Lindis grants Pharmanovia rights to market and spearhead its launch across Europe

Lindis Biotech GmbH, a clinical stage biopharmaceutical company, and Pharmanovia, a global pharmaceutical company, announced Thursday that catumaxomab has received marketing authorisation from the European Commission (EC), making the drug the only approved drug therapy for malignant ascites (MA) for patients living with this debilitating condition across Europe.

Under a licensing agreement, LINDIS has granted Pharmanovia the exclusive rights to bring catumaxomab to market and spearhead its launch across Europe.

Catumaxomab, a first-in-class therapeutic, is specifically designed to treat malignant ascites in adults with certain types of cancer (epithelial cellular adhesion molecule (EpCAM)-positive carcinomas) who are not eligible for other systemic anticancer therapies. Malignant ascites is a serious complication of advanced-stage cancers, characterised by the buildup of fluid in the abdomen, causing significant discomfort and severely impacting quality of life. The condition leads to considerable symptoms such as abdominal distension, pain, shortness of breath, fatigue, and fever.

Stephen Deacon, Chief Scientific Officer at Pharmanovia commented;”This European Commission approval of catumaxomab is a significant milestone for people living with malignant ascites.

Catumaxomab represents a novel therapeutic approach to this challenging condition. By targeting tumour cells and harnessing the power of the patient’s own immune system, we aim to improve quality of life for those living with malignant ascites in Europe.”

Pharmanovia CEO, Dr. James Burt, highlighted the broader implications of the approval. Burt said: “This approval not only brings a much-needed treatment to people with malignant ascites but also exemplifies Pharmanovia’s commitment to deepening our footprint within the specialty pharmaceutical sector. We are dedicated to delivering innovative and improved medicines to people in need, and this approval reinforces our position as a leader in providing access to essential therapies.”

Dr. Horst Lindhofer, Chief Executive Officer of Lindis Biotech, added: “We are delighted to receive marketing approval for catumaxomab. The approval highlights its potential to address the significant medical and treatment challenges faced by patients with malignant ascites. These individuals often endure invasive procedures like paracentesis, which carry risks of complications and severely impact their quality of life. Partnering with Pharmanovia to support commercialization, we are committed to ensuring that this groundbreaking therapy becomes accessible to all patients who can benefit from it.”