Imlifidase
Imlifidase is a unique antibody-cleaving enzyme originating from Streptococcus pyogenes that specifically targets IgG and inhibits IgG-mediated immune responses. The use of imlifidase is a novel approach to eliminate pathogenic IgG. It has a rapid onset of action, cleaving IgG-antibodies and inhibiting their activity within hours after administration.
Regulatory status
From imlifidase, we have developed a first-in-class therapy to enable kidney transplantation in highly sensitized patients. The European Commission has conditionally authorized our first product derived for the desensitization treatment of highly sensitized adult kidney transplant patients with a positive crossmatch against an available deceased donor1. Further to the current conditional authorization in the European Union (EU)/EEA and United Kingdom (UK), we are pursuing a path for regulatory approval in other countries including the U.S.
1. European Medicines Agency. Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/idefirix. Last accessed: November 2021.
Orphan designation
Orphan designation is granted to drugs intended for the treatment of life-threatening or chronically debilitating rare diseases where no therapeutic options are either authorized or where the drugs will be of significant benefit to those affected.
The European Medicines Agency (EMA) granted imlifidase orphan drug designation for the treatment of anti-glomerular basement membrane (anti-GBM) antibody disease (July 2018) and for the prevention of graft rejection following solid organ transplantation (January 2017).
In the European Union, the orphan designation provides for protocol assistance on the development of the drug, including clinical studies and certain exemptions or reductions in regulatory fees. In addition, the maintenance of the orphan designation at the time of marketing authorization grant provides for ten years of market exclusivity starting with the approval date against the authorization of similar medicinal products for the same therapeutic indication.
In the US, the FDA granted imlifidase orphan drug designation for the prevention of Antibody-mediated organ rejection in solid organ transplant patients (September 2015); Guillain-Barré syndrome (February 2018); anti-GBM antibody disease, also known as Goodpasture’s disease (July 2018). Orphan-designated products are granted market exclusivity against the same drug for the same indication for seven years after approval.
Patents and Intellectual Property
Imlifidase and its use is protected by several patent families, including granted patents and pending patent applications.
Patent protection is sought and obtained in the important markets, like the United States, Europe, Japan, and other jurisdictions. Significant patents are protecting our technology beyond 2035, with the possibility of five years of supplemental protection.
We continuously evaluate opportunities for market exclusivity for drug candidates through orphan drug designations and data exclusivity.
Manufacturing
Our manufacturing process takes place in close collaboration with two highly experienced, European based third party CMOs. Production is at a scale suitable for our commercial and clinical trial needs with the possibility to increase the capacity. The supply chain also includes packaging, labelling and distribution.