Visit Contract Pharma at Stand 121A63

Samsung Biologics and Ichnos Sciences Ink Mfg. Deal

11.05.19

Samsung to manufacture drug substance for ISB 830 Phase 3 clinical trials and for potential future global commercial supply upon regulatory approval.

Samsung Biologics has signed a long-term agreement with Ichnos Sciences for manufacturing drug substance for ISB 830, an anti-OX40 monoclonal antibody in development as a potential treatment for moderate-to-severe atopic dermatitis.
 
Based on an entirely new mechanism of action, ISB 830 has the potential to treat a range of autoimmune diseases beyond atopic dermatitis. Enrollment in a large randomized placebo-controlled Phase 2b study in atopic dermatitis was recently completed and results are expected in the first half of 2020. 
 
The prevalence of atopic dermatitis in the seven major markets (U.S., France, Germany, Italy, Spain, the UK, and Japan) currently exceeds 80 million patients and the market is expected to grow to $18.3 billion by 2027, according to GlobalData, a leading data and analytics company.
 
Ichnos, headquartered in Paramus, NJ, is a fully integrated global biotech company that is rapidly advancing its pipeline and has five novel, first-in-class candidates in clinical stage development. Samsung Biologics and Ichnos (formerly known as Glenmark Pharmaceuticals S.A.) entered into a Master Services Agreement in 2017 for Samsung Biologics to provide Ichnos with process optimization and manufacturing services. Ichnos and Samsung Biologics have now entered into a long term agreement for Samsung Biologics to manufacture drug substance for ISB 830 Phase 3 clinical trials and for potential future global commercial supply upon regulatory approval.
 
“As we progress our pipeline of clinical stage assets, including our most advanced biologic ISB 830, we are pleased to continue to work with Samsung Biologics to ensure continued drug substance supply for ISB 830,” said Alessandro Riva, chief executive officer, Ichnos Sciences. “We look forward to a mutually beneficial collaboration as we continue developing ISB 830 for autoimmune diseases, including atopic dermatitis.”
 
Since the beginning of the relationship, Samsung Biologics has continued to offer flexible business terms and the latest standards in technologies, along with maintaining the highest quality with full regulatory support and improved batch release from small to large scale. This long-term relationship aims to bring further growth to both companies with the goal of bringing ISB 830 to market for the treatment of atopic dermatitis and other autoimmune diseases.
 
“We are extremely proud to advance our ongoing relationship with Ichnos and truly appreciate the trust they have placed in Samsung Biologics to ensure delivery of high quality ISB 830 drug supply for clinical studies and for potential future commercial supply,” said Tae Han Kim, chief executive officer, Samsung Biologics. “Client satisfaction is our highest priority, and we look forward to generating future value for Ichnos via our continued collaboration.”
Visit Samsung at CPhI Worldwide booth 120D02.