Marcus Evans Group | Worldwide Headquarters | American Offices | Latin America | European Offices | African / Asian Offices

Shire rival Genzyme gets US approval for treatment for Fabry disease

Following manufacturing problems, Genzyme gets the go-ahead to make competitor to Shire’s Replagal

Shire has shaken off news of US approval for a rival to one of its key drugs.

The company’s Replagal treatment for Fabry disease had seen a boost to its sales following manufacturing problems at competitor Genzyme, which makes the rival drug Fabrazyme. There have been shortages of Genzyme’s product since June 2009 when the issues at its Allston Landing plant in the US emerged.

Shire has capitalised on the shortfall, with its market share of the Fabry disease treatment in Europe jumping from 45% in 2008 to around 80% now.

Last week Genzyme received European approval to manufacture Fabrazyme at its Framlington plant, but it was awaiting the go-ahead from US regulators. Now that has duly arrived. Despite the competitive threat, Shire’s shares have edged up 4p to £21.24 in falling market, and analyst Brian White at Shore Capital said:

This approval is largely in line with previous suggestions of an early February approval. It will however be some time before Genzyme can build inventory and return to offering full dosing to all Fabry patients in the US. For Shire the US has been unavailable to it as Replagal awaits FDA approval and we await an update on whether it has obtained a priority review which would suggest an approval in the second quarter of 2012, if not before.

Outside the US, we believe it will be a real challenge for Shire to grow its 81% market share. At the same time we believe that it will be difficult for Genzyme to encourage significant switching back given the length of time that patients have been well controlled on Replagal.

But Panmure Gordon’s Savvas Neophytou repeated his negative stance on the company:

On 18 January, when Genzyme received European approval for a new manufacturing site, the market clung onto the
US FDA approval as the true event. Today we have US approval as well, which should enable Genzyme to increase manufacturing capacity for Fabrazyme, thus providing headwinds for Shire’s Replagal. We reiterate our sell recommendation. © 2012 Guardian News and Media Limited or its affiliated companies. All rights reserved. | Use of this content is subject to our Terms & Conditions | More Feeds