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Samsung Bioepis is shifting gears moving into the development of novel biologics via a strategic collaboration with Takeda. The partners will initially focus on acute pancreatitis and jointly develop Takeda's preclinical candidate in the segment.



Settlling Global Patent Disputes 




Samsung Bioepis Co. Ltd. has joined hands with Takeda Pharmaceutical Co. Ltd. to develop novel biologics, moving beyond its core focus on biosimilars.


Under the strategic collaboration, the two companies will jointly fund and co-develop multiple novel innovative biologic therapies in unmet disease areas. The partnership brings together Samsung Bioepis’ agile biologics development platform with Takeda’s “best-in-class experts” in drug development. The two will collaborate in exploring novel drug substance, clinical development, regulatory approval and commercialization. Financial terms of the deal weren't disclosed.


Samsung Bioepis has been considering partnerships with global pharma companies to enter the novel drug development business as part of its long-term goal to become a leading global biopharma firm.


“Takeda’s extensive knowledge and expertise in drug development makes the company an ideal partner for us as we open a new chapter at Samsung Bioepis,” said Christopher Hansung Ko, president and CEO of Samsung Bioepis, in a statement.


The agreement is also in line with Takeda's R&D strategy and comes amid a series of deals by the Japanese company this year, which includes a licensing agreement for Tesaro’s Zejula (niraparib), a PARP inhibitor for cancer. (Also see "Deal Watch: Takeda Continues Transaction Spree With Four More Deals" - Scrip, 4 Aug, 2017.) Takeda has made major changes to its R&D strategy last year after deciding to focus on three core drug development areas: gastro-intestinal, oncology and CNS. (Also see "Interview: Setting The Course For Takeda’s R&D Future" - Scrip, 30 Jun, 2017.)


Right Time To Co-Work


The latest deal will enable the two companies to build synergies in terms of cost and time.

Samsung expects to "minimize risks” in diversifying into novel drugs through the collaboration with Takeda and expand its research and development capabilities in biosimilars into novel drug development.


Capitalizing on Takeda's strength in gastro-intestinal therapies, the two will initially co-develop Takeda's TAK-671, which is intended for the treatment of severe acute pancreatitis.


“So far, there isn’t any therapy developed for acute pancreatitis. The program is in preclinical stage, which we believe is the right time to co-work and create synergies,” said Samsung.


According to Biomedtracker, several companies including GlaxoSmithKline PLC , Stason Pharmaceuticals, D-Pharm Ltd. and Sun BioPharma Inc., are progressing development of pancreatitis drug candidates ranging from preclinical to Phase II, although there weren't any particular acute pancreatitis therapies in the pipeline.


In the US, 24.2 people out of 100,000 suffer from acute pancreatitis, while in South Korea, the disease affects about 20 out of 100,000.



For the time being, Samsung plans to pursue novel drug development in the form of co-development, rather than licensing deals, due to high risks.



Samsung Bioepis, which is a joint venture between Samsung BioLogics and Biogen Inc. , has a broad pipeline of biosimilars that includes six “first wave” candidates in immunology, oncology and diabetes.


Samsung Bioepis has so far launched biosimilar etanercept in Australia, Canada, South Korea and Europe (Also see "Samsung Bioepis's Etanercept Biosimilar To Be Rolled Out In Europe" - Scrip, 18 Jan, 2016.), while launching biosimilar infliximab in the US, Europe, Australia and South Korea. (Also see "Merck's Second-To-Market Renflexis Biosimilar Priced Below The First" - Scrip, 24 Jul, 2017.)


Its biosimilar adalimumab has received CHMP's recommendation and is awaiting approval in Europe (Also see "EU CHMP OKs Imraldi, Samsung Bioepis’ Biosimilar Of AbbVie’s Humira" - Scrip, 26 Jun, 2017.), while its biosimilar trastuzumab is undergoing regulatory approval in Europe. (Also see "Samsung Enters Oncology as Trastuzumab Accepted For EU Review" - Scrip, 4 Oct, 2016.)

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