The biotech company said it plans to spend €250m ($336.6m) on the new plant, which will help boost Genzyme’s biologics manufacturing and support the long-term growth of its Myozyme and Lumizyme treatments for the rare muscle disorder.
The new facility will include 8,000 litres of production capacity, a purification installation, room for capacity expansion, and commercial approvals for the new site are expected to begin in late 2014.
Scott Ganute, Genzyme’s president of global manufacturing and corporate operations, said: “The expansion of our Geel facility is a critical element of our manufacturing strategy and is fundamental to our mission.”
In a press release, Genzyme said it believes that its Pompe disease treatments have commercial potential comparable to its Gaucher’s disease treatment Cerezyme, which leads the market and generates 30 per cent of the firm’s annual revenues as a result of its hefty $200,000 (€147,821) a year price tag.
The emphasis on capacity is understandable given the supply problems Genzyme encountered for its both Cerezyme and its Fabry disease drugs Fabrazyme after numerous problems interrupted production at its plant in Allston, Massachusetts.
Fabrazyme petition
In related news Genzyme has been petitioned by a group of US citizens calling for a return to full dose allocation for Fabrazyme, which has been rationed to 70 per cent of the usual annual dose per patient since the shortages began.
The group argues that because the drug is a medically necessary product for which no alternative is available in the US the current system of rationing is unfair. They also criticise Genzyme for making only around 38 per cent of the Fabrazyme produced available in the US.
“The situation in the US is dire especially since Shire Pharmaceuticals has recently withdrawn its application for approval of Replagal [an alternative treatment] in the US,” said the petitioners.
Although the Allston manufacturing plant is now up and running, Genzyme plans to open an additional Massachusetts plant by the end of the year for the production of Fabrazyme.
Sanofi take-over bid
Meanwhile, French drugmaker Sanofi-Aventis is interested in the commercial potential of Genzyme’s experimental multiple sclerosis drug, Lemtrada, extending a takeover bid for the company to $18.5bn (€13.7bn).
Sanofi said it has set an expiration date to close the offer which will end just before midnight on February 15th in New York, though there remain “significant differences” between the companies when talking about contingent value right (CVR) in a deal involving Lemtrada.