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BioMarin Partner AnGes MG, Inc. Submits BLA to Japanese Ministry of Health
Date:8/19/2007

ion can be found at http://www.mpsvi.com.

About Naglazyme

Naglazyme is the first and only enzyme replacement therapy indicated for the treatment of MPS VI. As the first drug approved for MPS VI, regulatory agencies in both the United States and European Union have granted Naglazyme orphan drug status, which confers seven years and 10 years of market exclusivity, respectively. Additional information can be found at http://www.naglazyme.com.

Naglazyme is indicated for patients with MPS VI. Naglazyme has been shown to improve walking and stair-climbing capacity.

The most common adverse events observed in clinical trials in Naglazyme-treated patients were headache, fever, arthralgia, vomiting, upper respiratory infections, abdominal pain, diarrhea, ear pain, cough, and otitis media. Severe reactions included angioneurotic edema, hypotension, dyspnea, bronchospasm, respiratory distress, apnea, and urticaria. The most common symptoms of infusion reactions included fever, chills/rigors, headache, rash, and mild to moderate urticaria. Nausea, vomiting, elevated blood pressure, retrosternal pain, abdominal pain, malaise, and joint pain were also reported. No patients discontinued Naglazyme infusions for adverse events and all patients that completed the double-blind portion of the trial continue to receive weekly infusions of Naglazyme. Nearly all patients developed antibodies as a result of treatment, but the level of the immune response did not correlate with the severity of adverse events or impact the improvements experienced in endurance. Because antihistamine use may increase the risk of apneic episodes, evaluation of airway patency should be considered prior to the initiation of treatment. Consideration to delay Naglazyme infusion should be given when treating patients who present with an acute febrile or respiratory illness.

About BioMar
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SOURCE BioMarin Pharmaceutical Inc.

Copyright©2007 PR Newswire.

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