Jones Lang LaSalle
Barr interested in Croatian firm despite its difficulties with FDA
Thursday, June 01, 2006
Barr Pharmaceuticals is reportedly willing to pay $2.1 billion for Pliva, a Croatian maker of generic drugs.
That translates into a lot of kuna, the Croatian currency. But what exactly would Barr get in re turn?
For starters, the Woodcliff Lake- based generic drugmaker would get a foothold in Europe; right now, most of its business comes from the United States. Barr would also have total control over a deal with Pliva to develop a version of Amgen's biologic drug Neupo gen, which is used to reduce infec tions stemming from chemotherapy.
But there's more to this poten tial deal, and it's not an asset.
On April 28, Pliva received a warning letter from the Food and Drug Administration chastising the company for "significant devia tions" from good manufacturing practices at its facility in Zagreb, the Croatian capital. The problems involve various quality-control is sues -- leaking pipes, instruments not calibrated properly and incomplete records of laboratory samples, among other things.
The warning mentioned these deviations were similar to problems uncovered during previous FDA plant inspections, which prompted the agency to issue enforcement reports in August 2002 and again this past February. As a result, the FDA wrote to Pliva that until FDA inspectors can confirm the problems have been corrected, the agency will "recommend disapproval of any new applications listing your firm as the manufacturer of finished pharmaceutical drug products."
In other words, the FDA may choose not to approve new drugs for which Pliva seeks regulatory approval. The FDA also wrote that it may deny entry of Pliva products into the United States.
Currently, the company sells more than two dozen medicines here, including versions of Prozac, the naproxen pain reliever and cy closporine, an immunosuppressant, according to the company's Web site.
A Barr spokeswoman didn't re turn a telephone call seeking comment.
In a statement, Pliva, which employs between 400 and 500 people in the United States, mostly at its East Hanover offices, said it is tak ing "corrective action," but doesn't expect the manufacturing issues to have a material impact on its finances.
-- Ed Silverman
Barr interested in Croatian firm despite its difficulties with FDA
Thursday, June 01, 2006
Barr Pharmaceuticals is reportedly willing to pay $2.1 billion for Pliva, a Croatian maker of generic drugs.
That translates into a lot of kuna, the Croatian currency. But what exactly would Barr get in re turn?
For starters, the Woodcliff Lake- based generic drugmaker would get a foothold in Europe; right now, most of its business comes from the United States. Barr would also have total control over a deal with Pliva to develop a version of Amgen's biologic drug Neupo gen, which is used to reduce infec tions stemming from chemotherapy.
But there's more to this poten tial deal, and it's not an asset.
On April 28, Pliva received a warning letter from the Food and Drug Administration chastising the company for "significant devia tions" from good manufacturing practices at its facility in Zagreb, the Croatian capital. The problems involve various quality-control is sues -- leaking pipes, instruments not calibrated properly and incomplete records of laboratory samples, among other things.
The warning mentioned these deviations were similar to problems uncovered during previous FDA plant inspections, which prompted the agency to issue enforcement reports in August 2002 and again this past February. As a result, the FDA wrote to Pliva that until FDA inspectors can confirm the problems have been corrected, the agency will "recommend disapproval of any new applications listing your firm as the manufacturer of finished pharmaceutical drug products."
In other words, the FDA may choose not to approve new drugs for which Pliva seeks regulatory approval. The FDA also wrote that it may deny entry of Pliva products into the United States.
Currently, the company sells more than two dozen medicines here, including versions of Prozac, the naproxen pain reliever and cy closporine, an immunosuppressant, according to the company's Web site.
A Barr spokeswoman didn't re turn a telephone call seeking comment.
In a statement, Pliva, which employs between 400 and 500 people in the United States, mostly at its East Hanover offices, said it is tak ing "corrective action," but doesn't expect the manufacturing issues to have a material impact on its finances.
-- Ed Silverman
posted by Jones Lang LaSalle NJ News Blog at 12:38 PM
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