Genetic Engineering & Biotechnology News

APR15 2017

Genetic Engineering & Biotechnology News (GEN) is the world's most widely read biotech publication. It provides the R&D community with critical information on the tools, technologies, and trends that drive the biotech industry.

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6 | APRIL 15, 2017 | | Genetic Engineering & Biotechnology News Gail Dutton A technology for spraying a patient's own stem cells onto severe burns is helping pa- tients to leave the hospital within days of being admitted, rather than the weeks typi- cal for standard-of-care grafting techniques. Developed by RenovaCare, this autologous skin replacement technology—the first of its kind—results in scar-free healing. Before stem cells can be sprayed, they need to be isolated from a skin sample and suspended in liquid. Nevertheless, the whole process—the isolation, suspension, and spraying of stem cells—takes as little as 90 to 120 minutes. The process begins with a small sample (about 2 inches by 2 inches) of healthy skin. "We isolate the cells by removing the surrounding tissue," says Thomas Bold, RenovaCare's president and CEO. The cells are suspended in liquid, resulting in a product called the CellMist™ Solution, which is inserted, by way of syringe, into the SkinGun™, a patented device that can be used to spray the CellMist Solution into a wound gently and evenly. The cells aren't heavily manipulated, and no cultivation step is necessary before they are sprayed into wounds. "Our process re- sults in skin that looks and functions like the patient's own skin—which it is," asserts Bold. "With mesh grafting, the current stan- dard of care, you often don't achieve good clinical resolution." The Cell Gun When RenovaCare first began spraying stem cells, the company wasn't satisfied with their viability, Bold recalls. The high pressure created by pump-spray systems ruptured many of the fragile stem cells. A gentler ap- proach was needed. "We developed a technology where the cells are guided through the syringe and are picked up by an air stream," Bold details. "The needle is inside a tube that's pushing air, so the cells are nebulized outside." This gentle administration method enables a cell survival rate that exceeds 97%. Tests conducted at Berlin-Brandenburg Center for Regenerative Therapies, a research center at Charité-Universitätsmedizin Ber- lin, reported the SkinGun sprays 200 times more droplets of CellMist Solution than does conventional needle and syringe deposition, resulting in the deposition of 20,000 cells versus 91. The dispersal pattern is even, and growth rates are comparable to pipetting, which is considered the gold standard for cell deposition. Developing the SkinGun as a viable device took a couple of years. Patents for that work were issued in Germany. The company's first U.S. patent was issued at the beginning of 2017 for a delivery system that is more ad- vanced, smaller, and physician-friendly. This new patent reinforces the company's Ger- man patents and extends protection an addi- tional 30 months, to beyond the year 2035. Accelerated Healing The benefits to patients include the need to harvest less healthy skin, and dramatically RenovaCare's CellMist System Promises to Accelerate the Healing of Burns and Wounds Spray-On Stem Cells Can Step Up Healing Corporate Profile These images depict the recovery of a severely burned state trooper who was treated with the RenovaCare CellMist System, which comprises the company's CellMist Solution and SkinGun. The RenovaCare SkinGun gently sprays a patient's own stem cells onto severe burns for rapid, scar-free healing. The device achieves a high rate of cell viability (97.3%), which is essential to regen- erating skin for burns and chronic wounds. Insights Industry Watch After a year where shares plunged 74%, the CEO resigned, and his successor began layoffs, Endo International seemed headed for a much calmer 2017 in February when it reported fourth-quarter 2016 results that beat Wall Street forecasts. Instead, Endo encountered more rough sailing March 14, when a pair of FDA advisory panels concluded that the benefits of the company's abuse-deterrent extended-re- lease formulation of Opana ® ER (oxymorphone) no longer outweighed its risks. Not surprisingly, Endo disagreed: "The body of evi- dence established through clinical research demonstrates that Opana ER has a favorable risk-benefit profile when used as intended in appropriate patients," stated Matthew W. Davis, M.D., senior vice president, R&D, Branded Phar- maceuticals. The FDA drug safety and risk management and anes- thetic and analgesic drug products advisory committees issued their negative risk-benefit assessments of the refor- mulated Opana in an 18–8 vote. The FDA is not bound by the vote, though the agency typically aligns its decisions with the advice of advisory committees. While the vote could lead the FDA to actions that in- clude withdrawing Opana from the market, one analyst said Endo faces no immediate threat. "We expect it could be several months (or longer) be- fore any potential action is taken to pull the reformulated Opana ER from the market," Canacord Genuity pharma- ceuticals analyst Dewey Steadman said. "We believe any potential impact to Endo will be muted, given the prod- uct's small contribution to Endo's top and bottom lines." Opana ER generated $158.938 million in net revenues last year, down 10% from $175.772 million in 2015 thanks to more generic competition. Endo expects revenues from Opana ER and other legacy branded pain treatments to de- cline this year, as they did in 2016 (down 24% to $486.368 million). Generics revenues is also expected to fall. Those projected declines, plus divestitures and product discontinuations, explain why Endo is forecasting lower revenues for 2017—between $3.45 billion to $3.60 billion, compared with $4.010 billion in 2016, up 23% from 2015. Despite that jump, Endo finished 2016 with a $3.347 bil- lion loss, more than double 2015's $1.495 billion loss— and a stock that plummeted from $62.42 to $16.47. n Advisory Panels' Rebuff Could Have Been Worse for Endo

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