Pharmanovia has signed a licensing agreement with Lindis Biotech to commercialise catumaxomab, a new trifunctional bi-specific monoclonal antibody treatment for malignant ascites, a rare complication of advanced-stage cancers.

The agreement grants exclusive rights to Pharmanovia to market the antibody, designed for intraperitoneal administration in individuals with epithelial cellular adhesion molecule (EpCAM)-positive carcinomas ineligible for additional systemic anticancer therapies.

The company’s initiative to reintroduce catumaxomab to the market signifies its commitment to expanding its oncology portfolio.

Alira Health served as the transaction advisor to Lindis Biotech exclusively, steering the strategic direction and final negotiations of the deal.

Lindis Biotech CEO Dr Horst Lindhofer stated: “We are excited to partner with Pharmanovia to support the commercialisation of catumaxomab in Europe. 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.

“We look forward to working together while continuing to further expand our pipeline in other indications with high unmet medical need, such as bladder cancer.”

Catumaxomab originally received marketing authorisation under the Removab brand name in the European Union (EU) in April 2009.

It was the first T-cell engager trifunctional antibody and the first drug to receive approval globally for malignant ascites treatment, demonstrating safety and anti-tumour efficacy in more than 2000 subjects.

However, the therapy has not been on the market since 2014 and was withdrawn from the EU in June 2017 for commercial reasons.

Pharmanovia CEO Dr James Burt stated: “We’re looking to change that through this partnership with Lindis Biotech, reintroducing catumaxomab to the market, subject to full regulatory approval. We’re excited to put our strong capabilities in new chemical entities (NCEs) to bring this important medicine to patients.”