ImClone Systems Inc (formerly IMCL)

[Biowatch]

IMCL: FDA recently approved BB50, so Feuerstein mentions them? When IMCL learned to produce Erbitux more efficiently (more mg per liter), construction on BB50 slowed to a crawl, IIRC.

AMGN may have bought ABGX in part for their manufacturing capacity, but Dew opined for years that there was an overcapacity in manufacturing. Does anyone have hard (or even ballpark) numbers on available capacity versus biologic drugs approaching the market?

Several years ago, Tarnowski said informally, after an AM, that other companies had been interested in contracting manufacturing capacity from IMCL, but such an arrangement was a much lower profit model than making and selling your own drug.


>>FDA Approves ImClone Systems' New State-of-the-Art Manufacturing Facility

-- "BB50" Facility to Serve as Second Manufacturing Source for ERBITUX(R) --

NEW YORK--(BUSINESS WIRE)--Aug. 20, 2007--ImClone Systems Incorporated (NASDAQ: IMCL), a leader in the development and commercialization of novel cancer therapeutics, today announced that it has received approval from the Food and Drug Administration for a second facility to manufacture ERBITUX(R). The approval to manufacture ERBITUX in this new 250,000-square-foot multi-suite manufacturing facility, referred to as "BB50", more than doubles ImClone's total available production volume capacity for ERBITUX. This approval, in conjunction with ImClone's existing "BB36" manufacturing facility, enhances the Company's ability to meet increasing demand for ERBITUX in the worldwide market.

"The FDA approval of BB50 represents the culmination of ImClone's efforts over the last several years to establish this state-of-the-art facility. This now provides us with a great deal of strategic and operational flexibility in pursuing additional commercial opportunities going forward," said Richard P. Crowley, Senior Vice President, Biopharmaceutical Operations of ImClone Systems. "Together, our two manufacturing facilities provide us with the capacity to produce ERBITUX and future products for worldwide development and commercialization, and serve to support our initiatives for the long-term growth and success of ImClone."

Construction of BB50 was completed in the fourth quarter of 2005. This facility is designed to contain three distinct suites with a total future production volume capacity of up to 110,000 liters. The commissioning and initial validation of one of the suites was completed during the second quarter of 2006 and the Company began producing ERBITUX in this suite in June 2006. The other two suites at this facility will enable ImClone in the future to produce ERBITUX, additional ImClone products, or third-party products under contract manufacturing agreements. Both BB50 and BB36 are located on ImClone's Branchburg, N.J. campus.<<

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