Cinfa Biotech starts second clinical study of pegfilgrastim biosimilar candidate B12019

Pamplona, Spain, 26. September 2016

Cinfa Biotech S.L., the biosimilars company of Infarco group, today announced the start of the second clinical study with its lead development candidate B12019, a biosimilar version of Neulasta® (pegfilgrastim) to treat chemotherapy-induced neutropenia. The objective of the trial is to investigate the pharmacodynamics (PD) and immunogenicity of B12019 compared to Neulasta®.

The multiple-dose, randomised, double-blind, cross-over study will enrol 96 healthy volunteers in Germany. Secondary endpoints of the trial include pharmacokinetic (PK) and safety parameters. The study design is based on scientific advice from the European Medicines Agency (EMA) and is tailored to the specific properties of pegfilgrastim.

Dr. Ruediger Jankowsky, Managing Director of Cinfa Biotech GmbH, commented: “The successful clinical trial of B12019, which we reported in July this year, allowed for the immediate continuation of the clinical development program, especially since proving that we have such a high-quality product and a confirmed development strategy. The timely start of the second clinical study marks an important milestone in the development of B12019.”

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 in order to decrease the incidence of infections in patients undergoing chemotherapy.


About Cinfa Biotech

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.

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