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EOUL, Korea—As consumer electronics powerhouse Samsung inlate November unveiled "The Next Big Thing is Already Here," an aggressiveadvertising campaign for its Galaxy S II smartphone portfolio, its Biologicsdivision also announced a key biopharmaceutical partnership intended to advanceits position in what some industry watchers are calling "the next big thing" indrug development: biosimilars.
On Dec. 5, Samsung Biologics furthered its stated mission ofbecoming a major player in the biosimilars market with a newly announced jointventure with Biogen Idec, a Switzerland-based biotechnology company focused onneurodegenerative diseases, hemophilia and autoimmune disorders.
Earlier this year, ddnreported on Samsung's entrée into the biopharmaceutical business when itannounced a joint venture with contract research organization Quintiles (see "Helpinga new swimmer in the biopharma pool,"ddnApril 2011). That deal involved the construction of a biopharmaceuticalmanufacturing plant in the Incheon Free Economic Zone in Songdo, Incheon, SouthKorea. Samsung Biologics has stated that it intends to commercializebiosimilars by 2016, then expand into innovative biologics from there.
"At Samsung, one of our goals is to help patients around theworld by increasing the accessibility and affordability of existing medicines,"said Dr. Tae-Han Kim, CEO of Samsung Biologics, in a statement announcing thejoint venture with Biogen. "Since many of the world's top-selling drugs arebiologics, developing and making high-quality biosimilars is critical to thatgoal. By combining Biogen Idec's expertise in biologics with our businessacumen and proven record of success in new business development, we are takinga significant step toward becoming a major player in the biopharmaceuticalindustry and investing in an important growth engine for our company."
The as-yet-unnamed joint venture will develop, manufactureand market biosimilars. The independent entity will be based in Seoul andcontract with Biogen Idec and Samsung Biologics for technical development andmanufacturing services.
Samsung is considered the leader of the joint venture, asthe agreement calls for it to contribute $255 million for an 85-percent stake,and for Biogen Idec to put up $45 million for a 15-percent stake. Samsung'scontribution will be in the way of its biomanufacturing plant, while BiogenIdec will contribute its expertise in protein engineering and biologicsmanufacturing.
Completion of the transaction is subject to customaryclosing conditions, including antitrust clearance by the U.S. and Koreanregulators.
In a statement announcing the joint venture, Biogen Idec CEODr. George A. Scangos said his company is "impressed with Samsung's trackrecord of leadership and excellence in all their businesses" and is "excited tobe working with them."
"The future of healthcare will continue to be driven byinnovation, but it will also be about ensuring patients have access tocost-effective therapies, and biosimilars will play an important role in that,"Scangos added.
Yet, as Biogen Idec also explores the biosimilars market, itis taking care to not put all of its eggs in one basket, says Naomi Aoki, aspokeswoman for the company who notes that the joint venture will not pursuebiosimilars of Biogen Idec's proprietary products.
The manner in which the joint venture is structured allowsBiogen Idec "to keep a focus on our core business, but also takes advantage ofour expertise in protein and biologics manufacturing," Aoki says.
"We have always believed there should be a pathway forbiosimilars to come to market," she adds. "While innovation is going tocontinue to drive healthcare going forward, and bringing new treatments topatients is important, access to affordable medicines is also criticallyimportant. We think we have the capabilities and skill sets that lend themselves toparticipating in the biosimilars market, which will achieve that balance, butthis is not the business we are in or looking to get into."
The joint venture has agreed upon an initial portfolio, butit is not disclosing any details about specific therapeutic areas forcompetitive reasons, Aoki says.
"We're still in the early days of biosimilars, and it'stough to predict how the market will play out," she adds. "We expect this to bea significant market, especially as a number of very important biologics comeoff-patent in the next decade. We're a 15-percent owner of this joint venture,but we have the option of increasing our stake to 50 percent. As we see thismarket and business segment emerge, we'll be keeping an eye on it to see iffocusing on it makes sense for our business—because it doesn't really right now—whichgives us some flexibility down the road."
A $4 billion Fortune 500 company, Biogen Idec's top productsare AVONEX, an interferon beta-1a used to treat multiple sclerosis (MS);TYSABRI, a treatment approved for relapsing forms of MS in the United Statesand relapsing-remitting MS in the European Union; and RITUXAN, a treatment usedalone or with other medications to treat certain types of non-Hodgkin's lymphomaand rheumatoid arthritis.
