Dong-A ST and its Japanese partner Meiji Seika Pharma signed a global license-out agreement with Intas Pharmaceuticals for DMB-3115, a biosimilar of the inflammatory disease treatment Stelara, the Korean company said Wednesday.
Under the contract, Dong-A ST and Meiji Seika Pharma will research and develop the biosimilar and have the right to the exclusive supply of finished products while transferring the monopolized rights concerning its approval and marketing in the world except for Korea, Japan, and some Asian countries to the multinational company.
After its successful commercialization, DMBio, a subsidiary of Dong-A Socio Holdings providing CDMO services, will manufacture the biosimilar drug.
Aside from $10million in down payment with no obligation to return, the licensors will receive milestone payments of $95million and double-digit royalties on the sales revenue of the product from Intas Pharmaceuticals.
Intas Pharma will have its U.K.-based subsidiary, Accord Healthcare, handle the approval acquisition and marketing in Europe and the U.S.
Since 2013, Dong-A Socio Holdings and Meiji Seika Pharma had been co-developing DMB-3115. However, in July last year, the right for development and commercialization was handed over to Dong-A ST to conduct the global project efficiently.
Dong-A ST launched Phase 3 trial in Poland, Estonia, Latvia, and the U.S. in the first quarter of this year and plans to carry out additional trials in nine European countries sequentially.
Stelara is a biopharmaceutical product developed by Johnson and Johnson, which controls the activation of inflammatory cells. It is used to treat inflammatory diseases like psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis, and a blockbuster drug that recorded sales of $7.7 billion last year.
“The contract with Intas, highly experienced in global biopharmaceutical market and R&D, will help Dong-A Socio Group realize its dream of jumping to a global healthcare player through securing differential competitiveness,” a company official said. “Dong-A ST will make best efforts to focus on the success of the global phase 3 trials.
Intas is an India-based multinational pharmaceutical with a global sales network in more than 85countries. Last year, it had recorded 70 percent of its sales in international markets like the U.S. and Europe.