Timelines: 1991
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Ceredase®
A triumph for Genzyme, a godsend for patients
Genzyme introduces a targeted enzyme replacement therapy for Gaucher’s disease, a rare disorder that swells internal organs and weakens bones due to the lack of the enzyme glucocerebrosidase. The drug is called Ceredase®. Genzyme scientists are unable to patent most of the techniques that they employ in order to harvest, purify, and modify the enzyme for formulation as a pharmaceutical, for most of the protocols have already been published and circulate in the public domain. The Orphan Drug Act, however, provides Genzyme with exclusive license to market the product for seven years. Three years later, the company introduces a recombinant version of the enzyme, called Cerezyme®. Genzyme secures eighteen years of patent protection on the method employed to produce it. The patent will expire in 2013. The company’s enzyme replacements dramatically improve prognoses for patients with Gaucher’s disease. Prior to the introduction of these drugs, physicians could offer patients only palliative measures such as splenectomies and hip replacements.