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http://yahoo.reuters.com/financeQuo...mtfh02083_2006-01-11_21-13-50_n1143777_newsml
UPDATE 1-Glaxo has new shortage of heart, diabetes drugs
Wed Jan 11, 2006 04:13 PM ET
(Adds details on doctor letter)
CHICAGO, Jan 11 (Reuters) - GlaxoSmithKline Plc (GSK.L: Quote, Profile, Research) on Wednesday said it is experiencing a new shortage of its Coreg heart drug and diabetes drug Avandamet in the United States, due to processing difficulties at a plant in Puerto Rico.
The problems stem from earlier manufacturing issues at the Cidra, Puerto Rico, plant, which led Glaxo, Europe's No. 1 drugmaker, to sign a consent decree with the U.S. Food and Drug Administration.
That deal covered manufacturing problems there, which included drugs splitting and not containing the proper amount of active ingredient.
The new problems occurred because of new documentation mechanisms set in place in response to the consent degree, which is creating a logjam in getting drugs through the pipeline and out the door, according to Glaxo spokeswoman Nancy Pekarek.
"We are working through this and expect it to be a short-term issue," she said, adding that the glitches will not have a material financial impact and no effect on the products' quality.
Glaxo struck a deal with the FDA in April to fix the problems, and agreed to post a $650 million bond contingent upon either reconditioning drugs seized in March 2005, or destroying them and paying costs to the government.
The company is notifying doctors in a so-called "Dear Doctor" letter of its shortage of Coreg, a heart failure and high blood pressure drug; and to a lesser degree, Avandamet for diabetes, a spokeswoman for the company said.
Glaxo has alerted the FDA of the issue, she said.
The letter suggests that doctors with high blood pressure patients who have trouble getting their Coreg prescription may consider switching to a rival beta-blocker, the class of drugs that Coreg belongs to.
The letter suggests that for heart failure patients, doctors should consider prescribing Toprol-XL, a top-selling heart failure drug made by AstraZeneca Plc (AZN.L: Quote, Profile, Research) .
They are advising doctors to not start patients on Coreg until further notice.
"How long these issues may last is unclear," said Prudential Equity Group analyst Tim Anderson, who earlier wrote an investor note on the subject and rates Glaxo "underweight."
He did say the impact on fourth-quarter earnings is unclear, though it could be minimal due to Glaxo's large revenue base.
Coreg, Avandamet and Paxil CR, which are all experiencing some degree of shortage because of the Cidra plant issues, make up 5 percent of total Glaxo sales, according to Anderson.
© Reuters 2006. All Rights Reserved.
UPDATE 1-Glaxo has new shortage of heart, diabetes drugs
Wed Jan 11, 2006 04:13 PM ET
(Adds details on doctor letter)
CHICAGO, Jan 11 (Reuters) - GlaxoSmithKline Plc (GSK.L: Quote, Profile, Research) on Wednesday said it is experiencing a new shortage of its Coreg heart drug and diabetes drug Avandamet in the United States, due to processing difficulties at a plant in Puerto Rico.
The problems stem from earlier manufacturing issues at the Cidra, Puerto Rico, plant, which led Glaxo, Europe's No. 1 drugmaker, to sign a consent decree with the U.S. Food and Drug Administration.
That deal covered manufacturing problems there, which included drugs splitting and not containing the proper amount of active ingredient.
The new problems occurred because of new documentation mechanisms set in place in response to the consent degree, which is creating a logjam in getting drugs through the pipeline and out the door, according to Glaxo spokeswoman Nancy Pekarek.
"We are working through this and expect it to be a short-term issue," she said, adding that the glitches will not have a material financial impact and no effect on the products' quality.
Glaxo struck a deal with the FDA in April to fix the problems, and agreed to post a $650 million bond contingent upon either reconditioning drugs seized in March 2005, or destroying them and paying costs to the government.
The company is notifying doctors in a so-called "Dear Doctor" letter of its shortage of Coreg, a heart failure and high blood pressure drug; and to a lesser degree, Avandamet for diabetes, a spokeswoman for the company said.
Glaxo has alerted the FDA of the issue, she said.
The letter suggests that doctors with high blood pressure patients who have trouble getting their Coreg prescription may consider switching to a rival beta-blocker, the class of drugs that Coreg belongs to.
The letter suggests that for heart failure patients, doctors should consider prescribing Toprol-XL, a top-selling heart failure drug made by AstraZeneca Plc (AZN.L: Quote, Profile, Research) .
They are advising doctors to not start patients on Coreg until further notice.
"How long these issues may last is unclear," said Prudential Equity Group analyst Tim Anderson, who earlier wrote an investor note on the subject and rates Glaxo "underweight."
He did say the impact on fourth-quarter earnings is unclear, though it could be minimal due to Glaxo's large revenue base.
Coreg, Avandamet and Paxil CR, which are all experiencing some degree of shortage because of the Cidra plant issues, make up 5 percent of total Glaxo sales, according to Anderson.
© Reuters 2006. All Rights Reserved.
