Genzyme (GENZ) Gets an Approval for Lumizyme from the FDA

Genzyme (GENZ) Gets an Approval for Lumizyme from the FDA

Shares of Genzyme Corporation (NASDAQ: GENZ) continued to climb this morning, leveraged by yesterday�s nearly 6% hike on word from the U.S. Food and Drug Administration (FDA).

Cambridge, Massachusetts-based Genzyme recently announced that the FDA gave an approval to market Lumizyme in the U.S, making it�s the first treatment to get an approval in the country to specifically treat patients with late-onset Pompe disease. The company started working on a treatment for Pompe disease 10 years ago and has already invested almost $1 billion toward developing it. Commenting on the FDA approval, Henri A. Termeer, Genzyme�s chairman and CEO, said that he was happy and grateful to the FDA for approving Lumizyme ahead of its scheduled PDUFA date.

Monday Genzyme announced that the conditions for the consent decree for its Allston manufacturing plant have been finalized. These are in-line with the company�s expectations that were announced in April. The company will now pay an up-front disgorgement of past profits of $175 million and will continue to ship Cerezyme�, Fabrazyme�, and Thyrogen�, which are all produced, filled and finished at the Allston manufacturing plant. The company started with the implementation of a comprehensive remediation plan to improve quality and compliance at the Allston facility, last year. It submitted a plan to the FDA in October 2009.

Genzyme�s stock has a 52-week range of $45.39-$63.47.� It has a beta of 0.23. The stock ����������� has seen support at around $47.07 and resistance at around $53.58. It is currently trading below its 50-day and 200-day moving averages. The consensus recommendation on the stock is Outperform. It has 10 Buy, 1 Outperform, 5 Hold and 2 Underperform ratings, at the moment.

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