Cinfa Biotech S.L., the biosimilars company of Infarco group, today announced positive top-line data from a clinical trial with its lead development candidate B12019, a biosimilar version of Neulasta® (pegfilgrastim) to treat chemotherapy-induced neutropenia. The primary endpoints of the trial, to demonstrate the pharmacokinetic (PK) and pharmacodynamic (PD) equivalence of B12019 with the originator product, were met.
The single-dose, randomized, double-blind, cross-over study enrolled 172 healthy volunteers in Germany. It primarily investigated PK and PD of B12019 as compared to Neulasta®. Secondary endpoints were safety and immunogenicity. Cinfa Biotech’s B12019 demonstrated PK and PD equivalence to the originator product. Safety, tolerability and immunogenicity of the biosimilar candidate and Neulasta® were comparable. Further data from the trial will be presented at upcoming scientific conferences.
Dr Ruediger Jankowsky, Managing Director of Cinfa Biotech GmbH, commented: “We are pleased to have achieved this significant milestone in the development of our first biosimilar candidate B12019. All endpoints of the clinical trial have been met, confirming the high quality of our product candidate. These positive results confirm our development strategy, which is based on most up-to-date scientific considerations and includes a second clinical study to investigate the immunogenicity of B12019. We will
now accelerate the establishment of partnerships for commercialisation as we expect a timely submission for approval in Europe.”
Enrique Ordieres, President of Infarco, added: “We are progressing towards our goal to provide all patients with access to biological drugs, and we will continue to support Cinfa Biotech in this process.”
Pegfilgrastim is indicated to treat chemotherapy-induced neutropenia. The pegylated granulocyte colony-stimulating factor (G-CSF) receptor agonist is used to stimulate bone marrow to produce more neutrophils to decrease the incidence of infections in
patients undergoing chemotherapy.
Cinfa Biotech is headquartered in Pamplona, Spain, with offices in Munich, Germany. Founded in 2013 and supported by its parent company Infarco, the Company is creating a pipeline of biosimilar drugs for a range of indications to address the growing need for affordable therapies based on proven science, quality, safety and efficacy. A complete team of experts with decades of in-depth experience is conducting product development, clinical studies, manufacturing and quality control, according to the highest European standards. Cinfa Biotech’s first product candidate in clinical development is B12019, a biosimilar version of Neulasta® (pegfilgrastim). The commercialisation models will be customised to the needs of partners and markets.
With 50 years’ experience, Infarco today employs over 1,400 people and reinvests an average of 90% of its annual profits in its portfolio companies, thereby driving their development and innovation. Infarco’s first subsidiary, Laboratorios Cinfa, has become a recognised leader in the Spanish pharmaceutical market. As part of the internationalization strategy, the company also serves in currently over 50 countries and is further expanding.
For more information, please visit: http://www.cinfabiotech.com
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