Mesoblast, a company focused on regenerative medicine, plans to launch its first stem cell therapy product in Japan next year and then the United States in 2016, according to a report from The Australian.
There are no stem cell products with regulatory approval on a developed world market, but the company hopes a deal with JCR Pharmaceuticals — based in Japan — will make their products first. The company is worth $1.3 billion, according to the report, but Goldman Sachs issued a "sell" rating on Friday and the stock price hit a low of $4.10.
The company's stem cell products are being tested in a variety of applications, including spinal disc regeneration in the United States. However, the first product expected to gain approval and go on the market in Japan is Mesoblast's mesenchymal stem cells for treating childhood GVHD, which the company hopes to fast-track for approval in the United States and place on the market in 2016.
As for the spinal surgery trial, the company hopes to commence a phase three trial this year. Several surgeons participated in the phase two trial and discussed their preliminary observations with Becker's Spine Review:
"We really need a therapy like this," says Hyun Bae, MD, medical director and director of spine education at Cedars-Sinai Spine Center, in a Becker's Spine Review report. "We don't currently know what to do with these patients; surgery sounds like a big hurdle to them, so we do other therapies to try to help. I think Mesoblast has great promise because we can take these patients and return them to regular activity without surgery."
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