Samsung Bioepis starts work on original drug

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Samsung Bioepis starts work on original drug

Samsung Bioepis, a biopharmaceutical arm of Samsung, announced Monday it has joined forces with Japan’s No. 1 pharmaceutical company to develop an original treatment for severe acute pancreatitis.

The strategic partnership for a highly lucrative original drug marks a major leap forward for the Samsung subsidiary that has concentrated on developing biosimilars since it was established in 2012.

Biosimilars, according to the FDA, are biological products that are approved based on proof that they are highly similar to other FDA-approved products. The drugs have no clinically meaningful differences in terms of safety or effectiveness from the reference product, but they cost less.

Samsung Bioepis is a joint venture between the Kospi-listed Samsung BioLogics and Biogen, a multinational biotech firm based in Cambridge, Massachusetts. The company has invested $1.3 billion in drug development thus far.

Samsung Bioepis, based in Songdo, Gyeonggi, said it entered into a strategic collaboration agreement with Takeda Pharmaceutical to jointly fund and co-develop multiple novel biologic therapies in unmet disease areas. They will immediately begin working on the first therapeutic candidate, TAK-671, which is intended to treat severe acute pancreatitis.

“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. “Together with Takeda, we look forward to realizing this goal by accelerating the development of effective therapies for patients who are currently without a viable treatment option.”

Takeda, founded in 1781, is Japan’s largest drug maker by sales and one of the top 20 pharmaceutical companies in the world. It has been focusing research and development on treatments for cancer and diseases of the digestive and central nervous systems and has been scouting for acquisitions worldwide to ease dependence on domestic sales.

“At Takeda, we think differently about what makes a partnership successful and look to build on our strengths by collaborating with partners who have complementary expertise” said Daniel Curran, head of the Center for External Innovation at Takeda. “This collaboration with Samsung Bioepis does that, by combining our unique capabilities in development and manufacturing along with fresh and innovative clinical approaches, we will maximize the potential for successful introduction of important medicines to patients.”

No severe acute pancreatitis treatment is known to be under development, even though its occurrence is on the rise due to an increase in alcohol consumption worldwide. Acute pancreatitis occurs in 4.8 to 24.2 out of every 100,000 people, according to a thesis from 2010 that cited data from England, Denmark and the United States. In Korea it occurs 20 times out of every 100,000 people, with those in their 40s and 50s constituting the major patient demographic.

This marks the first time that Samsung Bioepis has gone beyond biosimilars and jumped into original drug development. In May 2010, two years prior to its foundation, Samsung Group declared that it would drive future growth in five key industries, which included the biopharmaceutical sector.

Bioepis has received approval for two biosimilars in Europe and one in the United States. Last month, it began selling Flixabi, a biosimilar version of Johnson & Johnson’s rheumatoid arthritis drug blockbuster Remicade in the United States. In June last year it obtained approval to sell Flixabi in Europe.

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