New advances in medical science can only be translated into new therapies through human clinical studies. Thus clinical operations are at the center of value growth for a biopharmaceutical developer. XBiotech incorporates a vertically integrated clinical operation that helps enable rapid transition of new molecules from the research bench, to the clinical bedside.
As of September 2014, the anti-IL-1α antibody MABp1 had been administered over 600 times to patients in 9 different clinical trials in the United States and Europe for various indications. All clinical trial activities, from clinical study design to FDA submission, from clinical site identification, initiation and medical monitoring to pharmacovigilance, has been conducted entirely by XBiotech’s clinical team without the use of any outside contract research organization. This is not only a highly cost effective means of executing clinical programs, it creates the basis for powerful and dynamic product development capabilities.
XBiotech is proud of the capabilities it has established with its clinical research team. And we are confident that these operations will continue to identify and advance our breakthrough therapies.
The diagram shows the relative development progress for various therapeutics in the pipeline. Note that all clinical trial activity to date has been conducted with a therapeutic antibody targeting chronic sterile inflammation. XBiotech intends to launch its first anti-infective therapy targeting methicilin resistant staphylococcus aureus (MRSA) before the end of 2014. XBiotech is also leveraging its manufacturing technology to develop ultra-low-cost biosimilar drugs. The lead molecule in this program is a "biobetter," which is expected to define a new market for the supportive care product G-CSF.