Stratatech, a Madison company with skin tissue to treat people with severe burns, is showing off its expanded quarters in University Research Park as it moves a step closer to seeking the government’s nod to sell its lead product, StrataGraft.
A $28 million addition onto Stratatech’s building at 535 Science Drive nearly triples the company’s space, from 13,000 square feet to 35,000 square feet, and the employee count is now 80, up from 65 last October.
The extra space will give the company enough capacity to manufacture StrataGraft for continuing clinical trials and eventually, for commercial use, if the U.S. Food and Drug Administration approves it.
“We’re very excited about this treatment,” said Steve Romano, executive vice president and chief scientific officer at Mallinckrodt Pharmaceuticals, Stratatech’s parent company.
Romano and Mallinckrodt CEO Mark Trudeau were among the corporate executives, government officials and community leaders who gathered under a white tent outside Stratatech’s building on Wednesday for a ribbon-cutting to mark completion of the addition, which was built by Vogel Bros. Building Co.
A regenerative skin tissue that helps the damaged skin repair itself, StrataGraft is in its third phase of clinical trials, with 71 patients — a full roster — participating in the study.
All have suffered serious burns over 3% to 49% of their bodies and are being treated at 12 burn centers around the country, from Florida to California, including at UW Hospital. They are receiving StrataGraft skin tissue either to substitute for or to supplement grafts of their own healthy skin to see if the engineered tissue is safe and effective.
In a 2015 study, after one application of StrataGraft, 27 of 28 patients had their wounds healed within three months. In some cases, the StrataGraft site looked better than applications of the patient’s own skin.
Skin grafts from a patient’s own body can leave painful wounds themselves and carry a risk of infection.
“What we are hoping is that this will really be a game-changer in the marketplace as far as how surgeons treat those burns,” Romano said.
Results of the phase 3 clinical trial are expected later this year, and if they are positive, the company plans to apply for U.S. Food and Drug Administration approval in early 2020, with approval possible by the end of 2020, Romano said.
The FDA designated the skin tissue a “regenerative medicine advanced therapy” in 2017, putting it on the fast track for consideration.
Stratatech was formed in 2000 after researchers in the UW-Madison lab of Lynn Allen-Hoffmann found human skin cells, from a foreskin discarded after circumcision, were immortal. The cells kept multiplying and did not die or develop viruses or tumors.
Mallinckrodt bought Stratatech in 2016 for $76 million in cash. Documents filed with regulators showed the British drug company could pay as much as $121 million more if certain regulatory and royalty milestones are met.
At Stratatech’s building on Science Drive, the new addition has equipped the company with a warehouse, quality control labs and offices to complement the clean-room manufacturing that already existed. (Mallinckrodt declined to allow news media to photograph any of the interior of the building, which is owned by University Research Park.)
During the manufacturing process, the frozen cells are incubated for an undisclosed period of time. When the tissue is ready, it is tested “to see if it has the appropriate architecture” and to make sure “it functions like normal skin,” said Allen Comer, senior director of clinical development for regenerative medicine.
In addition to the phase three trial, StrataGraft is in a phase two clinical trial in which 20 patients with more severe, third-degree burns are being treated to see if it will heal their wounds and if it can be applied more than once on the same area. That study is expected to run through February 2020.
A second Stratatech skin product, ExpressGraft, also is in clinical trials. The antimicrobial tissue is being tested on five patients with diabetic foot ulcers.
At least two other types of ExpressGraft are in the works, as well, according to the pipeline listed on Mallinckrodt’s website. One skin substitute in development would prevent infection and promote the growth of blood vessels. The other is aimed at averting a recurrence of skin cancer.
The company also has said it is conducting a test of StrataGraft on children who have suffered serious burns, but no information has been released on that yet.
Feds eye StrataGraft
At least two government agencies have been interested in Stratatech’s skin products. The Madison company has a continuing partnership with the U.S. Department of Health and Human Services through Project BioShield, a program of the Biomedical Advanced Research and Development Authority (BARDA).
BARDA has provided Stratatech with about $86 million, with another $160 million in potential future funds. BARDA has said it plans to stockpile the frozen tissue in case of a large-scale attack.
The U.S. Defense Department also was an early supporter of the company, providing nearly $4 million in 2010 from the Armed Forces Institute for Regenerative Medicine to help pay for clinical trials.
Romano said Mallinckrodt wants to address severe or rare health issues and Stratatech’s skin tissue products could fill that need.
“We knew what Lynn was doing was really breakthrough,” he said.
Allen-Hoffmann, who grew up on a sheep farm in the central Illinois village of Thawville, said she thinks every day about the case that inspired her to work on a skin graft product — a Wisconsin farmer who had to go through months of painful skin grafts after a propane tank explosion left him with burns over more than 95 percent of his body.
Allen-Hoffmann credits cooperation from the UW-Madison, the state of Wisconsin and the federal government for the company’s progress — from the discovery in her lab to getting a closet-sized office at University Research Park to the expanded building Stratatech now occupies. The company still has offices at the MGE Innovation Center, 510 Charmany Drive, as well.
“There’s an African saying: If you want to go fast, go by yourself. If you want to go far, you go together,” Allen-Hoffmann said.
Publicly traded, United Kingdom-based Mallinckrodt, founded in St. Louis in 1840, also owns Ikaria, a New Jersey company that makes INOmax nitric oxide delivery systems. Ikaria has a Madison manufacturing and research facility.
Mallinckrodt’s specialty brands division that includes Stratatech and Ikaria is based in Bedminster, New Jersey.