Biotech company Pharming Group NV and Shanghai Institute of Pharmaceutical Industry, a Sinopharm Company , announced 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.
To ensure world- wide commercialisation of the products developed and manufactured by SIPI, product development and manufacturing at SIPI will be implemented under Pharming’s fully ICH compliant quality assurance systems, and will be compliant with all CFDA, EMA and FDA regulatory guidelines.
SIPI will have commercialisation rights for the Chinese market for all new products developed; Pharming will retain global rights ex-China.
Over the past three decades, SIPI’s parent company, Sinopharm has established a number of collaborative relationships and pharmaceutical joint ventures with companies from the US, Japan, and Europe.
SIPI will pay Pharming €1.26 million upfront for the collaboration and a total of €0.84 million technology transfer related milestones associated with the implementation of the first technology transfer Ruconest (conestat alfa).
For every product developed by and manufactured, SIPI will pay Pharming a number of clinical and regulatory milestones. SIPI will supply Pharming on a cost plus basis for world- wide commercialisation. Pharming will pay SIPI 4% royalties on global sales (ex-China) and SIPI will pay Pharming 4% royalties on sales in China.
Until the technology transfer is completed and a Chinese marketing authorisation for SIPI produced conestat alfa has been granted, Pharming will supply SIPI with Ruconest® as an import drug for China, at a cost plus basis and 4% royalties and SIPI will pay Pharming a €0.3 million milestone upon receipt of a Ruconest® import license for China.
Sijmen De Vries, Chief Executive of Pharming commented:
“This collaborative product development with SIPI, aimed at developing new recombinant products in a cost effective manner, is a significant strategic achievement and will drive the future growth of Pharming. The combination of SIPI’s vast resources and product development capabilities and Pharming’s platform will allow us to jointly develop a biological pipeline by engaging in future multiple product development activities and significantly increase the output of our platform. This collaboration represents an important source of future products, including for the fastest growing pharmaceutical market in the world; China.”
Dr. Weigen Lu, President of SIPI commented:
“Combining Pharming’s validated technology platform with SIPI’s capabilities in manufacturing, development, domestic regulatory and Sinopharm’s commercialisation network, we have created an opportunity to provide for China’s rapidly increasing need to domestically developed world- class quality biological medicines and to bringing to Chinese patients affordable biological medicines, and by supplying Pharming, we can become a global exporter of such domestically produced competitive world- class biological medicines.”