Osiris Therapeutics

Medical research company

Osiris TherapeuticsIndustry| Pharmaceuticals

|

Headquarters|

Columbia, Maryland

United States

Key people

| Peter Friedli
(Chairman)
Greg Law
(CFO)
Frank Czworka
(COO)
Alla Danilkovitch
(CSO)
James Burns (Co-Founder)
Dr. Arnold Caplan (Co-Founder)
Kevin Kimberlin (Co-Founder)
Products| Grafix, Stravix, Cartiform, BIO4, Osteocel, Prochymal
Website| www.osiris.com

Osiris Therapeutics, Inc. was an American company founded in March 1993 following the identification of mesenchymal stem cells (MSCs) by Dr. Arnold Caplan and colleagues at Case Western Reserve University in Cleveland, Ohio.[1] Dr. Caplan contributed a license to certain technology and joined Kevin Kimberlin, James S. Burns, a biotech venture capitalist,[2][3] and Peter Friedli, as lead investor, to launch Osiris, named after the Egyptian god of fertility, resurrection, and the afterlife.[4] Early financing was provided by a number of entities, including Friedli Corporate Finance,[5] Three Arch Bay Health Sciences Fund, and Spencer Trask & Co.[1] By 1994, the state of Maryland provided a loan and equity investment to lure the company from Ohio in 1995.

## History

[edit]

In 1997, Osiris began a multi-million dollar research and licensing arrangement with Novartis, which acquired 8% of the company. Novartis dedicated 65 employees to develop stem cell treatments for bone and cartilage disorders, such as osteoporosis and arthritis.[1] Osiris also held a majority stake in Gryphon, a blood stem cell technology firm spun out of Johns Hopkins Medical School.[1]

The company's first chief executive officer (CEO) was co-founder James Burns, who held the position from the company's inception through at least 1999.[1][6] The company's Chief Financial Officer around this time was Michael Demchuk Jr.[1] In April 1999, Science magazine published the characterization of the MSC and data generated by Osiris scientists supporting the MSC's ability to differentiate in vitro into bone, cartilage and fat.[7] This paper has been cited 29,678 times as of August 2024.[8]

In 2006, when the company had 84 employees, Jeffries and Lazard Capital Markets took Osiris public, on NASDAQ, offering up 13% of the company as shares and raising $38.5 million, with funds intended for research, product development, loan servicing and clinical trial expenses. C. Randall Mills was CEO. By the time of the IPO, Osiris was marketing the first commercial product in the United States containing adult stem cells.[9] Marketed for fusion, it was called Osteocel.[10] The company sold Osteocel to NuVasive in 2009 for an upfront payment of $35 million at closing, and an additional $50 million in milestone payments.[11] In 2009, Osiris entered a billion-dollar agreement with Genzyme for cell therapy, receiving a $130 million up-front payment along with milestone payments for the development of Prochymal.[12]

## Research

[edit]

In May 2012, Osiris received the first regulatory clearance in the world for a systemically administered stem cell drug,[13] called Prochymal or remestemcel-L,[14] which was approved for pediatric Graft-versus-Host Disease (GvHD). Prochymal is a mesenchymal stem cell therapy derived from the bone marrow of healthy young adult donors, in which stem cells are isolated, expanded in culture, and processed to produce up to 10,000 doses from a single donation.[15] It was subsequently approved in Japan for Crohn's disease and the European Union for perianal fistulas.[16] In 2013, Osiris sold its MSC drug and associated patents to Mesoblast of Australia and renamed the drug Ryoncil.[17] Proceeds from this sale allowed the company to focus on its line of wound-healing products.[18]

THe transition by Osiris from product research to commercialization began with the introduction of Graphix, Stravix, and Chondrogen. In 2014, the peer-reviewed International Wound Journal reported the efficacy of Grafix for the treatment of diabetic foot ulcers.[19] CEO Lode Debrabandere resigned in 2016 in conjunction with activities that led to. Its temporary delisting from the NASDAQ stock exchange after the company failed to meet the exchange's requirements, including filing an annual report.[20][21] Debrabandere was succeeded by the company's chief business officer, Dwayne Montgomery, followed by Linda Palczuk, formerly of AstraZeneca. The company was relisted on the NASDAQ in August 2018.[22][23]

The company had $142 million in revenues for 2018. In 2019, Osiris was acquired for $660 million by Smith & Nephew plc, a global medical technology business.[24][25] All 360 employees were expected to remain with the firm, which would operate as a subsidiary to its parent.[25]

Ryoncil was successfully tested in a March 2020 pilot study at Mount Sinai Hospital in New York City on late-stage, ventilator-assisted COVID-19 patients suffering Acute Respiratory Distress Syndrome (ARDS).[26] Based on the results, the U.S. Food and Drug Administration approved a Phase 2/3 study on 240 patients at 30 sites around the U.S. The Cardiothoracic Surgical Trials Network ran the study, which was funded by the National Institutes of Health, and Mesoblast (the owner of the product) commenced the trial on May 5, 2020.[27]

In December 2024, the FDA approved Ryoncil (remestemcel-L), as the first mesenchymal stromal cell (MSC) therapy for pediatric patients with steroid-refractory acute graft-versus-host disease (GVHD).[28]

## Publications

[edit]

All authors were affiliated with Osiris unless otherwise noted.

* Pittenger MF, Mackay AM, Beck SC, Jaiswal RK, Douglas R, Mosca JD, Moorman MA, Simonetti DW, Craig S, Marshak DR (2 April 1999). "Multilineage Potential of Adult Human Mesenchymal Stem Cells". Science. 284 (5411): 143–7\. Bibcode:1999Sci...284..143P. doi:10.1126/science.284.5411.143. PMID 10102814.
* This article includes description of the adult stem cell harvesting method that provided Osiris a competitive advantage over other firms in being able to productively support clinical trials.[29]: 234

## References

[edit]

1. ^ a b c d e f Guidera, Mark (29 June 1997). "From cells arises Osiris". The Baltimore Sun. pp. D1, D2. Retrieved 15 August 2022 – via Newspapers.com.

* * *

Second part of article: "Cell research led to Osiris Therapeutics"
2. ^ "From cells arises Osiris Company was started four years ago in new area of medicine; Groundbreaking discovery; Firm has gained powerful ally with Novartis investment". Baltimore Sun. 1997-06-29. Retrieved 2025-01-31.
3. ^ "Game-changing Investments in Healthcare (Virtual)". HBS Healthcare Alumni Association. Retrieved 2025-01-31.
4. ^ Bell, Julie (26 September 2002). "New CEO at Osiris toiling as clock ticks". The Baltimore Sun. pp. C1, C9 (not available). Retrieved 14 August 2002.
5. ^ "Osiris Therapeutics Announces $20 million Private Placement". SEC.gov. 2007-06-06. Retrieved 2025-01-15.
6. ^ Guidera, Mark (11 April 1999). "Maryland companies near regeneration of tissue, bone". The Baltimore Sun. pp. D1, D8. Retrieved 15 August 2022 – via Newspapers.com.

* * *

Part 2 of article: "Maryland companies increase role in cell regeneration"
7. ^ Pittenger, Mark F.; Mackay, Alastair M.; Beck, Stephen C.; Jaiswal, Rama K.; Douglas, Robin; Mosca, Joseph D.; Moorman, Mark A.; Simonetti, Donald W.; Craig, Stewart; Marshak, Daniel R. (1999-04-02). "Multilineage Potential of Adult Human Mesenchymal Stem Cells". Science. 284 (5411): 143–147\. Bibcode:1999Sci...284..143P. doi:10.1126/science.284.5411.143. ISSN 0036-8075. PMID 10102814.
8. ^ Pittenger MF, Mackay AM, Beck SC, Jaiswal RK, Douglas R, Mosca JD, Moorman MA, Simonetti DW, Craig S, Marshak DR (April 1999). "Multilineage potential of adult human mesenchymal stem cells". Science. 284 (5411): 143–7\. Bibcode:1999Sci...284..143P. doi:10.1126/science.284.5411.143. PMID 10102814.
9. ^ "Stem cell use part of therapy". Baltimore Sun. 2005-09-23. Retrieved 2025-01-15.
10. ^ Ammerman, Joshua M.; Libricz, Joseph; Ammerman, Matthew D. (2013). "The role of Osteocel Plus as a fusion substrate in minimally invasive instrumented transforaminal lumbar interbody fusion". Clinical Neurology and Neurosurgery. 115 (7): 991–994\. doi:10.1016/j.clineuro.2012.10.013. PMID 23182179.
11. ^ "Osiris transfers Osteocel to NuVasive; UK biotech continues to suffer;". FierceBiotech. 30 March 2009. Retrieved 15 August 2022.
12. ^ Mack, George S. (2009-02-01). "Osiris seals billion-dollar deal with Genzyme for cell therapy". Nature Publishing Group. PMID 19204671. Retrieved 2025-03-22.
13. ^ Osiris Therapeutics, Inc. Form S-1 Registration Statement under the Securities Act of 1933, for the Fiscal Year Ended December 31, 2012, United States Securities and Exchange Commission
14. ^ Rattue, Petra (22 May 2012). "Prochymal - First Stem Cell Drug Approved". Medical News Today. Retrieved 13 August 2020.
15. ^ Pollack, Andrew (2012-05-18). "A Stem-Cell-Based Drug Gets Approval in Canada". The New York Times. Retrieved 2025-03-22.
16. ^ El-Nakeep S, Shawky A, Abbas SF, Abdel Latif O (May 2022). "Stem cell transplantation for induction of remission in medically refractory Crohn's disease". Cochrane Database Syst Rev. 2022 (5): CD013070. doi:10.1002/14651858.CD013070.pub2. PMC 9099217. PMID 35556242.
17. ^ Waltz, Emily (2013-12-01). "Mesoblast acquires Osiris' stem cell business". Nature Biotechnology. 31 (12): 1061. doi:10.1038/nbt1213-1061. ISSN 1546-1696. S2CID 32036070.
18. ^ Dance, Scott (12 October 2013). "Osiris Therapeutics to sell stem-cell drug". The Baltimore Sun. p. 10. Retrieved 16 August 2022 – via Newspapers.com.
19. ^ Lavery LA, Fulmer J, Shebetka KA, Regulski M, Vayser D, Fried D, Kashefsky H, Owings TM, Nadarajah J (October 2014). "The efficacy and safety of Grafix(®) for the treatment of chronic diabetic foot ulcers: results of a multi-centre, controlled, randomised, blinded, clinical trial". Int Wound J. 11 (5): 554–60\. doi:10.1111/iwj.12329. PMC 7951030. PMID 25048468.
20. ^ Mirabella, Lorraine (23 March 2016). "Osiris Therapeutics receives Nasdaq notice". Business Maryland: Daily Briefing. The Baltimore Sun. p. 10. Retrieved 16 August 2022 – via Newspapers.com.
21. ^ Irum, Tayyeba (10 March 2017). "Nasdaq to delist Osiris Therapeutics". S&P Global Market Intelligence. Retrieved 14 August 2022.
22. ^ "Osiris Relisting on NASDAQ" (PDF). 2018-08-01.[permanent dead link]
23. ^ "Osiris Receives Notice Of Delisting From NASDAQ" (Press release). Osiris Therapeutics. 13 March 2017. Retrieved 14 August 2022.
24. ^ "Smith & Nephew Completes Acquisition of Osiris Therapeutics, Inc" (Press release). Smith+Nephew. 17 April 2019.
25. ^ a b Cohn, Meredith (19 April 2019). "Columbia biotech company's sale finalized". The Baltimore Sun. p. 10. Retrieved 16 August 2022 – via Newspapers.com.
26. ^ Sheikh, Knvul; Thomas, Katie (8 April 2020). "More Coronavirus Vaccines and Treatments Move Toward Human Trials". The New York Times. Retrieved 13 August 2020.
27. ^ Knapp, Alex (2 May 2020). "Clinical Trials Of Mesoblast's Stem Cell Treatment For COVID-19 Set To Begin Soon". Forbes. Retrieved 13 August 2020.
28. ^ "FDA approves first mesenchymal stromal cell therapy". Biopharma-Reporter.com. 2024-12-19. Retrieved 2024-12-23.
29. ^ Hall, Stephen S. (2003). Merchants of Immortality. United States: Houghton Mifflin. ISBN 0-618-09524-1. Retrieved 17 August 2022 – via Open Library.

Authority control databases |

* ISNI

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