The version marketed by EUSA for Apeiron is called generically dinutuximab beta and is marketed under the brand name Isquette, and is manufactured in Chinese hamster ovary cells. History
Dinutuximab (originally called Ch14.18) was discovered by a group at University of California San Diego led by Alice Yu; this antibody and several others were brought into clinical trials funded by the National Cancer Institute. The NCI manufactured the mAbs for the Phase III trial of Ch14.18 in combination with GM-CSF and IL-2, which was halted due to clear efficacy; the results published in 2009. No company had offered by that time to get FDA approval and commercialize the drug, so the NCI kept manufacturing it and making it available under compassionate use. In 2010, the NCI signed an agreement with United Therapeutics under which the company took over manufacturing and would bring the drug to market.In the meantime in Europe, oncologists and patient advocates wanted to have the drug available in Europe, and made efforts to obtain the cell line used to make it from United Therapeutics and the originating lab at the NCI itself; when those efforts failed they reached out to a group at Memorial Sloan Kettering that had generated an anti-GD2 mAb and was making at MSK for administration to patients there, but this didnt work out either.
In March 2000, Knoll Pharmaceuticals and Abbott Laboratories, an American health care company, announced a co-promotion agreement for Vicoprofen, in which Abbott would promote Vicoprofen to its network of buyers, including physicians, hospitals, and surgical centers. In June 2002, Abbott Laboratories, paid $6.9 billion to acquire the entire Knoll pharmaceutical unit from BASF, including Vicoprofen. DEA classification
Vicoprofen was originally approved as a schedule III drug, but was later reclassified to a schedule II drug based on the DEA reclassification of hydrocodone containing products effective 6 October 2014. Research
The new drug application for Vicoprofen was approved based on data from both single and multiple dose analgesia trials. The single dose analgesia studies occurred in multiple surgical settings, including dental, back, and abdominal/gynecologic surgery in the U.S. and Puerto Rico. There were 1,537 patients enrolled over all trials, with 79% of the participants being female. There were 10 single dose analgesia trials included in the new drug application. All studies were similarly designed: after completion of a procedure in which pain was rated as moderate or severe, patients would be randomized into various treatment groups. The treatment groups included: ibuprofen only, hydrocodone only, Vicoprofen (hydrocodone/ibuprofen), and placebo. The participants pain would then be tracked over the next several hours by the self reporting of pain scores.There were four multiple dose trials included in the new drug application. These studies were all completed in the U.S., in settings including burn unit, post-operatively, and chronic pain settings.