Clovis Oncology Explained

Clovis Oncology
Type:Public
Traded As:NASDAQ:
Russell 2000 Component
Industry:Pharmaceutical
Founded: in Boulder, Colorado
Founder:Patrick Mahaffy
Hq Location City:Boulder, Colorado
Hq Location Country:U.S.
Revenue: $165 Million(2020)
Num Employees:429

Clovis Oncology is an American pharmaceutical company which mainly markets products for treatment in oncology.[1] Clovis was founded in 2009 and is headquartered in Boulder, Colorado.[2] The company is a publicly traded company on NASDAQ under the symbol CLVS[3] and is in the NASDAQ Biotechnology Index[4] with several products in its product pipeline.[5] As of December 31, 2017, the company was not profitable and had incurred losses in each year since its inception in April 2009.[6] In December 2022, Clovis Oncology filed for Chapter 11 bankruptcy.[7]

History

Clovis Oncology was founded in 2009 by Patrick Mahaffy in Boulder, Colorado. The company was named in honor of the Mahaffy cache, a collection of Clovis period stone tools dated to 11,000 BCE, discovered in the front yard of Mahaffy's home in Boulder.[8]

Product development

Rociletinib

The company was developing rociletinib,[9] as a treatment for non-small cell lung cancer.[10] [11] [12] A phase III trial was completed in April 2016[13] and had it been approved it would have competed with AstraZeneca's Tagrisso (osimertinib). According to the company web site as of November 2016 studies on the drug are no longer accepting new patients, but Clovis would continue to supply the drug to patients whose physicians had recommended continued treatment.[14]

In September 2018, the company and two former executives agreed to a $20 million settlement with the Securities and Exchange Commission on claims it exaggerated to investors the efficacy of Roci in patient trials.[15] [16]

Rucaparib

Rucaparib is a PARP inhibitor in Phase II and III clinical trials for advanced ovarian cancer.[17] In December 2016, the Food and Drug Administration granted an accelerated approval for the use of rucaparib "for the treatment of patients with deleterious BRCA mutation (germline and/or somatic)-associated advanced ovarian cancer who have been treated with two or more chemotherapies".[18] In 2023, rucaparib was sold to Pharmaand GmbH (Pharma&) as part of Clovis's bankruptcy proceedings.[19]

Lucitanib

Lucitanib is a VEGFR inhibitor.[20] It is also an inhibitor of FGFR1 and FGFR2 and has undergone clinical trials for advanced solid tumors.[21]

Notes and References

  1. Web site: Clovis Oncology: A Winning Or Losing Lottery Ticket? . Forbes . November 16, 2015 . January 4, 2016.
  2. Web site: CLVS Profile. finance.yahoo.com.
  3. Web site: Clovis Oncology Inc.. www.marketwatch.com. January 4, 2016.
  4. Web site: Overview NBI. nasdaq.com. January 4, 2016.
  5. Web site: Clovis Oncology – Products & Companion Diagnostics . Clovisoncology.com . January 4, 2016 . March 9, 2015 . dead . https://web.archive.org/web/20150309041623/http://clovisoncology.com/products-companion-diagnostics . March 9, 2015 .
  6. Clovis Oncology, Inc. Form 10-K for the fiscal year ended December 31, 2017.
  7. Web site: Singh. Vandana. Clovis Oncology Files for Chapter 11 Protection and Enters into Agreement to Sell FAP-2286. yahoo.com. December 12, 2022 . December 12, 2022.
  8. Web site: October 9, 2015. 13,000-year-old stone tool cache set for exhibit at CU-Boulder. live. July 22, 2021. The Chaffee County Times. en. https://web.archive.org/web/20210722044725/https://www.chaffeecountytimes.com/community/13-000-year-old-stone-tool-cache-set-for-exhibit-at-cu-boulder/article_f8a8acf8-6de1-11e5-a608-3329d46e72e8.html . July 22, 2021 .
  9. Web site: March 7, 2016. A Festivus for the Invest in Us -- It's Time for the Airing of Grievances Fox Business. . https://web.archive.org/web/20160307073333/http://www.foxbusiness.com/markets/2015/12/23/festivus-for-invest-in-us-it-time-for-airing-grievances.html. dead. March 7, 2016. March 15, 2021.
  10. Web site: Wallace. Alicia. Clovis Oncology stock bludgeoned after delay in cancer drug approval. www.denverpost.com. November 16, 2015 . January 4, 2016.
  11. Web site: Clovis Oncology Announces Regulatory Update for Rociletinib NDA Filing. https://web.archive.org/web/20160305131121/https://www.reuters.com/article/co-clovis-oncology-inc-idUSnBw165513a%2B100%2BBSW20151116. dead. March 5, 2016. www.reuters.com. January 4, 2016.
  12. Web site: FDA Requests Additional Data for Rociletinib in EGFR T790M-Mutant NSCLC . OncLive . November 16, 2015 . January 4, 2016.
  13. http://seekingalpha.com/news/3171379-investors-doubt-efficacy-clovis-lung-cancer-med-rociletinib-shares-11-percent Investors doubt efficacy of Clovis lung cancer med rociletinib, shares off 11%. April 2016
  14. Web site: About Clovis . November 18, 2016.
  15. News: Clovis Oncology, execs to pay $20 million to settle SEC charges. September 18, 2018. Reuters. September 28, 2018. en-US.
  16. Web site: Clovis, CEO, Ex-CFO Agree to Pay $20M+ to Settle SEC Charges GEN. GEN. September 19, 2018 . September 28, 2018.
  17. Web site: Rucaparib at Clovis . April 5, 2016 . https://web.archive.org/web/20160413233206/http://clovisoncology.com/products-companion-diagnostics/rucaparib/ . April 13, 2016 . dead .
  18. Balasubramaniam. Sanjeeve. Beaver. Julia A.. Horton. Sara. Fernandes. Laura L.. Tang. Shenghui. Horne. Hisani N.. Liu. Jinzhong. Liu. Chao. Schrieber. Sarah J.. Yu. Jingyu. Song. Pengfei. 2017-12-01. FDA Approval Summary: Rucaparib for the Treatment of Patients with Deleterious BRCA Mutation-Associated Advanced Ovarian Cancer. Clinical Cancer Research. 23. 23. 7165–7170. 10.1158/1078-0432.CCR-17-1337. 1557-3265. 28751443. free.
  19. Web site: Bell . Jacob . Navigating bankruptcy, Clovis reaches deal to sell cancer drug Rubraca . BioPharma Dive . 2023-04-07 . 2023-10-04.
  20. Web site: Lucitanib at Clovis . April 5, 2016 . https://web.archive.org/web/20160414225503/http://clovisoncology.com/products-companion-diagnostics/lucitanib/ . April 14, 2016 . dead .
  21. 25193991 . Phase I/IIa study evaluating the safety, efficacy, pharmacokinetics, and pharmacodynamics of lucitanib in advanced solid tumors . Annals of Oncology . 25 . 11 . 2244–51 . 10.1093/annonc/mdu390 . Soria. et al . 2014. free .

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