Back to top

Analyst Blog

The US Food and Drug Administration (FDA) recently issued a warning letter to Alexion Pharmaceuticals, Inc. (ALXN - Analyst Report) as the company did not comply with the current Good Manufacturing Practices (cGMP) at its manufacturing facility at Rhode Island. Alexion manufactures Soliris, its sole marketed product, at the facility. The drug is available for the treatment of paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome.

The US regulatory body issued a warning letter to Alexion Pharma following its inspection of the facility last year. The FDA issued a Form 483 Inspectional Observations to Alexion Pharma following the completion of the inspection on Aug 6, 2012. Alexion Pharma responded to the letter in the same month and subsequently provided additional information to the US regulatory body in Sep and Dec 2012.

However, the response did not satisfy the FDA which issued the warning letter to the company. The FDA also remains concerned about the quality system implemented by Alexion Pharma at the facility. The FDA further stated while issuing the letter that it is dissatisfied with the company’s inadequate investigation of bacterial contamination at its manufacturing facility at Rhode Island.

The news had a negative impact on Alexion Pharma’s shares. The company intends to address the concerns raised by the FDA in the warning letter. Alexion Pharma believes that the warning letter issued by the FDA will not impact the supply of Soliris.

Though current supplies of Soliris may not be interrupted, we believe further slipups by Alexion Pharma regarding Soliris will invite stricter action from the FDA. This will be catastrophic for the company since it is entirely dependent on Soliris for growth.

Alexion Pharma carries a Zacks Rank #3 (Hold).  Favorably placed stocks in the pharma space include Athersys, Inc. (ATHX - Snapshot Report), Cytokinetics, Inc. (CYTK - Snapshot Report) and Osiris Therapeutics, Inc. (OSIR - Analyst Report). All three stocks carry a Zacks Rank #1 (Strong Buy).

Please login to or register to post a comment.

New to Zacks?

Start Here

Zacks Investment Research


Are you a new Zacks Member or a visitor to

Top Zacks Features

My Portfolio Tracker

Is it Time to Sell?

One of the most important steps you can take today is to set up your portfolio tracker on Once you do, you'll be notified of major events affecting your stocks and/or funds with daily email alerts.

More Zacks Resources

Zacks Rank Home - Evaluate your stocks and use the Zacks Rank to eliminate the losers and keep the winners.

Mutual Fund Rank Home - Evaluate your funds with the Mutual Fund Rank for both your personal and retirement funds.

Stock/Mutual Fund Screening - Find better stocks and mutual funds. The ones most likely to beat the market and provide a positive return.

My Portfolio - Track your Portfolio and find out where your stocks/mutual funds stack up with the Zacks Rank.

Zacks #1 Rank Top Movers for Zacks #1 Rank Top Movers

Company Symbol Price %Chg
ERBA DIAGNO… ERB 3.00 +3.09%
SANCHEZ ENE… SN 34.18 +2.67%
THE PANTRY… PTRY 21.02 +2.09%
INTEL CP INTC 35.15 +1.88%
CLAYTON WIL… CWEI 117.30 +1.78%