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12:00 AM
 | 
Jul 13, 2009
 |  BioCentury  |  Strategy

Filling the Cerezyme vacuum

The expected shortages of Cerezyme imiglucerase from Genzyme Corp. for Gaucher's disease are unlikely to shake the biotech's market position in the short term, according to doctors contacted by BioCentury, even though the FDA requested treatment protocols last week from Shire plc and Protalix Biotherapeutics Inc. for their Phase III compounds. But in the long run which company gets market share could come down to price.

Genzyme temporarily stopped bulk production at its Allston, Mass., manufacturing facility in June after detecting a virus that impairs cell growth in one of six bioreactors. The stoppage affected inventories of Cerezyme, which the biotech expects to result in shortages over 6-8 weeks starting in August.

Shire said it already has submitted a protocol to FDA for velaglucerase alfa and expects a response by the end of the month. The glucocerebrosidase enzyme replacement therapy (ERT) is in three Phase III trials.

Elinat Brill Almon, Protalix SVP of product development, told BioCentury the company expects to submit a treatment protocol "as soon as possible" for its prGCD. The recombinant human glucocerebrosidase, expressed in plant cells, is in three Phase III trials.

But unless the shortage goes on longer than expected, doctors say they are more likely to follow guidelines issued by the Medical Advisory Board of the National Gaucher Foundation on how to manage patients over the next three months.

The guidelines suggest doctors continue treatment as usual for children, pregnant mothers and adults with active or severe disease who cannot tolerate a lower dose. Those patients with...

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