[USA] It has taken eight years for Boston Children’s Hospital and Chilean company Proteus to figure out how to create an improved class of anesthetics.
And now, thanks to an $85 million licensing agreement with a German pharmaceutical company, scientists are hoping to bring the drug to market.
The agreement, which was signed last week, allows German pharmaceutical company Grünenthal Group to license the drug Neosaxitoxin both in the U.S. and abroad.
The drug, which has concluded phase I clinical trials in the U.S., works as both an anesthetic and as a post-operative pain management drug.
In other words, doctors can do surgery under anesthesia, as well as give patients two to three days of pain relief without using opiates, all from a single injection.
“There is an importance in making people comfortable and alert and fits into a model of post-operative care, where you can accelerate rehabilitation,” said Dr. Charles Berde, a specialist in anesthesiology peri-operative and pain medicine at Boston Children’s Hospital, who helped research the drug. “We think it will be helpful for patients and we anticipate that it will have some benefit in terms of health care costs – getting people home sooner, recovering better, not needing other meds that have high cost or expense.”
While there are currently drugs on the market that promise post-operative pain relief, Dr. Dan Kohane, a specialist in medicine critical care at Boston Children’s Hospital who also did research on the drug, said that they aren’t able to knock out a patient enough for surgery, and don’t work well or for nearly as long as Neosaxitoxin.
The drug is derived from a toxin created by “red tide” algae blooms.
Scientists recreate the drug derivative using photosynthetic bacteria, which is hard to otherwise synthesize. Preclinical and phase I clinical work done in Boston have shown promising results, and a phase II clinical trial in Chile showed the drug was safe and effective.
Phase II clinical trials will have to be duplicated in the U.S. for the drug to be considered for approval by the U.S. Food and Drug Administration. That work will be spearheaded by Grünenthal.
According to Irene Abrams, senior director in the technology and innovation development office at Boston Children’s Hospital, the $85 million includes an upfront payment for the licensing deal, as well as development milestones to bring the drug to market.
While the hospital considered forming a spin out company to conduct the final push into regulatory approval, Abrams said Grünenthal made a compelling case for joining together.
“Grünenthal had the resources and ability to drive it to market more efficiently and quickly,” Abrams said.
The German company, which has an expertise in pain management, was also looking to expand into medicine used within hospital settings as well as looking to license technology from outside sources.
“There was a lot of synergy,” Abrams said.
Photo: COURTESY/BOSTON CHILDREN’S HOSPITAL The anesthetic, derived from a toxin produced by algae in Red Tide, will enter phase II clinical trials with the help of a German pharmaceutical company
View original article at: Boston Children’s makes deal to bring new red algae-derived anesthetic to market