Shire PLC announced a new recall of the attention deficit hyperactivity disorder patch Daytrana, saying 39 production lots would be pulled from the market because patients could have trouble taking off the protective liner from the patch.
Shire (nasdaq: SHPGY) voluntarily recalled thousands of Daytrana patches, made by its partner Noven Pharmaceuticals Inc. (nasdaq: NOVN), in 2008 for the same reason. The companies said the patches are still safe to use, but Shire said the patches no longer meet release liner removal specifications.
The companies said there are enough Daytrana patches on the market to meet demand from patients.
Noven is working on solutions for the liner issue. The Miami-based company said it expected the recall, and its costs will be paid for with a $3.8 million reserve established in case of further recalls. It backed its 2009 profit forecast.
On Monday, Shire withdrew a marketing application for Daytrana in Europe. The Basingstoke, U.K., company decided to focus instead on Equasym, a similar drug it bought from UCB Pharma last month. European regulators had asked Shire to conduct another clinical study of Daytrana before they would approve it.
Both drugs have the same active ingredient: methylphenidate, which is also found in Ritalin, Concerta, and Shire's older drug Adderall.
Noven shares fell 5 cents to $9.65 Friday morning. Shire's U.S-traded shares fell 23 cents to $35.38.
Shire (nasdaq: SHPGY) voluntarily recalled thousands of Daytrana patches, made by its partner Noven Pharmaceuticals Inc. (nasdaq: NOVN), in 2008 for the same reason. The companies said the patches are still safe to use, but Shire said the patches no longer meet release liner removal specifications.The companies said there are enough Daytrana patches on the market to meet demand from patients.
Noven is working on solutions for the liner issue. The Miami-based company said it expected the recall, and its costs will be paid for with a $3.8 million reserve established in case of further recalls. It backed its 2009 profit forecast.
On Monday, Shire withdrew a marketing application for Daytrana in Europe. The Basingstoke, U.K., company decided to focus instead on Equasym, a similar drug it bought from UCB Pharma last month. European regulators had asked Shire to conduct another clinical study of Daytrana before they would approve it.
Both drugs have the same active ingredient: methylphenidate, which is also found in Ritalin, Concerta, and Shire's older drug Adderall.
Noven shares fell 5 cents to $9.65 Friday morning. Shire's U.S-traded shares fell 23 cents to $35.38.
Source : http://www.forbes.com/feeds/ap/2009/03/20/ap6193230.html
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