institutional Venture Partners, J. H. Whitney & Company, and Kleiner Perkins Caufield & Byers.[5]

Products and development[edit]

Sorafenib (co-developed and co-marketed by Bayer and Onyx under the trade name Nexavar),[6] is a drug approved for the treatment of advanced renal cell carcinoma, or advanced kidney cancer, and for the treatment of hepatocellular carcinoma, the most common form of liver cancer.[7] The most common adverse reactions (≥20%), which were considered to be related to sorafenib, are fatigue, weight loss, rash/desquamation, hand-foot skin reaction, alopecia, diarrhea, anorexia, nausea and abdominal pain.[8] Sorafenib is also being evaluated in additional types of cancer, including thyroid[9] and breast cancers.[10]

Carfilzomib (marketed under the trade name Kyprolis) was approved by the FDA on June 20, 2012 for use in patients with multiple myeloma who have received at least two prior therapies, including treatment with bortezomib and an immunomodulatory therapy, and have demonstrated disease progression on or within 60 days of completion of the last therapy.[11][12] Carfilzomib is also being evaluated in other stages of multiple myeloma. The most commonly reported adverse reactions (incidence ≥ 30%) are fatigue, anemia, nausea, thrombocytopenia, dyspnea, diarrhea, and pyrexia.[12]

Regorafenib (marketed under the trade name Stivarga), is currently being studied as a potential treatment option in multiple tumor types.[13] On 27 September 2012, the FDA approved regorafenib for the treatment of patients with metastatic colorectal cancer (CRC) who have been previously treated with fluoropyrimidine-, oxaliplatin, and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if KRAS wild-type, an anti-EGFR therapy.[14] On February 25, 2013, the FDA approved regorafenib in a second indication to treat patients with locally advanced, unresectable or metastatic gastrointestinal stromal tumor (GIST) who have been previously treated with imatinib mesylate and sunitinib malate.[15] Regorafenib is a compound developed by Bayer. The most common adverse reactions (>/=20%) are asthenia/fatigue, HFSR, diarrhea, decreased appetite/food intake, hypertension, mucositis, dysphonia, and infection, pain (not otherwise specified), decreased weight, gastrointestinal and abdominal pain, rash, fever, and nausea.[16] In 2011, Bayer entered into an agreement with Onyx under which Onyx will receive a 20 percent royalty on any future global net sales of regorafenib in oncology. Bayer and Onyx jointly promote Stivarga in the United States.[17]

In June 2013, Amgen Inc offered to buy the shares of Onyx Pharmaceuticals for $120 per share, sending the shares up by around 30% after the news was announced.[18] Onyx announced on June 30, 2013, that it rejected the unsolicited proposal from Amgen. The Onyx board has authorized its financial adviser to contact potential suitors.[19] The acquisition was formally announced on 25 August 2013.[4]

In July 2014 the company announced the phase III failure of a Sorafenib-Capecitabine combination trial. The drug combination failed to increase progression free survival of patients with advanced breast cancer.[20]


  1. ^ "Frank McCormick Profile - Forbes.com". Forbes.com. Retrieved 2011-09-21.
  2. ^ Flinn, Ryan (2012-01-12), Reg Gale, ed., Onyx CFO Says Experimental Medicines Make Drugmaker ‘Attractive’ Purchase, Bloomberg, bloomberg.com, retrieved 2012-01-15
  3. ^ "Health CEOs: More Confidence, Challenges". CNBC. Retrieved 2012-02-27.
  4. ^ a b 'Amgen To Acquire Onyx Pharmaceuticals For $125 Per Share In Cash' http://www.amgen.com/media/media_pr_detail.jsp?releaseID=1849611
  5. ^ Pollack, Andrew (1992-03-17). "BUSINESS PEOPLE; Onyx Pharmaceuticals Gets Executive Team". The New York Times.
  6. ^ "FDA Approves Nexavar for Patients with Inoperable Liver Cancer". FDA.gov. 2007-11-19. Retrieved 2011-09-13.
  7. ^ "Liver Cancer". MD Anderson Cancer Center. Retrieved 2011-09-13.
  8. ^ "Sorafenib Prescribing Information" (PDF). U.S. Food and Drug Administration. Retrieved 2013-07-29.
  9. ^ "Nexavar into Phase III for thyroid cancer". Pharma Times. 2009-10-27. Retrieved 2011-09-13.
  10. ^ Burger, Ludwig (2011-02-24). "UPDATE 1-Bayer starts Phase III Nexavar breast-cancer trial". Reuters. Retrieved 2011-09-13.
  11. ^ "FDA approves Kyprolis for some patients with multiple myeloma". U.S. Food and Drug Administration. Retrieved 2013-07-29.
  12. ^ a b "KYPROLIS (carfilzomib) injection, powder, lyophilized, for solution". U.S. National Library of Medicine. National Institutes of Health. Retrieved 2013-07-29.
  13. ^ "Bayer Announces New Data on Oncology Portfolio To Be Presented at the ECCO-ESMO Congress 2009". Missing or empty |url= (help); |access-date= requires |url= (help)
  14. ^ "FDA Approves New Treatment for Advanced Colorectal Cancer". U.S. Food and Drug Administration. Retrieved 2013-07-29.
  15. ^ "FDA Approves Regorafenib (Stivarga) for GIST". CancerNetwork. 2013-02-26. Retrieved 2013-07-29.
  16. ^ "Regorafenib Prescribing Information" (PDF). U.S. Food and Drug Administration. Retrieved 2013-07-29.
  17. ^ "Securities and Excange Commission 8K Form". Securities and Exchange Commission. Retrieved 2013-07-29.
  18. ^ Caroline Humer (28 June 2013). "U.S. biotech Amgen offered to buy Onyx for $120 per share: report". Reuters.
  19. ^ "Onyx confirms, rejects Amgen's $120-per-share bid". Yahoo! Finance. Retrieved 2013-06-30.
  20. ^ http://www.genengnews.com/gen-news-highlights/sorafenib-capecitabine-combination-fails-phase-iii-trial/81250155/

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