Cinfa Biotech initiates biosimilar strategy with pegfilgrastim candidate to treat neutropenia

Pamplona, Spain – October 8, 2015

Cinfa Biotech S.L., the biosimilar company of Infarco group, today outlined the Company’s strategy to develop and commercialise biosimilar drugs. The Company’s first product candidate is B12019, a biosimilar version of Neulasta® (pegfilgrastim), starting clinical trials in 2015.

B12019 is a granulocyte colony-stimulating factor (G-CSF) receptor agonist for the treatment of chemotherapy-induced neutropenia. The product candidate has successfully finalised preclinical development and has an agreed clinical development program based upon scientific advice received from the European Medicines Agency (EMA). Furthermore, the manufacturing process (GMP) has been implemented at commercial scale.

Cinfa Biotech was established by Infarco group, Spain, in 2013. A committed investment of initially EUR 70 million underlines Infarco’s determination to apply its effective portfolio strategy, as realised by its affiliate company Laboratorios Cinfa as a leading supplier of quality drugs for the European market, now to biosimilars. Cinfa Biotech is creating a pipeline of biosimilars for several indications in oncology and inflammatory diseases to address the growing need for affordable biologics therapies based on proven science, quality, safety and efficacy. Product development, clinical studies, manufacturing and quality control at Cinfa Biotech are conducted in Europe according to the highest European standards.

Dr. Rüdiger Jankowsky, Managing Director of Cinfa Biotech, said: ”Cinfa Biotech’s pipeline and the development of B12019 is driven by a team of experts in development, manufacturing and commercialisation, a team which has already successfully developed and launched biosimilars in different markets throughout the world. Cinfa Biotech will be covering the entire value chain from biosimilar development to commercialisation. We are glad to provide patients, physicians, healthcare providers and business partners with affordable treatment options and competitive opportunities based on proven therapies.

Enrique Ordieres, President of Infarco, commented: “The founding of Cinfa Biotech and our investment in a biosimilar pipeline is following the logic of our successful business strategy. As demonstrated with Laboratorios Cinfa, which has become the leading quality supplier for retailing pharmacies in Spain, now present in over 50 countries, there is an urgent medical need to ensure that proven, advantageous and affordable medications are available to all patients. This concept will now be applied to complex and costly biologic drugs. We are committed to improving patient access to healthcare solutions and supporting national healthcare systems through reliable supply of high-quality products. Cinfa Biotech is our answer to this need.


About Infarco – parent company of Cinfa Biotech

Infarco, the parent company of Cinfa Biotech, holds a portfolio of pharmaceutical companies. With 50 years experience, Infarco represents the successful professional approach of a group of pharmacists to recover the central role of pharmacists in the pharmaceutical industry. The Company today employs over 1,200 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 successful developer and manufacturer and a recognised leader in the Spanish pharmaceutical market; it is the laboratory with the strongest presence in Spanish homes. As part of the internationalisation strategy, the company serves markets in currently over 50 countries and is further expanding.


About Cinfa Biotech

Cinfa Biotech is headquartered in Pamplona, Spain, with offices in Munich, Germany. The company was founded in 2013 and received an initial investment of EUR 70 million from Infarco to create a pipeline of biosimilar drugs 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 developing biosimilars for a range of indications. The
commercialisation models will be customised to the needs of partners and markets. Product development, clinical studies, manufacturing and quality control at Cinfa Biotech are conducted in Europe according to the highest European standards.


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