Satellite Banner
Technology
Networks
Scientific Communities
 
Become a Member | Sign in
Home>News>This Article
  News
Return

Pharming And Shanghai Institute Of Pharmaceutical Industry (SIPI) Establish Strategic Collaboration

Published: Wednesday, July 03, 2013
Last Updated: Wednesday, July 03, 2013
Bookmark and Share
Companies to share joint global biologicals development at SIPI using Pharming platform and know- how.

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.”


Further Information

Join For Free

Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 4,000+ scientific posters on ePosters
  • More Than 5,300+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.


Scientific News
Big Genetics in BC: The American Society for Human Genetics 2016 Meeting
Themes at this year's meeting ranged from the verification, validation, and sharing of data, to the translation of laboratory findings into actionable clinical results.
Stem Cells in Drug Discovery
Potential Source of Unlimited Human Test Cells, but Roadblocks Remain.
Automated Low Volume Dispensing Trends
Gain a better understanding of the current and future market requirements for fully automated LVD systems.
Cancer Genetics: Key to Diagnosis, Therapy
When applied judiciously, cancer genetics directs caregivers to the right drug at the right time, while sparing patients of unnecessary or harmful treatments.
Diabetes Missing Link Discovered
Researchers from the University of Auckland have shown that beta catenin plays a vital role in the control of insulin release from the pancreas.
Study Reveals New Role for Hippo Pathway in Suppressing Cancer Immunity
Hippo pathway signaling regulates organ size by moderating cell growth, apoptosis and stem cell renewal, but dysregulation contributes to cancer development.
Biological Link between the Gut Microbiome and Parkinson’s Disease
The findings suggest that targeting the gut microbiome may provide a new approach for diagnosing and treating Parkinson’s disease.
How the Brain Recognizes Faces
Machine-learning system spontaneously reproduces aspects of human neurology.
Boosting Effectiveness of Asthma Therapy
A team of scientists from UCSF has developed a new treatment to dampen bronchospasm.
Improved Stability, Shelf Life of Protein Drugs
Study improves protein drug stability and extend their shelf life by tested a novel route for non-covalent protein modification.
Scroll Up
Scroll Down
Skyscraper Banner

SELECTBIO Market Reports
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
4,000+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
5,300+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!