Osiris Therapeutics

Osiris Therapeutics, Inc. was 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. Dr. Caplan contributed a license to certain technology and joined Kevin Kimberlin, James S. Burns, a biotech venture capitalist, and Peter Friedli, as lead investor, to launch Osiris, named after the Egyptian god of fertility, resurrection, and the afterlife. Early financing was provided by a number of entities, including Three Arch Bay Health Sciences Fund and Spencer Trask & Co. By 1994, the state of Maryland provided a loan and equity investment to lure the company from Ohio in 1995.

A peer company, StemCells, emerged in 1995 in California with a focus on neural regeneration, but using stem cell technology emerging from the laboratory of Irving Weissman at Stanford University.

The year 1997 saw the start of a multi-million dollar research and licensing arrangement with Novartis, which initially acquired 8% of the company. It dedicated 65 employees to develop stem cell treatments for bone and cartilage disorders, including underwriting the cost of clinical trials, an arrangement that lasted until at least 1999. At the time, osteoporosis and arthritis were the top targets of Novartis research. The only direct competitor of Osiris at the time was a unit of Novartis, Systemix, which focused on stem cell treatments for cancer. Systemix was outside the scope of the deal Osiris had struck with Novartis. At the time, Osiris held also a majority stake in Gryphon, a blood stem cell technology exploitation firm spun out of Johns Hopkins Medical School.

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. The company's Chief Financial Officer around this time was Michael Demchuk Jr.

In 2006, when the company had 84 employees, Jeffries and Lazard Capital market 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. At the time of the IPO, Osiris was considered to be "the closest in (the United States) to bring a pure stem cell product to the market", with a marketed drug for bone regeneration called Osteocel. 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.

In 2010, Osiris received the first regulatory clearance in the world for a systemically administered stem cell drug, called Prochymal or remestemcel-L. IIt was approved for pediatric Graft-versus-Host Disease (GvHD). In 2013, Osiris sold its MSC drug and associated patents to Mesoblast of Australia and the drug was renamed Ryoncil. Osiris had spent more than two decades working on this product and the proceeds from this sale allowed the company to focus on a line of wound-healing projects.

Osiris transitioned from product research to commercialization with the introduction of Osteocel, Graphix, Stravix, and Chondrogen. In 2016, CEO, Lode Debrabandere, resigned. He was succeeded by the company's chief business officer, Dwayne Montgomery, then David and then Linda Palczuk, formerly of AstraZeneca. In March 2017, shares of Osiris were temporarily delisted from the NASDAQ stock exchange as the company failed to meet the exchange's requirements, including failure to file an annual report, after being granted additional time for compliance. The company was relisted on the NASDAQ in August 2018.

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

Ryoncil was 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. Based on the results, the FDA approved a Phase 2/3 study on 300 patients at 30 sites around the U.S. The Cardiothoracic Surgical Trials Network, funded by the National Institutes of Health, and Mesoblast (the owner of the product) commenced that trial on May 5, 2020.

Publications
Affiliation of all authors was with Osiris unless otherwise noted.


 * 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.
 * 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.