Pharming And Shanghai Institute Of Pharmaceutical Industry (SIPI) Establish Strategic Collaboration
•Joint global biologicals development at SIPI using Pharming platform and know- how
•SIPI to commercialise Ruconest® (conestat alfa) in China
Leiden, The Netherlands and Shanghai, China, July 01, 2013. Biotech company Pharming Group NV (“Pharming” or “the Company”) (NYSE Euronext: PHARM) and Shanghai Institute of Pharmaceutical Industry (“SIPI”), a Sinopharm Company , announced today that they have entered into a strategic collaboration for the development, manufacture and commercialisation of new products based on the Pharming technology platform. In addition, Pharming has also granted SIPI an exclusive license to commercialise Ruconest (conestat alfa) in China.
Under the terms of the agreement, Pharming will transfer the Pharming technology platform and manufacturing know- how to SIPI, such that joint global development for new products will take place at SIPI’s facilities in Shanghai and benefit from both the cost advantages of the Pharming platform and the competitive development and manufacturing costs structures at SIPI.
The first projects to be jointly developed at SIPI will be C1-inhibitor (conestat alfa) and Factor VIII. Under the agreement, SIPI will fund preclinical and manufacturing development.
Pharming will be responsible for obtaining Investigational New Drug (IND) applications from the US Food and Drug Administration (FDA) and/ or a Clinical Trial Application (CTA) from the European Medicines Agency (EMA); SIPI will be responsible for obtaining a Clinical Trial Permit (CTP) from the China Food and Drug Administration (CFDA) for each of the products
SIPI will fund and be responsible for clinical development in China and Pharming for all clinical development outside of China. Both parties will, wherever possible, coordinate and combine clinical development activities.