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Monday, Mar 18, 2024

Amgen Plans ‘Next Generation’ Production Plant

The past month has been a busy one for Amgen Inc. The Thousand Oaks-based biopharmaceutical firm announced the opening of a “next generation” drug manufacturing plant in Rhode Island, saw the European Commission greenlight a label expansion for the company’s bone drug Xgeva and received U.S. Food and Drug Administration approval of its request to expand the label of its leukemia drug Blincyto. On April 10, the company announced plans to build a new biomanufacturing plant in West Greenwich, R.I., where it will employ around 150 workers. It will be added to the company’s existing 75-acre property, where Amgen already has manufacturing facilities. The plant is designed so construction will take half the time of a traditional facility, Amgen said. It will incorporate green technologies that reduce the consumption of water and energy and have less carbon emissions than older plants. The company decided to build the plant based on incentives granted through the Tax Cuts and Job Act, the federal tax reform bill that was signed into law in December, the company noted in a statement. Rhode Island was chosen as the location on account of the success of the company’s existing facilities there, along with the quality of life in West Greenwich, Amgen said. Earlier this month, the European Commission granted Amgen’s request to expand the label of its bone drug Xgeva. Prior to the commission’s approval, which was announced April 2, Xgeva was indicated in Europe for the prevention of fractures and other skeletal complications in patients with solid tumors. The updated label expands the patient base to include those with multiple myeloma, a bone marrow cancer. Some studies estimate that as many as 80 percent of patients who have multiple myeloma have bone disease at diagnosis; an estimated 60,000 Europeans are living with the disease, according research published in 2013 by scientists from the International Agency for Research on Cancer. In the United States, the FDA approved Xgeva for use in multiple myeloma patients on Jan. 5. International sales of Xgeva were $418 million last year, while sales in the U.S. were around $1.2 billion. Amgen announced on March 29 that the label of Blincyto, a drug used to treat children and adults with b-cell precursor acute lymphoblastic leukemia, had been expanded in the U.S. to include patients with a subtype of the blood cancer that is linked to high rates of relapse. Blincyto is the only FDA-approved drug for treatment of the condition, known as minimal residual disease. “Because patients with (minimal residual disease) are more likely to relapse, having a treatment option that eliminates even very low amounts of residual leukemia cells may help keep the cancer in remission longer,” FDA Oncology Center of Excellence Director Dr. Richard Pazdur said in a statement. Sales of Blincyto were $114 million in 2017, according to Amgen. Amgen also announced in late March that it plans to open a “commercial affiliate” in Argentina. The company has had research and development facilities in the country for the past decade. While it has some contracts with distributors there, the new affiliate will be responsible for making Amgen’s drug portfolio available to a much larger population of patients, according to the company. Hiring is currently underway; the affiliate will officially open in the fourth quarter, a company spokeswoman said. Providence Expansion Providence Tarzana Medical Center’s $542-million expansion and renovation project, titled “Tarzana Reimagined,” is slated to begin construction this summer after winning approval from the L.A. City Council. The medical center announced April 2 that Mayor Eric Garcetti had signed off on an ordinance to build its structures, including upgrades to the emergency and diagnostic departments as well as a new patient wing. The hospital’s Providence Tarzana Foundation is currently raising $75 million to help cover the cost of the expansion. In other news from the Renton, Wash.-based nonprofit Providence Health & Services, two of its local skilled nursing facilities received 5-star ratings in a survey conducted by the Centers for Medicare and Medicaid Services. Providence Holy Cross Sub-Acute Care Center in Mission Hills and the Providence St. Elizabeth Care Home in North Hollywood were rated highly on the assessment. The survey takes into account quality of care and staffing, Providence said in a statement. The findings are published on the Medicare and Medicaid Services’ Nursing Home Compare website. The two nursing centers provide slightly different services. Staff at Providence Holy Cross specialize in treating patients who are dependent on ventilators or tracheostomies, while patients at St. Elizabeth are recovering from strokes or chronic conditions like dementia. Staff Reporter Helen Floersh can be reached at (818) 316-3121 or [email protected].

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