Cerus Corporation Explained

Cerus Corporation
Traded As:NASDAQ:
Foundation:
as Cerus Technologies Inc[1]
Location:Concord, California, United States
Key People:President and CEO William 'Obi' M. Greenman
Industry:Biotechnology
Revenue: $74.649 million (2019)[2]
Num Employees:254 (2019)[3]
Products:Blood transfusion products

Cerus Corporation is an American multinational biotechnology company headquartered in Concord, California that develops and provides a treatment system to pathogen-reduce human blood products for the healthcare industry.

History

In the mid-1980s, hematologist Laurence Corash developed a novel method of inactivating HIV particles contained in donated blood plasma using ultraviolet lights. He continued building prototypes with help from colleagues at the UC-San Francisco School of Medicine, and together with chemist John E. Hearst founded the company as Cerus Technologies Inc. on September 19, 1991, later to be renamed as Cerus Corporation in its initial 1996 SEC filing.[4] [5] [6] [7] [8] [9]

Products

The company's proprietary technology (called Helinx) was conceived by Corash in the mid-1980s as a method to protect patients from HIV-tainted plasma and platelet donations in the growing AIDS epidemic. These two blood components were found to be suitable to treat in ex-vivo isolation with the company's UV-A light process due to their naturally translucent properties. The UV exposure process works by intentionally damaging DNA and RNA material in foreign virus and bacteria that might be present, while remaining harmless to the donated blood plasma and platelets (which contains no RNA or DNA).[10] [11] [12] [13] [14] [15] [16]

In December 2001, the Helinx process was incorporated into a medical device called Intercept Platelet blood screening system, and Cerus entered an agreement with Baxter International Inc to jointly commercialize the device in the European Union healthcare market and gain regulatory approvals. In 2006, Cerus announced they had acquired all of Baxter's shared commercial rights to the Intercept blood system for plasma and platelets, and also revealed that they were working on expanding their system to treat red blood cells (which are more opaque and harder to treat). Cerus later entered into another commercialization agreement with Grifols S.A. to market and operate their products in blood centers in Spain and Portugal.[17] [18] [19]

Regulatory approvals

The Intercept Blood System for Platelets received EU CE MARK Class III certification in 2002, and US FDA pre-market approval on December 18, 2014. On March 10, 2016 the FDA granted an expanded modification on the existing approval to also treat platelets suspended in 100% plasma. In 2005 the platelet CE MARK was re-approved with a modification to extend platelet storage to seven days (previously five days).[20] [21] [22] [23] [24]

The Intercept Blood System for Plasma received EU CE MARK certification on November 21, 2006, and US FDA pre-market approval on December 16, 2014. Cerus also received certification under ISO 13485 for their blood plasma and platelet products in 2006.[25]

On August 23, 2020, Cerus received US FDA Emergency Use Authorization to treat the donated convalescent plasma from recovered COVID-19 patients, with the purpose of giving investigative antibody immunotherapy transfusions to other COVID-19 patients suffering an infection.[26]

Effectiveness

The product's primary purpose is to guarantee a clean supply of blood products, and deactivate both known and unknown pathogens with minimal added effort. The Helinx technology and INTERCEPT system have been shown effective on several types of viruses, but it is not universally effective due to some kinds of pathogens' RNA or DNA being more resilient to the process (such as hepatitis A, human parvovirus 19 and some bacterial spores). Studies have shown the system to be effective at neutralizing HIV, hepatitis B, hepatitis C, West Nile virus, SARS-1 COV, MERS CoV, Zika, dengue fever, and SARS-CoV-19. It is also touted as being able to render certain bacteria unable to replicate.[27]

In addition to pathogen neutralization, there are clinical trials in West Africa to test the effectiveness of using the INTERCEPT system to treat convalescent plasma from Ebola survivors, and administering the treated plasma to other patients still fighting an infection. Convalescent treatments using INTERCEPT are also being applied to Ebola survivor plasma donations at Emory University, and platelet donations in Puerto Rico, which has dengue fever and chikungunya infections in their population. Similarly, the US FDA has granted emergency use of INTERCEPT to sterilize convalescent COVID-19 patient plasma, although the US medical community harbors some disagreements on whether this approach will provide effective relief for its patients.

Market reception

The Intercept systems are in use in multiple EU healthcare settings. However, the US market had not gained traction among blood centers, due to its added costs on top of an ample domestic supply of pre-screened clean blood, plasma and platelet units. In developing countries with lower levels of health care access, the product is finding greater clinical and humanitarian trial opportunities due to high rates of collecting and using unsafe donated whole blood, low access to plasma and platelet separating equipment, and low supply of screening tests.

In 2016 during the height of the Zika virus spread, Cerus' technology was supplied to a designated blood center in Rio de Janeiro, Brazil for use in ensuring a clean blood supply for competing athletes in the 2016 Rio Olympic Games.[28]

Notes and References

  1. Web site: March 16, 2015 . SEC 10-K Filing archive 2015 for Cerus . live . https://web.archive.org/web/20170625190951/https://www.sec.gov/Archives/edgar/data/1020214/000119312515094038/0001193125-15-094038.txt . June 25, 2017 . October 15, 2020 . Security Exchange Commission.
  2. Web site: February 20, 2020 . Cerus Corporation Announces Record Fourth Quarter and Full Year 2019 Financial Results . live . https://web.archive.org/web/20201017185109/https://www.businesswire.com/news/home/20200220005820/en/ . October 17, 2020 . October 15, 2020 . Business Wire.
  3. Web site: October 15, 2020 . Cerus Corp - Company Profile and News - Bloomberg Markets . live . https://web.archive.org/web/20200818024119/https://www.bloomberg.com/profile/company/CERS:US . August 18, 2020 . October 15, 2020 . Bloomberg.com.
  4. Web site: October 15, 2020 . About Dr. Laurence M. Corash, Hematologist in San Francisco, CA . October 15, 2020 . US News.
  5. Web site: October 12, 2020 . Biography for Dr. Laurence M Corash MD. San Francisco, CA . live . https://web.archive.org/web/20171119035608/http://www.vitals.com/doctors/Dr_Laurence_Corash.html . November 19, 2017 . October 15, 2020 . Vitals.com.
  6. Web site: July 20, 2016 . Concord Biotech Company Cerus Donates Blood Sterilization Tech to Rio Ahead of Olympic Games . live . https://web.archive.org/web/20160928153520/http://www.nbcbayarea.com/news/local/Concord-Biotech-Co-Cerus-Donates-Blood-Sterilization-Tech-to-Rio-Ahead-of-Olympic-Games-387700752.html . September 28, 2016 . October 15, 2020 . NBC Bay Area News.
  7. Web site: October 15, 2020 . Cerus Corp. CERS - Quotes, Financials, News, Charts and Research - US News Best Stocks . live . https://web.archive.org/web/20201017185123/https://money.usnews.com/investing/stocks/cers-cerus-corp . October 17, 2020 . October 15, 2020 . U.S. News.
  8. Web site: September 4, 1996 . SEC S-1 Filing registration 1996 for Cerus Corporation . live . https://web.archive.org/web/20201017185110/https://content.edgar-online.com/ExternalLink/EDGAR/0000950149-96-001382.html?hash=b092fee48cfea9b3c0c426e82f3f6ef25bdc3b10ec5869f7e18ae2e66eb7974d . October 17, 2020 . October 15, 2020 . Security Exchange Commission.
  9. Web site: October 30, 2018 . John E. Hearst, Ph.D., Presented with the Albert Nelson Marquis Lifetime Achievement Award by Marquis Who's Who . live . https://web.archive.org/web/20181107104015/https://www.24-7pressrelease.com/press-release/457856/john-e-hearst-phd-presented-with-the-albert-nelson-marquis-lifetime-achievement-award-by-marquis-whos-who#:~:text=Hearst%20was%20a%20professor%20of%20chemistry%20with%20the,Technology%2C%20earning%20a%20Doctor%20of%20Philosophy%20in%201961. . November 7, 2018 . October 15, 2020 . Marquis Who's Who, via 24-7PressRelease.
  10. Nkohkwo. Asa’ah. Agbor. Gabriel. Asongalem. Emmanuel. Tagny. Claude. Asonganyi. Tazoacha. 2016-06-09. Whole blood pathogen reduction technology and blood safety in sub-Saharan Africa: A systematic review with regional discussion. African Journal of Laboratory Medicine. 5. 1. 363. 10.4102/ajlm.v5i1.363. 2225-2002. 5436399. 28879109.
  11. Schlenke. Peter. 2014. Pathogen Inactivation Technologies for Cellular Blood Components: an Update. Transfusion Medicine and Hemotherapy. english. 41. 4. 309–325. 10.1159/000365646. 1660-3796. 25254027. 4164100.
  12. Picker. Susanne M.. 2013-03-13. Current methods for the reduction of blood-borne pathogens: a comprehensive literature review. Blood Transfusion. 11. 3. 343–348. 10.2450/2013.0218-12. 1723-2007. 3729123. 23522896.
  13. Web site: New procedure could help protect U.S. blood supply . October 15, 2020 . The Tuscaloosa News . Google.com . Associated Press . June 5, 2001 . 2A .
  14. Web site: Testing marks first step toward sterilizing blood . October 15, 2020 . Neergaard . Lauran . Gettysburg Times . Associated Press . October 1, 2002 . A5 . Google.com .
  15. Web site: February 10, 2015 . Package Insert - INTERCEPT® Blood System for Plasma . bot: unknown . https://web.archive.org/web/20201017185125/https://wayback.archive-it.org/7993/20170723032026/https://www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/PremarketApprovalsPMAs/UCM427365.pdf . October 17, 2020 . October 15, 2020 . Cerus Corporation .
  16. Web site: December 16, 2014 . F.D.A. Approves System That May Make Blood Transfusions Safer . live . October 15, 2020 . The New York Times. https://web.archive.org/web/20141217173631/http://www.nytimes.com/2014/12/17/business/fda-approves-system-that-may-make-blood-transfusions-safer.html . December 17, 2014 .
  17. Web site: December 10, 2001 . Health care giant Baxter to license blood screeing system . live . https://web.archive.org/web/20040711084411/http://www.bizjournals.com/memphis/stories/2001/12/10/daily6.html . July 11, 2004 . October 15, 2020 . Memphis Business Journal.
  18. Web site: February 14, 2006 . Cerus Obtains Exclusive Rights to INTERCEPT Blood System from Baxter . live . https://web.archive.org/web/20120201114822/http://www.dotmed.com/news/story/1315 . February 1, 2012 . October 15, 2020 . DotMed Healthcare Business News.
  19. Web site: July 24, 2007 . Grifols And Cerus Agree To Commercialize INTERCEPT Blood System In Spain And Portugal . live . https://web.archive.org/web/20201017185159/https://www.meddeviceonline.com/doc/grifols-and-cerus-agree-to-commercialize-inte-0001 . October 17, 2020 . October 15, 2020 . Med Device Online.
  20. Web site: INTERCEPT Blood System Received TÜV Approval for Storage of Platelets up to 7 Days . live . https://web.archive.org/web/20201017185140/https://www.ots.at/presseaussendung/OTE_20050922_OTE0007/intercept-blood-system-received-tuev-approval-for-storage-of-platelets-up-to-7-days . October 17, 2020 . October 17, 2020 . OTS.at . en.
  21. Web site: Baxter and Cerus Reach Agreement with FDA on Steps to Gain Regulatory Approval for Innovative Pathogen Inactivation System. October 17, 2020. Infection Control Today.
  22. 2003 . Amotosalen: Allogeneic Cellular Immunotherapies system, INTERCEPT Plasma System, INTERCEPT Platelet System, S 59 . live . BioDrugs . 17 . 1 . 66–68 . 10.2165/00063030-200317010-00006 . 1173-8804 . 12534321 . https://web.archive.org/web/20201017185159/https://pubmed.ncbi.nlm.nih.gov/12534321/ . October 17, 2020 . October 17, 2020.
  23. Web site: December 18, 2014 . FDA Approval Letter – INTERCEPT Blood System for Platelets . bot: unknown . https://web.archive.org/web/20201017185137/https://wayback.archive-it.org/7993/20190208123648/https://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/PremarketApprovalsPMAs/ucm427494.htm . October 17, 2020 . October 15, 2020 . USFDA .
  24. Web site: March 10, 2016 . FDA Approval Letter – Supplement to INTERCEPT Blood System for Platelets . bot: unknown . https://web.archive.org/web/20201017185136/https://wayback.archive-it.org/7993/20190208123647/https://www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/PremarketApprovalsPMAs/UCM490959.pdf . October 17, 2020 . October 15, 2020 . USFDA .
  25. Web site: December 16, 2014 . FDA Approval Letter – INTERCEPT Blood System for Plasma . bot: unknown . https://web.archive.org/web/20201017185140/https://wayback.archive-it.org/7993/20170723032029/https://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/PremarketApprovalsPMAs/ucm427226.htm . October 17, 2020 . October 15, 2020 . USFDA .
  26. Web site: Commissioner . Office of the . 2020-08-24 . FDA Issues Emergency Use Authorization for Convalescent Plasma as Potential Promising COVID–19 Treatment, Another Achievement in Administration's Fight Against Pandemic . 2022-04-26 . FDA . en.
  27. Hashem. A. M.. Hassan. A. M.. Tolah. A. M.. Alsaadi. M. A.. Abunada. Q.. Damanhouri. G. A.. El‐Kafrawy. S. A.. Picard‐Maureau. M.. Azhar. E. I.. Hindawi. S. I.. 2019-11-06. Amotosalen and ultraviolet A light efficiently inactivate MERS‐coronavirus in human platelet concentrates. Transfusion Medicine (Oxford, England). 29. 6. 434–441. 10.1111/tme.12638. 0958-7578. 7169717. 31696565.
  28. Web site: July 13, 2016 . Concord's Cerus helps ensure blood safety for Rio Olympics . live . https://web.archive.org/web/20200719060055/https://www.sfchronicle.com/business/article/Concord-s-Cerus-helps-ensure-blood-safety-for-8376917.php . July 19, 2020 . October 15, 2020 . San Francisco Chronicle.

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