Samsung has already spent billions of dollars in short order to establish one of the largest biologics manufacturing operations in the world. Today it said it will spend billions more.
While short on details, the South Korean conglomerate announced plans to invest $22 billion across business lines it said will propel its growth in the futurer, including artificial intelligence, auto electronics and biopharmaceuticals.
“For biopharmaceuticals, Samsung has seen strong growth from both its contract manufacturing and biosimilar businesses. It will continue to invest heavily in the businesses, including developing and manufacturing biosimilars to combat chronic and difficult-to-cure diseases.”
Its Samsung BioLogics unit established its CDMO and biosimilars business quickly after Samsung decided it was a viable extension of its chemicals business. It has pledged to become the top biologics contract manufacturer in the world and is in the process of completing a third biologics plant at a site in Incheon next to two others—a feat accomplished in seven years.
With completion of the third facility, the company will have total capacity of 362,000 liters and will have invested 3 trillion won ($2.6 billion), in the massive buildup.
The unit has attracted top tier pharma and biotech business but has yet to make a profit. Last month it reported earnings that included a net loss of 9.6 billion won ($8.53 million) in the second quarter. It said the operating profit of Samsung BioLogics increased sharply by 13.7 billion won ($1.2 million) from the previous quarter and that it showed an improvement in its net loss as sales improved from its Samsung Bioepis subsidiary, a joint venture with Biogen to produce biosimilars.
Earlier accounting at the JV, however, has been called into question by Korean regulators. Last month, South Korea’s Securities and Futures Commission found that Samsung BioLogics “violated accounting standards by intentionally omitting information regarding the joint venture agreement with Biogen in its public disclosure.” It said it had referred its finding to prosecutors. Samsung has denied the allegations, saying it complied with all accounting standards.
The disclosures came even as Biogen paid about $700 million to increase its share in the JV to 49.9% from 5.4%. Biogen CEO Michel Vounatsos said in the company’s first-quarter earnings call that the biotech decided to up its stake because of the JV’s success. He said the joint venture’s European biosimilar revenue is tracking at about $500 million per year.
Samsung also hit a milestone last month with the FDA approval of its first finished product, a monoclonal antibody, at the second of the three plants. Samsung did not identify the product or the client. The plant is already approved by the FDA to make drug substances, and Europe has approved the facility to produce two finished products.
By: Eric Palmer
Source: Fierce Pharma
Echosens, a high-technology company offering liver diagnostic solutions, and Novo Nordisk A/S, a leading global healthcare company, announced a partnership to advance early diagnosis of non-alcoholic steatohepatitis (NASH) and increase awareness of the disease among patients, healthcare providers and other stakeholders.
Positive opinion based on Phase 3 ADAPT trial showing efgartigimod provided clinically meaningful improvements in strength and quality of life measures. If approved, efgartigimod will be the first neonatal Fc receptor (FcRn) blocker for the treatment of adults in Europe living with rare neuromuscular disease generalized myasthenia gravis (gMG).
Galapagos CEO Paul Stoffels, M.D., has finally taken the plunge on M&A. The newly minted chief executive has signed not one but two deals in an attempt to right the ship, bringing two small biotechs aboard for a combined 239 million euros ($251.4 million).