Pharmaceutical company Pharmanovia has signed an in-licensing agreement with Germany-based Lindis Biotech to commercialise catumaxomab for malignant ascites treatment.
Under the agreement, Pharmanovia has secured exclusive rights to market the trifunctional bi-specific monoclonal antibody.
Financial terms of the agreement were not disclosed.
Catumaxomab targets malignant ascites in adults with epithelial cellular adhesion molecule (EpCAM)-positive carcinomas who are ineligible for further systemic anticancer therapy.
Pharmanovia CEO James Burt said: “Our mission is to bring innovative and improved medicines to patients who need them, and this deal is the epitome of this.
“We have a first-in-class medicine, that can play a critical role in cancer supportive care that has previously been approved but is no longer available.
“We’re looking to change that through this partnership with Lindis Biotech, reintroducing catumaxomab to the market, subject to full regulatory approval.”
Last month, Lindis Biotech received a positive opinion for catumaxomab from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in October 2024 with the brand name Korjuny.
The European Union (EU) marketing authorisation is expected by the end of the year.
If approved, it will be the first and only drug approved for the specific, cancer-targeted treatment of malignant ascites.
Catumaxomab, originally marketed as Removab, was granted EU marketing authorisation in 2009 for the treatment of malignant ascites in adults with EpCAM-positive carcinomas when standard therapies are unavailable or ineffective.
As the first T cell engager trifunctional antibody, it was the first drug specifically approved for treating malignant ascites.
However, it was withdrawn from the EU market in 2017 for commercial reasons.
Lindis Biotech CEO Horst Lindhofer said: “Both companies share a firm belief in the profound impact this therapy can have on the lives of patients facing this devastating condition and uphold a steadfast commitment to making catumaxomab available to as many people as possible.
“Pharmanovia’s supportive care focus, broad European platform and strong expertise in the oncology space make them the ideal partner for us.”
Last month, Pharmanovia expanded its neurology portfolio with a new licensing agreement for Xadago (safinamide), an add-on treatment for idiopathic Parkinson’s disease, with CSL Seqirus.
