Sanofi-Aventis and Teva announce Copaxone storage application approval

Sanofi-Aventis and Teva Pharmaceutical Industries have announced that their application for new storage instructions for Copaxone (glatiramer acetate injection) has been approved by the US Food and Drug Administration and, through the mutual recognition procedure, also in Europe.

Under these new storage instructions, the storage time at room temperature for the pre-filled syringe of the compound has been increased from seven days to up to one month.

Copaxone is used to reduce the frequency of relapses in ambulatory patients suffering from relapsing-remitting multiple sclerosis who have experienced a minimum of two incidents of neurological dysfunction over the previous two years.

Laura K, a participant in the first pivotal trial of the compound, said: “For the past 15 years, Copaxone has allowed me to control my disease and has granted me the ability to maintain an active lifestyle.”

She added that in her profession as an equestrian who spends extended periods of time out of the home, the new instructions for the compound will make transport and storage “much easier”.

In February 2006, Teva Pharmaceuticals announced record results for the 2005 fiscal year, with a nine per cent rise in sales to $5.3 billion, with these figures enhanced by strong sales of Copaxone.