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Talk:Onyx Pharmaceuticals

Latest comment: 11 years ago by Adam Silverstein2 in topic Proposed Updates to Onyx Page 7/29
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Additions to Onyx page

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My name is Adam Silverstein. I am with WCG, a public relations agency for Onyx. I have previously contributed suggested edits to the Onyx Pharmaceuticals page and have been grateful for the guidance received from the Wikipedia community. I would like to suggest edits to the sections of the Onyx page based on events that have occurred since October 2011.

Onyx Pharmaceuticals
Company typePublic
Nasdaq: ONXX: [1])
IndustryBiotechnology
Founded1992
HeadquartersSouth San Francisco California U.S.
Key people
N. Anthony (Tony) Coles (CEO)
ProductsSorafenib (Nexavar)
Number of employees
450
Websitewww.onyx.com

Onyx Pharmaceuticals Inc. (Nasdaq: ONXX) 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 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 has said Onyx likes it prospects as in independent company and is focused on bringing new therapies to patients. [3]

Products and development

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Sorafenib (co-developed and co-marketed by Bayer and Onyx as Nexavar[4]), 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.[5] Sorafenib is also being evaluated in additional types of cancer, including lung,[6][7] thyroid[8] and breast cancers.[9]

In 2011, Bayer entered into an agreement with Onyx under which Onyx will receive a royalty on any future global net sales of regorafenib in oncology.[10] Regorafenib is being studied in Phase 3 trials [11] in demonstrated metastatic colorectal cancer, and gastrointestinal stromal tumors, a rare stomach cancer. [12]

Onyx is conducting clinical trials investigating carfilzomib, a selective proteasome inhibitor that is being studied as a treatment for multiple myeloma. Clinical trials for carfilzomib include a pivotal Phase 2 clinical trial designed to seek accelerated approval in the U.S.

In January 2011, the U.S. Food and Drug Administration (FDA) granted carfilzomib fast-track status, allowing Onyx to initiate a rolling submission of its new drug application (NDA) for carfilzomib.Clinical trials for carfilzomib include a Phase 2 clinical trial designed to seek accelerated approval in the U.S. In December 2011, the FDA announced that it granted carfilzomib standard review,[13] [14] designation for its NDA. The PDUFA date, or FDA decision date, is July 27, 2012. [15]

Onyx executive leadership team

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  • N. Anthony (Tony) Coles, M.D.: President, Chief Executive Officer and Member of the Board
  • Matthew K. Fust: Executive Vice President and Chief Financial Officer
  • Juergen Lasowski, PH.D.: Executive Vice President, Corporate Development and Strategy
  • Ted W. Love, M.D.: Executive Vice President, Research & Development and Technical Operations
  • Helen I. Torley, M.B., CH.B., M.R.C.P.: Executive Vice President and Chief Commercial Officer
  • Kaye Foster-Cheek: Senior Vice President, Global Human Resources
  • Suzanne M. Shema, J.D.: Executive Vice President, General Counsel and Corporate Secretary
  • Julianna Wood: Vice President, Public Affairs

Onyx Board of Directors

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  • N. Anthony (Tony) Coles, M.D.: President, Chief Executive Officer and Member of the Board
  • Paul Goddard PH.D.: Lead Director, Chairman and CEO Aryx Therapeutics Inc., Chairman, AP Pharma and Director, Adolor Corporation
  • Antonio J. Grillo-López, M.D.: Former Chairman, Neoplastic and Autoimmune Diseases Research Institute
  • Magnus Lundberg: Chief Executive Officer, Phadia
  • Corinne H. Nevinny: General Partner, LMNVC LLC
  • Bill Ringo: Executive Director, Sofinnova Ventures and Senior Advisor, Barclays Capital
  • Wendell Wierenga, PH.D: Executive Vice President, Research and Development, Santarus, Inc.
  • Thomas G. Wiggans: Former Chairman and CEO, Peplin, Inc., and Connetics Corporation

References

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  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. ^ "FDA Approves Nexavar for Patients with Inoperable Liver Cancer". FDA.gov. 2007-11-19. Retrieved 2011-09-13.
  5. ^ "Liver Cancer". MD Anderson Cancer Center. Retrieved 2011-09-13.
  6. ^ "A 3rd/4th Line Placebo-controlled Trial of Sorafenib in Patients With Predominantly Non Squamous Non-Small Cell Lung Cancer NSCLC. (MISSION)". ClinicalTrials.gov. 2009-03-17. Retrieved 2011-09-13.
  7. ^ "Profile:ONYX Pharmaceuticals Inc (ONXX.A)". Reuters. Retrieved 2011-09-13.
  8. ^ "Nexavar into Phase III for thyroid cancer". Pharma Times. 2009-10-27. Retrieved 2011-09-13.
  9. ^ "UPDATE 1-Bayer starts Phase III Nexavar breast-cancer trial". Reuters. 2011-02-24. Retrieved 2011-09-13.
  10. ^ "Burger, Ludwig (2011-10-12). Onyx settles claims with Bayer over cancer drug". Reuters. Retrieved 2012-02-24.
  11. ^ {{cite web|url=http://clinicaltrials.gov/ct2/show/NCT01103323?term=regorafenib&rank=10 | title=Patients With Metastatic Colorectal Cancer Treated With Regorafenib or Placebo After Failure of Standard Therapy Publisher=ClinicalTrials.gov | accessdate=2012-02-24]]
  12. ^ "Stomach Cancer: Causes publisher=Mayo Clinic". Retrieved 2012-02/24. {{cite web}}: Check date values in: |accessdate= (help); Missing pipe in: |title= (help)
  13. ^ "Onyx shares slide after FDA forces investors to wait on standard carfilzomib review". Fierce Biotech. Retrieved 02-24-12. {{cite web}}: Check date values in: |accessdate= (help)
  14. ^ "Fast Track, Accelerated Approval and Priority Review; Accelerating Availability of New Drugs for Patients with Serious Diseases". FDA. Retrieved 02-24-12. {{cite web}}: Check date values in: |accessdate= (help)
  15. ^ "Beacon Breaking News – Carfilzomib to Get Standard, Not Priority, FDA Review". The Myeloma Beacon. Retrieved 02-24-12. {{cite web}}: Check date values in: |accessdate= (help)
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Latest comment: 12 years ago1 comment1 person in discussion

Adam Silverstein (talk) 23:55, 27 February 2012 (UTC)Reply

Edits to Onyx Page

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Latest comment: 12 years ago1 comment1 person in discussion

I would ask Wikipedia community to please reach out to me if there are questions or concerns about suggested edits made to the Onyx page. Adam Silverstein (talk) 21:32, 23 March 2012 (UTC)Reply

Proposed Updates to Onyx Page 7/29

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Latest comment: 11 years ago1 comment1 person in discussion

My name is Adam Silverstein. I am with WCG, a public relations agency for Onyx Pharmaceuticals. I have previously contributed edits to this page (please see talk sections above for reference) appreciate the guidance I received from the Wikipedia community. On behalf of Onyx, I would like to open a conversation and suggest additional edits that reflect the FDA-approved indications and safety information for carfilzomib, sorafenib, and regorafenib.

I welcome feedback from any editor and thank you for your guidance. Adam Silverstein (talk) 20:31, 29 July 2013 (UTC)Reply

Sorafenib

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Current:

Sorafenib (co-developed and co-marketed by Bayer and Onyx under the trade name Nexavar),[1] 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.[2] Sorafenib is also being evaluated in additional types of cancer, including lung,[3][4] thyroid[5] and breast cancers.[6]

Revised:

  • Adds information on areas where sorafenib is being studied
  • Adds information on adverse reactions

Sorafenib (co-developed and co-marketed by Bayer and Onyx under the trade name Nexavar),[7] 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.[8] 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.[9] Sorafenib is also being evaluated in additional types of cancer, including thyroid[10] and breast cancers.[11]

Carfilzomib

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Current:

As of September 2011, Onyx is conducting clinical trials investigating carfilzomib, a selective proteasome inhibitor that is being studied as a treatment for multiple myeloma. Clinical trials for carfilzomib include a pivotal Phase 2 clinical trial designed to seek accelerated approval in the U.S. In January 2011, the U.S. Food and Drug Administration (FDA) granted carfilzomib fast-track status, allowing Onyx to initiate a rolling submission of its new drug application for carfilzomib.[12] In December 2011, the FDA announced that it granted carfilzomib standard review,[13] [14] designation for its new drug application. The PDUFA date, or FDA decision date, is July 27, 2012. [15]


Revised:

  • Adds information on approved indications and adverse reactions

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.[16] [17] 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.[17]

Regorafenib

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Current:

In 2011, Bayer entered into an agreement with Onyx under which Onyx will receive a royalty on any future global net sales of regorafenib in oncology.[18] Regorafenib is being studied in Phase 3 trials[19] in demonstrated metastatic colorectal cancer, and gastrointestinal stromal tumors, a rare stomach cancer.[20]

Revised:

  • Adds details on approved indications

Regorafenib (marketed under the trade name Stivarga), is currently being studied as a potential treatment option in multiple tumor types.[21] 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.[22] 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.[23] 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.[24] 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.[25]


References

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  1. ^ "FDA Approves Nexavar for Patients with Inoperable Liver Cancer". FDA.gov. 2007-11-19. Retrieved 2011-09-13.
  2. ^ "Liver Cancer". MD Anderson Cancer Center. Retrieved 2011-09-13.
  3. ^ "A 3rd/4th Line Placebo-controlled Trial of Sorafenib in Patients With Predominantly Non Squamous Non-Small Cell Lung Cancer NSCLC. (MISSION)". ClinicalTrials.gov. 2009-03-17. Retrieved 2011-09-13.
  4. ^ "Profile:ONYX Pharmaceuticals Inc (ONXX.A)". Reuters. Retrieved 2011-09-13.
  5. ^ "Nexavar into Phase III for thyroid cancer". Pharma Times. 2009-10-27. Retrieved 2011-09-13.
  6. ^ "UPDATE 1-Bayer starts Phase III Nexavar breast-cancer trial". Reuters. 2011-02-24. Retrieved 2011-09-13.
  7. ^ "FDA Approves Nexavar for Patients with Inoperable Liver Cancer". FDA.gov. 2007-11-19. Retrieved 2011-09-13.
  8. ^ "Liver Cancer". MD Anderson Cancer Center. Retrieved 2011-09-13.
  9. ^ "Sorafenib Prescribing Information" (PDF). U.S. Food and Drug Administration. Retrieved 2013-07-29.
  10. ^ "Nexavar into Phase III for thyroid cancer". Pharma Times. 2009-10-27. Retrieved 2011-09-13.
  11. ^ "UPDATE 1-Bayer starts Phase III Nexavar breast-cancer trial". Reuters. 2011-02-24. Retrieved 2011-09-13.
  12. ^ "Onyx multiple myeloma drug wins FDA fast-track status". San Francisco Business Times. 2011-01-31. Retrieved 2011-09-21.
  13. ^ "Onyx shares slide after FDA forces investors to wait on standard carfilzomib review". Fierce Biotech. Retrieved 02-24-12. {{cite web}}: Check date values in: |accessdate= (help)
  14. ^ "Fast Track, Accelerated Approval and Priority Review; Accelerating Availability of New Drugs for Patients with Serious Diseases". FDA. Retrieved 02-24-12. {{cite web}}: Check date values in: |accessdate= (help)
  15. ^ "Beacon Breaking News – Carfilzomib to Get Standard, Not Priority, FDA Review". The Myeloma Beacon. Retrieved 02-24-12. {{cite web}}: Check date values in: |accessdate= (help)
  16. ^ "FDA approves Kyprolis for some patients with multiple myeloma". U.S. Food and Drug Administration. Retrieved 07/29/13. {{cite web}}: Check date values in: |accessdate= (help)
  17. ^ a b "KYPROLIS (carfilzomib) injection, powder, lyophilized, for solution". U.S. National Library of Medicine. National Institutes of Health. Retrieved 07/29/13. {{cite web}}: Check date values in: |accessdate= (help)
  18. ^ "Burger, Ludwig (2011-10-12). Onyx settles claims with Bayer over cancer drug". Reuters. Retrieved 2012-02-24.
  19. ^ "Patients With Metastatic Colorectal Cancer Treated With Regorafenib or Placebo After Failure of Standard Therapy Publisher=ClinicalTrials.gov". Retrieved 2012-02-24.
  20. ^ "Stomach Cancer: Causes". Mayo Clinic. Retrieved 2012-02-24.
  21. ^ "Bayer Announces New Data on Oncology Portfolio To Be Presented at the ECCO-ESMO Congress 2009". {{cite web}}: |access-date= requires |url= (help); Check date values in: |accessdate= (help); Missing or empty |url= (help)
  22. ^ "FDA Approves New Treatment for Advanced Colorectal Cancer". U.S. Food and Drug Administration. Retrieved 07/29/13. {{cite web}}: Check date values in: |accessdate= (help)
  23. ^ "FDA Approves Regorafenib (Stivarga) for GIST". CancerNetwork. 2013-02-26. Retrieved 07/29/13. {{cite news}}: Check date values in: |accessdate= (help)
  24. ^ "Regorafenib Prescribing Information" (PDF). U.S. Food and Drug Administration. Retrieved 07/29/13. {{cite web}}: Check date values in: |accessdate= (help)
  25. ^ "Securities and Excange Commission 8K Form". Securities and Exchange Commission. Retrieved 07/29/13. {{cite web}}: Check date values in: |accessdate= (help)
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