Date: 2013-07-01
Type of information: Collaboration agreement
Compound: Ruconest® (Rhucin® in non-European territories - conestat alfa) and Pharming\'s transgenic technology platform
Company: Pharming (The Netherlands) Shanghai Institute Of Pharmaceutical Industry (SIPI) (China)
Therapeutic area: Rare diseases - Genetic diseases
Type agreement: collaboration
development
Action mechanism:
Disease:
Details: * On July 1, 2013, Pharming Group and Shanghai Institute of Pharmaceutical Industry (SIPI), a Sinopharm Company , have 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 develo ped 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 FDA and/ or a Clinical Trial Application (CTA) from the 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.
Financial terms: 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 R uconest® 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.
Latest news:
