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January 2008 US Myozyme Supply Update

In April 2007, Genzyme implemented measures to manage the limited supply of Myozyme® (alglucosidase alfa) in the United States in order to ensure uninterrupted treatment for as many patients as possible.  Since April, both the patient and physician communities have...

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Genzyme Study of Myozyme® for Late-Onset Pompe Patients

CAMBRIDGE, Mass. – Genzyme Corp. (Nasdaq: GENZ) announced today that its Late Onset Treatment Study (LOTS) of Myozyme® (alglucosidase alfa) met its co-primary efficacy endpoints.  The study was undertaken to evaluate the safety and efficacy of Myozyme in juvenile and...

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MTAP Fact Sheet June 2007

MTAP, the Myozyme® (alglucosidase alfa) Temporary Access Program, is a clinical program to provide access to Myozyme produced by a larger scale manufacturing process for a limited time until this manufacturing scale is approved by the FDA.  Patients enrolled in MTAP...

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Genzyme Pompe Program Update—June 2007

Genzyme would like to take this opportunity to provide a brief update to the Pompe patient community regarding the US supply of Myozyme® (alglucosidase alfa).  As planned, Genzyme submitted the necessary documentation to the FDA this month for the licensure of the...

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MTAP Fact Sheet May 2007

MTAP, the Myozyme® (alglucosidase alfa) Temporary Access Program, is a clinical program to provide access to Myozyme produced by a larger scale manufacturing process for a limited time until this manufacturing scale is approved by the FDA.  Patients enrolled in MTAP...

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Genzyme Pompe Program Update—April 2007

As many of you are aware, a standard part of the biologics drug development process is to incrementally scale-up manufacturing capacity as demand for the product increases. During the development of Myozyme®, Genzyme began the manufacturing process using a smaller...

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Letter From IPA and Genzyme Concerning LOTS

Dear IPA members, Pompe patients, family members and GSD-net participants, The IPA board received several questions concerning participation in the LOTS trial. As there are certain restrictions to the market approval of Myozyme we asked Genzyme to make a written...

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European Commission Approves Genzyme’s Myozyme®

Product is First Treatment for Pompe Disease Genzyme Corp. (Nasdaq: GENZ) announced today that it has received marketing authorization for Myozyme® (alglucosidase alfa) in the European Union. Myozyme has been approved for long-term enzyme replacement therapy in...

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