Aurobindo Pharma on Wednesday said its unit has entered into a licensing pact with Evive Biotech to commercialise Ryzneuta in the US market.
The product, a novel dimeric G-CSF long-acting fusion protein without pegylation, is currently under late-stage review by the US Food and Drug Administration for chemotherapy-induced neutropenia (CIN).
In addition to the US health regulator, Evive's Marketing Authorization Application (MAA), and New Drug Application (NDA) for Ryzneuta are currently under review by European and Chinese regulators.
Neutropenia is a common side-effect of chemotherapy and is a condition characterised by low levels of neutrophils, a type of white blood cell that fights infection.
The licensing pact has been inked between Evive and Acrotech Biopharma (Acrotech), a New Jersey-based and wholly-owned subsidiary of Aurobindo Pharma USA Inc, Aurobindo Pharma said in a statement.
As part of the agreement, 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 the product in the US, it added.
"Ryzneuta provides Acrotech the opportunity to expand its offerings to oncology patients and is aligned with our vision of commercialising scientifically advanced products. Additionally, expanding into CIN creates future growth opportunities for us," Acrotech Biopharma President Ashish Anvekar said.
Evive CEO Simon Li said despite the current options, CIN remains a significant clinical condition for most cancer patients, creating the need for more potent and convenient treatment.
"Acrotech has proven and strong capacity to commercialise proprietary medications, we look forward to partnering with them for bringing this novel medicine to more cancer patients with CIN in the US," he added.
Evive Biotech, a subsidiary of Yifan Pharmaceutical, is a global biopharmaceutical company devoted to developing a portfolio of novel biological therapies for patients worldwide.
