Aurobindo Pharmas step-down subsidiary to commercialize Ryzneuta in the United States

23 Nov 2022 , 12:10 PM

Evive Biotech (Evive), a global biopharmaceutical company devoted to developing novel biologic therapies and a subsidiary of Yifan Pharmaceutical Company. New Jersey-based Acrotech Biopharma (Acrotech) is a wholly-owned subsidiary of Aurobindo Pharma USA Inc. It was formed as a global platform to commercialize innovative proprietary medications. Evive has entered into a license agreement with Acrotech to commercialize Ryzneuta (Efbemalenograstim alfa) in the US. Ryzneuta is a novel dimeric G-CSF 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). 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. In addition to the BLA submitted to US FDA, Evives marketing authorization application (MAA), and New Drug Application (NDA) for Ryzneuta are currently under review by European and Chinese regulators. Dr. Ashish Anvekar, president of Acrotech Biopharma, said: ?We are very excited to partner with Evive to bring this valuable therapeutic option to patients. Ryzneuta provides Acrotech Biopharma the opportunity to expand its offerings to oncology patients and is aligned with our vision of commercializing scientifically advanced products. Additionally, expanding into CIN creates future growth opportunities for us. We believe Ryzneuta will offer patients suffering from CIN a very compelling and accessible treatment option.? Aurobindo Pharma develops, manufactures and distributes generic pharmaceuticals, branded specialty pharmaceuticals and active pharmaceutical ingredients. The pharmaceutical company reported 41.3% fall in consolidated net profit to Rs 409.45 crore on a 3.7% decline in net sales to Rs 5,673.65 in Q2 FY23 over Q2 FY22. The scrip rose 0.71% to currently trade at Rs 463.95 on the BSE. Powered by Capital Market – Live News