Pharming agrees collaboration with Shanghai Institute of Pharmaceutical Industry (SIPI)

Dutch biotech company Pharming Group and Shanghai Institute of Pharmaceutical Industry (SIPI), a Sinopharm company, have agreed to develop, manufacture and commercialise new products based on Pharming technology.

Pharming has also granted SIPI an exclusive licence to commercialise Ruconest (conestat alfa) in China.

Under the terms of the agreement, Pharming will transfer its technology platform and manufacturing know-how to SIPI, to enable joint global development for new products to take place at SIPI’s facilities in Shanghai. The firms aim to benefit from ‘both the cost advantages of the Pharming platform and the competitive development and manufacturing cost structures at SIPI’.

SIPI will pay Pharming €1.26 upfront and €840,000 associated with the first technology transfer of Ruconest.

The deal also includes clinical and regulatory milestones and royalty payments.

We can become a global exporter of such domestically produced competitive world-class biological medicines

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 China.

Sijmen De Vries, Chief Executive of Pharming said this collaborative product development with SIPI ‘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,’ he said.

‘This collaboration represents an important source of future products, including for the fastest growing pharmaceutical market in the world; China.’

Weigen Lu, President of SIPI, added that: ‘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 develop world-class quality biological medicines and to bring to Chinese patients affordable biological medicines.

He added that by supplying Pharming, ‘we can become a global exporter of such domestically produced competitive world-class biological medicines’.