Samsung to make drug for US firm
Samsung BioLogics said Tuesday it had signed a contract with a U.S. biotech firm to expand the manufacture of a drug to combat atopic dermatitis that is undergoing clinical trials.
Since the contract also guarantees commercial manufacture, Samsung BioLogics expects it will lead to greater opportunities in the lucrative atopic dermatitis drug market.
The company said it had signed a long-term agreement with Ichnos Sciences to manufacture the latter’s ISB 830 atopic dermatitis drug for phase three clinical trials.
With the contract, Samsung BioLogics will manufacture at least $15.1 million worth of the drug, up from an existing deal of $8.62 million, which was signed in June 2018.
ISB 830 is an anti-OX40 monoclonal antibody, believed to have the potential to treat a range of autoimmune diseases beyond atopic dermatitis. A randomized placebo-controlled phase two study was completed recently.
Additionally, the new deal also guarantees Samsung the drug’s commercial manufacturing worth $66.44 million, if Ichnos Sciences wins regulatory approval at the conclusion of phase three trials next year.
Ichnos Sciences is a biotech spinoff from the global pharmaceutical company Glenmark, and has five candidate drugs in the pipeline — treatments for breast cancer, myeloma, osteoarthritis, neuropathic pain and atopic dermatitis. Of them, the two for atopic dermatitis and neuropathic pain are on the fastest track, as they are both in phase three trials.
Samsung BioLogics and Ichnos Sciences formed their first partnership in 2017 with a Master Service Agreement for the Korean firm to provide the U.S. company with process optimization and manufacturing services.
Commercial manufacturing of the drug will depend on market demand, and Samsung Biologics is considering producing it at its Incheon Plant 3, which is the world’s largest single bio manufacturing plant.
“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 a high-quality ISB 830 drug supply for clinical studies and for potential future commercial production,” Samsung BioLogics CEO Kim Taehan said.
“Client satisfaction is our highest priority, and we look forward to generating future value for Ichnos via our continued collaboration.”
The contract is expected to expand Samsung BioLogics presence in the global atopic dermatitis market.
According to market tracker Global Data, the seven largest markets for the condition worldwide are the U.S., France, Germany, Italy, Spain, the U.K. and Japan - and these are growing by an average 11.1 percent annually with their value anticipated to reach $18.3 billion by 2027.
“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 a continued drug substance supply for ISB 830,” Ichnos Sciences CEO Alessandro Riva said.
“We look forward to a mutually beneficial collaboration as we continue developing ISB 830 for autoimmune diseases, including atopic dermatitis.”
Samsung BioLogics Plant 3 in Incheon