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.
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 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.”
About SIPI/ Sinopharm
Shanghai Institute for Pharmaceutical Industry (SIPI) was established in 1957 and became part of Sinopharm in 2010. Within Sinopharm, SIPI is an integrated applied science institute with a long history and strong capability in Chinese pharmaceutical industry, SIPI discovers, develops medicines and transfers technologies. In addition, SIPI has a graduate school of Pharmacy.
China National Pharmaceutical Group Corporation, (Sinopharm) is the largest medical and healthcare group in China which is directly managed by State-owned Assets Supervision and Administration Commission of the State Council (SASAC), with the core businesses of distribution, logistics, retail, scientific research and manufacture of healthcare related products. Associated built on the basis of the four state-owned companies: China National Pharmaceutical (Group) Corporation, China National Pharmaceutical Industry Corporation, China National Pharmaceutical Foreign Trade Corporation and China National Medical Equipment Industry Corporation, Sinopharm was established in 1998. In 2003, China National Group Corporation of Traditional & Herbal Medicine joined Sinopharm. In 2009, Sinopharm restructured with China National Bio-tech Group (CNBG). As well as in 2010, Shanghai Institute of Pharmaceutical Industry (SIPI) and China National Service Corporation for Chinese Personnel Working Abroad (CNSC) joined Sinopharm. So far, Sinopharm owns 10 wholly owned or holding subsidiaries, and 5 listed companies including Sinopharm Group Co., Ltd. (01099.HK), China National Medicines Co., Ltd. (600511.SH), Beijing Tiantan Biological Products Co., Ltd. (600161.SH), Shyndec Pharmaceutical Co., Ltd. (600420.SH) and Shenzhen Accord Pharmaceutical Co., Ltd. (200028.SZ). The sales revenue of Sinopharm exceeded RMB 160 billion in 2012. It is the only Chinese pharmaceutical company whose sales revenue exceeds RMB 100 billion.
Sinopharm is aiming to be an international pharmaceutical and healthcare group which covering the whole industrial chain and can give strong impetus to the industry as well as the first Chinese pharmaceutical company of the Global Top 500 Corporations during the period of "the 12th Five-Year-Plan".
About Factor VIII and Haemophilia A
Haemophilia A is an X chromosome linked hereditary disorder caused by defects in the Factor VIII (FVIII) gene that lead to lower levels of the functional FVIII protein. Lack of functional FVIII diminishes the body’s clotting ability, which in turn can lead to damaging or fatal bleeding episodes. The global rhFVIII market was estimated to worth US$3.8 billion in 2009, with 90% of sales in the developed markets and very high unmet medical needs in the developing markets, such as China. In addition, only approximately 50% of the world-wide estimated haemophilia market can currently be supplied with appropriate FVIII therapy. Hence, there is still a high unmet medical need in this field with an estimated total market potential of US$10 billion.
suc6, jurps