London - Hikma Pharmaceuticals PLC (Hikma), the multinational pharmaceutical company, today announces an exclusive license agreement with CanariaBio, a Korean biopharmaceutical company focused on the development and commercialization of immunotherapies for cancer.

Under the terms of the agreement, Hikma has an exclusive license to commercialise Oregovomab in 18 Middle East and North Africa (MENA) countries.

Oregovomab is a murine monoclonal antibody and a first-in-class anti-CA125 immunotherapy drug candidate. It is being tested in combination with carboplatin and paclitaxel for patients with advanced ovarian cancer. Oregovomab has obtained Orphan Drug Designations from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency.

'Ovarian cancer is ranked as the eighth most common cancer in women globally[1] and the first-line treatment for this disease has not changed for many years. We have been actively expanding our oncology portfolio through R&D and in-licensing, in order to address unmet medical needs in different types of cancer and bring renewed hope to cancer patients in the MENA region,' said Mazen Darwazah, Hikma's Executive Vice Chairman and President of MENA. 'We believe Oregovomab can potentially improve the treatment outcomes for patients with advanced primary ovarian cancer. We are excited about the collaboration with CanariaBio as it will bring hope to our cancer patients in MENA and strengthen our oncology portfolio.'

About Oregovomab

Oregovomab is a murine monoclonal antibody direct to the tumour-associated antigen CA125 that stimulates a host cytotoxic immune response against tumour cells expressing CA 125, a biomarker commonly found in ovarian cancer (OC). In a randomized Phase II clinical trial, oregovomab demonstrated a significant improvement in progression-free and overall survival in advanced OC treatment when administered simultaneously with first-line chemotherapy. Oregovomab yielded a median progression-free survival of 41.8 months compared with 12.2 months with standard chemotherapy (HR, 0.46, P=0.0027). This promising schedule is currently investigated in a phase III trial.

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