Aurobindo Pharma’s wholly owned step-down subsidiary -- Acrotech Biopharma LLC has entered into a license agreement with Evive Biotech to commercialize Ryzneuta (Efbemalenograstim alfa) in the US. Ryzneuta is a novel dimeric GCSF long-acting fusion protein without pegylation. The Biologics License Application (BLA) of Ryzneuta is currently under late-stage review by the US FDA for Chemotherapy-Induced Neutropenia (CIN).
Under review by the US FDA, Ryzneuta is developed for the treatment of CIN in cancer patients after chemotherapy. Neutropenia is a common side-effect of chemotherapy and is a condition characterized by low levels of neutrophils, a type of white blood cell that fights infection. This important partnership builds on the comprehensive global development program of Ryzneuta, which includes 12 clinical trials and has enrolled over 1,200 subjects to date in multiple territories including the US, EU, and China.
Evive will be responsible for the ongoing development, manufacturing, registration, and supply of Ryzneuta while Acrotech will use its sales and commercialization capabilities to market and distribute Ryzneuta in the US. In addition, both companies may conduct additional development of the Product to explore further opportunities for Ryzneuta.
Aurobindo Pharma is engaged in manufacturing pharmaceutical products. It offers active pharmaceutical ingredients, intermediates and generic formulations like astemizole, domeperidone and omeprazole; anti-infective, oral and sterile antibiotics, pain management and osteoporosis segments.
