Genzyme will build a €250 million manufacturing plant in Geel, Belgium, for its Pompe disease therapies, Myozyme® and Lumizyme®. The new plant, sited next to its existing manufacturing site for Myozyme and Lumizyme, will have a capacity of 8,000 liters, with room for expansion. Genzyme said it expects commercial approvals for the new site will start during late 2014.
Meanwhile, production capacity at its current plant at Geel is also being increased to 12,000 liters, with the addition of a third bioreactor that is scheduled for approval by the end of 2011. Genzyme separately operates a 160 L production plant in the U.S. for patients with infantile-onset Pompe disease.
Bioreactor contamination issues leading to shortages of Myozyme and other Genzyme drugs over the last 18 months have been well-documented, together with the significant financial and regulatory headache that ensued. Having to shut down one of its production plants meant that for a prolonged period Genzyme was forced to reserve the Myozyme it could keep manufacturing, for the treatment of infants and children with Pompe disease in the U.S..
Myozyme and Lumizyme are alglucosidase alfa enzyme-replacement therapies. Genzyme suggests that the Pompe disease drugs could match its Gaucher disease therapy Cerezyme in terms of commercial potential. It says that 1,400 of the 10,000 or so Pompe disease patients worldwide are currently treated with either Myozyme or Lumizyme, which are the only drugs approved for the disease.
Myozyme is currently available in 48 markets worldwide including the U.S., for all Pompe disease patients, and the firm hopes to increase this to 60 markets by the end of 2011. Lumizyme was cleared by FDA in May 2010, specifically for the treatment of patients aged eight years and older with late-onset (noninfantile) Pompe disease who do not have evidence of cardiac hypertrophy. Genzyme notes that Myozyme has been specifically shown to improve ventilator-free survival in patients with infantile-onset Pompe disease. In Europe the drug is indicated with infants, children, and adults with the neuromuscular disease.
In its fourth quarter 2010 financial review, released last week, Genzyme projected that 2011 will see it reap double-digit growth in revenues, driven at least in part by Myozyme and Lumizyme. Global revenues for the two drugs during the fourth quarter of 2010 were $128 million, up 39% compared with the same period in 2009. Full-year 2010 sales of Myozyme and Lumizyme increased 27% to $412 million. The firm notes that the revenue increases were in part a reflection of increased sales of the more recently approved Lumizyme.