Genzyme plans new Belgium facility
pharmafile | January 25, 2011 | News story | Manufacturing and Production | Belgium, Genzyme, Lumizyme, Myozyme, Pompe disease, Sanofi-Aventis, alglucosidase alfa
US rare disease drug specialist Genzyme, the subject of a hostile takeover offer from France’s Sanofi-Aventis, says that it will build an additional manufacturing plant in Geel, Belgium.
The 250 million-euro ($334 million) facility will support the long-term growth of Myozyme (alglucosidase alfa) and Lumizyme (alglucosidase alfa) for Pompe disease and the company held a ceremony yesterday in Geel to mark the start of its construction.
It will include 8,000 litres of production capacity, a complete purification installation, and ample room for additional future capacity expansions. Commercial approvals for the new site are expected to start late 2014.
Genzyme is struggling to recover from a manufacturing crisis that led to shortages of two key drugs: Cerezyme (imiglucerase for injection) for Gaucher disease; and Fabrazyme (agalsidase beta) for Fabry disease.
The company has also signed a consent decree with the FDA agreeing to correct manufacturing quality violations at its Allston, Massachusetts, manufacturing facility and to turn over to the federal government $175 million in “unlawful profits” from the sale of products that were made at the plant.
Genzyme currently produces Myozyme and Lumizyme – which generated combined sales of $128 million in the fourth quarter of 2010 – at an adjacent plant in Geel, where it is increasing production capacity to 12,000 litres with the addition of a third bioreactor scheduled for approval by the end of this year. The company is also continuing its 160L production in the US for patients with infantile-onset Pompe disease.
The investment in Geel is part the firm’s programme to increase its overall biologics manufacturing capacity four fold. About 150 new jobs will be created as part of the expansion, bringing the total workforce at the site to nearly 600 people.
Committed to reliable supply
“The expansion of our Geel facility is a critical element of our manufacturing strategy and is fundamental to our mission,” said Scott Canute, Genzyme’s president of global manufacturing and corporate operations.
He added: “We are committed to delivering a reliable supply of high quality medicines to our patients. This investment ensures continued supply to our patients in the Pompe community for the long term.”
Genzyme believes that its Pompe disease treatments represent a commercial opportunity that is comparable to that of Cerezyme for Gaucher disease. The company estimates that there are about 10,000 Pompe patients worldwide; approximately 1,400 Pompe patients are currently treated with either Myozyme or Lumizyme, which are the only treatments approved for the disease. Myozyme is currently available in 48 markets worldwide and Genzyme expects to increase this to 60 markets by the end of this year.
Sanofi takeover offer
Meanwhile, Sanofi yesterday extended its takeover bid deadline for a second time, with the French pharma company’s offer for Genzyme – unchanged at $69 a share – now due to close on 15 February.
Genzyme has so far resisted overtures from French pharma company Sanofi, which launched a takeover bid in July. Sanofi subsequently made a hostile offer for the biotech, appealing directly to Genzyme’s shareholders.
The companies remain in discussions about the structure of a ‘contingent value right’, a type of right given to shareholders of an acquired company for extra payments, concerning Genzyme’s multiple sclerosis treatment Lemtrada (branded as Campath in oncology).
Phil Taylor
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