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Extended storage for Teva MS drug

By Anna Lewcock, 06-Jun-2007

Related topics: Excipients, raw materials and intermediates, Ingredients

The market's first non-interferon based drug for the treatment of multiple sclerosis (MS) can now be stored at room temperature for up to a month, following approval from US and EU authorities.

Teva Pharmaceutical's Copaxone (glatiramer acetate) pre-filled syringe formulation, first introduced in Europe in 2004, can now be stored at room temperature for up to one month rather than the seven days that was previously approved.

 

 

 

This brings the product in line with the extended storage times possible with some of the other MS products on the market that it is competing with, which are predominantly interferon-based. The supplemental amendment was approved by both the US Food and Drug Administration (FDA), and the European authorities under the Mutual Recognition Procedure (MRP).

 

 

 

The drug itself takes the form of a daily injection and is indicated for reduction in the frequency of attacks for patients suffering with relapsing-remitting multiple sclerosis (RRMS), the most common form of MS which affects around 85 per cent of newly diagnosed patients.

 

 

 

Copaxone has a dual mechanism of action, working on both the inflammatory and neurodegenerative aspects of MS, and has positive effects on re-myelination. It has also been shown to maintain sustained efficacy over a period of 12 years.

 

 

 

Copaxone was the first Israeli-developed innovative drug to receive FDA approval, and Teva invested heavily in manufacturing facilities for the product, establishing two state-of-the-art sites in Israel. The company also has agreements with Sanofi-Aventis to provide the drug across North America.

 

 

 

Copaxone has the edge over some of the other MS treatments currently available due to the fact that it is not based on interferons which can be associated with very unpleasant side-effects.

 

 

 

One other non-interferon based treatment currently on the market is the troubled drug Tysabri (natalizumab) developed in a collaboration between Elan an Biogen Idec. Although a fellow non-interferon treatment, Tysabri was notoriously associated with potentially fatal side-effects and has been on and off the market over the past few years.

 

 

 

Avonex (interferon beta-1a) from Biogen is the current market-leading MS drug worldwide, bringing in revenues of around $1.7bn (€1.3bn) over 2006, though Copaxone was not too far behind, generating €1.1bn in revenues. Tysabri, in contrast, managed a somewhat paltry $36m (€26.7m).

 

 

 

Rebif (interferon beta-1a) from Merck Serono is another major competitor, and is the company's best selling drug accounting for 58.1 per cent of sales over 2006 and bringing in $1.45bn (€1.1bn). The company is also in the process of developing an oral MS treatment based on cladribine which could prove particularly lucrative if it can win the race to become the first oral MS therapy to hit the shelves.

 

 

 

Teva was also in the process of developing an oral formulation of Copaxone, but plans were dropped last year following disappointing trial results. The company were not available to comment on any further plans for Copaxone prior to going to press.