BMS Plans to Build $660-Million Bulk Biologics Manufacturing Facility

Bristol-Myers Squibb Company (BMS, New York, NY, www.bms.com) plans to build a large-scale multiproduct bulk biologics manufacturing facility in the United States. The company’s board of directors approved a capital expenditure of $660 million for the project.

BMS has not made a final decision about the location of the facility, but it has narrowed its choice to four possible states-Massachusetts, Rhode Island, New York, and North Carolina- said Anthony Hooper, BMS's president of US Pharmaceuticals, at an investor briefing this week. The company will make a decision regarding the location by the end of the second quarter of this year and will begin construction in the third quarter. The company plans to complete construction by 2009 and bring the first commercial supply on-line by 2011.

The new capacity provided by the new biologics facility will be in addition to biologics supply agreements that BMS has with Lonza AG (Basel, Switzerland, www.lonza.com) and Celltrion Inc. (Incheon, South Korea, www.celltrion.com), said Hooper.

The new bulk biologics manufacturing facility will be used to support current and pipeline biologics drugs. BMS has two biologics on the market: “Orenica” (abatacept) and “Erbitux” (cetuximab). “Orenica,” its first internally developed biologic, was approved by the US Food and Drug Administration (Rockville, MD, www.fda.gov) in December 2005 for treating rheumatoid arthritis. In January 2006, BMS submitted a supplemental biologics license application to FDA for the licensure of a third-party manufacturing facility to support increased production capacity for Orenica. “Erbitux” was approved for a second cancer indication earlier this month to treat head and neck cancer. It also is approved for treating colorectal cancer.

Key biologics in development are belatacept for treating solid-organ-transplant rejection and the anticancer therapy ipilimumab, which BMS has licensed from Medarex Inc. (Princeton, NJ, www.medarex.com).

Board approval for the $660-million capital project comes as BMS continues its cost-cutting program. The company has a goal of reducing costs by $500 million by 2007 and by an additional $100 million by 2008. These savings will be in addition to annual reductions of $200 million already achieved in 2004 and 2005, primarily gained through realigning its US and European sales forces, restructuring pharmaceutical development, and some outsourcing of information technology activities. 

Separately, BMS received FDA priority review for its investigational oncology treatment, dasatinib.