Aurobindo Pharma on Wednesday said that its wholly-owned subsidiary Acrotech Biopharma has entered into a license agreement with global biopharmaceutical company Evive Biotech to commercialise Ryzneuta in the United States.
Ryzneuta is used in the treatment of chemotherapy-induced neutropenia (CIN) in cancer patients. Neutropenia is a condition caused by the side effects of chemotherapy.
The Biologics License Application (BLA) of Ryzneuta is currently under late-stage review by the US Food and Drug Administration (USFDA). Additional clinical trials are being planned to demonstrate the improved clinical efficacy of Ryzneuta.
The 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, the European Union, and China.
Evive will be responsible for the ongoing development, manufacturing, registration, and supply of Ryzneuta, while Acrotech will use its sales and commercialisation 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.
The BLA submitted to USFDA, Evive’s Marketing Authorisation Application, and New Drug Application for Ryzneuta are currently under review by European and Chinese regulators.
Aurobindo Pharma shares are currently trading at Rs 459.70, down 0.23 percent.
