EMA OK for second Shire Replagal plant

The new facility, in Lexington, Massachusetts, will purify the Replagal active pharmaceutical ingredient (API), agalsidase alfa, which Shire will continue to produce at its cell culture plant in Alewife, Cambridge.

Shire’s additional capacity will not have escaped the attention of French drugmaker Sanofi which bought​ US biotech Genzyme, producer of rival Fabry disease treatment Fabrazyme, earlier this year.

Genzyme has been working to correct a number of contamination problems with its manufacturing operations that cut Fabrazyme production levels, forcing the firm to ration supplies and recommend reduced dosages.

During this period some​ US Fabry disease patients asked the government to break Genzyme’s Fabrazyme patents arguing that, in certain cases, the reduced dosages resulted in increased pain and gastrointestinal problems.

In Europe, where Replagal has been approved since 2001, the EMA started recommending that Fabry patients who had not reacted well to the lower doses were switched to Shire’s drug.

All of which seems to have had a positive impact on sales. According to Shire’s most recently quarterly report revenue from Replagal increased 55 per cent in Q1 to $105m (€72.3m).

However, Shire spokesman Jennifer Mann told in-Pharmatechnologist.com that while market opportunity was ‘an important factor’​ in the company’s decision to develop the Lexington site it was not the only reason, explaining that: “It’s about providing increased flexibility of supply for patients."​

Shire also plans to seek further regulatory approval to begin making its Gaucher’s disease drug Vpriv at the Lexington facility by the end of the year.

This approval, if granted, would be of interest to Genzyme given that its own Gaucher’s disease drug Cerezyme, production of which was also interrupted, has started to lose market share to Vpriv.