Alexion Pharma (ALXN) Receives cGMP Warning Letter from FDA for R.I. Facility


Alexion Pharma (ALXN) Receives cGMP Warning Letter from FDA for R.I. Facility
On March 27, 2013, Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN) received a Warning Letter from the U.S. Food and Drug Administration (FDA) regarding compliance with current Good Manufacturing Practices (cGMP) at our Rhode Island manufacturing facility. The Warning Letter follows an FDA inspection which concluded on August 6, 2012. At the conclusion of that inspection, the FDA issued a Form 483 Inspectional Observations, to which Alexion responded in August 2012 and provided additional information to the FDA in September and December 2012. The observations concern commercial and clinical manufacture of Soliris at this facility.
Based on current information, we believe that the supply of Soliris to patients will not be interrupted and that the Warning Letter does not restrict production of Soliris or shipment of Soliris from the Rhode Island facility. We continue to manufacture products, including Soliris, in this facility. Additionally, a third party manufacturing facility is currently approved worldwide for production of Soliris. Further, an additional third party manufacturing facility was validated in 2012 for production of Soliris, and we are currently completing our regulatory submissions for this facility. We anticipate first approval for this additional facility to occur in the fourth quarter of 2013. Finally, we estimate that our current inventory of Soliris licensed for commercial sale is sufficient for at least four-thousand patient-years of patient treatment.
The Warning Letter relates to certain observations that the FDA believes were inadequately addressed by our responses to the Form 483. The Warning Letter cites inadequate investigation of bacterial contamination of certain batches, and the failure to ensure compliance with cGMP. The Warning Letter states that deficiencies from a 2011 inspection were also observed in the 2012 inspection, and the FDA expressed a general concern that we have not implemented a robust quality system.
We believe that, since our initial response to the FDA, we have adequately addressed certain of the Form 483 observations, and we will work diligently to resolve outstanding FDA concerns discussed in the Warning Letter.
Unless and until we are able to correct outstanding issues to the FDA's satisfaction, the FDA may withhold approval of requests for export certificates for certain countries. The FDA may also withhold approval of pending drug applications listing the Rhode Island facility. We will notify appropriate international regulatory authorities of the Warning Letter, and it is possible that the letter may impact our ability to supply Soliris manufactured at our Rhode Island facility outside the United States.